Deals Shaping The Medical Industry, April 2015

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced March 2015.

IN VITRO DIAGNOSTICS

Mergers & Acquisitions

HalioDx

Qiagen NV

Qiagen Marseille SA

Management of Qiagen NV division Qiagen Marseille SA have formed a new company, HalioDx, through a buy-out. All assets and liabilities will transfer, with the exception of an IP portfolio, research tax credit, and cash assets. (Mar.)

HalioDx will be staffed by Qiagen Marseille’s management team (which were all with the company when it was known as Ipsogen and bought by Qiagen a few years ago), along with 75 other Qiagen Marseille employees. The company is tasked with developing immuno-oncology assays, with its first focus falling on Immunoscore, an immunohistochemistry colon cancer test it concurrently in-licensed from INSERM. (CE mark is expected within 18 months.) INSERM additionally licensed the firm a wide portfolio of patents on biomarkers discovered by Dr. Jérôme Galon and his research team. HalioDx starts operations with €7.5mm in Series A funding it received from management, MI Care, Sham Innovation Santé, and Sofipaca.

Alliances

Biotech-IgG AB

BL&H Co. Ltd.

Vigilant Biosciences Inc.

Vigilant Biosciences Inc. signed its first marketing partners for the OncAlert oral cancer risk assessment system. BL&H Co. Ltd. gets exclusive rights for five years in Korea, while Biotech-IgG AB has exclusive rights in Denmark, Norway, and Sweden for three years. (Mar.)

The OncAlert system consists of a rapid point-of-care assessment test and a quantitative lab assay. Using a simple oral rinse, OncAlert detects certain protein markers that are known to indicate an elevated risk of early-stage cancer, even if the patient has no symptoms. It can be used on anyone, but marketing will be focused towards those who are or have been smokers, people who consume alcohol, and patients with the human papillomavirus. Both companies will detail OncAlert in the dental and oncology markets; BL&H will also focus on otorhinolaryngology physicians, and unlike BL&H, could pay milestones to Vigilant. Launch of the product in both companies' territories is expected by the second half of this year or early 2016.

Danaher Corp.

Leica Biosystems Ltd.

Novacyt SA

Novacyt SA chose Leica Biosystems Ltd. to exclusively sell its NOVAPrep cytology platform in China, Hong Kong, Macau, and Taiwan for an initial period of five years. (Mar.)

NOVAPrep is a liquid-based cytology system that is already marketed in France, and recently gained approval in China. (Launch is expected there during the second half of 2015.) While primarily indicated for the screening of cervical cancer, NOVAPrep tools are also available for non-gynecological cancers as well. To better preserve DNA in comparison to traditional cytology methods, Novacyt’s technology provides for automated cell spreading over slides, and automated call sampling for complete molecular analysis.

Exact Sciences Corp.

Ironwood Pharmaceuticals Inc.

Ironwood Pharmaceuticals Inc. will nonexclusively co-promote Exact Sciences Corp.’s colorectal screening diagnostic Cologuard in the US for an initial period of one year, with the chance for an extension. (Mar.)

Cologuard is the only noninvasive stool DNA screening test for colorectal cancer to be approved by the FDA. Ironwood will use its 160 sales reps, who currently detail their own IBS/constipation therapy Linzess (linaclotide), to introduce the diagnostic to primary care physicians and gastroenterologists. Exact Sciences looks forward to expanding its reach for Cologuard to more physicians as an alternative for patients who don’t want to undergo invasive colonoscopy procedures. Ironwood will be compensated by Exact Sciences for net sales it generates, though the company will keep Linzess as its primary promoted product on sales calls.

Financings

OpGen Inc.

OpGen Inc. filed for its initial public offering on Nasdaq. (Mar.)

Investment Banks/Advisors: Maxim Group LLC

TearLab Corp.

TearLab Corp. (point-of-care tests that measure biomarkers in tears to help diagnose and manage ophthalmic disease, initially dry eye) received $15mm up front in six-year debt financing from CRG LP and its affiliates. (Mar.)

MEDICAL DEVICES

Mergers & Acquisitions

Becton Dickinson & Co.

CRISI Medical Systems Inc.

Becton Dickinson & Co. acquired CRISI Medical Systems Inc., a privately held firm developing devices that improve the safety of intravenous drug delivery. (Mar.)

The acquisition marks the culmination of a successful alliance between the two, which began in 2013 and resulted in the development and FDA approval of the BD Intelliport medication management system. BD and CRISI worked together to design the device, which CRISI claims is the first FDA-approved system capable of preventing medication errors at the point of delivery. Intelliport is a wireless IV injection port that attaches to patient IV tubing and performs automated drug-allergy checks, records medication dose and time of delivery, and wirelessly transmits all data to the patient’s electronic medical record. It was approved in December 2014, and BD expects the system to launch this spring. The acquisition is highly complementary to BD’s pending purchase of CareFusion; BD committed $11.8bn to buy the medication management and patient safety company in October 2014, and says that the two entities will enhance BD’s end-to-end IV medication safety offerings.

Boston Scientific Corp.

Endo International PLC

American Medical Systems Holdings Inc.

Boston Scientific Corp. will pay Endo International PLC $1.6bn in cash to acquire the men’s health business of its American Medical Systems Holdings Inc. division. The deal also includes a $50mm earn-out payment that could be realized in 2017 based on 2016 sales of the acquired unit. (Mar.)

AMS’s men’s health and prostate health businesses will become part of Boston Scientific Urology and Women’s Health, adding products including the GreenLight XPS and Greenlight HPS laser therapy systems for benign prostatic hyperplasia, the AMS 800 urinary control system for stress urinary incontinence, and the AMS 700 inflatable penile prosthesis for erectile dysfunction. Joined together with Boston Scientific’s complementary devices for pelvic organ prolapse, kidney stones, female stress urinary incontinence, and abnormal uterine bleeding, BS claims that the combined businesses could see annual sales of about $1bn. (AMS’s women’s health business, with its own products for pelvic organ prolapse and female stress urinary incontinence, are not part of the acquisition; Endo is exploring its options for that unit after having paid over $800mm in litigation fees following lawsuits surrounding defective vaginal mesh implants.) The divestiture comes just a few years after Endo paid $2.9bn to buy AMS, and half a year after the company decided to put AMS up for sale in an effort to focus on Endo’s pharmaceuticals business. AMS’s men’s health unit brought Endo about $400mm in sales last year on an adjusted income of $130mm, with a staff of about 800 employees. Investment Banks/Advisors: JP Morgan Chase & Co. (Boston Scientific Corp.); Bank of America Merrill Lynch (Endo International PLC)

Cardinal Health Inc.

Johnson & Johnson

Cordis Corp.

Johnson & Johnson exited the cardio stent space through the sale of its Cordis Corp. business to Cardinal Health Inc. for $1.9bn in cash ($1.6bn, net of the present value of tax benefits). Cardinal will fund the deal through existing cash and $1bn in new senior unsecured notes. (Mar.)

Post-transaction, Cardinal Health’s medical segment CEO Don Casey will take the helm of the acquired entity. Cordis’ cardiovascular products include SMART self-expanding stents, Vista Brite Tip guiding catheters, Precise Pro Rx carotid stenting system, and the AngioGuard Rx guidewire system. In April 2014, Cardinal Health paid $320mm for extravascular closure device company AccessClosure, gaining entry in to the US interventional cardiology space. Cordis’ portfolio is complementary to AccessClosure’s CE-marked and FDA-approved Mynx femoral artery sealing system. Following the divestiture of Cordis, J&J’s remaining cardiology assets include its Biosense Webster electrophysiology device business and the anti-coagulant drug Xarelto (rivaroxaban) (sold by Janssen via license from Bayer). For FYE 2014, Cordis generated $780mm in revenues, split equally between its cardiology and endovascular offerings. About 70% of its sales come from outside the US. Investment Banks/Advisors: Goldman Sachs & Co. (Cardinal Health Inc.)

Alliances

Arc Medical Design Ltd.

Norgine BV

Norgine BV will sell Arc Medical Design Ltd.’s Endocuff Vision endoscope device in major European markets, Australia, and New Zealand. (Mar.)

Endocuff Vision is a disposable endoscopic overtube that fits onto the distal end of an endoscope and helps expand visualization during colonoscopies. Unique arms on the device stretch the mucosal surface of the colon to more accurately locate adenomas that could be indicative of disease, including colorectal cancer. The device is highly complementary to Norgine’s line of bowel cleansing products used in preparation for colonoscopy, including Klean-Prep, Movicol/Movicolon, and Moviprep. Norgine plans to launch Endocuff Vision in the UK during the second quarter of this year.

Financings

Bovie Medical Corp.

Electrosurgical medical device company Bovie Medical Corp. netted $11.3mm in a follow-on offering of 4.8mm shares at $2.50. Immediately prior to the offering, the company entered into a share exchange agreement in which Series A holders of 6% convertible preferred stock and December 2013 warrants were exchanged for newly created Series B convertible preferred shares. (Mar.)

Investment Banks/Advisors: Craig-Hallum Inc.

Hansen Medical Inc.

Hansen Medical Inc. raised $35mm through the sale of 53.8k convertible preferred shares at $650. (Mar.)

InspireMD Inc.

InspireMD Inc. (embolic protection systems) netted $12.7mm through the follow-on public sale of 34.5mm common shares at $0.40 each. The company also issued five-year warrants to buy another 34.5mm shares exercisable at $0.55 per share. The funds will help support the launch of its CGuard EPS and commercialization of MGuard Prime. (Mar.)

Investment Banks/Advisors: Dawson James Securities Inc.; HC Wainwright & Co.

Theralase Technologies Inc.

Therapeutic medical laser company Theralase Technologies Inc. publicly sold 18.2mm shares at $Cdn0.44 to net $Cdn7.4mm ($5.9mm). Investors also received 60-month warrants to buy 18.2mm shares at $Cdn54. Existing stockholders purchased approximated 179 shares. (Mar.)

Investment Banks/Advisors: Euro Pacific Canada Inc.; Ladenburg Thalmann & Co. Inc.

PHARMACEUTICALS

Mergers & Acquisitions

AbbVie Inc.

Pharmacyclics Inc.

AbbVie Inc. is buying Pharmacyclics Inc. for $261.25 per share (a 31% premium) in cash (58%) and AbbVie equity (42%), valuing the transaction at $20bn. (Mar.)

AbbVie now has its hands on Pharmacyclics’ lead product Imbruvica (ibrutinib), a Bruton's tyrosine kinase (BTK) inhibitor approved for chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom's macroglobulinemia. (The therapy has potential in other oncology indications including solid tumors.) In 2014 the drug generated global sales of $548mm ($492mm in the US alone), which was 75% of the company’s total revenues of $730mm for the year. In late-2011, Pharmacyclics signed on Janssen Biotech as its global development and marketing partner for Imbruvica. (There had been recently speculation that Janssen’s parent Johnson & Johnson was interested in acquiring Pharmacyclics.) In the cancer space, AbbVie itself has one marketed cancer drug, Lupron (leuprolide), and several in late-stage clinical trials. Imbruvica is a welcome addition to AbbVie’s portfolio, which is led by the tumor necrosis factor (TNF) inhibitor Humira for various conditions including arthritis, Crohn's, ulcerative colitis, and plaque psoriasis. The drug generated $12.5mm in worldwide sales for 2014, however AbbVie has been facing competition from several companies such as Pfizer, Amgen, Hospira, which have Humira biosimilars in their pipelines. This is AbbVie’s first merger since its failed attempt at buying Shire for $53mm last year. At the end of 2014, Pharmacyclics had $857mm in cash, cash equivalents, and marketable securities. Investment Banks/Advisors: Centerview Partners LLC; JP Morgan & Co. (Pharmacyclics Inc.); Morgan Stanley & Co. (AbbVie Inc.)

Arrowhead Research Corp.

