Deals Shaping the Medical Industry (6/06)

The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Windhover's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.

In Vitro Diagnostics

Acquisitions

PerkinElmer Inc.

Spectral Genomics Inc.

PerkinElmer has acquired Spectral Genomics, a company focused on developing technology that detects chromosomal abnormalities. (May)

Spectral Genomics, which was established in 2000 by scientists at Baylor College of Medicine, brought in $12.3mm through venture rounds, with its $9.3mm Series B closing in early 2004. It specializes in diagnostics to determine prenatal genetic defects, genetic testing for diseases including cancer, and evaluating the effectiveness of drugs used in cancer treatments. The company also offers the Spectral Ware array analysis software, an automated way to produce a molecular karyotype profile. Spectral Genomics products, which have been distributed by GE Healthcare since 2005, include the Spectral Chip and the Constitutional Chip, which offer whole genome analysis allowing scientists to determine the precise area of chromosomal deletions and amplifications that indicate a greater chance for developing certain diseases. The products are used by researchers in various fields, including pharmaceutical and biotech companies, cytogenetic researchers, and clinics. PE says the acquired company's offerings will complement its own molecular medicine and genetic screening products.

Joint Arrangements

Abbott Laboratories Inc.

Advanced Life Science Institute Inc.

Abbott Laboratories has licensed global rights to Advanced Life Science Institute's (Japanese biotech developing reagents for detection of cancer and viral diseases) IP pertaining to Pro-gastrin-releasing peptide (ProGRP), a biomarker used to diagnose and monitor small-cell lung cancer (SCLC). (May)

There is currently no FDA-approved diagnostic to test serum for SCLC, a rapidly spreading cancer that can attack a patient's whole body. Physicians in Japan are already applying ProGRP findings to the diagnosis and management of SCLC; ALSI launched reagents for both SCLC and the hepatitis C virus in the mid-1990s. Since that time it out-licensed its HCV antibody detection IP to Chiron.

Alifax SPA

Nymox Pharmaceutical Corp.

In their second distribution agreement, Alifax SPA (medical diagnostics and lab equipment) agreed to market and sell in Italy diagnostics developer Nymox Pharmaceutical's NicAlert tobacco detection system. (May)

NicAlert, which Nymox acquired through its 2000 takeover of diagnostics maker Serex, uses urine or saliva samples to measure levels of cotinine, a nicotine metabolite that indicates tobacco exposure. The test was FDA-approved in 2002 and recently received the CE mark in Europe. Some uses for the diagnostic include testing student athletes for smoking, and for R&D purposes in tobacco research studies. In addition to NicAlert, Nymox offers the TobacAlert diagnostic to evaluate exposure to second-hand smoke. Alifax, which markets a number of electronic calibration systems, also sells in Italy Nymox's AlzheimAlert test for Alzheimer's disease.

Asuragen Inc.

Digene Corp.

Molecular diagnostics company Asuragen licensed Digene (nucleic acid tests for cancer and infectious diseases in women) exclusive worldwide rights to distribute and market the Signature cystic fibrosis screening tests. (Apr.)

Digene pays money up front plus regulatory milestones for the right to sell the Signature CF 2.0 ASR diagnostic and a next-generation diagnostic called Signature CF Expand that Asuragen is developing to include ethnic-specific mutations for possible use in newborns. Digene has the first right of refusal on future Asuragen genetic diagnostics. With the help of Luminex's xMAP technology to perform bioassays on multiple analytes within a single sample, Signature screens for a mutation in the gene that codes for the cystic fibrosis transmembrane conductance regulator (CFTR) protein; this mutation can cause the hereditary lung disease. Digene will add the Signature systems to its own diagnostics, marketed by various partners including Roche, Mitsubishi, and Cytec, for human papillomavirus, blood viruses, chlamydia, gonorrhea, hepatitis B, and cytomegalovirus. The company believes that the potential for the next-generation product in prenatal testing will fit in well with its focus on women's health. Currently, Tm Bioscience's Tag-It is the only FDA-approved test on the US market for the CFTR gene mutation; Clinical Micro Sensors has recently filed for clearance of its Esensor detection system, which also screens for the mutation.

Biosite Inc.

Oxford Genome Sciences (UK) Ltd.

Oxford Genome Sciences (OGeS, personalized cancer treatments) and Biosite (proteomics for diagnostics) have entered into an agreement to develop protein-based colorectal cancer tests that can be used in place of traditional invasive colonoscopy exams. (Apr.)

OGeS will use its OGAP (Oxford Genome Anatomy Project) database to identify at least 25 proteins in blood and tissue samples from patients with relapsing colorectal cancer. OGAP integrates molecular, cellular, phenotypic, and clinical information to speed discovery and validation of drug targets and biomarkers. Using one or more of the markers OGeS discovers, Biosite will develop blood-based diagnostics that will enable doctors to identify recurring colorectal cancer early enough to tailor effective options for therapeutics. It will add the new diagnostic to its line of tests for cardiovascular, infectious, cerebrovascular, and thromboembolic diseases.

deCode genetics Inc.

Illumina Inc.

Illumina (tools for analyzing genetic variation and function) and deCode genetics agreed to develop diagnostics for gene variants, previously identified by deCode, involved in cardiovascular, metabolic, and oncologic diseases. (May)

Specifically, the tests will look for genes that code for leukotriene A4 hydrolase, transcription factor 7-like 2 (TCF7L2), and BARD1, each linked to heart attack, Type II diabetes, and breast cancer, respectively. The companies will co-develop the diagnostics using Illumina's multi-sample single-nucleotide polymorphism (SNP) genotyping (detection and analysis of individual genetic variations) technology, and jointly validate biomarkers. Illumina is responsible for manufacturing, marketing, and selling the resulting diagnostics on its BeadXpress system (set to be launched in late 2006). The companies will share development costs and split profits. In a related agreement, Illumina will install its SNP genotyping platform at deCode's facilities, allowing deCode to perform genomic studies on up to 100,000 samples using Illumina's Sentrix HumanHap300 genotyping BeadChips, Infinium assays, and laboratory information system. The addition of the technology expands deCode's offerings in its contract genotyping business and supports internal drug target discovery programs, which are focused on cardiovascular, neurological, metabolic, and respiratory diseases. Illumina is a new player in the diagnostics market--it acquired CyVera in February 2005, a move that gave Illumina capabilities in in vitro and molecular testing.

Monogram Biosciences Inc.

Pfizer Inc.

Building on a 2002 partnership in HIV, Monogram Biosciences and Pfizer have entered a new three-year deal to collaborate on the development of Monogram's co-receptor tropism assay, which is now being used in clinical trials for HIV/AIDS indications of Pfizer's Maraviroc, a Phase III CCR5-antagonist compound. (May)

Pfizer has made a $25mm equity investment in Monogram through a senior secured convertible note due May 2010. The note will bear 3% interest payable quarterly in cash or Monogram common stock; the conversion price will initially equal a 20% premium to Monogram's closing average during a specified period prior to the note's issuance. The cash infusion from Pfizer would bring Monogram's cash resources to $92mm. The companies will together develop the assay to study with Pfizer's Maraviroc that works by blocking the CCR5 receptor (which HIV uses to gain entry to the cell) and thus may prevent the virus from entering and infecting the immune system's healthy CD4 T-cells. Pfizer will have nonexclusive commercialization rights outside the US. Monogram's diagnostic monitors tropism--the course taken by the virus to access the CD4 cells--in HIV antiretroviral therapy. Tropism data may assist in identifying patients most likely to respond to CCR5 antagonists and may be helpful in deciding when to initiate therapy in new patients. The goal of the collaboration is to make the co-receptor tropism assay available for patient use globally. Studies have demonstrated 80-85% of newly diagnosed HIV patients, who were previously untreated, have dominant CCR5-tropic virus. This percentage drops to 50-60% in those previously treated with anti-retroviral medicines.

Financings

ChondroGene Ltd.

Canadian functional genomics firm ChondroGene grossed $Cdn20mm ($18mm) through the private placement of 12.5mm common shares priced at $Cdn1.60 each (a 19% discount to the market average) to Westwind Partners. It will use the proceeds for development and commercialization of ColonSentry, its lead blood test used to detect precancerous polyps and colon cancer. (May)

Home Diagnostics Inc.

Home Diagnostics Inc. (HDI), a company specializing in diabetes management, filed to sell up to $115mm in common stock in its initial public offering. (May)

The company sells blood glucose monitoring systems, incorporating biosensor and photometric technology, to food stores, drug stores, and mass merchandisers. HDI was one of the first companies to successfully use a co-branding approach to market its glucose systems by partnering with large retailers to put both its name and the store's name on the meters and test strips. HDI's key products are SideKick, a small, disposable system; TrueTrack Smart System, which requires only a small blood sample for testing; TrackEASE Smart System, designed for frequent use; and Prestige IQ, a product for patients with dexterity or visual impairments. The company faces competition from firms such as Bayer, Becton Dickinson, and LifeScan (a J&J company), which offer similar glucose detection meters. Almost $5mm of the proceeds from the offering will go towards the purchase of manufacturing equipment to develop new products, including TrueTrack system enhancements, strip coding technology to improve calibration to monitors, and wireless technology that allows integration and communication with other devices. Other proceeds will be used to redeem outstanding Series F preferred shares and pay outstanding debt. In addition to glucose monitors, HDI also markets disease management software for diabetic patients and disposable supplies such as lancing devices, lancets, and ketone test strips. Investment Banks/Advisors: William Blair & Co.; Deutsche Bank AG; Piper Jaffray & Co.; JP Morgan Chase & Co.

Qiagen NV

Qiagen NV (nucleic acid separation, purification, amplification, and instrumentation supplies) has raised $300mm (including the overallotment) with the private placement of 20-year 3.25% senior convertible notes to ex-US institutional investors. The notes, which were sold under Regulation S in $100k denominations, convert into 15mm common shares priced at $20 each. Earlier this month Qiagen announced the $38mm acquisition of nucleic acid purification products company Gentra. (May)

Trinity Biotech PLC

Trinity Biotech PLC (diagnostics for infectious diseases, STDs, blood coagulation disorders, and autoimmune diseases) has completed two private offerings that together netted $24mm. The company raised $21.8mm through the sale to institutional US, UK, Swiss, and Irish investors of 2.7mm American Depositary Shares (ADS) priced at $8.60 apiece (a 5% discount). The company's CEO, Ronan O'Caoimh, bought 224k ADSs for $8.96 each (about market average), netting $1.99mm. Roth Capital Partners and J&E Davy acted as placement agents for the offering. (Apr.)

