Glenmark Pharmaceuticals S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. (GPL) and Merck Serono, a division of Merck KGaA, have reached a mutually amicable settlement to terminate their on-going agreement on GRC 8200. Under these terms, Glenmark would get the global rights back from Merck Serono for Glenmark's DPPIV inhibitor Melogliptin, GRC 8200, a treatment for type 2 diabetes in phase II of clinical development.
The new settlement agreement follows Merck Serono's recently announced decision to re-focus its portfolio and its withdrawal from investing further into diabetes research and development. Under the terms of this settlement, Merck Serono will be responsible for successful transfer of all activities at no cost to Glenmark. Apart from payments by Merck Serono to Glenmark for completion of some on-going activities, no payments or refunds would be due from either party to the other for the termination of the agreement.
Glenmark will continue to run the on-going clinical and non-clinical development of GRC 8200 and expects the top-line results from Phase IIB studies to be available towards the end of FY09.
"It is unfortunate to end our relationship with Merck Serono for GRC 8200 since they have contributed a lot of expertise in the development during the last year. However, the data package so far is very promising and we are confident of finding a co-development partner to take the molecule further during the course of the calendar year 2008," said, Glenn Saldanha, MD and CEO, GPL.
DPPIV inhibitors are a class of drugs that work by inhibiting the activity of the DPP-IV enzyme, thereby stimulating the secretion of higher levels of insulin. Several DPPIV inhibitors are in development or under review for the US market. So far, the only approved DPPIV inhibitor in the US is Januvia from Merck & Co., which is not related to Merck of Germany. This class of drugs is expected to constitute a significant part of diabetes therapy by managing blood-glucose levels without the associated risk of hypoglycaemia that may be experienced with other diabetes medication. Analysts' estimates project peak annual sales for the DPPIV inhibitor class of products in excess of EUR 9 billion.
GRC 8200, Glenmark's lead DPPIV inhibitor, is a novel, oral DPPIV inhibitor in development for type 2 diabetes. It is currently in phase II clinical trials in South Africa and India. phase I studies showed that the compound was very well tolerated by the subjects at all dosage levels and there were no significant adverse events reported. More than 90 per cent inhibition of the DPP-IV enzyme was observed within 1 hour at all doses tested. In preclinical studies, the compound appears to be effective and well tolerated when given at pharmacological doses. GRC 8200 has recently received the International Non-proprietary Name (INN) "Melogliptin", from the World Health Organization (WHO).