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Glenmark expects to obtain approval for the initiation of clinical studies for the drug during this fiscal year.
Glenmark expects to obtain approval for the initiation of clinical studies for the drug during this fiscal year.

Glenmark develops new anti-cancer drug

The firm expects to obtain approval for initiation of clinical studies for the drug during this fiscal year

Mumbai: Glenmark Pharmaceuticals Ltd, which is focusing on inventing new medicines as one of its core areas of business, has entered the anti-cancer segment with the discovery of a new drug candidate.

Glenmark Pharmaceuticals SA, its research unit in Switzerland, said on Wednesday that it has initiated studies of a novel clinical development candidate—GBR 1302—discovered and developed by its biologics research centre. It is the first clinical development candidate in the antibody based cancer therapy group, Glenmark said.

Glenmark expects to obtain approval for the initiation of clinical studies for the drug during this fiscal year.

The firm has been successful in developing many new drug molecules targeting therapeutic areas such as diabetes, pain management, inflammation and multiple sclerosis and had licensed out these molecules to global drug makers that include French multinational Sanofi SA, US drug makers Eli Lilly and Co. and Forest Laboratories Inc., and Germany’s Merck KgaA.

“GBR 1302 is significant for Glenmark on multiple levels as it is our first bispecific antibody and it represents the entry of Glenmark into the oncology innovator space, which has a huge commercial potential," said Michael Buschle, chief scientific officer and president, biologics, Glenmark Pharmaceuticals.

Glenmark’s new cancer drug candidate is a novel biological molecule similar to exiting antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine, which will be used in the treatment of breast and ovarian cancers.

GBR 1302’s mode of action is different from the existing drugs in this class as it kills cancer cells more rapidly and completely, the company said in a statement. It is also not subject to the same resistance escape mechanisms as the existing therapies, it said.

For Glenmark, which started out as a generic drug maker, discovery research is a big revenue earner as it successfully adopted a business model of finding synergy in selling generic drugs in the mass market and at the same time pursuing discovery research for licensing income.

“This is a unique model that Glenmark identified very early in its growth stage," says Buschle, who has been spearheading the research strategy for the Indian company from the beginning.

“Because it started early and could formulate a sustainable discovery business plan, which helped reducing the investments and overheads for an otherwise expensive drug research business, Glenmark was able to develop a range of new molecules and successfully make licensing deals with Big Pharma," he said.

In the past 10 years, Glenmark licensed out seven new molecules to global drug makers, although some of them came back to the company due to various reasons, including changed business priorities of the licensees and unforeseen risks in the advanced stages.

“We have a handful of the projects in the discovery pipeline, which are promising and covers many new therapies with huge market potential," Buschle said.

With this business model, the Mumbai-based drug maker is trying to reinstate Indian pharma’s confidence in discovery research where its bigger rivals, including Dr Reddy’s Laboratories Ltd and Ranbaxy Laboratories Ltd, have lost hope.

The key strength that Glenmark built in this business is the small but stable research team at two of its research locations—La Chaux-de-Fonds in Switzerland and Mhape in Maharashtra—and a strong basic platform for both chemistry as well as biological research.

“India has a lot of talent, especially in science, and it has the cost advantage as well, and Switzerland is a location where there is more clarity and predictability as far as policies and regulations are concerned," Buschle said in an interview on Wednesday. “Both these are essential for a sustainable discovery business."

“We have kept a big team in India, the low-cost location, and a comparatively smaller team in high-cost location, Switzerland, which is also part of a conscious decision to make the business sustainable," he said. Glenmark also maintains partnerships with small technology companies to keep cost overheads low.

“Glenmark’s business model combining the generic business for main revenue and discovery research for licensing income is a unique model and the company has maintained it in a sustainable way so far, although many of its rivals in India stopped this model due to initial failures," said a life sciences partner with a global consultancy firm.

But the high risk that Glenmark is taking by following this model is the general unpredictability on the success of each of the new research projects and the failure of the final outcomes (molecules), which the company itself has faced in at least four of its earlier outlicensing deals, said this consultant, who didn’t want to be identified.

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