Investment Banks/Advisors: Roth Capital Partners

Pharmaceuticals

Acquisitions

AstraZeneca PLC

Cambridge Antibody Technology Group PLC

AstraZeneca has offered to pay £13.20 ($24.96) per share (a 72% premium to the market average) to buy the remaining 80% of Cambridge Antibody Technology Group PLC that it does not already own. It is effectively paying £567mm for the remaining stake, and valuing all of CAT at £702mm, about 4 times the company's 2005 revenues of £194mm. (May)

The companies first partnered in 2004 when they agreed to co-develop monoclonal antibodies for respiratory and inflammatory diseases. At that time, AZ paid £75mm for a 19.9% stake in CAT. Now, AZ has determined that a full takeover of CAT will be beneficial and help it to expand its own research in therapeutic antibodies and add treatments for cancer, immunology, dermatological conditions, and infectious diseases. In addition to bringing on CAT's development activities in these areas, AZ will benefit from ongoing collaborations that CAT will maintain, including a deal with Abbott Laboratories for Humira, in which AZ will now be eligible to receive a portion of the royalty stream, and licensing agreements with other groups such as Protherics, Targacept, Atherogenics, and its most recent venture--an agreement to co-promote Abraxis' breast cancer treatment Abraxane. Investment Banks/Advisors: Goldman Sachs & Co. (AstraZeneca PLC); Morgan Stanley & Co. (Cambridge Antibody Technology Group PLC)

Biogen Idec Inc.

Conforma Therapeutics Corp.

Biogen Idec has agreed to acquire anticancer drug company Conforma Therapeutics for $150mm. (May)

Biogen Idec will buy all of Conforma's issued and outstanding stock for $150mm, and could pay an additional $100 in earn-outs based on developmental milestones. Conforma's employees and operations will be consolidated into Biogen Idec's main headquarters. The acquired company's pipeline consists of candidates that target heat shock protein 90 (HSP90) molecules responsible for controlling the growth of cancer cells. The compounds bind to activated forms of HSP90 and attack tumor cells while sparing surrounding healthy tissue. CNF1010, Conforma's ansamycin candidate, is in Phase I trials and has shown progress in inhibiting the growth of breast, lung, ovarian, stomach, brain, and blood cell tumors in mice. The company's other Phase I compound, CNF2024, is a synthetic orally available HSP90 inhibitor for treating various cancer types. In 2005, Conforma licensed from Sumitomo Pharmaceuticals North American and European rights to the anthracycline amrubicin (CNF3140), which is currently entering Phase II for small-cell lung cancer. Prior to the close of the acquisition, rights to the compound will be transferred to a new start-up, Cabrellis Pharmaceuticals, for continued development.

Merck & Co. Inc.

Abmaxis Inc.

Merck has agreed to pay $80mm in cash to acquire human monoclonal antibody therapeutics developer Abmaxis, which will now operate as a wholly owned subsidiary. (May)

The parties have been strengthening their relationship since 2004 when Abmaxis agreed to re-engineer and optimize an unspecified MAb from Merck's pipeline. Using its AISIM (Abmaxis In-Silico IMunization) platform, Abmaxis developed an automated method of designing customized antibody libraries and using computational algorithms to speed up therapeutic antibody discovery and optimization. Merck and Abmaxis reached the first milestone in their agreement late last year when Merck re-engineered an antibody with positive results; it is because of the success of the agreement that Merck decided to buy the company. Merck adds Abmaxis and its drug discovery technologies to its own growing field of discovery and biologics development efforts. Investment Banks/Advisors: Seven Hill Partners (Abmaxis Inc.)

Merck & Co. Inc.

GlycoFi Inc.

Impressed with results of a collaboration formed by the parties last year, Merck has decided to acquire glycoprotein therapeutics developer GlycoFi for $400mm cash. (May)

GlycoFi was set up in 2000, has 55 employees, and raised $34.6mm in four venture rounds; Merck took part in an undisclosed amount of investing during the rounds. GlycoFi will operate as a wholly owned subsidiary of Merck. GlycoFi's glycoengineering and biological drug optimization technologies allow for the production of proteins (such as monoclonal antibodies) from yeast for more rapid and cost-effective drug molecule development. Merck adds the platforms to its own existing yeast production system that was used in the development of its Gardasil papilloma vaccine. In December 2005, the companies entered an agreement to apply GlycoFi's technologies to optimize certain Merck vaccine and antibody candidates. Concurrent with the GlycoFi acquisition, Merck has also announced the purchase of one of its other drug development partners, private biopharma company Abmaxis, for $80mm.

Joint Arrangements

Abbott Laboratories Inc.

ImaRx Therapeutics Inc.

ImaRx Therapeutics (developing compounds to treat disorders that accompany blood clots) has gained rights to Abbott Laboratories' anti-thrombosis drug, Abbokinase (urokinase). (May)

Urokinase is an enzyme created in kidneys to dissolve blood clots. Abbokinase, which is taken from neonatal kidney cells that have been produced in tissue cultures, is administered via IV to decrease fibrinogen and plasminogen in a patient's bloodsteam. The drug has been on the market since its approval in 1978 for acute massive pulmonary embolism. After the manufacturing of Abbokinase was suspended in 1999, Abbott worked to ensure compliance with cGMP (current Good Manufacturing Practice) standards and make sure several additional tests were performed on the product to increase its safety. Abbokinase was reintroduced in late 2002 for a second indication, dissolving pulmonary emboli in patients with unstable hemodynamics (low blood pressure). ImaRx says the in-licensed product will complement its drug candidates, including recombinant urokinase and recombinant pro-urokinase, which have both finished Phase III studies.

Active Biotech AB

Chelsea Therapeutics Inc.

Active Biotech AB (treatments for autoimmune disease, cancer, and inflammation) and immunology company Chelsea Therapeutics will co-develop and co-commercialize Active's I-3D portfolio of dihyrdoorotate dehydrogenase (DHODH)-inhibiting compounds to treat transplant rejection and autoimmune diseases. (May)

Terms of the agreement call for the companies to jointly fund and take part in clinical development of the orally active I-3D compounds. Chelsea gets exclusive marketing rights in North and South America, while Active retains rights in all other parts of the world. Active also receives clinical development milestones, and each party will pay royalties to the other based on sales in respective markets. The I-3D compounds have shown positive preclinical results in the inhibition of DHODH and have potential to treat rheumatoid arthritis, psoriasis, and systemic lupus erythematosus; two of the candidates are slated to begin clinical trials in 2007. Through the licensing of the I-3D compounds, Chelsea boosts its autoimmune pipeline that includes its lead candidate CH1504, in Phase I trials for RA, psoriasis, inflammatory bowel disease, and certain cancers.

Adams Respiratory Therapeutics Inc.

UCB Group

Adams Respiratory Therapeutics has acquired the OTC liquid cough suppressant Delsym (dextromethorphan polistirex) from global pharmaco UCB Group (treatments for cancer, neurological, immunological, and inflammatory diseases). Adams also received a license to the 12-hour delivery technology that is incorporated into the product. (May)

UCB gets an up-front payment of $122mm, modest royalties for five years, and forms a cost-plus-structured manufacturing supply agreement with Adams. According to market research firm IRI, Delsym is the second-leading OTC cough syrup in the US, achieving $40mm in sales and a 14% market share in 2005. The product has been sold in the US since December 1982. Adams expects Delsym to add value to its portfolio of respiratory products including the Mucinex (guaifenesin) line of congestion relievers; the antitussive Humibid (acquired from Cornerstone Biopharma); and Tri-Nasal for allergies (co-promoted with Muro Pharmaceutical). The company is also developing a Phase II compound, erdosteine, which was licensed from Edmond Pharma in May 2005, for chronic obstructive pulmonary disease. UCB says the deal is part of its strategy to focus on novel drug formulations for severe and chronic diseases.

Akzo Nobel NV

Organon NV

Gene Logic Inc.

Trying to put some life back in its R&D pipeline, Organon (Akzo Nobel's health care business) will identify new therapeutic applications for its discontinued compounds using Gene Logic's (drug discovery and development services) repositioning platform. (Apr.)

Gene Logic's Drug Repositioning and Selection (DRS) technology, a system that maps out new plans for clinical development of discontinued, stalled, or deprioritized drug candidates in Phase II or III studies, will help Organon identify alternative disease indications for its compounds using in vivo animal models as well as in vitro and in silico tests. Gene Logic gets a milestone payment for each drug candidate that Organon chooses to take into development; the compound would be jointly owned and possibly jointly developed and sold. In addition to repositioning, DRS can also evaluate safety of and genetic variable responses to drugs. Pfizer, Roche , and Millennium Pharmaceuticals have each applied Gene Logic's DRS platform to their own pipelines. Organon first collaborated with Gene Logic in 1997 on a custom delivery deal and a few years later subscribed to the company's gene expression databases.

AnGes MG Inc.

Vical Inc.

Tokyo's AnGes MG (gene therapy) has agreed to help DNA-based drug delivery company Vical with Phase III trials of the melanoma vaccine candidate Allovectin-7 (May)

AnGes will fund the trials with a total of $22.6mm in cash and equity investments and gets exclusive marketing rights in certain parts of Asia. It purchased about $6.9mm worth of Vical common stock (1.06mm shares at $6.50 each, a 7% premium) up front, and will buy an additional $3.95mm worth of stock subject to certain conditions. AnGes will pay Vical royalties on sales in its territories (double-digit royalties in Tokyo and single-digit for other Asian territories), and could also pay up to $77.5mm in sales-based milestones. Vical retains exclusive rights in the US and the rest of the world, and will pay AnGes tiered and fixed royalties in those areas, respectively. Allovectin-7 is an intralesional injectable cancer immunotherapeutic that was developed using Vical's DNA delivery technology. The plasmid/lipid complex contains DNA sequences encoding the MHC-I antigen and is currently entering Phase III trials after completing a Special Protocol Assessment with the FDA. This is the second collaboration for the parties in the last 12 months; Vical previously granted AnGes exclusive worldwide rights to its DNA delivery technology to develop cardiovascular products.

Angiotech Pharmaceuticals Inc.

Athersys Inc.

Athersys (cell therapies for cardiovascular disease, cancer, and bone marrow transplantation) and Angiotech Pharmaceuticals (biomaterials) will jointly develop stem-cell therapeutics for cardiovascular disease. (May)

Angiotech's ADDVANCE (Angiotech Drug Device Venture and Capital Enterprises) division has made an equity investment in Athersys, which will also get development and commercialization milestones and a share of profits. The companies will first apply Athersys's MultiStem IP that is derived from adult stem cells in myocardial infarction patients. Athersys and Angiotech anticipate the drug candidate will enter Phase I studies next year; they may later develop therapeutics for peripheral vascular disease and chronic ischemia. MultiStem uses Multi-Potent Adult Progenitor Cells (MAPC), which can be isolated from bone marrow and non-embryonic tissues, and are capable of developing into a large number of cell types. The MAPC technology was originally developed by Dr. Catherine Verfaillie at the University of Minnesota .

