Glenmark may become first indian firm with NCE

Completes Phase-III trial of Crofelemer

Glenmark Pharmaceuticals is close to become the first Indian company to develop an original novel chemical entity (NCE) to treat diseases.

An NCE is a molecule developed in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Indian drug companies, which specialise in reverse engineering novel drugs to make low-cost generic versions, are trying to develop NCEs. At least 80 such molecules are in different phases of trials, but so far none has reached the final stage. It takes about 10-15 years and a billion dollars to develop an NCE.

Glenmark and its partners today said Crofelemer, a first-in-class (first of its kind) anti-diarrhoeal drug for HIV-associated diarrhoea, had successfully completed the third and final phase of clinical trials.

Crofelemer, likely to be launched in about 140 countries within the next two years, would open up a minimum $80-million opportunity for Glenmark, said its spokesperson.

Glenmark in-licensed this molecule from US-based Napo Pharmaceuticals about five years ago for co-development. Another co-developer of the drug, Salix Pharmaceuticals has the right to sell Crofelemer in the US, Europe and Japan, which together have an opportunity of about $300 million in sales.

Glenmark would supply the entire active pharmaceutical ingredient (API) of Crofelemer and set up an API manufacturing facility in India, said executives.

The basic agent of the drug was extracted from the bark latex of a South American tree, Croton lecheri, and was initially developed by Napo. Glenmark teamed up with Napo since the first stage of clinical trials. Crofelemer reached the final stage of Phase-III trials in 2006.

“Glenmark will invest significant resources to fast track its development plan to ensure early regulatory approvals and launch in most of our markets,” said Glenn Saldanha, chief executive officer and managing director of Glenmark Pharmaceuticals.

Glenmark shares today rose to a 52-week high of Rs 379.9 on the Bombay Stock Exchange and finally closed at Rs 376.90, up by 3.56 per cent.