Novartis AG

For the second time, Arrowhead Pharmaceuticals Inc. is taking on unwanted RNAi assets from Big Pharma; in this case, Novartis AG divested its RNAi R&D pipeline and related assets. Novartis, which will assign Arrowhead patents and patent applications, announced in April 2014 that it was significantly cutting internal drug discovery activities in the RNAi field. (Mar.)

Arrowhead paid $35mm up front: $10mm in cash ($7mm was paid during Arrowhead's first fiscal quarter of 2015 to allow the company to evaluate the business prior to the acquisition, and the rest is due within 30 days of closing) and $25mm in Arrowhead common stock (approximately 3.3mm shares based on Arrowhead's market average, representing a 6% stake; $15mm of that figure will be issued within 30 days of closing). In addition, the company is responsible for development and sales milestones for each target plus single-digit escalating royalties. The transaction is the latest in a string of deals in which Big Pharma has abandoned work in RNAi, a field that has received large investments in the past but has been difficult to prove out, especially because of challenges with drug delivery and failure to show efficacy. While Roche has pursued interest in other oligonucleotide fields such as antisense (with Santaris and Isis, for example), the company exited RNAi research in 2011, selling its IP to Arrowhead. Notably, last year Merck divested Sirna Therapeutics to Alnylam for $186mm, a mere fraction of the $1.1bn Merck spent on Sirna in 2006, still the largest transaction to date in RNAi. Still, others aren't completely giving up on RNAi--Sanofi/Genzyme expanded its broad collaboration with Alnylam recently. And smaller biotechs like Alnylam, Arrowhead, and Dicerna have had luck in the clinic. The current deal also includes exclusive rights to other Novartis RNAi patents and patent applications; the assignment to Arrowhead of a 2005 license agreement between Novartis and Alnylam (under this alliance, Arrowhead gets access to Alnylam's IP, excluding delivery, for 30 gene targets chose by Novartis); and three preclinical candidates. The IP includes protection on RNAi-trigger design rules and modifications, which Novartis believes are not covered under competitor patents. It's not clear if Novartis' January 2015 agreement to use Caribou Biosciences' CRISPR/Cas9 platform in RNAi drug target screening and validation is included in the Arrowhead sale.

Baxter International Inc.

SuppreMol GMBH

Baxter International Inc. and its Baxalta Inc. division paid €200mm ($225mm) to acquire privately held SuppreMol GMBH, which is developing treatments for allergic and autoimmune diseases. (Mar.)

SuppreMol’s work is focused on Fc-gamma receptors, specifically soluble Fc-gamma receptor IIB (sFcyRIIB) and lead candidate SM101, which completed Phase IIa trials for idiopathic thrombocytopenic purpura and systemic lupus erythematosus. The company also has a handful of preclinical monoclonal antibody projects, which together with SM101 highly complement Baxter BioScience’s ongoing work in immunology. Baxter BioScience, which is in the process of splitting off from Baxter into a new public entity reportedly to be named Baxalta (with Baxter’s medtech products existing separately), agreed to maintain SuppreMol’s operations in Munich. SuppreMol was formed in 2002 as a spin-off from the Max Planck Institute, and has since raised about €51mm in venture rounds from investors including MIG, Santo, BioMedInvest, Max Planck Society, and FCP Biotech.

Catalyst Biosciences Inc.

Targacept Inc.

Publicly traded Targacept Inc. reverse merged with fellow biotech, privately held Catalyst Biosciences Inc. The combined entity will retain Catalyst's name, will be owned 65% by Catalyst's investors (subject to adjustment), and is expected to have $40mm in cash at closing ($35mm from Targacept and the rest from Catalyst). The new board will have four Catalyst and three Targacept directors. (Mar.)

Targacept shareholders get a special $20mm dividend in cash, plus redeemable convertible notes worth $37mm (the notes may be converted within two years into common stock of the newly combined company at $1.31. Targacept's stock is currently averaging $2.61.) Catalyst expects to trade on Nasdaq once the deal closes. Targacept, which was founded in 1997 and spun off of RJ Reynolds three years later, had focused on developing candidates against neuronal nicotinic receptors (NNRs, or what the company calls NNR Therapeutics), which are located on nerve cells and regulate nervous system activity. But the biotech has been struggling since it lost its major partner AstraZeneca in 2012 for its nicotinic channel blocker TC5214, which didn't meet its primary endpoint in efficacy and tolerability studies for major depressive disorder (Targacept had independently tested TC5214 in overactive bladder, but discontinued that program as well). AZ and Targacept had worked together on a preclinical research collaboration, but that agreement, which included TC6683 (Alzheimer's disease), also terminated in 2014. Targacept ended up discontinuing other NNR candidates including TC1734 (mild-to-moderate AD) and TC5619 (schizophrenia and ADHD). The company recently switched efforts toward TC6499, an NNR alpha 3-beta 4 modulator in Phase I for diabetic gastroparesis, but it appears the new Targacept/Catalyst will not pursue the NNR candidates--Targacept shareholders retain rights to the monetization of any of the NNR assets for two years. In 2014, Targacept recorded a $46.7mm net loss on $3.6mm in net operating revenues. Catalyst, which has raised $81mm in venture financing to date, develops protein treatments engineered from human proteases and its partners include MedImmune, Pfizer (via Wyeth), and J&J's Centocor. Catalyst's pipeline covers hemostasis, led by Phase I PF05280602 (through the Pfizer deal), a Factor VIIa therapeutic for hemophilia and surgical bleeding; and complement-driven diseases including dry AMD and delayed graft function in kidney transplantation. The combined company will focus on the Pfizer-partnered programs in hemophilia. Investment Banks/Advisors: Stifel Nicolaus & Co. Inc. (Targacept Inc.)

Concordia Healthcare Corp.

Covis Pharma SARL

Concordia Healthcare Corp. acquired all the assets of private Swiss spec pharma Covis Pharma SARL (generics) and related subsidiaries for $1.2bn in cash, over eight times the private company’s estimated 2014 revenues, projected to be between $140-145mm. Concordia will fund the purchase with a combination of term loans, bonds, and equity financing committed through RBC Capital Markets, including a concurrent $250.3mm bought deal public offering. (Mar.)

Mostly through in-licensing, Covis has established a portfolio of 18 marketed generics across three business lines--branded, injectables, and authorized. Top branded generics--with a focus in cardiology--are Dibenzyline (phenoxybenzamine) Dyrenium (triamterene), and Dutoprol (hydrochlorothiazide and metoprolol), along with four other products (covering various therapeutic areas) licensed in the US from Sanofi in 2013. Covis injectables are Fortaz (ceftazidime) and Zinacef (cefuroxime), both antibiotics for bacterial infections; Zantac (ranitidine) for ulcers; and Lanoxin (digoxin) for congestive heart failure and arrhythmias (all four were acquired from GlaxoSmithKline in 2011). (Covis has a 2014 partnership with Par Pharmaceutical, which distributes the authorized generic version of Lanoxin in the US.) Anti-depressant Parnate (tranylcypromine; also acquired from GSK), and Plaquenil (hydroxychloroquine; an anti-malarial for lupus and rheumatoid arthritis, acquired from Sanofi) are among Covis’ authorized generics. Covis also has late-stage development programs in cardio, CNS, oncology, and rheumatology. Concordia will integrate the Covis portfolio into its existing business, which spans various therapeutic areas and has grown through recent licensing deals for epilepsy (Eisai) and irritable bowel syndrome (Revive Pharmaceutical) therapies, and the 2013 acquisition of private US spec pharma Pinnacle Biologics (orphan drugs mainly in cancer indications). Investment Banks/Advisors: RBC Capital Markets (Concordia Healthcare Corp.)

Endo International PLC

Salix Pharmaceuticals Ltd.

Endo International PLC launched an unsolicited proposal to acquire gastrointestinal specialist Salix Pharmaceuticals Ltd. for a combination of 1.4607 Endo common shares and $45.00 in cash per Salix share, which would value the deal at $11bn ($171.81 for each Salix share). (Mar.)

Last month Valeant Pharmaceuticals International Inc. signed a definitive agreement to pay $10bn in cash for Salix ($158.00 per share). Following the news of Endo’s bid, Valeant said it was committed to its all-cash, agreed-upon transaction. (The tender offer expires end-of-day March 31, 2015.) Endo believes its offer is better for Salix’s stockholders because it would create a combined firm with a diverse platform of branded and generics across areas including urology, pain, and gastroenterology; benefit from a highly talented management team; and have a financial structure allowing for continued growth. Salix will review both deals and take the one that is in the best interest of its stockholders. Should Endo win-out, it would help Salix pay the break-up fee owed to Valeant. Endo is committed to buying what it considers to be attractive assets; last year it acquired several firms including Grupo Farmaceutico Somar (branded, generic and OTC drugs), Dava (generics), and Auxilium (focused on men’s health). Salix’s lead revenue-generating product is Xifaxan (rifamixin) for hepatic encephalopathy and travelers' diarrhea. Investment Banks/Advisors: Bank of America Merrill Lynch; Credit Suisse Group (Endo International PLC)

Ikaria Inc.

Mallinckrodt PLC

In a cash transaction valued at $2.3bn, Mallinckrodt PLC acquired privately held critical care company Ikaria Inc. (neonatal respiratory therapies and device combinations) from PE firm Madison Dearborn Partners (MDP). (Mar.)

Formed in 2007 through a merger with fellow critical care medicine developer INO Therapeutics, Ikaria’s science comes from the Fred Hutchinson Cancer Research Center. The company attempted an IPO in 2010, but withdrew the filing a few months later due to poor market conditions. In December 2013, MDP paid $1.6bn to buy a majority stake in Ikaria, which concurrently spun off another company, Bellerophon Therapeutics, with rights to three late-stage candidates (two in pulmonary arterial hypertension (PAH) and one for congestive heart failure). Ikaria held onto INOmax (nitric oxide), the only FDA-approved treatment for newborns suffering from hypoxic respiratory failure (HRF) due to persistent pulmonary hypertension (high blood pressure in the arteries of the lungs). INOmax includes the vasodilator drug component; the INOmax DS inhalation delivery system that works with most ventilators used in neonatal intensive care units (NICUs) and enables administration of operator-determined concentrations and patient monitoring; and on-site training with 24/7 technical support. The therapy is also marketed in Puerto Rico, Australia, Mexico, and Japan; approved in Europe for PAH; and in a US Phase III trial for bronchopulmonary dysplasia in preterm infants. The remaining candidate in Ikaria’s pipeline is intravenous terlipressin, approved in several European countries, and in Phase III for hepatorenal syndrome (kidney failure in late-stage liver cirrhosis patients), originally in-licensed in 2008 from Orphan Therapeutics. Mallinckrodt just last month suspended Phase II trials in acute respiratory distress syndrome for the injectable HP Acthar Gel--its only respiratory candidate, acquired in its buy of Questcor Pharmaceuticals last year. HP Acthar Gel, however, is approved for 18 other indications, including renal disease/failure. The acquisition will enable Mallinckrodt to accelerate growth in its Specialty Brands segment, particularly its pipeline in nephrology, and also broaden its hospital presence from diagnostic radiology and pain management to critical care respiratory therapies in the NICU. For fiscal 2015, the transaction is expected to add at least $150mm in net sales. Investment Banks/Advisors: Goldman Sachs & Co. (Mallinckrodt PLC)

Johnson & Johnson

Janssen Pharmaceuticals Inc.

XO1 Ltd.

To strengthen its cardiovascular disease pipeline, Janssen Pharmaceuticals Inc. acquired private anticoagulants developer XO1 Ltd. for an undisclosed sum. (Mar.)

XO1 spun off from the University of Cambridge and Addenbrooke’s Hospital in mid-2013, getting rights to their synthetic anticoagulant antibody ichorcumab. At the time the company also raised $11mm in Series A funding from Index Ventures. Ichorcumab is XO1’s lone asset. The preclinical thrombin inhibitor is designed to prevent blood clotting, but unlike common thrombin-targeting drugs, ichorcumab does not cause excessive bleeding.