Angiotech Pharmaceuticals Inc.

Genzyme Corp.

Angiotech (biomaterials and drug-coated therapeutic devices) and Genzyme have entered into an agreement to develop drug and biomaterial device combination treatments to prevent tumor re-growth following cancer removal surgery. (May)

Angiotech and Genzyme have complementary drug development, screening, biomaterials, and oncology experience that both will contribute for joint research. Genzyme gets all clinical development, manufacturing, and worldwide commercialization rights to resulting products, and Angiotech retains the option to co-promote. Both parties will share development costs and profits equally. The therapeutic/biomaterial combinations that come out of the deal will act locally, not systemically, at the site of removed tumors, and may also be effective in treating inoperable tumors and reducing local tumor side effects.

Argenta Discovery Ltd.

PainCeptor Pharma Corp.

Scientists from PainCeptor Pharma (acute and chronic pain treatments that target the peripheral nervous system) and Argenta Discovery (develops respiratory medicines in-house) will work together on PainCeptor's acid-sensing ion channel (ASIC) inhibitors for the treatment of pain. (May)

Argenta will contribute medicinal chemistry capabilities and CADD (computer-aided drug design) services that incorporate hit identification, lead optimization, and 3-D modeling. The companies have the option to expand the agreement. ASIC inhibitors, which have been studied in animal models, block acid-induced responses to tissue injury, pain, and inflammation from diseases associated with chronic pain, including angina, stroke, arthritis, cancer, infections, and traumatic injuries. PainCeptor believes its approach to developing compounds that act on the peripheral nervous system avoids common side effects seen with pain drugs, such as opioids, that act on the CNS. The company is initially developing inhibitors that target the ASIC 1A and 3 subtype receptors. PainCeptor, created in 2003 through the merger of university spin-outs Antalium and Neuroceptor, first partnered the ASIC program with NeuroSearch in 2004.

Aspen Pharmacare

Roche

In anticipation of a widespread avian flu outbreak, Roche has granted Aspen Pharmacare (brand, generic, and OTC pharmaceuticals for the African market) nonexclusive rights to produce generic oseltamivir (Tamiflu) in Africa. (May)

Roche will provide technical, preclinical, and clinical data to help Aspen move production along. Roche may also supply Aspen with the active ingredient and could receive sales royalties. Aspen will manufacture the drug at its oral solid dose plant in South Africa, which is an FDA-approved facility. Roche has been working with various worldwide partners, including Shanghai Pharmaceuticals, Hetero Drugs, DSM, Martek, and Sanofi-Aventis, to boost production of the antiviral to 400mm treatments annually by the end of 2006. Research shows that Tamiflu, a neuraminidase inhibitor with worldwide sales of $1.2bn last year, has increased survival rates of animals infected with various H5N1 strains; Roche hopes to conduct additional research as the virus evolves into a human strain.

AstraZeneca PLC

AstraZeneca Pharmaceuticals LP

Biovail Corp.

Biovail Pharmaceuticals Inc.

AstraZeneca Pharmaceuticals LP has chosen drug delivery firm Biovail Pharmaceuticals to promote its Zoladex (goserelin acetate) endometriosis product in the US and Puerto Rico. (May)

AstraZeneca will continue to manufacture and supply the drug and Biovail will market it to obstetricians and gynecologists in the specified territories. Zoladex 3.6mg was approved to treat endometriosis (both to provide pain relief and reduce endometriotic lesions) in women over 18 years of age. The drug is injected into the upper abdominal wall every 28 days for six months. Biovail's specialty sales force, with previous experience in the Ob/Gyn and general women's health markets, adds Zoladex to its line of women's health products and candidates; most recently, the company supplemented this segment with a promotion agreement for Ortho-McNeil's Ultram (tramadol) in extended and controlled-release formulations for the treatment of chronic pain.

Bausch & Lomb Inc.

SurModics Inc.

Surface modification technology and drug delivery developer SurModics licensed eye care company Bausch & Lomb exclusive rights to patents covering the use of genistein, a soy isoflavone, for retinal diseases. (May)

SurModics got the genistein IP after it fully acquired InnoRx in January 2005; InnoRx originally licensed the patents from the inventor, retinal specialist Eugene de Juan, Jr., MD, InnoRx's founder and now a SurModics consultant. The soy ingredient, which exhibits anti-oxidant, anti-angiogenic (specifically against vascular endothelial growth factor), and apoptotic properties, may have potential in diabetic macular edema--in animal studies, it reduced retinal vascular leakage. The isoflavone IP will complement a group of compounds recently licensed from Cephalon that Bausch & Lomb is developing for diabetic macular edema and age-related macular degeneration. Bausch & Lomb sells prescription products that treat ocular allergies, inflammation, glaucoma, hypertension, corneal edema, and other eye ailments.

BioLineRx Ltd.

Gevys Pharmaceuticals Ltd.

Gevys Pharmaceuticals (CNS treatments and technologies) licensed BioLineRx (develops medicines for oncology, cardiovascular, neurological, infectious, and inflammatory diseases) exclusive development and marketing rights to BL3010 for acute and chronic pain. (May)

Gevys will be eligible for sales royalties. BL3010, a combination of three approved drugs, incorporates a delivery technology that administers active ingredients at 10 to 500 times lower than their normal doses while still increasing potency and reducing side effects and toxicity. Since the candidate is made up of known products, BioLineRx can skip early-stage safety trials and plans to begin a Phase I/II study. The company's other pain project is a preclinical neurotransmission modulator for chronic pain expected to start clinical trials in 2008.

BioProgress PLC

Uluru Inc.

BioProgress PLC (using polymer and film technologies to deliver drugs) and Uluru (wound care, plastic surgery, oral health products) will team up to develop an anti-emetic. (May)

The companies will create the new drug candidate using both BioProgress's film technology (acquired from Aquafilm--soluble films for many industries--in early 2004) and Uluru's Oradisc platform, a film that latches onto mucous membranes to enable the systemic sustained release of drugs. The finished product is expected to be a fast-acting, melt-in-the-mouth film strip that releases the nausea drug over a period of several hours. The companies may develop additional drug candidates for different indications.

Borean Pharma AS

Roche

Borean Pharma AS (therapeutic proteins) licensed Roche exclusive development and marketing rights to preclinical apolipoprotein A-1 (Apo A-1) for the treatment of atherosclerosis. (May)

Roche also gets all IP related to the protein, which Borean acquired through its 2004 takeover of Proteopharma. Apo A-1, Borean's lead candidate, is a naturally occurring component of high-density lipoproteins; studies have found that the presence of Apo A-1 in the blood inversely correlates with atherosclerotic incidence. In animal studies, Apo A-1 reduced the amount of plaques formed in arteries affected by atherosclerosis more effectively than a monomeric form of the protein. The candidate was developed with Borean's trimerization technology, which polymerizes molecules in bunches of three to increase the trimer's bond to a target. Roche expects Apo A-1 to complement compounds in its own pipeline, including a nuclear receptor modulator (in collaboration with Nippon Shinyaku) and a cholesteryl ester transfer protein inhibitor (licensed from Japan Tobacco), that are being studied to treat cardiovascular disease. Last year, Borean, a 2001 spin-off of Aarhus University, raised €5.5mm ($6.7mm) in a Series A financing to support Apo A-1's development.

CellGate Inc.

IsoTeknika Inc.

CellGate (molecular transporters and developing cancer drug candidates) has granted IsoTeknika (developing therapeutics for autoimmune diseases and prevention of organ transplant rejection) the option for an exclusive license to develop and market porphyrin conjugates that use CellGate's transporter platform to topically deliver the immunosuppressant ISA247 to patients with mild-to-moderate psoriasis. (Apr.)

CellGate gets $200k up front and another $300k on predetermined dates while it is performing feasibility studies over the course of one year to determine if the technology will successfully work with the drug candidate. IsoTeknika is currently conducting Phase III studies in Canada for the use of ISA247 in the systemic treatment of psoriasis and in Phase IIa trials to prevent organ transplant rejection in renal failure patients.

Cephalon Inc.

Pharmacopeia Drug Discovery Inc.

Pharmacopeia Drug Discovery (internally focuses on immunological diseases and provides drug discovery services) and Cephalon agreed to identify active drug candidates to advance through to safety and efficacy clinical trials. (May)

Cephalon will pay Pharmacopeia $15mm up front and identify hits and lead compounds. Once a compound is chosen, the companies will work together to move it into clinical trials, with Pharmacopeia providing medicinal chemistry and biological services and Cephalon supplying additional biological expertise (the company has researched cell signaling pathways, kinase inhibition, apoptosis, and angiogenesis). This phase of the deal is expected to last for three years. Cephalon is in charge of developing and marketing any candidates that advance further and will pay Pharmacopeia clinical, regulatory, and sales milestones, plus up to double-digit sales royalties. Pharmacopeia has an option to clinical development, and by electing this option, would pay Cephalon identical milestones and sales royalties. The companies have not disclosed the therapeutic areas involved in this alliance, but Cephalon is mainly a neurology company that also develops and markets treatments for oncology, cardiovascular, and infectious diseases. This is Pharmacopeia's second big drug discovery deal this year--in March it agreed to identify drug candidates for GSK's Center of Excellence for External Drug Discovery.

Diatos SA

Gilead Sciences Inc.

French biotech Diatos SA has licensed exclusive worldwide development and commercialization rights from Gilead Sciences to DaunoXome (liposomal daunorubicin), a drug sold by Gilead in over 20 countries for AIDS/HIV-related Kaposi's sarcoma. (May)

Diatos will focus on marketing of the compound for its approved indication in Europe and Brazil, and hopes to sign partners for commercialization in other territories. The company will also continue clinical trials that are underway for the drug as a treatment for acute myeloid leukemia. It will pay Gilead $4.7mm in up-front and milestone payments based on regulatory approval in new indications aside from Kaposi's sarcoma, and could also receive sales royalties. Daunorubicin in sustained-release liposomal formulation was developed to allow for higher dosing levels without increasing the risk for cardiotoxic and hematotoxic side effects that are common with systemic non-sustained release forms of the drug. Diatos adds it to its anticancer pipeline that includes DTS301, a new form of paclitaxel that is in Phase II trials for esophagus cancer (with MacroMed) and breast cancer, and other candidates based on the company's Vectocell drug delivery technology and Tumor-Selective Prodrug platform.

