Deal potential of Rs 1,447 crore for development of molecule to treat chronic pain.
After a gap of more than 30 months, Glenmark Pharmaceuticals has succeeded in outlicensing a new chemical entity (NCE), a new drug under development. It has done so to Sanofi-Aventis, the French multinational drug maker, in a deal potentially worth $325 million (Rs 1,447 crore).
Glenmark Pharmaceuticals SA, a wholly-owned subsidiary of Glenmark Pharmaceuticals, today signed the formal agreement with Sanofi to offer a license for the development and commercialisation of GRC 15300, a first-in-class novel molecule to treat chronic pain, the companies said in a statement.
Glenmark is the leading new drug research company in India, with five molecules under development and a record of many outlicensing deals to MNCs.
"This agreement continues to demonstrate Glenmark’s world-class innovative R&D and validates Glenmark’s leadership in the Indian drug discovery arena," said Glenn Saldanha, managing director and chief executive of GPL.
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Glenmark was trying to out-license its new molecules under development for the past two to three years. It had succeeded in out-licensing four molecules since 2004 at regular intervals and had so far earned Rs 650 crore in such deals. It, however, faced setbacks in the past two years, as most of the out-licensed molecules were returned by their partners at various stages of development and the company could not get new ones. A global slowdown and right valuations were deterrents in finalising new deals, Saldanha had earlier told Business Standard.
GRC 15300 is in the first phase of human clinical trials, as a potential next-generation treatment for various pain conditions, including diabetic neuropathic pain and osteoarthritic pain.
Glenmark would soon receive an upfront payment of $20 million (close to Rs 90 crore), as well as development, regulatory and commercial milestone payments over the next four-five years if the drug reaches commercialisation stage. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialised under the license. The drug addresses a market worth over $3-billion and drugs in this category are rare, said sources.
Sanofi-Aventis will have exclusive marketing rights for North America, the European Union and Japan, subject to Glenmark's right to co-promote the products in the United States and five East European countries. Sanofi will also have co-marketing rights in 10 other countries, including Brazil, Russia, and China, whereas Glenmark will retain exclusive rights in India and the rest of the world.
"There continues to be a medical need for safer and more efficacious products for the treatment of painful diabetic neurophathy and osteoarthritis pain,” said Marc Cluzel, Executive Vice President, Research and Development, Sanofi. It is the first such drug development deal for Sanofi-Aventis in India.
Glenmark has had a roller-coaster ride in its efforts to become a new drug research company. Its flagship drug under development, Oglemilast -- outlicensed to Forest Laboratories of the US in September 2004 -- failed in clinical trials for chronic obstructive pulmonary disease or smoking-induced acute bronchitis, in August last year. Oglemilast is still being studied for the treatment of asthma and results are expected within two months. Oglemilast (code named GRC 3886), was stuck in the second phase of trials for more than two years, as the US Food and Drug Administration had sought additional safety data on this drug.
Merck, which was developing a diabetes drug of Glenmark, had returned the molecule two years earlier, saying it had lost interest in pursuing diabetes drug research. Eli Lilly, which had in-licensed an osteoarthritis and pain molecule from Glenmark, also suspended further development in October 2008.
As mentioned earlier, Glenmark has five molecules under development and is banking on Crofelemer, an anti-diarrheal molecule under development. This molecule is now in the third phase of clinical trials and data on the final lap of clinical trials are expected soon. Glenmark hopes to launch Crofelmer in developing countries by next year.
Indian companies such as Dr Reddy's, Glenmark, Lupin and Piramal Healthcare are working on 50-70 drug candidates to become the first Indian drug maker to come out with at least one original molecule in the commercial stage before 2010-11. New drug development is a complex process and for a single product to make it to the market, many hundreds or thousands of compounds have to be tested, and the pre-clinical and clinical failure rates are high, in a process involving 10-12 years.