Kite Pharma Inc.

T-Cell Factory BV

To expand its presence beyond the US and into Europe, Kite Pharma Inc. acquired privately held Dutch biotech Kite Pharma EU for $21mm (€20mm) up front ($17mm cash and $4mm in Kite stock; 66,120 shares), plus up to $230 (€242.5mm) in development-, regulatory-, and sales-based earn-outs. The acquired company has been renamed Kite Pharma EU. (Mar.)

T-Cell Factory was founded by [Netherlands Cancer Institute] (NKI) professor Dr. Ton Schumacher (who becomes Kite Pharma EU’s CSO) and Technische Universitat Munchen professor Dr. Dirk Busch to discover and develop T-cell receptors (TCRs) for specific tumors. The company’s work is based on its TCR-GENErator platform which acts as a TCR cloning technology to discover, characterize, and select tumor-specific TCRs that can be used to genetically engineer T-cells used in gene therapies for cancer. Through the acquisition, Kite gains control of the technology, and becomes party to existing T-Cell Factory license agreements with partners including IBA GMBH, Sanquin Blood Supply Foundation, and the NKI. Kite also gets access to European manufacturing facilities, which will help the company on its mission of initiating clinical trials of its autologous T-cell therapy projects in that country.

Malin Corporation plc

Serenus Biotherapeutics

Malin Corporation PLC acquired a 41% stake in privately held specialty pharmaceuticals company Serenus Biotherapeutics Inc. for $18mm in upfront cash and will have the right to invest up to an additional $25mm to increase its stake to up to 76% upon the completion of certain predefined strategic and operational milestones. (Mar.)

Established just nine months ago, Serenus is focused on aligning with biopharma partners to expand the latter’s drugs to Sub-Saharan regions in Africa. The company states it’s building a pipeline in multiple therapeutics areas for chronic and infectious diseases and will offer late-stage drug development, in-licensing, registration, and commercialization services for these therapies already approved in the US, Europe, and Japan. Concurrently with the transaction, Malin will consider implementing an Irish holdings structure and will position Ireland as a hub for future in-licensing and commercialization activities. The proceeds from the deal will be used by Serenus to fund operations, secure commercialization arrangements with partners, and to build out its clinical development and supply chain.

Mariel Therapeutics Inc.

Ember Therapeutics Inc.

Metabolic disease-focused Ember Therapeutics and Ember Therapeutics Inc. (therapies for osteoarthritis and kidney fibrosis) are merging to form a combined entity that will retain the Ember Therapeutics name. (Mar.)

Ember Therapeutics was launched in late-2011 by Third Rock Ventures, which concurrently contributed the entire $34mm to the firm’s Series A. In 2012 the company in-licensed exclusive rights to IP from three research institutions—Dana-Farber Cancer Institute (irisin, a hormone with potential for obesity treatment); Joslin Diabetes Center (bone morphogenetic protein 7 (BMP-7) for manipulating brown fat as treatment for Type II diabetes and obesity); and Brigham and Women’s Hospital (retinaldehyde dehydrogenase 1 (Aldh2a1) and thioesterase superfamily member 1 (Them1) associated with brown fat pathways and mechanisms). However in late-2014 Ember shut its doors because it failed to sign partnerships to enable its programs to move forward. Mariel also has BMP-7 assets, which it acquired from Stryker Corp. in July 2014. The firm is using the IP to develop therapeutics for osteoarthritis, organ fibrosis conditions including chronic kidney disease and Alport’s syndrome, lupus, and obesity. Combining its own BMP-7 technology with Ember’s will allow Mariel to work in multiple therapy areas. The combined firm’s pipeline will include four clinical-stage projects.

Orgenesis Inc.

MaSTherCell SA

[Orgenesis Inc.] acquired private cell therapy company MaSTherCell SA for approximately $24.6mm. Orgenesis issued 42.4mm common shares at $0.58 as consideration. (Mar.)

MaSTherCell, a 2011 spin-off of ULB (Universite Libre de Bruxelles), is a tech-driven contract developer and manufacturer specializing in cell therapy for medicinal products. The acquisition will help accelerate Orgenesis' lead candidate, Autologous Insulin Producing Cells for Type I diabetes, from preclinical to clinical testing, diversify its business model and product offering by creating a vertically integrated company, and provide a stronger financial position. The two businesses will remain independent after the acquisition however will be strategically aligned. MasTherCell will also appoint two members of the board to the newly combined entity. Prior to the transaction, the companies had a strategic manufacturing agreement in place.

Pulmatrix Inc.

Ruthigen Inc.

Closely held Pulmatrix Inc. reverse merged with public biotech Ruthigen Inc. and will exchange its debt and equity for 81% of Ruthigen's outstanding shares. Each Pulmatrix share will be exchanged for 0.148187124066461 Ruthigen shares. (Mar.)

Pulmatrix’s CEO will retain his position at the combined entity, which keeps the Pulmatrix name and will trade on Nasdaq. Some existing Pulmatrix investors will contribute $10mm in exchange for equity. Post-transaction, the company will focus on developing Pulmatrix's pipeline of next-generation inhaled therapeutics, led by PUR0200, the Phase II bronchodilator for COPD. It also has three preclinical inhalants that fight infections related to cystic fibrosis, plus an early-stage candidate for idiopathic pulmonary fibrosis. Pulmatrix’s therapies incorporate its iSperse inhaled dry powder drug delivery platform. Ruthigen’s only candidate RUT5860 is designed to prevent infection associated with abdominal surgery; it’s also being evaluated as an anti-infective for cardiovascular and orthopedic procedures. The candidate was licensed to Ruthigen from Oculus Innovative Sciences, which concurrently spun off the company in January 2013. Investment Banks/Advisors: Palladium Capital Advisors (Pulmatrix Inc.); Dawson James Securities Inc. (Ruthigen Inc.)

Sun Pharmaceutical Industries Ltd.

GlaxoSmithKline PLC

GlaxoSmithKline PLC sold its Australian opiates business to Sun Pharmaceutical Industries Ltd. (Mar.)

GSK says because of portfolio transitions, including a switch in focus to innovative drugs in Australia, it's attempting to simplify operations through the divestiture. The move is not surprising, given that a few years ago the company stopped selling the chronic pain drug Kapanol (sustained-release morphine) in Australia, giving back rights to its manufacturer Mayne Pharma. The Big Pharma first got involved in the poppy industry in the 1950s. According to estimates from Research Delta Advisors, sales from GSK's opiate business fall in the $70-90mm range. The current transaction includes poppy-derived raw materials used for producing pain medications, plus product inventory and manufacturing sites in Latrobe (Tasmania), where the poppy crop is harvested and processed, and Port Fairy (Victoria), which extracts medicinal alkaloids from poppy. The Tasmanian facility supplies 25% of the global share of opiates. Sun, which has recently been plagued with FDA citations for issues at its manufacturing plants in India, plans to offer jobs to current opiate business employees. The company has been involved in poppy farming since it acquired a Hungarian API plant in 2005. Sun later expanded controlled substances manufacturing capabilities when it bought Chattem Chemicals in 2008.

Alliances

AbbVie Inc.

C2N Diagnostics LLC

C2N Diagnostics LLC licensed AbbVie Inc. exclusive global rights to develop and commercialize a portfolio of anti-tau antibodies for Alzheimer's disease and other neurological conditions. (Mar.)

Tau proteins stabilize microtubules, but when they become defective they may lead to neurological conditions. Anti-tau antibodies can delay the progression of neurodegenerative disease. Last year C2N received exclusive rights to Washington University School of Medicine’s suite of technologies diagnosing Alzheimer’s disease and mild cognitive impairment. At that time C2N said it intended to validate the technique through partnerships with pharma companies.

Alexion Pharmaceuticals Inc.

Blueprint Medicines

Blueprint Medicines licensed Alexion Pharmaceuticals Inc. rights to drug candidates selectively targeting an activated kinase to treat a rare genetic disease. (Mar.)

Alexion pays $15mm up front, over $250mm in preclinical, clinical, regulatory, and sales milestones, plus royalties. Blueprint brings to the alliance a kinase drug discovery platform, which encompasses a kinase inhibitor library and drug target identification via genomic sequencing. Since the company was founded in 2011, it has used its technology in the cancer area, but is now expanding. Blueprint is responsible for identifying, optimizing, and researching candidates before IND filing. Alexion, which will reimburse Blueprint for this research, takes over further development and future commercialization. The company already has experience in rare diseases with Soliris, on the market for paroxysmal nocturnal hemoglobinuria; the product achieved worldwide sales over $2bn in 2014. Alexion is also awaiting BLA approval on asfotase alfa for the rare metabolic bone disease hypophosphatasia (an FDA decision is expected in late August 2015; a day before the current alliance, the FDA granted the drug a priority review). A few months ago, Alexion partnered with X-Chem in a drug discovery deal focused on ultra-rare diseases.

Alkahest Inc.

Grifols SA

Grifols SA paid $37.5mm in cash up front for a 45% stake in Alkahest Inc. (aging diseases). Grifols will also make another $12.5mm payment and will hold two seats on Alkahest's board. (Mar.)

Grifols and Alkahest plan to develop plasma-based drugs for cognitive decline in aging and CNS diseases, including Alzheimer's. Grifols will fund this work and holds worldwide rights to resulting products. Alkahest is eligible for milestones and sales royalties. Grifols makes for an experienced partner--the company says it has a 19% global market shares of plasma-based medicines. In addition, Grifols has pipeline candidates for Alzheimer's disease, including two Phase I active immunotherapies and a preclinical somatastatin-14 molecule through the company's majority holding in Araclon. Grifols is also developing a Phase II/III combination of albumin and immune globulin for AD. Alkahest isolates factors from human blood and plasma that may be used in aging and neurodegenerative diseases. The company's work incorporates research done by Stanford University scientists including Tony Wyss-Coray, PhD. Last year Dr. Wyss-Coray and colleagues published animal testing results showing that systemic administration of young blood plasma into older mice improved age-related cognitive impairments. In addition, they've found that giving human recombinant colony-stimulating factor 1 improved memory deficits in mouse models of Alzheimer's. Alkahest, which was founded in 2014, is located in J&J's new JLABS incubator, which is part of the Big Pharma's innovation initiative to drive early-stage research. Alkahest, along with 21 other start-ups, receives assistance from JLABS including equipment (managed by J&J), networking opportunities, and instruction in business.

Alkermes PLC

Recro Pharma Inc.

Recro Pharma Inc. received global rights to Alkermes PLC's meloxicam candidates for pain. The deal also includes the acquisition of Alkermes' Gainesville, Georgia GMP manufacturing plant, along with any milestones or royalties generated by several products made at that facility. In addition, Recro will buy substantially all of the assets and liabilities of Alkermes' Daravita division. Recro's president and CEO Geraldine Henwood was a member of Alkermes' board, but will be resigning. (Mar.)

Alkermes took over the plant in Georgia, along with meloxicam and the marketed drugs that are part of this transaction, when it merged with Elan Drug Technologies in 2011. The company says these were non-core assets, and it will be consolidating manufacturing activities to its Athlone, Ireland, and Wilmington, Ohio facilities. In the current agreement, Alkermes gets $50mm up front (Recro concurrently borrowed this money from OrbiMed), up to $120mm in development and commercialization milestones, low double-digit sales royalties (Strategic Transactions assumes 10-29%), and warrants to buy 350k Recro common shares at twice the closing price of Recro's stock on the day prior to deal closing. (Recro's shares are presently averaging $3.29.) Recro will now have rights to Alkermes' Phase II NSAID meloxicam (N1539), administered in intravenous and intramuscular forms (Alkermes advanced the candidate as far as Phase III for postsurgical pain, but in 2012, trials halted); and a Phase II parenteral formulation of meloxicam IV/IM. In addition, Recro will receive manufacturing and royalty revenue from the following marketed products: Ritalin LA (methylphenidate) for ADHD; Focalin XR (dexmethylphenidate) for ADHD; Verelan (verapamil) for hypertension; Zohydro ER (hydrocodone) for musculoskeletal and postoperative pain (Zogenix recently sold this business to Pernix); and BiDil (isosorbide dinitrate and hydralazine) for heart failure. Recro, which netted $32mm in its IPO last year, focuses on reformulating non-opioid drugs for post-surgical pain management, so meloxicam will fit in well with the company's pipeline, especially in the hospital acute pain market Recro aims to target. Its lead program is Phase II intranasal dexmedetomidine, an alpha-2 adrenergic agonist (marketed by UCB as the IV drug Precedex) that has been tested in chronic low back pain and breakthrough cancer pain. The company is also working on another alpha-2 adrenergic-targeting compound fadolmidine for postoperative and neuropathic pain. Investment Banks/Advisors: Lazard LLC (Alkermes PLC)

Amgen Inc.