Eisai Co. Ltd.

Sumitomo Chemical Co.

Dainippon Sumitomo Pharma Co. Ltd.

Eisai has licensed development, manufacturing, and marketing rights to Dainippon Sumitomo Pharma's Gasmotin (mosapride). The license covers 10 countries that include China, India, and ASEAN members, such as Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand, and Vietnam. (Apr.)

Gasmotin, a selective serotonin 5-HT4 receptor agonist, helps to relieve gastrointestinal symptoms that accompany chronic gastritis, such as heartburn, nausea, or vomiting. The compound stimulates receptors in nerve plexuses of the gastrointestinal tract and increases the release of acetylcholine. Gasmotin has already been launched in Japan, China, and Korea and Eisai intends to have it on the market in ASEAN countries as soon as possible. Eisai is already marketing Pariet, a proton pump inhibitor for GERD, and Selbex for gastritis and gastric ulcers in Asia.

Entelos Inc.

Roche

In a two-year deal, Entelos (provides models that predict human response to therapeutics) will use its Metabolism PhysioLab technology to analyze the effects of Roche's compounds on metabolic pathways and/or biomarkers. (May)

Roche is responsible for R&D funding plus milestones and will use the information, along with existing preclinical and clinical data, to better design future clinical trials. PhysioLab incorporates aerospace engineering, medical decision analysis, and computer science technologies. It is a mathematical model of a disease that uses genomic, proteomic, physiologic, and environmental data to create virtual patients that simulate each subpopulation of a disease, from the most to least severe cases. Computerized experiments can be performed on these virtual patients to determine clinical responses to potential treatments. The Metabolism PhysioLab platform analyzes digestion, absorption, storage, mobilization, oxidation, and hormonal processes of carbohydrate, fat, and protein. Other companies and organizations that have used Entelos's metabolic computer model include J&J and the American Diabetes Association.

Esprit Pharma Inc.

Novavax Inc.

Novavax (drug delivery technologies) has granted Esprit Pharma exclusive North American development and marketing rights to its micellar nanoparticle (MNP) testosterone lotion in Phase II for female hypoactive sexual desire disorder (HSDD). (May)

Novavax gets clinical and regulatory milestones, plus royalties. Esprit is responsible for leading, and funding, all clinical programs, and Novavax will manufacture the finished product in its Philadelphia facility. Novavax's drug delivery technologies include MNP, and Novasomes and Sterisomes, which are subcutaneously injected solvent- and oil- free emulsions. Researchers estimate that about one-fourth of women in the US suffer from HSDD. The companies say the money on this deal is similar in scope to that of a deal they entered last year. Last year's deal, worth about $12.5mm in cash, gave Esprit N. American rights to Estrasorb, a treatment for severe menopausal hot flashes.

Flamel Technologies SA

Rhei Pharmaceuticals Inc.

Flamel Technologies SA (delivery of small molecules and proteins) licensed Rhei Pharmaceuticals, a company that in-licenses, develops, and sells drugs in the Chinese market, exclusive rights to sell the controlled-release aspirin Asacard in the Greater China territory including China, Taiwan, Hong Kong, and Macau. (May)

Flamel is in charge of commercially manufacturing the product. Asacard is marketed in multiple countries, including France and the UK--where it was launched by Flamel's European partner Searle (now Pfizer)--for prevention of cardiovascular disease. The drug incorporates Flamel's Micropump technology, which formulates tablets or capsules with thousands of microparticles that are released in the stomach and passed to the small intestine where the active ingredient is delivered at a controlled- or delayed-release rate over time. Compared with other aspirin formulations, Asacard has fewer GI side effects by avoiding Cox-1 inhibition and does not come in direct contact with the lining of the stomach and intestine. Flamel has incorporated the Micropump technology into other pipeline compounds including acyclovir for herpes and metformin for Type II diabetes. In addition, GSK, Merck, and TAP Pharmaceutical have licensed the delivery system to develop long-acting versions of their drug candidates.

Forbes Medi-Tech Inc.

KineMed Inc.

Cardiovascular disease-focused Forbes Medi-Tech signed an exclusive agreement with KineMed (studies molecular kinetics in diseases) to find non-CV uses for an undisclosed compound. (Apr.)

KineMed will use its KineMarker assays for in vivo analysis of compounds from Forbes's synthetic, small-molecule library (called FM-VPx). KineMed and Forbes can each opt to further develop the compound for any indication. KineMarker technology, originally licensed to KineMed from the University of California, tests a drug candidate's ability to target a disease by looking at the movement of the molecule--tagged with a non-radio-isotope--through the disease's metabolic pathways. Some of the diseases that KineMed has studied with the assays include cancer, Alzheimer's disease, and diabetes. Last year, the company applied this technology to Sosei's compound library.

General Electric Co.

GE Healthcare

Isogenica Ltd.

UK peptide discovery company Isogenica will use its CIS display technology to find peptides that bind to disease targets GE Healthcare will identify. (May)

The project will be run by a joint steering committee, and GE will have the option to develop any resulting imaging agents. CIS is an in vitro technology that uses the activity of RepA, a DNA-binding protein that attaches only to the molecule it was expressed from; thus the system generates libraries of high-affinity polypeptides in which each links to its own encoding DNA sequence. GE says it is interested in making deals like this one, with biotechs and academic research centers, because peptide-based radiopharmaceuticals offer hope for early diagnosis and fit in with the company's interest in personalized medicine.

GlaxoSmithKline PLC

Japan Tobacco Inc.

Japan Tobacco (tobacco, pharmaceutical, and food products) licensed GlaxoSmithKline exclusive worldwide rights to manufacture, develop, and market a preclinical MEK (mitogen-activated/extracellular signal-regulated protein kinase) inhibitor that has the potential to treat oncology and inflammatory diseases. (Apr.)

In exchange for the rights, GSK pays money up front, milestones, plus sales royalties. Japan Tobacco keeps co-promotion rights in Japan. The MEK inhibitor involved in this project consists of mitogen-activated protein kinase (MAPK), an important enzyme in the extracellular signal-regulated protein kinase (ERK) pathway. The ERK set of reactions are responsible for cell proliferation, differentiation, apoptosis, and angiogenesis. Another Big Pharma, AstraZeneca, is also working on an MEK inhibitor for cancer (in collaboration with Array BioPharma).

Immunomedics Inc.

UCB Group

Immunomedics (MAbs for cancer and autoimmune diseases) has granted UCB exclusive worldwide rights to develop, market, and sell the humanized monoclonal antibody epratuzumab for all autoimmune disease indications. The compound has already shown potential for systemic lupus erythematosus (SLE) and Sjögren's syndrome. (May)

Immunomedics gets $38mm up front ($25mm plus $13mm in development reimbursements) and could receive up to $165mm ($145mm in cash and $20mm in equity investments) upon regulatory approvals for various indications and within specific territories. It is also eligible for royalties in addition to an extra potential $135mm in sales-based milestones. Epratuzumab targets the CD22 marker on activated B-cells and is in two Phase III clinical trials for moderate and severe SLE, for which it has fast-track status. UCB is responsible for all development and commercialization costs associated with the compound; it will add epratuzumab to its own pipeline of candidates for various autoimmune and inflammatory diseases.

Intercell AG

Kirin Brewery Co. Ltd.

Kirin Brewery has been granted worldwide rights to develop and market monoclonal antibodies that protect against infections caused by Streptococcus pneumoniae. The license covers antigens discovered with Intercell AG's (vaccines for infectious diseases) Antigen Identification Program (AIP) technology. (Apr.)

Kirin will provide an up-front payment of €4mm ($4.9mm), milestones of €36mm, and what the companies call "significant" royalties. It will also pay for Intercell's development contributions. The companies will jointly complete preclinical work; Kirin is in charge of all clinical studies, registration, and marketing. The AIP platform determines protective antigens in vaccines that can block a pathogen's effectiveness. Kirin has experience in developing antibodies--it has used the KM Mouse (which it developed in collaboration with Medarex) to generate fully human antibodies to cancer (including solid tumors), infectious diseases, and inflammatory conditions.

IsoTeknika Inc.

Lux Biosciences Inc.

Canadian biotech IsoTeknika (auto-immune diseases and diagnostics) licensed ophthalmic disease company Lux Biosciences exclusive worldwide development and marketing rights to ISA247 for the treatment and prevention of all eye disorders, expanding the candidate's use beyond immunosuppression. (May)

Lux pays $3mm up front, milestones, and sales royalties, all of which could total up to $32.7mm. The company will fund preclinical and clinical development, which will be monitored by a joint committee of Lux and IsoTeknika members, as well as marketing activities and product registration. IsoTeknika will consult on clinical trial design and regulatory filings. ISA247 (renamed LX211 by Lux) has been studied in Phase III trials for psoriasis and Phase IIb trials for kidney transplant rejection. Lux plans to take LX211 into Phase III clinical trials, initially for the inflammatory eye disease uveitis in 2007, funding the development with money from its just-announced $36mm Series A financing. The candidate inhibits the calcineurin enzyme and has been shown to be less toxic than other calcineurin blockers such as cyclosporine and tacrolimus. IsoTeknika has also partnered the compound with Roche and Atrium Medical, and last month gave CellGate an option to exclusively license the compound for topical delivery.

Kos Pharmaceuticals Inc.

Kos Life Sciences Inc.

SkyePharma PLC

Jago Holding AG

After several attempts to secure a partner, drug delivery company SkyePharma's Jago Holding subsidiary has signed a deal with Kos Pharmaceuticals' (respiratory and cardiovascular medicines) Kos Life Sciences unit, giving Kos exclusive rights to the Phase III asthma candidate Flutiform. (May)

Kos will have rights in the US and first negotiations rights in Canada in exchange for a $25mm up-front payment, up to $140mm in regulatory and sales milestones, plus a mid-teens royalty rate. SkyePharma is responsible for completing Phase III trials, filing the NDA (expected in the second half of 2007), and product supply; Kos will take over further development starting with Phase IIIb trials, possibly investigating the drug candidate for the additional indications of chronic obstructive pulmonary disease and pediatric asthma, and conduct post-marketing studies. Flutiform is a twice-daily combination of formoterol and fluticasone in a metered-dose inhaler that incorporates SkyePharma's SkyeDry technology, which helps improve the stability of the active ingredients and reduce loss in adsorption. It may compete against GSK's Advair and AstraZeneca's Symbicort. SkyePharma is looking to partner Flutiform in European and other international markets. In the US, the company hopes to take advantage of Kos's marketing capabilities, backed by an anticipated 1,000-person sales force when Flutiform is launched. The deal expands Kos's reach into the respiratory category, providing the company with a potential companion to its asthma treatment Azmacort (acquired from Aventis in 2004).

