The Hindu Business Line : Glenmark to seek FDA clearance for trials

Mumbai, April 10 Glenmark expects to file an investigational new drug (IND) application with the US regulatory authority by August, to start the first phase of human trials on its monoclonal antibody (GBR 500).

The prospective drug molecule, GBR 500, is being developed to target multiple sclerosis, chronic obstructive pulmonary disease and inflammatory bowel disease, a note from the company said.

Mr Glenn Saldanha, Glenmark’s Managing Director and Chief Executive Officer, said that the prospective molecule is Glenmark’s first NBE (new biological entity) to enter clinical studies from the company’s pipeline of 11 NCEs (new chemical entities) and NBEs.

Stating that its wholly-owned subsidiary Glenmark Pharmaceuticals SA (Switzerland) had completed pre-clinical studies, the Mumbai-based drug company said that it would it would seek regulatory clearance from the US Food and Drug Administration to start phase I trials on the prospective molecule. It expects to complete these trials in this fiscal, followed by a Proof-of-Concept phase IIa study. Glenmark has already manufactured sufficient antibody for conducting phase I and II clinical studies, it said.

Glenmark shares were down over three per cent on the BSE at Rs 508.35.

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