Celimmune LLC

Amgen Inc. licensed newly formed Celimmune LLC exclusive global rights (excluding Japan) to develop, manufacture, and commercialize the Phase II monoclonal antibody AMG714 for celiac disease. (Mar.)

Under the agreement, Amgen has an exclusive option to reacquire AMG714 after the completion of additional clinical trials. Celimmune will commence Phase II studies of AMG714 in treating diet non-responsive celiac disease and refractory celiac disease (celiac disease-triggered T-cell lymphoma). The mAb is an antagonist to interleukin-15, which plays a key role in celiac disease. If successfully developed and approved, AMG714 would be the first drug available for the condition. (There are currently no compounds in clinical development that target the IL-15 cytokine.)

ANI Pharmaceuticals Inc.

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceuticals USA Inc.

ANI Pharmaceuticals Inc. acquired Teva Pharmaceuticals USA Inc.'s approved ANDA for flecainide 50mg, 100mg, and 150mg tablets. (Mar.)

ANI plans to re-launch the product in the next year. Teva's generic flecainide came from its 2008 Barr Pharmaceuticals takeover. The branded version of flecainide was launched by Valeant as Tambocor for the treatment and prevention of arrhythmias, including paroxysmal supraventricular tachycardias and sustained ventricular tachycardia. Valeant got flecainide through its 2012 acquisition of Medicis, which bought the drug from Graceway Pharmaceuticals (3M owned flecainide, but sold its pharmaceutical operations to Graceway in 2006).

Astellas Pharma Inc.

Vical Inc.

Astellas Pharma Inc. licensed Vical Inc. exclusive worldwide rights to develop, commercialize, and manufacture its preclinical antifungal candidate ASP2397 for invasive Aspergillus infections. (Mar.)

Vical paid $250k in cash up-front and issued Astellas 861k common shares (worth $870k). Astellas also stands to receive up to $99.5mm in development, regulatory, and sales milestones, plus tiered single-digit sales royalties, which can be reduced on a country-by-country basis in certain circumstances where there isn’t exclusivity in the country. Astellas will complete certain IND-enabling, non-clinical studies and conduct a tech transfer of the ASP2397 manufacturing technology at Vical’s request within a specified time. Astellas has the first right to prosecute and enforce all licensed patents globally, while Vical has certain step-in enforcement rights. Throughout the deal term, neither company can manufacture or commercialize any competing antifungal with the same method of action as ASP2397; should Vical be acquired by a company that does, the competitor product must be divested, the deal would be terminated, or the acquirer would have to shell out milestones and royalties for the competitor antifungal. ASP2397 has a low propensity for P450 drug-drug interactions and in preclinical studies has demonstrated faster fungicidal activity than marketed therapeutics and activity against azole-resistant fungal pathogens. Phase I trials are slated to commence in H1 2016. Vical intends to develop ASP2397 as a front-line therapy for invasive aspergillosis and as part of combination regimen for preemptive treatment of fungal infections. Under a mid-2011 deal, Astellas and Vical are partners for the ASP0113 cytomegalovirus vaccine.

AstraZeneca PLC

Daiichi Sankyo Co. Ltd.

AstraZeneca PLC chose Daiichi Sankyo Inc. to co-promote the newly approved constipation therapy Movantik (naloxegol) in the US. Daiichi paid $200mm in cash up front, and could hand over up to $625mm in sales-based milestones. (Mar.)

AZ holds global rights to Movantik (approved in the EU as Moventig) under a 2009 deal with the drug’s originator Nektar Therapeutics. The therapy gained FDA approval in September 2014 to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain, and a launch in the US (as a non-controlled substance) is planned for April 2015. While both companies will carry out commercialization activities with their own sales forces, AZ is responsible for manufacturing and will book all sales, in addition to making sales-related commission payments to Daiichi. Movantik is the first mu-opioid pill to make it to the market, and once there, faces competition from Salix’s mu-opioid injectable Relistor (methylnatrexone). Takeda/Sucampo also sell an oral OIC therapy (Amitizia (lubiprostone)), but its mechanism of action differs in that it is a chloride channel activator.

Athersys Inc.

Roche

Chugai Pharmaceutical Co. Ltd.

Athersys Inc. licensed Roche’s Chugai Pharmaceutical Co. Ltd. exclusive rights to develop and commercialize in Japan its MultiStem cell therapy for ischemic stroke. (Mar.)

Athersys receives $10mm in cash up-front, up to $45mm in development ($7mm tied to Phase II) and regulatory milestones, $146.2mm in sales milestones, and double-digit sales royalties. Athersys will supply Chugai with the finished product and receive additional payments. Based on Athersys’ MAPC (Multipotent Adult Progenitor Cells) technology, MultiStem is derived from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. The Phase II therapy has demonstrated the ability to reduce inflammation and immune system modulation in the ischemic area, and protect and rescue damaged or injured cells. In addition to ischemic stroke, MultiStem is also being evaluated for other cardiovascular indications as well as neurological, inflammatory, and immune diseases. Under a late-2009 tie-up, Pfizer has worldwide rights MultiStem for inflammatory bowel disease (Athersys kept full rights in all other indications).

Autotelic Inc.

Daewoong Pharmaceutical Co. Ltd.

Daewoong Pharmaceutical Co. Ltd. granted US-based Autotelic Inc. rights to distribute its Olostar (olmesartan medoxomil/rosuvastatin) in the US and Canada for high blood pressure and hyperlipidemia simultaneously. (Mar.)

Daewoong claims that Olostar is the first available fixed-dose therapy combining olmesartan and rosuvastatin. The drug incorporates a bi-layer tablet technology to minimize physical and chemical interactions between the two active ingredients. Daewoong successfully launched the drug in South Korea last April. Autotelic will perform clinical trials in the US and expects to launch Olostar in the licensed territories in 2019. Daewoong will supply Autotelic with the product--with an estimated value of $272mm--for the first ten years post-launch. The Korean firm has its sights set on bringing the therapy to over 50 European countries once the product hits the US market.

Bavarian Nordic AS

Bristol-Myers Squibb Co.

Bristol-Myers Squibb Co. received an option to exclusively license Bavarian Nordic AS's Phase III Prostvac (rilimogene galvacirepvec), a cancer vaccine for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). (Mar.)

BMS pays $60mm up front and may exercise its option during a certain period after Phase III data is available. If the option is exercised, the company would be responsible for an $80mm fee plus another $50-230mm in payments if the median overall survival benefit of Prostvac exceeds that shown in Phase II. In addition, BMS would pay $110mm in regulatory milestones, up to $495mm in sales milestones, and tiered double-digit royalties. Bavarian entered into a supply agreement stating it will commercially manufacture the product. Designed using Bavarian's vaccinia-fowlpox virus (VF)/TRICOM technology, Prostvac prompts a cellular and humoral immune response against prostate-specific antigen (PSA). BioMedTracker forecasts worldwide revenue for the drug at $601mm by 2025. It has a 38% likelihood of approval (LOA), 3% above average for Phase III prostate cancer candidates; the bump in LOA was due to Phase II trial data released in 2009 that showed an encouraging overall survival signal. Prostvac is currently being tested in combination with BMS's Yervoy (ipilimumab), its marketed CTLA4 inhibitor for melanoma, making Prostvac an obvious addition to the Big Pharma's pipeline. Bavarian believes checkpoint inhibitors such as Yervoy enhance the anti-cancer activities of Prostvac. (The company is also undertaking combination studies with anti-androgen and radiation therapies.) BMS and Bavarian may conduct additional exploratory studies of Prostvac together with BMS's immuno-oncology agents. In prostate cancer, BMS is also developing Ixempra (which is already approved in breast cancer) and LY3012207 (in collaboration with Eli Lilly), both in Phase II, and Opdivo (approved for melanoma and non-small-cell lung cancer) in Phase I in partnership with Ono Pharmaceutical.

BHV Pharma Inc.

Islet Sciences Inc.

BHV Pharma Inc. (Brighthaven Ventures) licensed Islet Sciences Inc. exclusive worldwide rights--excluding Japan, Korea, Taiwan, China, and Latin America--to develop and commercialize its Phase IIb SGLT2 inhibitor remogliflozin etabonate for Type II diabetes and non-alcoholic steatohepatitis (NASH). (Mar.)

BHV receives $5mm up front, $35.1mm in pre-regulatory approval milestones, up to $76.75mm in post-regulatory approval milestones, and sales royalties. Islet’s license will only become effective if it raises a minimum of $10mm and pays BHV the up-front fee by May 31, 2015. Through the inhibition of SGLT2 activity, remogliflozin demonstrated its ability to decrease re-absorption of glucose by the kidney thus helping to improve glucose control in Type II diabetics. Remogliflozin was originated by Kissei, which granted GlaxoSmithKline rights globally with the exception of Japan, Korea, China, and Taiwan in 2002; GSK handed back rights seven years later, and in early 2011 BHV received the license in those territories. In 2014, Islet entered into a merger agreement with BHV Pharma, and Islet was to be the surviving entity to operate under new parent Avogenx. However, with the current licensing deal that transaction has been terminated. In October 2014, BHV licensed Libbs Farmaceutica exclusive rights to develop and commercialize remogliflozin in certain in Latin American territories and Brazil.

Boehringer Ingelheim GMBH

Pharmaxis Ltd.

For a fee of €1.25mm ($1.33mm), Pharmaxis Ltd. granted Boehringer Ingelheim GMBH an option to license exclusive worldwide rights to its Phase I non-alcoholic steatohepatitis (NASH) candidate PXS4728A, an inhibitor of semicarbazide-sensitive amine oxidase (SSAO; also known as vascular adhesion protein-1 (VAP-1)). (Mar.)

NASH, called the "silent" liver disease, often occurs in patients with diabetes, or those who are obese. Potentially marketing a product in NASH would be a natural extension for BI, which is active in the diabetes area with products such as Basaglar, Jardiance, and Tradjenta (through its collaboration with Eli Lilly). BI has a period within which it may conduct due diligence, but the company must make a decision to exercise the option by May 15, 2015, in exchange for a €27.5mm up-front payment. Should BI take the option, it would also get related SSAO/VAP-1 inhibitors, patents, and know-how, and would be responsible for future development, manufacturing, regulatory filings, and commercialization. Pharmaxis would be eligible for Phase II and III initiation milestones; regulatory milestones in major markets such as the US, EU, China, and Japan; sales milestones; milestones tied to an additional indication; and royalties. PXS4728A works by blocking SSAO to prevent formation of cytotoxic agents that are involved in oxidative stress and linked to chronic inflammatory diseases. The candidate is also in Phase I for COPD, but BI is most interested in the NASH indication. Pharmaxis has two marketed products in the respiratory field (Bronchitol for cystic fibrosis and the Aridol test for asthma/lung responsiveness), but the company restructured in 2013, slashing 30% of its workforce and consolidating manufacturing facilities, after failure to launch Bronchitol on its own. (The company raised $44mm in 2009 to fund commercialization, but ended up partnering the drug with Chiesi in 2014).