Medarex Inc.

Oxford Genome Sciences (UK) Ltd.

Personalized cancer medicine company Oxford Genome Sciences (OGeS) and Medarex have partnered to discover new targets for colorectal and other cancers. (May)

The companies will use their respective technologies to discover, develop, and commercialize, on a 50/50 basis, human antibody therapeutics. OGeS will first use its Oxford Genome Anatomy Project (OGAP), which combines genomic, proteomic, and clinical information from blood and tissue samples, to find colorectal cancer targets. Medarex will then apply to those targets its UltiMAb Human Antibody Development System to generate fully human monoclonal antibodies. Both parties have been deal-active in recent months; OGeS partnered with the University of Oxford to use OGAP to identify colorectal cancer biomarkers, and Medarex has entered UltiMAb agreements with Ono Pharmaceutical and Organon.

MedPointe Inc.

Questcor Pharmaceuticals Inc.

Specialty pharma MedPointe licensed Questcor Pharmaceuticals (prescription CNS drugs) US rights to the insomnia drug Doral (quazepam), a selective benzodiazepine receptor agonist, for $2.5mm in cash. (May)

Questcor will also make a milestone payment of $1.5mm within 45 days of FDA approval of an alternative source to manufacture and supply the active ingredient initially for three years. Doral, originally developed by Schering-Plough, was sublicensed to Carter-Wallace (now MedPointe) by Ivax in 1996. Questcor will pay Ivax a royalty on net sales and re-introduce Doral in the third quarter of 2006, backed by a 40-person neurology sales force. The drug will complement the company's severe multiple sclerosis treatment, HP Acthar gel, sold by the same reps. Questcor says that Doral has a longer half-life and better side effect profile compared with traditional benzodiazepines and other sleep disorder treatments. In 2005, the drug had ex-factory sales, or sales after leaving the manufacturer, of $1.1mm. Questcor has been concentrating on its CNS business since selling two marketed drugs and an imaging agent to QOL Medical last October.

Mission Pharmacal Co.

Presutti Laboratories LLC

Presutti Laboratories LLC (specialty pharmaceuticals) has granted Mission Pharmacal (provides drugs, nutraceuticals, and diagnostics for unmet medical needs) US marketing and manufacturing rights to its Tindamax (tinidazole tablets) for the sexually transmitted disease trichomoniasis. (Apr.)

Tindamax is a second-generation 5-nitroimidazole drug approved by the FDA in mid-2004 not only for the STD, but also for infections of the intestines, including giardiasis (caused by the parasite Giardia duodenalis in water) and amebiasis (caused by the protozoan parasite Entamoeba histolytica), as well as amebic liver abscess (a pocket of pus in the liver that is also caused by the Entamoeba histolytica parasite). The tablets are available in 250mg and 500mg and can be prescribed as a one-day, one-dose treatment for trichomoniasis or giardiasis in men and women. Each year in the US, there are about 7.4 million patients treated for trichomoniasis (making it the most common non-viral STD) and 2.5 million are treated for giardiasis. Investment Banks/Advisors: William Blair & Co. (Presutti Laboratories LLC)

PharmaKodex Ltd.

Unilever PLC

Vectura Group PLC

Unilever PLC, through its VC branch Unilever Ventures, has teamed up with Vectura Group PLC (pulmonary drug delivery) to form a UK joint venture, named PharmaKodex Ltd., which will develop a pipeline of prescription and OTC candidates. (May)

Established last year as a spin-off of Vectura's oral and transdermal delivery technologies (so Vectura could focus on inhaled delivery), PharmaKodex will get significant equity funding from both Vectura and Unilever. It will gain two Unilever enabling platforms: Encapsol, an encapsulation technology; and for formulation/solubilization, Maxsol NS, a nanoparticle technology to improve oral bioavailability. Additionally it has Vectura's Accustar, an easy-to-swallow Solid Syrup presentation capable of rapid dissolution, as well as Pandermal, a patchless transdermal delivery system with high payload capability. The JV will have a pipeline of seven prescription compounds (five oral and two transdermal) and six OTC candidates for indications including CNS, anti-infective, GI, musculoskeletal, and cough/cold. The company will utilize the enabling and delivery technologies of both partners to reformulate the existing versions of already-approved drugs for new indications or improved administration. PharmaKodex will first, through licensing deals, bring forward a small number of OTC products. The company believes these will reach the market quickly and should generate revenues for the development of the prescription pipeline, which it plans to bring to Phase II before partnering. PharmaKodex anticipates a Series A round in which it hopes to get financing from mostly UK life science backers, but also European and US investors.

PsychoGenics Inc.

Sosei Co. Ltd.

PsychoGenics (CNS drug discovery) and Japanese pharma Sosei (new uses for existing drugs) will combine resources to discover and eventually sell CNS medicines. (Apr.)

PsychoGenics will use its in vivo drug discovery technologies to evaluate CNS activity of candidates from Sosei's Drug Reprofiling Platform, a database of known drugs and compounds stalled in development that were licensed to Sosei from various Japanese pharmaceutical companies. PsychoGenics's behavioral animal tests incorporate robotics, computerized video, and bioinformatics analyses to automate the capture of discovery data. It has partnered its platform with pharmas, academic institutions, and non-profits such as Eli Lilly, Harvard Medical School , and the ALS Association to discover therapies for anxiety, depression, amyotrophic lateral sclerosis, pain, and other neurological diseases.

Schering-Plough Corp.

Schering-Plough Research Institute

Xoma Ltd.

Antibody developer Xoma will apply its technologies to targets chosen by Schering-Plough Research Institute (SPRI) to discover and develop monoclonal antibody therapeutics. (May)

In exchange for its IP and expertise, Xoma will receive an up-front payment, milestones, R&D funding, and sales royalties. The company says the collaboration could be worth between $25-75mm. Xoma will first identify antibodies to at least one SPRI target; it will then use its Human Engineering technology to humanize those antibodies. Xoma will handle preclinical studies and cell line and process development, and it will generate antibodies for use in the first clinical trials.

Financings

Acusphere Inc.

Acusphere (uses its porous microparticle technology to create new drug formulations) has netted $37.7mm with the private placement of 5.8mm units to institutional investors. The units, which included one common share and a warrant to buy 0.30 common shares at $7.97 each, were priced at $6.97 apiece (a 3% premium). Cowen & Co. acted as placement agent for the transaction. (Apr.)

Investment Banks/Advisors: Cowen & Co. LLC

Adherex Technologies Inc.

Cancer drug company Adherex Technologies grossed $6.5mm through the private placement of 7.75mm common shares priced at $0.84 each (a 14% discount to the market average). Investors (including Quintiles PharmaBio Development) also received 0.30 of a common share purchase warrant for every share bought; each whole warrant entitles the buyer to one common share at an exercise price of $0.97 each over the course of four years. Rodman & Renshaw acted as the placement agent. (May)

Investment Banks/Advisors: Rodman & Renshaw Inc.

AdventRx Pharmaceuticals Inc.

AdventRx (antiviral and cancer therapeutics) filed for and then withdrew a follow-on public offering of 15.4mm common shares. Based on the company's trading average before the initial announcement, AdventRx could have grossed over $72mm. Citing poor market conditions, the company decided to pull the filing and instead focus on initiating pivotal clinical trials on its candidates, one of which is CoFactor; it just completed Phase II trials in conjunction with the widely used chemotherapy 5-fluorouracil (5-FU) to treat metastatic colorectal cancer. (May)

Investment Banks/Advisors: Fortis Securities Inc.; UBS Investment Bank; RBC Capital Markets; CIBC World Markets Corp.

Amicus Therapeutics Inc.

Amicus Therapeutics, a developer of small molecules for genetic diseases, hopes to raise up to $86.25mm in its initial public offering. (May)

The company, founded in 2002, will put most of the proceeds towards clinical and preclinical development of its pipeline of medicines for lysosomal storage diseases, or disorders affecting lysosomal enzyme metabolism. Its lead candidate Amigal is in Phase II trials for Fabry disease, which often causes kidney failure and cardiac and neurological problems. Amicus just filed an IND for its second candidate, AT2102, for Gaucher disease, and AT2220 is in preclinical studies for the muscle debilitating Pompe disease. The company acquired worldwide patent, development, and commercialization rights to these candidates from Mount Sinai School of Medicine. The orally-administered treatments, which Amicus calls pharmacological chaperones, selectively bind to misfolded proteins to help increase protein stability and biological activity. Amicus says that pharmacological chaperones provide broader tissue distribution, an easier route of administration, and a simpler manufacturing method compared with the current standard of treatment for lysosomal storage diseases, enzyme replacement therapy. Genzyme and Shire's marketed enzyme replacement therapies are expected to compete with Amicus's products. Eventually the company may apply the pharmacological chaperone technology to neurological, cardiovascular, oncology, and metabolic diseases. So far, Amicus has raised over $80mm with private financings, completing a Series C round last September. Investment Banks/Advisors: Morgan Stanley & Co.; Goldman Sachs & Co.; Pacific Growth Equities

Avigen Inc.

Avigen, a company concentrating on CNS disorders, netted about $19.4mm through a private placement of 3.9mm common shares priced at $5.37 each (a 7% discount) to institutional investors including Biotechnology Value Fund, Apex Capital, Federated Kaufman Fund, and Fort Mason Capital. RBC Capital Markets acted as the lead placement agent with CIBC World Markets as the co-lead. The company will use the proceeds to develop its pipeline of small-molecule candidates tolperisone (AV650) in Phase III for neuromuscular spasms and spasticity (just licensed this year from Sanochemia Pharmazeutika); AV411 in Phase I for chemotherapy- and trauma-induced neuropathic pain; and AV513, a preclinical candidate for hemophilia. Avigen is also conducting animal studies of another compound, AV333, for neuropathic pain. (May)

Investment Banks/Advisors: CIBC World Markets Corp.; RBC Capital Markets

Caprion Pharmaceuticals Inc.

Caprion Pharmaceuticals (proteomics) has filed for its initial public offering on the Toronto Stock Exchange. (May)

Caprion states that it will use 80% of the proceeds to continue clinical programs, 10% for preclinical studies, and the remainder for corporate purposes. Its lead candidate ShigamAbs is an intravenously administered combination of two monoclonal antibodies and is currently in Phase I trials to treat Shigatoxin-producing E. coli infection. Caprion's other clinical compound is CAP232, an IV peptide in Phase I/II trials for melanoma and pancreatic cancer. The company uses its CellCarta discovery engine to identify proteins for use as drug targets; the technology is the basis of collaborations with Biogen Idec, Abbott, Icos, and the National Institute of Allergy and Infectious Disease. Investment Banks/Advisors: Versant Ventures; GMP Securities; Orion Securities Inc.; Canaccord Capital Corp.; TD Securities Inc.

