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Glenmark sells a biologic

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Mr Glenn Saldanha (left), Managing Director and CEO, Glenmark Pharmaceuticals, along with Dr Michael Buschle, President - Biologics, at a press conference in Mumbai on Monday.

Mr Glenn Saldanha (left), Managing Director and CEO, Glenmark Pharmaceuticals, along with Dr Michael Buschle, President - Biologics, at a press conference in Mumbai on Monday.

Pharmaceuticals has been booming in India recently, and now a novel biologic product (extracted from living cells) has hit the headlines. ET reports:

Mumbai’s Glenmark Pharmaceuticals has licensed a new biotech drug to France’s Sanofi which has the potential to generate revenues of $613 million or 2,734 crore.

Glenmark will receive $50 million ( 223 crore) or 8% of the potential deal value as an upfront payment in the next three months, chairman Glenn Saldanha said at a press conference on Monday.The company also stands to earn double-digit royalties on sales, he said.

Glenmark has sold marketing rights to Sanofi in North America, Europe, Japan, Argentina, Chile and Uruguay. While it has retained co-marketing rights in Russia, Brazil, Australia and New Zealand, in India, it has exclusive rights.

The product, GBR 500, is still in early human trials and being evaluated as a treatment for Crohn’s disease or chronic inflammation of the bowels. It could also work in case of number of other inflammatory conditions such as multiple sclerosis and ulcerative colitis, the company said.

Another report in ET clarifies that the company has been a sort of research powerhouse, quite unusual in India:

[Glenmark] has cracked an outlicensing deal every year from 2004 to 2007 and after facing a few setbacks in 2008 and 2009, it has revived the trend since 2010. This latest deal reinforces the company’s strength in innovative R&D. The deal is also special because it is the first time that an Indian company has discovered a novel biologic worthy of being outlicensed.

However, for the company’s investors, it has not been a cakewalk. Glenmark’s stock has been one of the most volatile in the Indian pharma sector. Though the company has cracked the maximum deals outlicensing its researched molecules, it also has had its fair share of setbacks.

Four of the past five molecules outlicensed by it have since been suspended. Despite this, the company has not exhausted its efforts to discover new chemical and biological entities. Glenmark Pharma , with an annual turnover of Rs 3,000 crore, spends a modest 4-5% of its sales in R&D.

Pharmiweb adds:

GBR500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders. GBR500 has completed a Phase I dosing study in the US and has been well tolerated with a good pharmacokinetic profile.

“There continues to be a strong medical need for safer and more efficacious products for the treatment of Inflammatory Diseases,” said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi. “GBR500 brings an innovative approach to Sanofi’s Immuno-Inflammation portfolio, which we believe may address a significant gap in treating Inflammatory Diseases which would be of huge benefit to patients”.

According to Glenn Saldanha, M.D., Chief Executive Officer of GPL, “This collaboration on a novel first-in-class monoclonal antibody validates Glenmark’s world-class innovative R&D capabilities in the drug discovery area. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics.”

TOI interviewed Glenn Saldanha. An excerpt:

TOI: How is the landscape for Indian companies pursuing research?

GS: Drug discovery research is a long gestation activity and could take over a decade for getting a drug to market. We see a lot of activity on the Indian space in getting small molecules i.e. new chemical entities, to clinical trials. It is important that Indian companies have the patience and the resources to be in drug development space because there are highs and lows. But you need to keep moving forward and keep evolving every few years.

On the other hand, the novel biologics space is relatively new and we would take a few years before we develop capabilities in this area.

At the same time, you must be able to market your molecule as development costs are extremely high when your molecule reaches clinical development. Also, when one is doing drug discovery you would need to develop it for the entire world and it would be difficult to develop it keeping a particular country or a region in mind. This adds to our challenge.

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