Bristol-Myers Squibb Co.

Novo Nordisk AS

Novo Nordisk AS licensed Bristol-Myers Squibb Co. exclusive worldwide rights to a discovery-stage biologics program that modulates the innate immune system to treat autoimmune diseases. (Mar.)

The deal comes as Novo reprioritizes efforts to focus where it is strongest, diabetes (for which the company markets 12 products), as well as diabetes complications and obesity. Last year the company ceased R&D in the inflammatory disease area, suspending trials on the Phase II anti-IL-20 candidate NN8226 for rheumatoid arthritis. (Interestingly, Novo holds rights to the patents protecting NN8226 from ZymoGenetics, which Bristol bought in 2010.) Meanwhile, immunology and inflammation is a top therapeutic area for Bristol, representing $1.8bn in 2014 sales. The company sells Orencia for rheumatoid arthritis, and Nulojix for kidney transplant rejection, and has several candidates in the pipeline including Phase II sifalimumab for lupus (via BMS's Medarex acquisition, and partnered with MedImmune).

Bristol-Myers Squibb Co.

ZAI Lab Ltd.

ZAI Lab Ltd. received exclusive Chinese rights (including in Hong Kong and Macau) to develop, manufacture, and sell Bristol-Myers Squibb Co.'s Phase III kinase inhibitor brivanib for cancer, including hepatocellular carcinoma (HCC). (Mar.)

BMS gets development milestones and tiered royalties, and holds an option to co-promote brivanib in China where it would share profits. The Big Pharma had been developing the candidate in the US for multiple cancer types, including colorectal, uterine, and liver, but in 2013 the company suspended Phase III trials, following disappointing results a year earlier from a study of brivanib versus Bayer/Amgen's Nexavar (sorafenib) for advanced HCC in which brivanib failed to meet its primary overall survival objective. Nexavar still remains the only marketed product available for HCC, while multiple candidates in the pipeline have failed in this area, also including AbbVie's linifanib and Pfizer's Sutent (sunitinib). While Nexavar is launched in China, the drug is expensive and thus is limited by reimbursement. ZAI, a 2013 start-up which is backed with $30mm in Series A financing, is also developing programs in-licensed from another Big Pharma: two of Sanofi's preclinical compounds for chronic respiratory diseases.

Calithera Biosciences Inc.

High Point Pharmaceuticals LLC

TransTech Pharma Inc.

Calithera Biosciences Inc. licensed exclusive global rights to preclinical hexokinase II inhibitors from TransTech Pharma LLC and its sister company High Point Pharmaceuticals LLC. (TransTech spun High Point out in 2008.) (Mar.)

Calithera will pay High Point $600k up front, $30.5mm in development and regulatory milestones, $77mm in sales milestones, and mid-single-digit royalties (Strategic Transactions assumes 4-7%). It also agreed to fund up to $1.1mm during the first year of the deal for costs associated with four full-time employees at High Point to develop additional hexokinase II inhibitors. (Milestones quoted are for the first developed project; additional payments and royalties will apply to subsequent projects.) Calithera will fund all development work on the licensed assets. The company’s own cancer pipeline already includes a glutaminase inhibitor in Phase I and an arginase inhibitor in preclinical studies.

Coronado Biosciences Inc.

Checkpoint Therapeutics Inc.

TG Therapeutics Inc.

Checkpoint Therapeutics Inc., a newly formed division of Fortress Biotech Inc., granted TG Therapeutics Inc. exclusive rights to develop and sell two immuno-oncology antibodies. (Mar.)

Upon its formation, Checkpoint licensed the antibodies (targeting programmed cell death ligand 1 (PD-L1) and glucocorticoid-induced tumor necrosis factor receptor related protein (GITR) from the Dana-Farber Cancer Institute. Checkpoint is now handing over rights for development of the preclinical antibodies for the treatment of blood cancer to TG, while it retains rights to develop for solid tumors. TG paid $500k up front, and will make up to $164mm in development and sales milestones payments, plus tiered single-digit royalties. The compounds are expected to enter clinical trials in 2016.

Coronado Biosciences Inc.

NeuPharma Inc.

NeuPharma Inc. (also known as Suzhou Neupharma Co. Ltd.) granted Fortress Biotech Inc. exclusive rights to develop and sell its irreversible third generation EGFR inhibitors for cancer globally, excluding certain countries in Asia. (Mar.)

Coronado will pay money up-front, development and sales milestones, and single-digit royalties. NeuPharma’s compounds have shown positive preclinical activity in non-small cell lung cancer patients with certain EGFR mutations; the companies anticipate getting the most advanced project into clinical trials during the first half of 2016. The deal rounds out an extremely active month for Coronado who, after restructuring last year, is following its plans of gaining new therapies and creating new subsidiaries. A couple weeks ago, it created the new division Checkpoint Therapeutics, which in-licensed immuno-oncology compounds from Dana-Farber and signed a concurrent agreement surrounding the targets with TG Therapeutics. At the same time as announcing the NeuPharma deal, Coronado also announced the creation of another division--Mustang Therapeutics--which will develop CART therapeutics simultaneously licensed from City of Hope.

DARA BioSciences Inc.

Mission Pharmacal Co.

Concurrent with getting US commercialization rights to the oral thrush drug Oravig (miconazole) from Onxeo SA, Midatech Pharma US Inc. granted Mission Pharmacal Co. a license to co-promote the product in the primary care market. (Mar.)

Oravig (sold as Loramyc outside the US) is the first available orally dissolving buccal tablet for oral thrush. The once-daily treatment works by adhering to the oral mucosa where it provides a sustained local release of miconazole over several hours. Under a 2013 deal, DARA co-promotes Mission’s Aquoral for dry mouth and Ferralet for anemia.

DARA BioSciences Inc.

Onxeo SA

Onxeo SA licensed Midatech Pharma US Inc. rights to commercialize the oral thrush drug Oravig (miconazole) in the US. (Mar.)

DARA gets the NDA for Oravig (sold outside the US as Loramyc) and also has the right to seek regulatory clearance in Canada, where the company would hold exclusive rights if approved. DARA books revenues and Onxeo receives sales milestones. Oravig is the only available orally dissolving buccal tablet for oral thrush. DARA will conduct a pediatric study, which could lead to an expanded indication for Oravig. The company is planning to launch the therapy later this year. Concurrent with the licensing, DARA signed on Mission Pharmacal Co. to co-promote Oravig in the US primary care market. In 2012, Onxeo (then known as BioAlliance Pharma) licensed Vestiq Pharmaceuticals rights to commercialize Oravig in the US, but BioAlliance regained those rights two years later because Vestiq’s sales team did not meet expectations and goals.

Denovo Biopharma LLC

Eli Lilly & Co.

Denovo Biopharma LLC acquired all rights to Eli Lilly & Co.’s schizophrenia candidate pomaglumetad methionil, which Lilly brought into Phase III trials but abandoned after it failed to meet primary endpoints. (Mar.)

Denovo now holds all IP, data, and information for the project, and has rights to develop, manufacture, and sell it globally. Lilly retains an option to buy the compound back for an undisclosed predetermined price following clinical trials. Pomaglumetad is an mGluR2/3 agonist that is thought to target neurotransmitters that stimulate the brain but are dysfunctional in schizophrenics. Denovo plans to use its genomics platform to identify response-associated biomarkers as companion diagnostics that could help guide patient selection and improve success rates for the therapy. The deal marks Denovo’s second in-licensing, garnering the company its second project. The first also came from Lilly: in September 2014, it acquired all rights to the Big Pharma’s enzastaurin, which had previously failed in Lilly’s Phase III trials for diffuse large B-cell lymphoma.

Evotec AG

Second Genome Inc.

Evotec AG and Second Genome Inc. will work together to discover and develop small-molecule therapies for microbiome-mediated diseases. (Mar.)

Both firms will screen microbiome-mediated targets provided by Second Genome. The collaboration combines Second Genome’s microbiome discovery platform with Evotec’s technology platform, chemical libraries, and preclinical expertise. The alliance will focus on creating new therapeutics for microbiome-mediated diseases in the gut. Also, in exchange for a license to some existing Evotec assets, Second Genome will make payments including undisclosed money up-front; preclinical and clinical development and regulatory milestones; and sales royalties.

G&W Laboratories Inc.

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. sold several assets in the US to G&W Laboratories Inc., including a generic drug manufacturing plant and multiple products. The transaction is a result of Teva's cost-reduction program initiated in late 2013 with the goal of cutting $2bn in annual expenses by 2017 and reducing 10% of its global workforce. (Mar.)

G&W acquired a facility in Sellersville, Pennsylvania, that produces multiple dosage forms (tablets, capsules, liquids, creams, and ointments), plus all buildings, land, and equipment. The company will offer jobs to current employees. For a certain period of time, G&W will manufacture and supply drugs out of that plant until Teva transfers that work to another place. G&W also gets 25 Teva products to manufacture sell in the US under the G&W label, plus up to two additional Teva drugs that will be available under the G&W name, but manufactured by Teva at its Zagreb, Croatia facility.

Genmab AS

iDD Biotech SAS

Genmab AS licensed exclusive rights to iDD Biotech SAS’s preclinical antibodies targeting Death Receptor 5 (DR5) (also known as Trail Receptor 2 (TRAIL-R2)) for cancer. (Mar.)

The deal includes multiple antibodies, including malignant glioma candidate IDD004, as well as related patents and know-how. Genmab paid €2.5mm ($3.7mm) up front, and committed to up to €101.5mm in development and sales milestones, plus single-digit royalties. The company has multiple antibody projects in preclinical and clinical trials for cancer in addition to one on the market--Arzerra (ofatumumab)--for chronic lymphocytic leukemia.

Hanmi Pharmaceutical Co. Ltd.

Eli Lilly & Co.

Eli Lilly & Co. paid $50mm up front for exclusive global rights (excluding China, Hong Kong, Taiwan, and Korea) to Hanmi Pharmaceutical Co. Ltd.’s Bruton’s kinase inhibitor HM71224 for autoimmune diseases. (Mar.)

The deal also includes up to $640mm in development, regulatory, and sales milestones, plus tiered double-digit royalties. HM71224 is entering Phase II; the companies plan to study it in rheumatoid arthritis, lupus, lupus nephritis, Sjögren’s syndrome, and other related autoimmune conditions. Lilly is responsible for all development, regulatory, manufacturing, and commercialization activities in its territories. HM71224 joins a few other autoimmune assets in Lilly’s pipeline, including two Phase I projects for lupus and RA, and baricitnib in Phase III for RA. (It had another Phase III compound tabalumab in trials for RA and lupus, but the plug was pulled on that after trials failed.) The deal is the first between the two partners, though Hanmi has teamed up with Big Pharma in the past; under a 2012 collaboration, GlaxoSmithKline and Hanmi are using Hanmi’s incrementally modified drug technology to create new evidence-based formulations.

Hanmi Pharmaceutical Co. Ltd.

Spectrum Pharmaceuticals Inc.

Spectrum Pharmaceuticals Inc. licensed exclusive global rights (excluding Korea and China) to Hanmi Pharmaceuticals Co. Ltd.’s pan-HER inhibitor poziotinib, which is in Phase II trials for gastric, head and neck, breast, and non-small cell lung cancers. (Mar.)

Spectrum will develop, manufacture, and sell the compound in its territories, and Hanmi will fund the rest of the current Phase II trials. Poziotinib has shown high response rates and positive clinical activity, particularly in early trials of breast cancer patients for whom previous therapies had failed. Spectrum adds the compound to an already strong oncology pipeline that includes various late-stage projects for solid and blood tumors. The deal is the second tie-up for the partners; in early 2012, Spectrum licensed global rights (excluding Korea, China, and Japan) to Hanmi’s GCSF compound for chemotherapy-induced neutropenia.

Ignyta Inc.