ConjuChem Inc.

ConjuChem (peptide therapeutics) grossed $14.18mm ($Cdn15.75mm) with a bought deal public financing of 7.5mm shares at $2.10 each. The money will support ongoing development of its compounds, including two that are based on the company's Drug Affinity Construct (DAC) and Preformed Conjugate-Drug Affinity Construct (PC-DAC) bioconjugation platforms that create drugs that are safer and last longer than other therapeutics. (May)

Investment Banks/Advisors: Sprott Securities Ltd.; Orion Securities Inc.

Derma Sciences Inc.

Derma Sciences (manufactures and markets sprays and ointments for dermatological conditions and wound healing) has raised $6.4mm with the private placement of 10.9mm common shares priced at $0.60 each (a 26% discount) to accredited investors, including drug development partner Comvita New Zealand (which provided $1mm). The backers also received five-year warrants to buy an additional common share at $1 each. The company will use the proceeds to pay for its $6.5mm acquisition of wound dressing company Western Medical announced earlier this month. (Apr.)

Investment Banks/Advisors: Oppenheimer & Co. Inc.; Taglich Brothers Inc.

DOR BioPharma Inc.

DOR BioPharma (developing biodefense vaccines and therapeutics for cancer side effects) has raised $3.63mm with the private placement of 13.1mm common shares priced at $0.28 each (a 22% discount) to Iroquois, Nite Capital, Platinum Partners, Highbridge, Alpha Capital, Bristol Capital, and several individual investors. The backers also received three-year warrants to buy an additional 13.2mm common shares at $0.45 apiece. Midsouth Capital acted as placement agent for the transaction. The company will use the proceeds to continue the development of candidates in its biodefense programs, including vaccines for ricin and botulinum toxins, to prepare for the upcoming NDA filing for orBec, a corticosteroid that has completed Phase III studies for intestinal graft vs. host disease. (Apr.)

Investment Banks/Advisors: Midsouth Capital

Dynavax Technologies Corp.

Private equity firm Symphony Capital has formed financing and clinical development vehicle Symphony Dynamo and funded the new company with $50mm to continue development on Dynavax's cancer, hepatitis B and hepatitis C programs. (Apr.)

Dynamo will develop Dynavax's immunostimulatory sequence compounds, including its Phase II non-Hodgkin's lymphoma compound and preclinical hepatitis B and hepatitis C projects. Symphony Capital has financed the venture with $20mm up front and will provide another $30mm within one year. In addition, Dynavax has issued Dynamo investors five-year warrants to purchase 2mm common shares at $7.32 per share (Dynavax's current market price is around $5.45). At specified times during the term of the agreement, Dynavax has the exclusive option to buy back any or all of the programs under development at Dynamo. Investment Banks/Advisors: JMP Securities LLC

Enzon Pharmaceuticals Inc.

Enzon Pharmaceuticals netted $267.5mm (including the overallotment) through the sale of 4.0% senior convertible notes due 2013. The notes convert to common stock at $9.55 per share. The company is developing injectable therapeutics for cancers and life-threatening diseases using its PEGylation and antibody engineering technologies. Enzon has partnerships with various drug development companies including NatImmune, Nektar Therapeutics, SkyePharma PLC, and Schering-Plough. (May)

Hana Biosciences Inc.

Oncology therapeutics company Hana Biosciences netted $37.6mm through the private placement to institutional investors of 4.7mm common shares priced at $8.50 each (an 18% discount to the market average.) Oppenheimer and the Jeffries Group acted as placement agents. Hana will use the proceeds to fund the upcoming launch of Zensana (ondansetron oral spray) for chemotherapy-induced nausea and vomiting. (May)

Investment Banks/Advisors: Jefferies Group Inc.; Oppenheimer & Co. Inc.

Hutchison China Meditech Ltd.

Hutchison China Meditech Ltd. (Chi-Med), the holding company of a health care group based in China (but itself incorporated in the Cayman Islands), has gone public over the AIM. It sold 14.55mm ordinary shares at 275 pence, for net proceeds of £37mm ($68mm). The company is a division of diversified, Hong Kong-based Hutchison Whampoa Ltd. (May)

Chi-Med's health care group, which was set up in 2000 and has around 1,900 employees, reported 2005 sales of $37.9mm. The company develops and sells (primarily in Asia) traditional, botanical Chinese medicines. It also has a pharmaceutical R&D unit focused on cancer and autoimmune diseases; this business has a radiosensitizer in Phase I/II US trials for head and neck cancers, as well as a candidate for Crohn's disease. Chi-Med plans to use the bulk of the money raised to finance its pharmaceutical R&D efforts. The company wishes to soon bring its products to the US and European markets. Investment Banks/Advisors: Panmure Gordon; Lazard LLC

Medivation Inc.

Medivation (therapeutics for neurological diseases and cancers) netted $13.25mm through the private placement of 3mm common shares priced at $4.75 each (a 9% discount to the market average). Emerging Growth Equities acted as the placement agent. Medivation will put the proceeds towards its drug candidates in development, including dimebon, in Phase II trials for Alzheimer's disease and preclinical studies for Huntington's disease, and a series of preclinical compounds for prostate cancer. (May)

MethylGene Inc.

Canadian cancer and infectious disease therapeutics developer MethylGene has raised $19.9mm ($Cdn22.8mm) by selling units at $3.10 apiece to new investors ProQuest Investments (which led the transaction), Domain Public Equity Partners, CIBC Capital Partners, and Pappas Ventures, and to an existing institutional investor FTQ (which now holds a 15.4% stake). (May)

Each unit consists of a common share and 0.30 of a three-year purchase warrant (making a total of 7.4mm common shares plus 2.2mm warrants, the latter exercisable at $3.90, $4.10, and $4.25 in the first, second, and third years, respectively). Using its platform that inhibits the histone deacetylase enzymes, which are thought to regulate disease processes, the company has brought two oncology candidates into development: MGCD0103 and MG98.

Minrad International Inc.

Interventional pain management company Minrad International netted $30.4mm in its initial public offering of 10mm common shares at $3.25. (May)

The company will put about $10mm of the proceeds towards a capital investment in its corporate headquarters and expansion of its Pennsylvania facility. Another $5mm will fund new product development, including a generic formulation of the inhalation analgesic desflurane (expected to be launched in 2007 following expiration of Baxter's patent), a delivery system for halogenated ethers in the conscious sedation of hospital patients, and an adsorbent to remove carbon dioxide from the gas stream during anesthesia. Minrad sells the generic inhalation anesthetics isoflurane, enflurane, and sevoflurane, which are administered to human and veterinary patients during surgery. The company also markets SabreSource, an imaging device accessory to the C-arm fluoroscope, and the disposable needle placement instrument Light Sabre used to view minimally invasive surgical procedures for pain management. These technologies also have potential in orthopedics, neurosurgery, and interventional radiology. Investment Banks/Advisors: Oppenheimer & Co. Inc.; KeyBanc Capital Markets; Maxim Group LLC

Neurologix Inc.

Neurologix (gene delivery for neurological disease) raised $12mm with the private placement of about 345k shares of Series C preferred stock at $35. Each share can be converted into 19.66 common shares. The financing was led by General Electric Pension Trust and DaimlerChrysler Corp. Master Retirement Trust and included funds managed by ProMed Management (specifically ProMed Partners, ProMed Partners II, ProMed Offshore Fund, and ProMed Offshore Fund II). (May)

Investors also received warrants to buy an additional 2.2mm common shares for $2.05 each (14% higher than the present market average). The financing will help the company complete Phase I trials of NLXP101 (glutamic acid decarboxylase) for Parkinson's disease and find manufacturing partners for the compound. Neurologix is working with Medtronic on a companion micro-infusion catheter to deliver NLXP101. The company also plans to put the money towards NLXE201, in Phase I studies for epilepsy, and other (preclinical) polypeptides, which will be developed for Huntington's disease and neuroprotection. The compounds incorporate Neurologix's NLX technology, which uses a viral vector to deliver and introduce a therapeutic gene into the cell.

NicOx SA

NicOx SA (developing nitric-oxide-donating therapeutics for inflammatory, cardiovascular, and metabolic conditions) has netted €43mm ($53.6mm) through the sale of 4.6mm new ordinary shares at €10 each (a 7% discount) to 43 US and European institutional investors. The company will use the proceeds to continue development of its lead drug candidate, HCT3012, which is in Phase III for osteoarthritis. (Apr.)

Novacea Inc.

Novacea (oncology therapeutics) has netted $37.78mm in its initial public offering. The company sold 6.25mm common shares at $6.50 each, after originally anticipating a price between $11-13. (May)

Novacea will use the proceeds to continue development of its clinical-stage cancer candidates. The lead is DN101, in Phase III trials for androgen-independent prostate cancer. It is being developed to work alongside other chemotherapeutics, such as docetaxel (Taxotere), to improve treatment outcome. Novacea is developing its two other candidates with partners: oral vinorelbine was in-licensed through a 2005 deal with Pierre Fabre for metastatic breast or non-small cell lung cancer and is entering Phase III trials in the US and Canada, while AQ4N, licensed from KuDOS in 2003, is entering Phase I/II in the US, Canada, and Mexico for glioblastoma multiforme. Investment Banks/Advisors: Cowen & Co. LLC; Pacific Growth Equities; Bear, Stearns & Co. Inc.; HSBC

Osiris Therapeutics Inc.

Osiris Therapeutics (stem cell company developing treatments for inflammatory, orthopedic, and cardiovascular conditions) has filed for an initial public offering that could bring in up to $80mm. (May)

Osiris, which had originally intended to raise $30mm in 1997 with an IPO that was later withdrawn, plans to use the proceeds to repay its outstanding $20.6mm promissory note and to continue clinical studies of its drug candidates. The company is developing Phase II Prochymal for acute graft vs. host disease and Crohn's disease; Phase I Provacel to prevent scarring of heart muscle in patients who have suffered myocardial infarction; and Phase I/II Chondrogen to regenerate the meniscus cartilage of the knee and prevent osteoarthritis. Osiris already markets Osteocel for osteoconduction, osteoinduction, and osteogenesis; the product enables orthopedic surgeons to treat conditions that require bone growth without the pain of autograft harvesting. Investment Banks/Advisors: AG Edwards & Sons Inc.; Deutsche Bank AG; First Albany Capital Corp.; Pacific Growth Equities

Peregrine Pharmaceuticals Inc.

