One of the leading pharmaceuticals companies in India, Glenmark has stated that it is expecting to file an investigational new drug (IND) application with the US regulatory authority by the month of August. The officials of the company have stated that the application will be filed for starting the first phase of human trials on its monoclonal antibody, named the GBR 500. They said that the company is developing the prospective drug molecule to target multiple sclerosis, chronic obstructive pulmonary disease and the inflammatory bowel disease.
The Managing Director and Chief Executive Officer of Glenmark, Mr. Glenn Saldanha was talking about the new drug and said that the prospective molecule is the first NBE (new biological entity) of the company. He said that they are planning to enter clinical studies with the molecule from the companys pipeline of 11 NCEs (new chemical entities) and NBEs. He also said that the wholly-owned subsidiary of Glenmark, named the Glenmark Pharmaceuticals SA (Switzerland) did complete the pre-clinical studies.
Informing that the company would seek regulatory clearance from the US Food and Drug Administration for starting the phase I trials on the prospective molecule, Mr. Saldanha said that the company is expecting to complete these trials within this fiscal. He added that a Proof-of-Concept phase IIa study would follow the phase I trials. The company has also informed in an official statement that Glenmark has already manufactured sufficient antibody for conducting the phase I and II clinical studies.
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| Posted : 4/12/2008 |
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