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. sold Ignyta Inc. four of its cancer candidates. The transaction includes related assets, liabilities, and obligations, including those under existing in-licensing agreements, plus right, title and interest in IP, compounds, products, contracts, books, records, data, and inventory. (Mar.)

Teva gained a 6% stake in Ignyta, which issued 1.5mm shares (worth approximately $11mm) as payment. Ignyta also paid $852k in cash for product inventory. Concurrent with the alliance, Ignyta raised $41.6mm through a registered direct offering to Teva and health care investors. (The RDO shares, plus the stock that Ignyta issued to Teva as part of the deal, will give Teva a total 11.9% stake in Ignyta.) The alliance greatly expands Ignyta's pipeline, which the company started building in 2013 when it acquired Actagene Oncology and that firm's Oncolome drug design database (containing DNA sequences, gene copy number variants, and RNA transcript levels from primary human tumors). Ignyta has since brought in additional compounds (kinase inhibitors, including lead candidate entrectinib) from Nerviano Medical Sciences, and now adds in the following Teva compounds: Phase I/II RXDX105 (formerly CEP32496), a BRAF, EGFR, and RET inhibitor for melanoma, non-small cell lung cancer (NSCLC), and metastatic colorectal cancer; preclinical RXDX106 (CEP40783), a selective, pseudo-irreversible AXL and cMET inhibitor for solid tumors, including NSCLC; preclinical RXDX107 (CEP40125; nanoformulation of modified bendamustine) for solid tumors; preclinical RXDX108 (TEV44229), an atypical PKCiota kinase inhibitor for PKCiota-amplified squamous NSCLC and K-Ras mutant colorectal cancer, NSCLC, and pancreatic ductal adenocarcinoma; and back-up PKCiota kinase inhibitors. Teva gained the candidates when it bought Cephalon in 2011. Ambit Biosciences (now part of Daiichi) discovered CEP32496 and CEP40783 under a screening collaboration with Cephalon initiated in 2006. Regarding the bendamustine program RXDX107 (developed through a 2010 collaboration with Cancer Research Technology), Teva recently got US and Canadian rights to Eagle's proprietary bendamustine formulation EP3102, which, at the NDA-filed stage, is a lot more advanced than preclinical RXDX107, and could be why Teva is parting with that candidate. Further, following a portfolio review in late 2014, Teva stated it would be focusing on CNS and respiratory diseases, and reducing resources toward oncology and women's health.

ImmunoGen Inc.

Takeda Pharmaceutical Co. Ltd.

Takeda Oncology

Takeda Pharmaceutical Co. Ltd., through its Takeda Oncology division (also known as Millennium Pharmaceuticals Inc./B-/), licensed exclusive rights to use ImmunoGen Inc.’s antibody-drug conjugate (ADC) technology to develop targeted therapies against two undisclosed cancer targets. (Takeda has an option to apply the technology to a third target, for an additional fee.) (Mar.)

ImmunoGen got $20mm up front, and could see up to $420mm in milestones ($210mm per target), plus royalties. The licensed technology uses ImmunoGen’s cell-killing payload agents (including new DNA-acting IGN payload agents) that are attached to a targeting vehicle via specialized engineered linkers and only released once inside the cancer cells. Takeda’s rights will allow the company to develop, manufacture, and sell resulting projects. The platform was used in the development of Roche’s Kadcyla (ado-trastuzumab emtansine), which is on the market for HER2-positive metastatic breast cancer patients who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Other major pharma partners utilizing the technology include Amgen, Eli Lilly, Novartis, and Sanofi.

infirst Healthcare Ltd.

Johnson & Johnson

McNeil Consumer Pharmaceuticals

In a fixed-term agreement, Johnson & Johnson’s McNeil Consumer Pharmaceuticals licensed UK-based infirst Healthcare Ltd. exclusive rights to commercialize, distribute, and manufacture the popular OTC products Mylanta and Mylicon in the US. (Mar.)

Mylanta provides relief of heartburn, acid indigestion, sour stomach, and gas, and Mylicon is used in infants to relieve the discomfort of gas. Infirst will sell the products with the help of its sales partner Advantage Consumer Healthcare. Infirst spun out from SEEK drug discovery group and is initially offering products for inflammatory pain, cough and cold, and now GI problems.

Innovent Biologics Inc.

Eli Lilly & Co.

Eli Lilly & Co. penned an agreement with Innovent Biologics Inc. to develop at least three new cancer drugs in China over the next ten years. (Mar.)

Throughout the deal term, Innovent will lead development and manufacturing activities for most projects in China, while Lilly gets commercialization rights in the rest of the world. Included in the transaction are Lilly’s cMet inhibitor for non-small cell lung cancer (a review of Lilly’s pipeline leads Strategic Transactions to assume that this compound is Phase II LY2875358); Innovent’s mAb-targeting CD20, IBI301, a biosimilar to Ritxuan (rituximab) that is entering Phase I for leukemia; and a preclinical immuno-oncology molecule. Lilly also gets rights to develop and sell up to three more preclinical bispecific immuno-oncology candidates outside of China. Lilly paid $56mm up front, and could also pay Innovent up to $400mm in development, regulatory, and sales milestones, plus royalties, for the single preclinical immuno-oncology compound. The deal is the second large international tie-up for Lilly in one day; it also just paid $50mm up front (and committed up to $640mm in milestones) in exchange for rights to Hanmi Pharmaceutical’s BTK inhibitor HM71224 for autoimmune diseases and rheumatoid arthritis.

Jamieson Laboratories Ltd.

Probi AB

Probi AB licensed Jamieson Laboratories Ltd. rights to distribute and supply its Probi Digestis probiotic in Canada. (Mar.)

Jamieson’s Digestive Care daily relief contains Probi Digestis and is approved for relieving gas, bloating, and abdominal discomfort associated with irritable bowel syndrome. Jamieson will immediate launch the product and starting in May 2015 the company will begin an extensive marketing campaign that includes TV advertising, PR, in-store displays, digital advertising, and social media. The Probi Digestis name will appear prominently on the Digestive Care package. Jamieson claims it's the leading Canadian producer of vitamins and supplements.

Jazz Pharmaceuticals PLC

EUSA Pharma

EUSA Pharma spun off of its former parent Jazz Pharmaceuticals PLC and paid $34mm to purchase five products that it will now sell independently. (Mar.)

Jazz bought EUSA in 2012 for $650mm; with significant funding from original EUSA investor Essex Woodlands, EUSA (with original CEO Dr. Bryan Morton back on board) will now operate on its own again, with headquarters this time based in UK. It takes over the following products from Jazz: Caphosol (supersaturated calcium phosphate rinse) for oral mucositis; Collatamp collagen surgical implant impregnated with gentamicin to prevent infection during hemostasis treatment; Custodiol, a storage solution for transplanted organs; anti-freeze antidote fomepizole; and Xenazine (tetrabenazine) for movement disorders associated with Huntington’s chorea and hemiballismus. The five products had combined 2014 sales of about $27mm. Dr. Morton will head up a staff of 60 employees (many of whom were with EUSA when it was acquired by Jazz) in offices in the UK, US, Germany, France, and the Netherlands.

Johnson & Johnson

Janssen Pharmaceutica NV

Kura Oncology Inc.

Johnson & Johnson’s Janssen Pharmaceutica NV licensed Kura Oncology Inc. exclusive rights to develop and commercialize the Phase II-ready protein farnesyl transferase inhibitor tipifarnib for cancer indications. (Mar.)

Concurrent with the licensing agreement, Kura emerged as a new public company--after reverse merging with defunct public shell entity Zeta Acquisition--and raised $52.5mm through a private placement. The financing will help pay for tipifarnib’s Phase II studies, which are expected to commence in Q2 2015 in patients with tumors characterized by HRAS mutations, and Q3 in peripheral T-cell lymphomas. J&J originated the compound and developed it through pre-NDA submission in 2005; the FDA didn’t approve it citing inadequate trial results for colorectal, lung, brain, pancreatic, and urothelial cancers. Just three months ago Janssen granted Eiger’s EB Pharma subsidiary exclusive rights to tipifarnib, and back-up compound, in the field of virology.

MultiCell Technologies Inc.

MultiCell Immunotherapeutics Inc.

Oxis International Inc.

Oxis Biotech Inc.

Oxis Biotech Inc. and MultiCell Immunotherapeutics Inc. (MCIT) agreed to use MCIT’s antibody-drug conjugate technology to develop three new ADCs containing two of Oxis’ lead drug candidates. (Mar.)

MCIT’s platform uses multivalent cleavable linkers that allow for tethered drugs to be released either extracellularly or intracellulary. The linkers can also attach multiple drugs per antibody, and don’t require any modification of the drug before it can be released. The three resulting compounds will contain Oxis’ lead preclinical candidates OXS2175 for triple-negative breast cancer and OXS4235 for multiple myeloma and associated osteolytic bone lesions. Oxis paid an up-front licensing fee of $500k and agreed to reimburse up to $1.125mm in R&D costs, in exchange for exclusive rights to the ADCs. MCIT could also get $2.25mm in development milestones per candidate ($6.75mm total), $2mm per project in regulatory milestones ($6mm total), and 3% royalties on sales. Oxis has a three-year option to buy manufacturing rights to all three compounds; if exercised, it pays MCIT another $10mm.

NantWorks LLC

NantCell LLC

Sorrento Therapeutics Inc.

Sorrento Therapeutics Inc. and NantWorks Inc. have entered into their second agreement in less than six months, again centered around the development of immunotherapies for cancer. (Mar.)

The two first joined forces in December 2014 to create the joint venture now known as Nantibody LLC, which will develop immuno-oncology monoclonal antibodies for cancer, with initial targets including anti-PD-1, anti-PDL-1, anti-CTLA4, additional immune checkpoint antibodies, antibody-drug conjugates, and bispecific antibodies. The current deal involves NantWorks’ subsidiary NantCell LLC, which gets an exclusive license certain of Sorrento’s antibodies (including mAbs against the checkpoint inhibitors PD-1 and PD-L1, all discovered using Sorrento's G-MAB library) and CAR-TNK projects. (CAR-TNKs or Chimeric Antigen Receptor Tumor attacking Neukoplasts are being developed under a separate collaboration between Sorrento and Conkwest, also signed in December 2014.) In exchange for the rights, NantCell paid Sorrento $10mm up front and it will also issue Sorrento $100mm of its equity following the closing of an upcoming NantCell financing. Sorrento also gets an undisclosed share in the profits of any compounds that make it to the market.

Navidea Biopharmaceuticals Inc.

Norgine BV

SpePharm AG

Norgine BV and its SpePharm AG division will exclusively sell Navidea Biopharmaceuticals Inc.’s radiopharmaceutical Lymphoseek (technetium Tc 99m tilmanocept) in the European Union. (Mar.)

Norgine paid $2mm up front and could make up to $5mm in milestone payments, plus royalties. Navidea will supply the product, but all regulatory maintenance responsibilities, in addition to pricing, reimbursement, sales, and marketing activities transfer to Norgine. Lymphoseek is a receptor-targeting lymphatic mapping agent used for the intraoperative detection and imaging of sentinel lymph nodes in patients with cancers that may have spread to the lymph nodes, including breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. Navidea looks forward to the new visibility for Lymphoseek in Europe; Norgine plans to launch it there in early 2016.

Novartis AG

Novartis Pharmaceuticals Corp.

Semma Therapeutics

Novartis Pharmaceuticals Corp. and Semma Therapeutics agreed to team up in a partnership. (Mar.)

There was minimal information disclosed on their alliance, which Semma announced concurrently with a $44mm Series A financing led by MPM Capital. MPM runs a sidecar fund with Novartis; in past deals in which these parties have joined together, Novartis has gotten an option on the biotech's asset, so it's possible that the agreement with Semma is option-based. Semma's CEO Robert Millman previously was the president of CoStim Pharmaceuticals, which Novartis bought in 2014. The money that Semma expects to make on the Novartis deal, coupled with the Series A funding, are expected to support the start-up through clinical proof-of-concept trials for its lead cell therapy candidate in Type I diabetes. This program, based on research by Harvard University's Doug Melton, PhD, could provide an unlimited supply (billions) of insulin-producing pancreatic beta cells (grown from stem cells) to diabetic patients.