Peregrine Pharmaceuticals (has clinical-stage candidates for cancer and viral diseases) netted $4.9mm by selling 4mm common shares at $1.23 (a 15% discount) to institutional investor Double U Master Fund (managed by Navigator Asset Management). (Apr.)

Pharmasset Inc.

Pharmasset (developing therapeutics for viral diseases) has filed for an initial public offering of up to $75mm in common shares. (May)

The company will use the proceeds to continue development of its lead drug candidates, clevudine and racivir, and for preclinical studies of R4048. Both clevudine and racivir are in Phase II: racivir is in development for HIV and clevudine, in-licensed from Bukwang Pharm Co. in mid-2005, should start Phase III trials in hepatitis B by the end of this year. Roche and Pharmasset are co-developing prodrugs of the Pharmasset compound PS16130, including R4048 for hepatitis C, expected to begin Phase I trials at the beginning of 2007. Investment Banks/Advisors: UBS Investment Bank; JMP Securities LLC; Banc of America Securities LLC

Scolr Pharma Inc.

Scolr Pharma (specialty pharmaceuticals and drug delivery technologies) has netted $10.9mm in a placement of 2.37mm common shares at $5 each (a 6% discount) to institutional investors. Taglich Brothers and Roth Capital Partners acted as placement agents. (Apr.)

Scolr is using its Controlled Delivery Technology to create extended-release formulations of gabapentin (the active pharmaceutical ingredient, or API, in Pfizer's Neurontin) for neural pain and as an adjunct treatment for epilepsy; the allergy and common cold drug pseudoephedrine; the decongestant phenylephine, which is sometimes substituted for pseudoephedrine due to regulatory restrictions; ondansetron (the API in GSK's Zofran) for nausea and vomiting caused by chemotherapy and radiation; and immediate-release forms of the APIs in Eli Lilly's osteoporosis drug Evista and Abbott Laboratories' Tricor for hypercholesterolemia. Investment Banks/Advisors: Taglich Brothers Inc.; Roth Capital Partners

Sirna Therapeutics Inc.

Sirna Therapeutics (developing RNAi drug candidates) has netted $41.1mm in a follow-on public offering of 9mm common shares at $5 each. The company had originally planned to sell only 8mm shares. Some stockholders, including Oxford Bioscience Partners, the Sprout Group, and Venrock Associates, had planned to sell off 2mm shares in a secondary offering but decided against it. Sirna is developing treatments for age-related macular degeneration, hepatitis B and C, asthma, Huntington's disease, diabetes, respiratory syncytial virus, and dermatological conditions. (May)

Investment Banks/Advisors: JP Morgan Chase & Co.; Leerink Swann & Co.; CIBC World Markets Corp.; Brean Murray & Co. Inc.; UBS Investment Bank

Sonus Pharmaceuticals Inc.

Cancer therapeutics company Sonus Pharmaceuticals netted $28.8mm by selling 6.13mm common shares at $5 each (a 9% discount) to a group of new and existing institutional investors led by Federated Kaufmann. Sonus will use some of the proceeds to fund its share of development costs for Tocosol, a paclitaxel breast cancer candidate it licensed to Schering AG last year. (May)

Investment Banks/Advisors: Punk, Ziegel & Co.; Needham & Co. Inc.; ThinkEquity Partners LLC

Tapestry Pharmaceuticals Inc.

Tapestry Pharmaceuticals (developing cancer therapeutics) netted $24mm in the private sale of 12.75mm common shares at $2 (a 45% discount). Investors also received warrants to buy another 12.75mm common shares at $2.40. (Apr.)

Participants included Special Situations Funds (managed by KPS Investments), Tang Capital Partners, Baker Brothers Investments, Biotechnology Value Fund, Fort Mason Partners, Capital Ventures International, Merlin BioMed, Versant Capital Management, Heights Capital Management, Xmark JV Investment Partners, and individual backers. Investment Banks/Advisors: Ferghana Securities; Reedland Capital Partners

Vaccinoma Inc.

Australia's Vaccinoma (therapeutic cancer vaccines) has filed for its initial public offering, hoping to bring in AUS$17mm ($12.8mm) through the sale of 17mm shares priced at AUS$1 each. (Apr.)

The company will use the proceeds mainly to continue clinical trials of its melanoma vaccine, which is entering Phase III. The global market for melanoma is estimated at about $1.5bn, and Australia carries the highest incidence of skin cancer in the world. Vaccinoma intends to pursue cGMP manufacturing and orphan drug status in the US following its IPO and to continue human trials there, where it has received $11mm in research funding from the FDA, the National Institutes of Health , and the National Cancer Institute . Outside of melanoma, Vaccinoma will put a portion of the IPO funding towards upcoming Phase I trials of a breast cancer vaccine candidate. It plans to list on the Australian Stock Exchange, and hopes to bring on its first staff members post-IPO; up until now, it has mainly been operating as a virtual company.

Ziopharm Oncology Inc.

Ziopharm Oncology (in-licenses cancer therapeutics) netted $34.4mm by privately placing about 7.9mm common shares at $4.63 (a 7% discount). New investors ProQuest Investments, LB I Group (affiliated with Lehman Brothers), Emerging Technology Partners, Knott Partners, Panacea Asset Management, and Cycad Group were the US buyers, while Henderson Global, from the UK, and funds associated with Medical Strategy in Germany also participated. (May)

Paramount BioCapital and Griffin Securities acted as the placement agents. The company will use the funds for clinical development of its lead product candidates: ZIO101 is an organic arsenic in Phase I/II trials for advanced myeloma and ZIO201 is in Phase I/II trials for advanced sarcoma and solid tumors. Investment Banks/Advisors: Paramount BioCapital Inc.; Griffin Securities Inc.

Research/Analytical

Acquisitions

Thermo Electron Corp.

Fisher Scientific International Inc.

Analytical instrument maker Thermo Electron Corp. will reverse-merge with Fisher Scientific International (research products and services) to create the new company Thermo Fisher Scientific. Thermo will pay about $9.6bn in stock and take on $2.2bn of Fisher's debt. (May)

Thermo is giving two shares of its common stock (averaging $38.57 apiece) for each Fisher share. Thermo's shareholders will own 39% of the new company while Fisher's investors maintain the other 61%. Thermo's CEO will assume the same role for the combined company, which is expected to have over $9bn in revenues in 2007. The deal--expected to close in the fourth quarter of this year--will create a company that offers both laboratory equipment and the consumable supplies, such as biochemicals and bioreagents, used in the lab (approximately 80% of Fisher's revenues are generated from consumable products). In addition, Fisher markets cell-culture media, liquid-handling systems, diagnostic kits and reagents, lab instruments, workstations, and fume hoods, and safety-related products such as personal protection equipment. The company also provides scientific and health care services for clinical trial testing and outsourced manufacturing. Fisher, which has about $434mm cash on hand as of March 31, 2006, brought in $5.6bn in revenues and a net income of $389mm in 2005. Thermo markets its analytical instruments in chromatography, mass and molecular spectroscopy, environmental monitoring, and other areas to scientific, drug discovery, clinical, environmental and industrial laboratories. Just last year, the company sold its Thermo BioStar diagnostics subsidiary to Inverness Medical Innovations to focus on its instrumentation business. Investment Banks/Advisors: Rothschild Inc.; Lehman Brothers Inc. (Thermo Electron Corp.); Lazard LLC; Goldman Sachs & Co. (Fisher Scientific International Inc.)

Financings

Illumina Inc.

Illumina (functional genomics research and analysis) netted $96.2mm in a follow-on offering of 4.025mm common shares (including the overallotment) at $25.50 each. The company's genotyping and gene expression profiling systems are offered to researchers requiring large-scale genomic work-ups. (May)

Investment Banks/Advisors: Goldman Sachs & Co.; Merrill Lynch & Co. Inc.; Robert W. Baird & Co. Inc.; Cowen & Co. LLC

Supplies, Equipment & Devices

Acquisitions

Angiotech Pharmaceuticals Inc.

Quill Medical Inc.

Biomaterial and drug-coated device company Angiotech has agreed to acquire Quill Medical (minimally invasive surgical wound closure) for $40mm in cash plus sales earn-outs. (May)

Angiotech takes on all of Quill's technologies and IP, and also gains control of the company's Contour Threads anchoring suture line that is licensed to Angiotech's Surgical Specialties division. Contour Threads and other Quill suturing and wound-healing threading products have tiny, evenly spaced barbs that are self-anchoring, as opposed to customary smooth sutures. Contour Threads are FDA-approved to provide the effect of a minimally invasive face lift-type procedure (lifting sagging tissue) without dissection and open surgery. In addition to aesthetics, Angiotech believes the technology, which it will integrate into its own wound healing business, has implications in all areas of surgery that require suturing, including general surgery and specialty tissue repair.

Hologic Inc.

AEG Elektrofotografie GMBH

Women's health care and diagnostics developer Hologic has acquired Germany's privately held AEG Elektrofotografie GMBH (photoconductor materials manufacturer) and its associated group of companies for €21mm ($26mm) plus earn-outs. (May)

Hologic paid €16.3mm in cash and issued 109,720 of its common shares (valued at €4.6mm based on the pre-announcement market average) to AEG. It has also agreed to pay an additional earn-out of €1.7mm cash if AEG's 2006 EBITDA exceeds a pre-set amount. AEG was founded in 1970 and had 2005 revenues of approximately €42.7mm. The company makes photoreceptors for electrophotographic processes such as copying, printing, and x-ray imaging. The company also manufactures amorphous selenium photoconductor coatings, and is the sole selenium supplier for Hologic's Selenia full-field digital mammography detectors. AEG is the third acquisition for Hologic in recent months; in April it bought both R2 Technology (CAD system developer) and Suros Surgical (minimally invasive biopsy and tissue excision systems).

Johnson & Johnson

Ethicon Inc.

Vascular Control Systems Inc.

Johnson & Johnson's Ethicon division has completed the acquisition of Vascular Control Systems, a company that is developing minimally invasive medical devices to treat fibroids and control bleeding during obstetric and gynecological procedures. (May)

Vascular Control, established in 1998, markets two doppler-guided devices. The flostat clamp is used for bilateral temporary occlusion of arteries in the uterus during laparoscopic myomectomy and other conservative surgeries, while the Cstat is designed to limit blood loss during open GYN procedures.

Joint Arrangements

American Medical Systems Holdings Inc.

BioControl Medical Ltd.

