Company Watch

Glenmark's receives 25 million Euros from Merck

Our News Bureau - Mumbai

Glenmark Pharmaceuticals SA received 25 million Euros from Merck KgaA in Q3 FY2007, after the anti-trust clearance in US. This constitutes the upfront payment under the recently concluded collaboration agreement for Glenmark's DPP-IV inhibitor GRC 8200, between the two parties.

GRC 8200 is a novel, oral DPP-IV inhibitor and Glenmark's lead molecule for Type II diabetes. It is currently in Phase II clinical trials in South Africa and India. Under the agreement, Merck will develop, register and commercialise GRC 8200 for markets in North America, Europe and Japan, while Glenmark will retain commercialisation rights for India. The partners will share commercialisation rights for other markets in the remainder of the world. Additionally, Merck will bear the cost of all ongoing studies and will be responsible for planning, managing and sponsoring all development activities in the future.

The value of all payments to Glenmark could total up to 190 million Euros, including the recently received up-front payment of 25 million Euros and various milestone payments, which will ensue upon successful development and launch of mono-therapy and combination products based on GRC 8200. Upon commercial launch, Glenmark will supply the active ingredient to Merck and will receive royalties on net sales of the product. Apart from this, Glenmark has three other programmes across obesity, inflammation and pain management at the pre-clinical stages, two of which will enter the clinics in FY2007.

In yet another development, Glenmark SA has applied for Phase I clinical trials in Europe GRC 6211. Its leading vanniloid receptor (VR1) antagonist compound is indicated for osteoarthritis, dental pain, neuropathic pain and urinary incontinence.

The Phase I study will be conducted by Kendle, a global CRO, using single and multiple oral doses with the objective of assessing safety and bioavailability of GRC 6211 in healthy human beings. Additionally, Glenmark would also be conducting a Proof of Concept (Phase IIA) study on patients with dental pain. Glenmark hopes to complete Phase I by June 2007 and the dental pain study by October 2007. Dr Swaroop Kumar V V S, President-Drug Discovery and Clinical Development, Glenmark said, "Pre-clinical studies have demonstrated GRC 6211 to be highly potent with functional IC50 of 3.8 nM and good bioavailability across species tested. The molecule also exhibited greater than 2600 selectivity over other TRP channels."

Glenmark is in discussions for potential licensing partners for this compound. Company sources said that the timing of the licensing would depend on the deal terms and ability to get co-promotion rights in some of the regulated markets. The company is looking at launching the molecule in 2011, aiming to be an early launcher in this class. "GRC 6211 is Glenmark's third and an exciting molecule to enter the clinics from its pipeline of six NCEs. The pain market is amongst the largest markets and this novel target presents an excellent opportunity," commented Glenn Saldanha, Managing Director and CEO, Glenmark Pharmaceuticals.