Pernix Therapeutics Holdings Inc.

Zogenix Inc.

Pernix Therapeutics Holdings Inc. bought Zogenix Inc.’s Zohydro ER (hydrocodone bitartrate capsules) assets for $100mm--$30mm cash, $20mm in Pernix stock (1.68mm shares), and a $50mm six-month promissory note--plus up to $12.5mm in regulatory and $271mm in pre-determined annual sales milestone targets of up to $1bn annually. (Mar.)

Under the agreement, Pernix will buy a pre-defined amount of Zohydro inventory, receive the NDA and related IND applications, and take over Zogenix's royalty and manufacturing obligations with Alkermes' Daravita (Zogenix’s manufacturer under October 2012 deal). The transaction also includes licenses to patents providing protection through 2030, trademarks, contracts, books and records, marketing materials, and data. Zogenix sales team and other Zohydro-dedicated employees (about 100 in all) will transfer to Pernix. Zohydro ER is an opioid agonist indicated for managing pain that's severe enough to require continuous daily therapy and for which alternative treatment options are inadequate. The drug was first approved by the FDA in 2013 without abuse-deterring properties, stirring up controversy that the pure hydrocodone painkiller was too easy for opioid addicts to abuse. However an abuse-deterrent version--Zohydro with BeadTek--was approved in January 2015 (launch expected in April). An NDA submission for ZX007, a tablet version of Zohydro ER with abuse-deterrent properties, is anticipated for mid-2016 and will have patent protection through 2030. Pernix will assume regulatory and financial responsibility to amend the Zohydro ER label to include abuse-deterrent claims, and pay for development of ZX007; Zogenix will provide transitory assistance for up to 18 months. Zogenix would receive the $12.5mm regulatory milestone upon approval of ZX007, which is in development with partner Altus Formulation. (Zohydro originated in the labs of Elan (now Perrigo)) and Elan sold its drug delivery business to Alkermes in 2011.) Following the divestiture, Zogenix will focus on two late-stage CNS therapies--ZX008 for Dravet syndrome (a rare form of epilepsy; Phase III trials expected to commence this year) and long-acting Relday (risperidone injection) for the maintenance treatment of schizophrenia (Phase III planned for H1 2016). Investment Banks/Advisors: Leerink Partners LLC (Zogenix Inc.)

Pharmalink AB

Synartro AB

Pharmalink AB acquired a preclinical anti-inflammatory candidate from Synartro AB. (Mar.)

Synartro developed the compound, which combines an anti-inflammatory drug conjugated to a biopolymer, using its drug delivery technology that creates locally acting drugs with limited systemic exposure. Pharmalink plans to develop the candidate for osteoarthritis and will use its own technology and expertise in developing locally administered therapies without systemic effects. The company will add the compound to its pipeline consisting of two clinical-stage therapeutics--Nefecon (PL-56) for IgA nephritis and Busulipo (MZH-2) for conditioning prior to transplantation.

PsychoGenics Inc.

Resilience Therapeutics Inc.

PsychoGenics Inc. (also known as PGI Drug Discovery LLC) acquired an equity stake in neuro start-up Resilience Therapeutics Inc. (Mar.)

The companies also agreed to discover and optimize candidates for stress-related diseases, namely post-traumatic stress disorder (PTSD). Jeff Sabados, a former Navy SEAL, established Resilience last year with the goal of curing PTSD. The company has in-licensed several targets from academia (including Emory University, Scripps Research Institute, Tulane University, and the University of Vermont) thought to be involved in triggering the disorder, including pathways underlying fear learning, reward, and stress responses. PsychoGenics will contribute various drug discovery technologies including SmartCube, which presents challenges to mice, extracts more than 2k features during a particular session, and then uses bioinformatics analytics to determine what drugs might be ideal treatments, based on a comparison of the behavioral models with a reference database. The partners will use PsychoGenics' platforms to screen compounds, develop biomarkers, and validate targets.

Financings

ADMA Biologics Inc.

Infectious disease-focused ADMA Biologics Inc. netted $10.6mm through the follow-on offering of 1.4mm common shares (including the overallotment) at $8 each. Proceeds will help fund the anticipated launch of its lead antibody candidate RI002, an injectable, human plasma-derived immunoglobulin for primary immune deficiency disease. (Mar.)

Investment Banks/Advisors: Laidlaw & Co.; Maxim Group LLC; Raymond James & Associates Inc.

AEterna Zentaris Inc.

AEterna Zentaris Inc. (oncology, endocrinology, and women's health) netted $35mm through the public sale of 59.7mm units at $0.62 apiece. Each unit consisted of one common share, 0.75 of a five-year Series A warrant exercisable at $0.81, and 0.50 of an 18-month Series B warrant exercisable at $0.81. In cases where an investor or its affiliates will end up with more than the initial beneficial ownership limitation, each common share in the units will be replaced with a Series C pre-funded warrant for a common share, for which the company would immediately receive proceeds of $0.62 per warrant. (Mar.)

Investment Banks/Advisors: Canaccord Genuity Inc.; HC Wainwright & Co.; Maxim Group LLC; Roth Capital Partners

Amarin Corp. PLC

Cardiovascular-focused Amarin Corp. PLC raised $52.8mm through the private placement of 352mm American Depositary Shares at $0.15 to new and returning shareholders. Each ADS represents one Series A convertible preferred share, and each 10 Series A preferred shares may be consolidated as one ordinary share. Some of the proceeds will support the commercialization of its hypertriglyceridemia drug Vascepa (icosapent ethyl). (Mar.)

AmpliPhi Biosciences Corp.

AmpliPhi BioSciences Corp. (treatments for drug-resistant infections) netted $12mm through the private sale of 78.8mm common shares at $0.165 (a 16% discount) to new and returning investors and its partner Intrexon. The company also issued 19.7mm five-year warrants; each warrant can buy 0.25 shares of common stock and is exercisable at $0.215 per share. Roth Capital and Griffin Securities were the placement agents. (Mar.)

Investment Banks/Advisors: Griffin Securities Inc.; Roth Capital Partners

Anthera Pharmaceuticals Inc.

Anthera Pharmaceuticals Inc. (treatments for autoimmune and inflammatory conditions) netted $23.5mm through the follow-on public offering of 5.6mm common shares at $4.50 each. The company recently announced positive results from its Phase III trial of blisibimod for IgA nephropathy; blisibimod is partnered with Zenyaku Kogyo in Asia. (Mar.)

Investment Banks/Advisors: Piper Jaffray & Co.

Assembly Biosciences Inc.

Assembly Biosciences Inc. (infectious disease therapies) netted $70.5mm through the follow-on public offering of 5.56mm common shares at $13.50 each. (Mar.)

Investment Banks/Advisors: Credit Suisse Group; William Blair & Co.

BioLineRx Ltd.

BioLineRx Ltd. (specialty pharma developing therapies for a variety of diseases including CNS, infectious, cardiovascular, and autoimmune) netted $27mm through the public sale of 14.4mm American Depositary Shares (including the overallotment). Each ADS was sold at $2 and represents ten ordinary shares. (Mar.)

Investment Banks/Advisors: JMP Securities LLC; Maxim Group LLC; Roth Capital Partners

Cellectis SA

French cancer immunotherapies firm Cellectis SA netted $212.3mm through its initial public offering of 5.5mm American Depositary Shares (representing 5.5mm ordinary shares) at $41.50 each on the Nasdaq Global Market. The company originally planned to sell 3.5mm ADSs; it went public on the Alternext market of Paris’ Euronext in 2007. (Mar.)

Investment Banks/Advisors: Bank of America Merrill Lynch; Jefferies & Co. Inc.; Oppenheimer & Co. Inc.; Piper Jaffray & Co.

Champions Oncology Inc.

Champions Oncology Inc. (personalized cancer therapies) grossed $14mm through the private sale of 35.3mm shares at $0.40 (a 14% premium). First-time buyer New Enterprise Associates led and was joined by returning investors Battery Ventures, Perceptive Advisors, Sabby Capital, and company director Daniel Mendelson. Participants also received five-year warrants to purchase 19.4mm more shares. (Mar.)

Cidara Therapeutics Inc.

Antifungal-focused Cidara Therapeutics Inc. filed for its initial public offering on Nasdaq. (Mar.)

Investment Banks/Advisors: BTIG LLC; Jefferies & Co. Inc.; Leerink Partners LLC; Needham & Co. Inc.; Wedbush PacGrow Life Sciences

Concert Pharmaceuticals Inc.

Concert Pharmaceuticals Inc. (improves drugs with deuterium substitution) netted $47mm through the follow-on public offering of 3.3mm common shares at $15.15 per share. Some of the proceeds will support program development including its Phase I D-ivacaftor for cystic fibrosis. (Mar.)

Investment Banks/Advisors: JMP Securities LLC; Robert W. Baird & Co. Inc.; Roth Capital Partners; Wells Fargo Securities LLC

Concordia Healthcare Corp.

Canadian pharma in-licenser Concordia Healthcare Corp. (acquires established pharmaceuticals and orphan candidates) raised $Cdn320mm ($250.3mm) in a bought deal financing through which underwriters have agreed to buy 3.7mm subscription receipts at $Cdn85. The company will put proceeds toward its concurrent acquisition of Covis Pharmaceuticals. Each subscription receipt entitles the holder to receive one Concordia common share contingent upon successful closing of the Covis transaction. (Mar.)

Investment Banks/Advisors: GMP Securities; RBC Capital Markets

Coronado Biosciences Inc.

Fortress Biotech Inc. (immunotherapies for cancer and autoimmune diseases) sold a promissory note for $10mm to an undisclosed investor. National Securities Corp. was the placement agent. The note matures in 36 months, or 42 months if the company can extend the date. After the first 24 months (or 30 if extended), the note is to be repaid at a rate of 1/12 of the principal amount for 12 months. (It holds an 8% coupon payable quarterly during the first 24 or 30 months and monthly thereafter.) Proceeds will fund future technology and product acquisitions, and will also be used to create new subsidiaries. (Mar.)

Investment Banks/Advisors: National Securities Corp.

Cyclacel Pharmaceuticals Inc.

Cancer drug developer Cyclacel Pharmaceuticals Inc. netted $9.3mm through the public sale of 10mm shares at $1. Some of the proceeds will fund Phase III trials of sapacitabine for myelodysplastic syndromes, ALL, and CLL, as well as Phase I trials of Cyclacel's second-generation CDK inhibitor CYC065 for solid tumors and leukemias. (Mar.)

Investment Banks/Advisors: HC Wainwright & Co.

DepoMed Inc.

Pain management company Depomed Inc. raised $575mm by selling senior secured notes to Deerfield affiliates (including Deerfield Private Design Fund III, Deerfield Partners, Deerfield International Master Fund, Deerfield Special Situations Fund, Deerfield Private Design Fund II, and Deerfield Private Design International II) and BioPharma Secured Investments III Holdings Cayman (managed by Pharmakon Advisors). (Mar.)

Eagle Pharmaceuticals Inc.

Eagle Pharmaceuticals Inc. (proprietary formulations of approved specialty injectables) netted $47mm in a follow-on equity offering of 1.2mm shares at $42. Selling stockholders offered 130k shares. Eagle may use a portion of the net proceeds for acquisitions or investments in complementary products or technologies. (Mar.)

Investment Banks/Advisors: Cantor Fitzgerald & Co.; Piper Jaffray & Co.; RBC Capital Markets; William Blair & Co.

Epizyme Inc.