BioControl Medical (developing next-generation implantable devices) granted American Medical Systems Holdings (gynecological and urological devices and procedures) an exclusive license to use its miniaturo implantable electrical stimulation system for urological, GYN, and other pelvic conditions. AMSH will first complete the development of miniaturo for urge incontinence and interstitial cystitis. (Apr.)

BioControl gets up to $52.5mm: a $25mm up-front payment; milestones that include $7.5mm upon completion of a pilot trial for urge or frequency incontinence, $7.5mm when 30 devices are ready for implantation and AMSH gets the CE Mark or once five devices have been implanted, and $10mm when the device is given FDA approval for the first indication; and an additional payment of $2.5mm when all of the designated employees have remained at the company for a one-year period. AMSH has also agreed to pay royalties for the first ten years of the agreement, consisting of 6% for the first three years, 5% for the next three years, and 4% for the remaining term. In addition to the miniaturo system, BioControl has the implantable neurostimulator CardioFit in development for congestive heart failure.

Bang & Olufsen Medicom AS

Bespak PLC

Bespak PLC (airway management devices and consumer dispensers) and Bang & Olufsen Medicom AS (drug delivery devices to improve patient compliance) signed an exclusive agreement to jointly develop, manufacture, and sell Bang & Olufsen's Assist Actuated Inhaler, aiming to reach the asthma and COPD markets. (Apr.)

Assist will contain a single-increment dose counter that helps patients prevent both under- and over-counting in order to achieve exact dosing. The device is designed to release the drug ingredient with about half the force of a conventional inhaler. The companies are looking for a pharmaceutical partner to provide a metered-dose inhaler (MDI) companion. Bang & Olufsen will contribute its IP and expertise in design and development of dose-counting mechanisms while Bespak provides knowledge of valve technologies used in a variety of formulations. Pharmas that have used Bespak's MDI valves include Schering-Plough, GSK, and Sanofi-Aventis. Bespak recently got a boost to its airway management business through the December 2005 acquisition of King Systems, which makes disposable critical care products.

Devax Inc.

SurModics Inc.

Medical device developer Devax licensed rights to use hydrophilic technology from SurModics (surface modification technologies for drug delivery, cell encapsulation, devices, and diagnostics) in its Axxess Biolimus A-9 eluting bifurcation stent for interventional cardiology procedures. (Apr.)

SurModics's technology consists of a lubricious coating (called PhotoLink) that is applied to medical device substrates to reduce static friction on the surface, allowing physicians more precise control and ease of use while increasing patient comfort. Axxess is a drug-eluting stent made up of expanding nickel titanium alloy that can reach both branches of a coronary bifurcation. It incorporates the cell growth inhibitor compound Biolimus A-9, which Devax licensed from Occam International in 2004. Bravo, another drug-eluting coating technology that SurModics has developed, is used with the company's coronary stent and I-vation eye implant.

Female Health Co.

Fuji Latex Co. Ltd.

Fuji Latex Co. Ltd. has agreed to exclusively sell and distribute Female Health Co. 's FC Female Condom in Japan. (Apr.)

The companies first signed an importation and quality agreement in early 2004; since that time, Fuji Latex has gotten Japanese regulatory approval to import the FC Female Condom. The companies say that out of all of the developed countries, Japan is the largest male condom market; Fuji Latex, already considered one of the largest manufacturers and distributors of male condoms there, plans to begin marketing the female product this month. The FC Female Condom is already sold in over 100 countries, including the US, the UK, Australia, Canada, France, Germany, Japan, and Mexico. It is marketed under the brand names Bliss, Care, Confidom, Feel, Femidom, Femy, OK Female Condom, Preservativo, Protectiv, and Reality.

General Electric Co.

GE Healthcare

St. Jude Medical Inc.

GE Healthcare and St. Jude Medical (cardiovascular devices) will work together on the development of a cardiovascular ultrasound imaging system with intracardiac echocardiography capabilities. The device will be used to treat patients with heart rhythm disease and those who have suffered a stroke. (May)

The product will combine GE's ultrasound IP with St. Jude Medical's catheter technology to enable doctors to see real-time imaging of the heart, complete with a direct view of blood flow and other catheters that are used in cardiac procedures. The companies say the device will have many uses, including the treatment of atrial fibrillation (AF; the most common form of heart rhythm disease) and use in ablation procedures, in which certain tissues of the heart are removed to reestablish normal electrical flow. It is estimated that about 8 million people worldwide suffer from heart rhythm disease; 380,000 patients are diagnosed with AF each year.

pSivida Ltd.

PSivida has signed an evaluation agreement with an undisclosed large medical device company under which it will explore the delivery of cardiovascular therapeutics with pSivida's drug delivery platforms. (Apr.)

PSivida has undergone similar evaluations that later turned into licensing deals with Bausch & Lomb, Alimera Sciences, and Beijing Med-Pharm. B&L is using pSivida's surgically implanted Retisert and Vitrasert sustained-delivery technologies to dispense drugs for uveitis, while Alimera has licensed pSivida's injectable Medidur IP (in Phase III) to release the same drug as B&L at the same pace for diabetic macular edema. BMP has licensed rights to BrachySil, which uses pSivida's BioSilicon technology to deliver a therapeutic for patients with inoperable liver cancer.

Financings

Alphatec Holdings Inc.

Medical device firm Alphatec Holdings netted $71.4mm with its initial public offering of 9.3mm common shares priced at $9 each. The company originally hoped to bring in $149.5mm when it filed in February. (Jun.)

The company expects to use about half of the funding to obtain regulatory approval for some of its product candidates, for sales and marketing activities, R&D, and product or business acquisitions. Alphatec Holdings merged with Alphatec Spine (now a wholly owned subsidiary) in a March 2005 transaction led by HealthpointCapital. It is developing surgical products such as screws, spacers, and plates for use in spinal procedures. In September 2005, Alphatec acquired all the assets of Cortek, which specializes in allografts used in spinal fusions. Investment Banks/Advisors: Deutsche Bank AG; First Albany Capital Corp.; RBC Capital Markets

BioMimetic Therapeutics Inc.

BioMimetic Therapeutics (drug-device orthopedic products) has completed its IPO, selling 4.6mm common shares at $8 each to net $31.3mm. The company had hoped to bring in up to $50mm. (May)

BioMimetic's first product, GEM 21S, combines recombinant human platelet-derived growth factor with the synthetic bone matrix beta-tricalcium phosphate (ß-TCP). It is FDA approved to treat bone loss that results from periodontal disease. Under a January 2003 agreement, a Sankyo subsidiary licensed worldwide rights to develop, market, and manufacture the product. BioMimetic is currently developing another combination candidate, GEM OS1, for use in stimulating bone regeneration in fractures that require surgery. A third candidate, GEM OS2 is an injectable bone matrix designed to treat fractures that don't require surgery as well as for use in prophylactic bone augmentation. Investment Banks/Advisors: Deutsche Bank AG; First Albany Capital Corp.; AG Edwards & Sons Inc.; Pacific Growth Equities

LeMaitre Vascular Inc.

LeMaitre Vascular (develops, manufactures, and markets devices to treat peripheral vascular disease) has filed for an initial public offering of common shares to bring in up to $69mm. (Apr.)

LV, established as Vascutech in 1983, will use the proceeds to pay down debt and expand its sales force (which currently sells products in Europe, Japan, and the US). The company posted 2005 sales of $30.7mm and earnings of $55k. LV makes disposable and implanted medical devices--including catheters, clips, stents, and vein strippers under the brand names AnastoClip, EndoFit, Flexcel, and InvisiGrip--that are used by cardiovascular surgeons. It has also created devices to make access sites for patients on dialysis and those with aortic aneurysms. Investment Banks/Advisors: Cowen & Co. LLC; Goldman Sachs & Co.; JMP Securities LLC; CIBC World Markets Corp.

Northstar Neuroscience Inc.

Northstar Neuroscience (developing an implantable stimulation system to help patients recover from stroke) has sold 8.17mm common shares (including the overallotment) at $15 apiece, netting $113.9mm. The company had initially anticipated a smaller offering of 6mm shares at $12-14, which would have brought in only $78mm. (May)

The company, which was established in mid-1999, will use about $7mm of the proceeds for a clinical trial of the Northstar Stroke Recovery System, an electrical stimulation device that is implanted in the cortex to help stroke patients use their arms or hands; another $26mm will be used to develop systems for other neurological conditions; $16mm will go towards sales and marketing efforts. In addition to stroke recovery, Northstar plans to develop other stimulation systems for speech problems, tinnitus, and tremors due to stroke. Investment Banks/Advisors: Cowen & Co. LLC; First Albany Capital Corp.; Citigroup Inc.; Leerink Swann & Co.

Restore Medical Inc.

Restore Medical (produces medical devices for sleep and breathing disorders) netted $29.8mm in its initial public offering of 4mm common shares priced at $8 apiece, slightly lower than its planned price range of $9-11 (the company initially expected in March to raise up to $50mm). (May)

It will use portions of the proceeds to develop improvements and enhancements to its Pillar palatal implant system for obstructive sleep apnea (OSA) and snoring. Pillar, which has been sold in the US for both indications since October 2004, consists of three polyester inserts that are implanted in the soft palate to help reduce the vibration caused by snoring and open up the airway. Restore believes the device has many advantages over other treatments because it involves a one-time, minimally invasive procedure requiring only topical or local anesthesia and is long lasting. The company will also use money from the IPO to expand domestic and international marketing efforts. In the US, its 12-person sales force promotes the device to two target physician groups: otolaryngologists and oral maxillofacial surgeons. In addition to Pillar, Restore is researching treatments for tongue obstructions that cause OSA and improved diagnostics to find areas of obstructed airways. Investment Banks/Advisors: Deutsche Bank AG; First Albany Capital Corp.; RBC Capital Markets

Spectranetics Corp.

Spectranetics Corp. (single-use medical devices for minimally invasive cardiovascular procedures) has netted $47.9mm with the follow-on public offering of 4.1mm common shares (including the overallotment), priced at $12.50 each. (May)

Investment Banks/Advisors: Jefferies Group Inc.; Montgomery & Co. LLC; First Albany Capital Corp.; Rodman & Renshaw Inc.

SyntheMed Inc.

SyntheMed (biomaterials and drug delivery technologies) has raised $6mm with the private placement of 15mm common shares priced at $0.40 each (a 47% discount) to US and European investors. Clubb Capital acted as placement agent for the transaction. (Apr.)

Investment Banks/Advisors: Clubb Capital Ltd. © 1999 Windhover Information Inc., South Norwalk, CT--Page --Current Query: