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news.Glenmark Pharmaceuticals SA, the Swiss subsidiary of India's Glenmark Pharmaceuticals, has signed a collaboration agreement with Japan's Teijin Pharma Limited, a subsidiary of Teijin Limited, for a respiratory disorders product.
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The two companies have entered into a collaboration agreement for Glenmark’s PDE4 inhibitor GRC 3886, which is currently in development for chronic obstructive pulmonary disorder (COPD) and asthma. The compound may also have utility in other inflammatory conditions such as rheumatoid arthritis.
PDE4 inhibitors target the underlying cause of both COPD and asthma by blocking inflammation through a non-steroid dependent mechanism. In preclinical trials, GRC 3886 was shown to be a highly specific PDE4 inhibitor with potential for the indications of asthma and COPD.
The phase I studies were conducted in the UK by Quintiles, a global contract research organization, and have recently been completed. The phase I studies have demonstrated that GRC 3886 is well tolerated and exhibits predictable pharmacokinetics in human volunteers. The molecule has been found to be non-emetic and without any apparent cardiovascular effects at the highest doses tested in the study.
Additionally, the drug has exhibited a long half-life, suggesting a once-daily-dosing regimen may be possible in future studies in patients.
Teijin Pharma will have the exclusive right to develop, register and commercialize GRC 3886 for all potential indications for which the product might receive approval in the Japanese market. Teijin Pharma will pay Glenmark a high up-front payment upon initiation of the agreement, and a further milestone on commencement of phase I studies in Japan.
Teijin Pharma will also pay Glenmark other milestones on crossing each successive stage in the development and commercialization of the product for the Japanese market. The cumulative value of these upfront and milestone payments could be up to $53 million if all the milestones are completed.
Additionally, after commercial launch, Teijin Pharma will pay Glenmark annual sums marginally higher than the first quartile of net sales of the product in Japan, towards supply of the active pharmaceutical ingredient (API) and royalties.
Glenmark announced a similar deal for the territory of North America with Forest Labs in September 2004. After these two collaborations, Glenmark retains rights to GRC 3886 for all markets excluding North America and Japan and is in discussions with potential collaboration partners for Europe as well.