Epizyme Inc. (epigenetic cancer therapeutics) netted $117mm by publicly selling 6mm shares at $20.75. Proceeds will fund Phase I and Phase II trials (outside of Japan) of EPZ6438 for B-cell lymphomas and adult and pediatric INI1-deficient tumors; ongoing Phase I trials of EPZ5676 for acute leukemias with alterations in the MLL gene; and further development of preclinical projects. (Mar.)

Investment Banks/Advisors: Cowen & Co. LLC; JMP Securities LLC; Leerink Partners LLC; Mizuho Bank Ltd.; RBC Capital Markets; SunTrust Banks Inc.

Esperion Therapeutics Inc.

Esperion Therapeutics Inc. (developing therapies that lower LDL-cholesterol levels) netted $190.2mm through the follow-on sale of 2.01mm common shares (including the overallotment) at $100 each. Funds will be used to finish developing ETC1002 for hypercholesterolemia; develop a fixed-dose combination of ETC1002 and ezetimibe for statin intolerant patients; pre-commercial activities of ETC1002 in statin intolerant patients; and commence a trial for high-risk patients who have had a cardiovascular event. (Mar.)

Investment Banks/Advisors: Credit Suisse Group; JMP Securities LLC; Needham & Co. Inc.; RBC Capital Markets; Stifel Nicolaus & Co. Inc.; UBS Investment Bank

Galena Biopharma Inc.

Galena Biopharma Inc. (oncology) netted $35.7mm through the public sale of 24.4mm common shares at $1.56. Investors also received five-year warrants to buy 12.2mm shares at $2.08. Proceeds will fund current operations, development activities, and commercialization of products including Abstral (sublingual fentanyl for breakthrough cancer pain) and Zuplenz (ondansetron oral soluble film for chemo- and radiation-induced nausea and vomiting). (Mar.)

Investment Banks/Advisors: MLV & Co. ; Maxim Group LLC; Noble Financial Group; Raymond James & Associates Inc.; Roth Capital Partners

Genocea Biosciences Inc.

Infectious disease-focused Genocea Biosciences Inc. netted $48.6mm through the follow-on sale of 6.27mm common shares (including the overallotment) at $8.25 each. Half of the funds will support ongoing clinical trials of Phase II GEN003 for genital herpes, and additional money (10%) will fund Phase II GEN004 for pneumococcal infections. (Mar.)

Investment Banks/Advisors: Cowen & Co. LLC; Needham & Co. Inc.; Piper Jaffray & Co.; Stifel Nicolaus & Co. Inc.

Heat Biologics Inc.

Heat Biologics Inc. (cancer immunotherapies) netted $11.4mm through the public sale of 1.9mm shares (including the overallotment) at $6.50. This was the first follow-on offering for Heat since the company's $24.2mm IPO in July 2013. (Mar.)

Investment Banks/Advisors: Aegis Capital Corp.; HC Wainwright & Co.

Horizon Pharma PLC

Horizon Pharma PLC (markets products for arthritis, inflammation, and orphan diseases), via its Horizon Pharma Investment Ltd. subsidiary, netted from qualified institutional investors $386.5mm by selling seven-year 2.50% exchangeable unsecured senior notes (including full exercise of the $50mm overallotment). The company originally planned to sell $300mm in notes. (Mar.)

Investment Banks/Advisors: Avondale Partners; Cowen & Co. LLC; Guggenheim Partners LLC; JMP Securities LLC; Jefferies & Co. Inc.; Morgan Stanley & Co.; UBS Investment Bank

Ignyta Inc.

In a registered direct offering, Ignyta Inc. (targeted cancer treatment) raised $41.6mm by selling 4.2mm shares at $10 (a 32% premium) to Teva Pharmaceutical Industries Ltd. (which bought 1.5mm shares) and unnamed health care investors (2.7mm shares). Concurrent with the RDO, Ignyta acquired four Teva oncology programs; as part of their deal, Teva received 1.5mm in Ignyta shares as payment. Together, Teva now owns 11.9% of Ignyta. (Mar.)

Intra-Cellular Therapies Inc.

Intra-Cellular Therapies Inc. (uses CNSProfile drug discovery technology to develop treatments for schizophrenia, bipolar disorders, and other neurological diseases) netted $107mm in a follow-on public offering of 4.8mm shares (upsized from 4.25mm) for $24. Existing investors agreed to purchase 875k shares. (Mar.)

Investment Banks/Advisors: Cowen & Co. LLC; JMP Securities LLC; Ladenburg Thalmann & Co. Inc.; Leerink Partners LLC; RBC Capital Markets; SunTrust Banks Inc.

KemPharm Inc.

KemPharm Inc. (creates new molecular entities via prodrug technology) filed for its initial public offering. (Mar.)

Investment Banks/Advisors: Canaccord Genuity Inc.; Cowen & Co. LLC; Oppenheimer & Co. Inc.; RBC Capital Markets

Kura Oncology Inc.

Kura Oncology Inc. (precision medicines for blood and solid cancers) came out of the gates as a new public company following a reverse merger with defunct public shell entity Zeta Acquisition. Kura concurrently raised $52.5mm through a private placement, and converted $7.5mm in bridge notes to common shares. (Mar.)

Investment Banks/Advisors: Leerink Partners LLC; National Securities Corp.

Kythera Biopharmaceuticals Inc.

Kythera Biopharmaceuticals Inc. (aesthetic medicine) netted $117.5mm through the follow-on sale of 2.6mm common shares at $48 each. Funds will help support ongoing Phase III trials and eventual commercialization of injectable ATX101 for submental fullness (commonly known as double chin). (Mar.)

Investment Banks/Advisors: Bank of America Merrill Lynch; Cowen & Co. LLC; Goldman Sachs & Co.; Leerink Partners LLC

Minerva Neurosciences Inc.

Institutional investors including Federated Investors, Highland Capital, Perceptive Advisors, Cormorant Asset Management, Johnson & Johnson Innovation-JJDC, Index Ventures, and DAFNA Capital Management bought 6.3mm shares of Minerva Neurosciences Inc. (clinical-stage candidates for schizophrenia, depression, and other neurological diseases) stock at $4.94 (a 4% discount), netting the company $29mm. Jefferies was the placement agent. (Mar.)

Investment Banks/Advisors: Jefferies & Co. Inc.

Novavax Inc.

Novavax Inc. (recombinant nanoparticle vaccines and adjuvants) netted $164.5mm via the follow-on sale of 24.1mm $7.25 each. Funds will help the company begin Phase III trials of its RSV vaccines, and progress other programs in development. (Mar.)

Investment Banks/Advisors: Citigroup Inc.; JP Morgan & Co.; Janney Montgomery Scott Inc.; Ladenburg Thalmann & Co. Inc.; Piper Jaffray & Co.; Wedbush PacGrow Life Sciences

Portola Pharmaceuticals Inc.

Portola Pharmaceuticals Inc. netted $94.1mm in a follow-on offering of 2.5mm shares at $40 per share. The proceeds will be used to fund commercial, manufacturing, and infrastructure costs for lead compounds, Factor Xa inhibitors andexanet alfa and betrixaban; an ongoing Phase III trial of betrixaban; clinical and manufacturing work toward a BLA for andexanet alfa; and a Phase I/IIa proof of concept study for cerdulatinib in hematologic cancers. (Mar.)

Investment Banks/Advisors: Cowen & Co. LLC; Credit Suisse First Boston; Morgan Stanley & Co.; Sanford C Bernstein

Pulmatrix Inc.

As part of its reverse merger with public biotech Ruthigen Inc., Pulmatrix Inc. will raise $10mm in a private placement to certain existing institutional investors. Prior to the merger Pulmatrix was a private company but post-transaction it will combine with Ruthigen and trade on Nasdaq. (Mar.)

Retrophin Inc.

Retrophin Inc. (orphan disease therapies) netted $140.5mm through the public sale of 7.9mm common shares (including the overallotment) at $19. Pricing of the offering came two days after the FDA approved Cholbam (cholic acid capsules) for bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders. Retrophin acquired rights to Cholbam from Asklepion in January, and will use some of the FOPO proceeds to pay the $27mm cash milestone associated with the drug's approval. (Mar.)

Investment Banks/Advisors: Deutsche Bank AG; JMP Securities LLC; Leerink Partners LLC; Nomura Securities International Inc.

Ritter Pharmaceuticals Inc.

Gastrointestinal disease-focused Ritter Pharmaceuticals Inc. filed for its initial public offering. (Mar.)

Investment Banks/Advisors: Aegis Capital Corp.

SteadyMed Therapeutics Inc.

SteadyMed Ltd. (pharmaceuticals for orphan & high-margin specialty markets) netted $37.2mm through the sale of 4.7mm shares at $8.50 (below the anticipated $12-14 range) in its IPO. In January the company raised $12.2mm in an equity financing led by Deerfield and Federated Investors. (Mar.)

Investment Banks/Advisors: JMP Securities LLC; RBC Capital Markets; Wells Fargo Securities LLC

Summit Therapeutics PLC

Public UK biotech Summit Therapeutics PLC (formerly Summit Corp. PLC; focused on orphan and rare diseases) netted $31.8mm in an IPO on Nasdaq of 3.45mm ADSs (or 17.25mm ordinary shares; each ADS represents five ordinary shares.) at $9.90 per ADS, or $1.98 per ordinary share. (Mar.)

Investment Banks/Advisors: JMP Securities LLC; Needham & Co. Inc.; Oppenheimer & Co. Inc.

Tekmira Pharmaceuticals Corp.

Two months after announcing its acquisition of OnCore Biopharma, Arbutus Biopharma Corp. (HBV therapeutics) netted $142.8mm through the follow-on sale of 7.5mm common shares at $20.25 each. (Mar.)

Investment Banks/Advisors: JMP Securities LLC; Lazard LLC; Leerink Partners LLC; Nomura Securities International Inc.; RBC Capital Markets; Wedbush PacGrow Life Sciences

Tesaro Inc.

Cancer drug developer Tesaro Inc. netted $180mm through the public sale of 3.76mm common shares (including partial exercise of the overallotment) at $51 apiece. (Mar.)

Investment Banks/Advisors: BMO Financial Group; Citigroup Inc.; Deutsche Bank AG; Leerink Partners LLC; Mizuho Bank Ltd.; Robert W. Baird & Co. Inc.

TetraPhase Pharmaceuticals Inc.

Tetraphase Pharmaceuticals Inc. (infectious disease treatments) netted $162.7mm in a follow-on offering of 4.9mm shares (including the overallotment) at $35 per share. The company will use the proceeds to fund pre-commercial activities and prepare for the commercial launch of Phase III eravacycline for complicated urinary tract infections (including establishing a sales force and purchasing commercial quantities of the drug). (Mar.)

Investment Banks/Advisors: BMO Financial Group; Guggenheim Partners LLC; Nomura Securities International Inc.; Stifel Nicolaus & Co. Inc.; SunTrust Banks Inc.

Valeant Pharmaceuticals International Inc.

Valeant Pharmaceuticals International Inc. netted $1.43bn through the registered offering of 7.29mm common shares at $199 each. The money will help fund the $11bn acquisition of Salix. (Mar.)

Investment Banks/Advisors: Barclays Bank PLC; DNB ASA; Deutsche Bank AG; HSBC Investment Bank PLC; Morgan Stanley & Co.; RBC Capital Markets; SunTrust Banks Inc.; The Mitsubishi Bank

ZS Pharma Inc.

ZS Pharma Inc. (treatments for renal, cardiovascular, liver, and metabolic diseases) netted $174.6mm in a follow-on offering of 4mm shares (upsized from 3.3mm) at $46.25. The company will use the proceeds to advance its hyperkalemia candidate ZS9: to complete its ongoing long-term safety trial ZS005; the long-term extension study ZS004e; scale-up of API manufacturing capacity; build-up of product inventory; and launch a sales and marketing force in the US. (Mar.)

Investment Banks/Advisors: BMO Financial Group; Credit Suisse Group; JP Morgan & Co.; LifeSci Capital LLC; William Blair & Co.