Biocon’s Alzumab Is Priced At Half Of Its Rival Brands, But Will It Change The Game?

The Indian drug manufacturer has taken a giant leap with the launch of its indigenously researched psoriasis treatment. But experts suggest the task to establish it against larger products will be extremely daunting.

MUMBAI – Biocon Ltd.’s novel anti-CD6 antibody itolizumab, branded Alzumab, has hit the shelves in India for use in the treatment of moderate-to-severe forms of plaque psoriasis. The much-awaited launch of the first-in-class infusion drug marks Biocon’s entry into a global chase for solutions to combat the painful autoimmune skin condition.

Approved earlier this year by India’s drug regulator, the Drug Controller General of India, Alzumab is Biocon’s second commercialized monoclonal antibody, coming six years after it launched Biomab (nimotuzumab) used to treat head and neck cancers.

Taking On The Titans

CD6 is described as a pan T-cell marker involved in co-stimulation, adhesion and maturation of T-Cells, which have been found to play a leading role in autoimmune diseases. Alzumab, by binding to CD6, regulates T-cell activation and causes reduction in synthesis of pro-inflammatory cytokines and possibly plays a role by reducing T cell infiltration at sites of inflammation.

Unlike biologics like cytokine inhibitors, which act downstream in the pro-inflammatory cascade, Biocon said its itolizumab acts upstream inhibiting the formation of cytokines, resulting in lower infection rates and longer remission periods.

Updated data show Alzumab completed the Phase III study TREAT-PLAQ in India. Two other positive Phase IIa dose finding studies were conducted – one each in rheumatoid arthritis and psoriasis. The drug has been used to treat more than 300 patients in India. Of these, about 100 patients received the drug for 52 weeks with an encouraging safety and tolerability profile.

The global market for psoriasis drugs is estimated to reach $8 billion by 2016, according to Biocon. Global research firm Decision Resources places the psoriasis market at $20 billion by the turn of the decade, almost quadrupling from present levels.

That enormous opportunity has triggered new permutations and combinations as global drug firms like Novartis AG, AstraZeneca PLC and Eli Lilly & Co. actively seek novel interventions to modulate the immune system (Also see "Psoriasis Market Snapshot: An Area Drug Makers Are Itching To Get Into" - Pink Sheet, 23 Jul, 2012.).

With that backdrop, Biocon has strong commercial challengers as its larger peers edge out each other, not just on technology but also switching to easier modes of delivery from injectables to oral medicine.

Novartis has become the latest Big Pharma to join the fray by partnering with Ensemble Therapeutics Corp. to develop oral small molecules against traditional biologic targets. Last week, Novartis said it will develop Ensemble’s synthetic macro-cycle drug targeting IL-17. Although the pathway is known and has been researched by global drug manufacturers, the paradigm would alter with an oral drug alternative (Also see "Novartis Joins Ensemble To Develop An Oral IL-17 Blocker" - Pink Sheet, 6 Aug, 2013.).

Alzumab will also be pitted against established titans like Johnson & Johnson’s Stelara (ustekinumab) and Remicade (infliximab), AbbVie Inc.’s Humira (adalimumab) and Amgen Inc.’s Enbrel (etanercept) – each garnering a bulk of the world psoriasis and osteoarthritis market.

An Indian marketing consultant said Biocon will have to present reams of clinical data to get prescribers onboard to put new patients on the latest biologic drug, but if the response rates are good, a low pricing strategy can be a winner.

“It may not be too long to see global drug companies formulating price cuts as historically effective launches have led to price corrections,” he said, asking not to be identified.

A Pipeline Within A Product

The field for autoimmune treatments is likely to get even more complex with a host of generic alternatives reaching the market (Also see "Korean Companies Step Up Development Of Enbrel Biosimilars As Amgen Ramps Up Its Pipeline" - Scrip, 15 Jul, 2013.).

In April, Cipla Ltd. announced it will sell biosimilars of Enbrel in India that will be sourced from a Chinese partner (Also see "Made In China, Sold In India: Cipla’s First Splash In Biosimilars Is A Cut Price Version Of Enbrel" - Scrip, 18 Apr, 2013.).

Biocon is still a long way off from the global turf as the biotech aims for an IND filing in the U.S. in the coming months while it continues to seek global partners to add teeth to its clinical development programs.

Biocon is playing up on Alzumab’s comparative advantages as part of its marketing strategy. The company said Alzumab is the world’s first novel anti-CD6 demonstrating an “excellent safety and efficacy profile with very low opportunistic infection rates and a longer remission period.” Also, Alzumab hopes to ride on its less aggressive dosing regimen and a longer treatment-free period that aids better compliance and convenience.

Roughly 1% to 2% of the Indian population is expected to suffer from psoriasis, according to Biocon, which hopes Alzumab’s pricing, about half of competing brands will give it the needed jumpstart. Reports in the Indian media suggest Alzumab will cost $123 (INR 7,500) for each bottle although no insights were shared on the treatment cycle or total treatment period.

In a discussion earlier in January, Biocon Chairman Kiran Mazumdar Shaw said she expects Alzumab to reach INR 1 billion ($16.35 million) in the Indian market over a four-year span. Over the past 10 years, Biocon said it spent nearly INR 1 billion in developing the product (Also see "Biocon Hopes For EU Insulin Launch In Two Years; Pushes On With A Maturing Pipeline" - Scrip, 28 Jan, 2013.).

On the eve of the launch, Shaw noted the new line of treatment will usher in a “paradigm shift in the management of psoriasis.”

“We are proud that this will be the first instance of a breakthrough innovation from India with a potential to treat multiple autoimmune diseases and making a difference to a much larger patient population across the world,” she added.

Biocon touted itolizumab as a “potential pipeline within a product,” highlighting its likely action on rheumatoid arthritis and multiple sclerosis.

Biocon said Alzumab addresses the Th27 pathway making it a “best-in-class” treatment for psoriasis, adding that in addition to Th2, Th27 cells play a critical role in autoimmune diseases giving Alzumab a widely differentiated mechanism of action against marketed compounds.