Glenmark finishes Phase I UK trial of asthma drug

Glenmark Pharmaceuticals has successfully completed Phase I single and multiple dosing studies on its oral PDE4 inhibitor molecule GRC 3886 in the UK.

In pre-clinical trials, GRC 3886 was shown to be a highly specific phosphodiesterase 4 (PDE4) inhibitor with potential for the indications of asthma and Chronic Obstructive Pulmonary Disease (COPD).

The Phase II studies on GRC 3886, according to the company, could be initiated early next year. The studies would be conducted by Forest Laboratories Inc, Glenmark's development partner for GRC 3886 in North America.

Glenmark Switzerland, the drug maker's subsidiary, earlier entered into a collaborative agreement with Forest in September 2004. Under the agreement, post Phase 1, Forest will be responsible for the development and commercialisation of GRC 3886 in North America.

Glenn Saldanha, MD and CEO of Glenmark Pharmaceuticals, said, "While the efficacy of a drug candidate in clinical trials is generally first established in Phase II trials, GRC 3886's inhibitory effect on TNF-Alpha suggests that we have reached dosages in these Phase I studies which are both well tolerated and biologically active based on this surrogate end point."

Forest has made an upfront payment of $10 million to Glenmark Switzerland upon initiation of the agreement and future milestones are linked to steps on the successful development and commercialisation of the product.

The total value of all milestone payments could be $190 million. If successful, the drug is expected to be ready for launch by 2009.

Additionally, after commercial launch, Glenmark will earn royalties in the "mid-teens" from Forest on net sales of the product in North America.

Glenmark will also earn further revenues on exclusive supply of active pharma ingredient (API) for formulation and sale by Forest, the company said in a media release.

Glenmark is evaluating similar alliances with potential partners to take GRC 3886 forward in the European and Japanese markets for asthma, COPD and for additional indication of rheumatoid arthritis.