New Delhi: Drug maker Glenmark Pharmaceuticals on Monday said it is planning to submit new drug application (NDA) in the US for Crofelemer used in the treatment of HIV-associated diarrhoea.
The application would be filed in consortium with Napo Pharmaceuticals and Salix Pharmaceuticals.
Besides this, the company is also planning to submit its applications for the regulatory approvals in developing countries (ROW markets) and expects to get it by early 2010.
“It is expected that by the first-half of 2010, the NDA for HIV-Associated diarrhoea would be filed in the US. Glenmark also plans to make regulatory submissions in ROW markets (excluding North America, Europe, China and Japan) and obtain approvals starting in 2010,” the company said in a statement.
Crofelemer is a new chemical entity from Glenmark, which is currently undergoing phase III clinical trials in the US. The protocol of the study has been reviewed and approved by US health regulator Food and Drug Administrator (US FDA) as a special protocol assessment.
Once Crofelemer enters the market, Glenmark expects to generate revenue of around $80 million through sales in developing countries alone. In addition, the company would be entitled to receive royalty of sales in the western markets from Napo.