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US FDA nod for Glenmark Pharmaceuticals' anti-diarrhoea drug

The US Food and Drug Administration (FDA) has approved an anti-diarrhoea drug, co-developed by Glenmark Pharmaceuticals and US-based Salix Pharmaceuticals Inc.

twitter-logoE Kumar Sharma | January 2, 2013 | Updated 19:05 IST

E Kumar Sharma
An anti-diarrhoea drug, co-developed by Glenmark Pharmaceuticals partnering Salix Pharmaceuticals Inc of the US, has received approval from US drugs regulator, the Food and Drug Administration (FDA).

The peak sales of the drug will be in the region of $80 million (or close to Rs 500 crore) in three to five years after launch, according to a Glenmark executive.

The drug, Crofelemer 125 mg, is aimed at treating diarrhoea in patients with HIV/AIDS and on anti-retroviral therapy. The original compound for this drug was discovered by a US company Napo Pharmaceuticals Inc.

Glenmark licensed this from Napo in July 2005 and since then, Glenmark and Salix have been co-developing the new chemical entity (NCE), as new drug molecules are called in the pharmaceuticals business.

Salix, which conducted the Phase III clinical trials - testing on humans - in the US, has now got FDA approval and this paves the way for Glenmark to launch the drug in other markets. Glenmark did the earlier pre-clinical and clinical development work (phase I and phase II trials).

Glenmark has the exclusive rights to sell this drug in India and 140 emerging markets, not including China, while Salix has the rights for developed markets.

The two will pay a royalty on the sales of the drug to Napo, which originally discovered it. The added upside for Glenmark is that it will also supply the basic input for making this formulation to Salix.

The drug has been a source of concern for Glenmark and Napo as Napo Pharmaceuticals Inc had wanted to terminate its licensing agreements and the matter went into arbitration in the US, which went in Glenmark's favour.

In a press statement, Glenn Saldanha, Glenmark's Chairman and MD said: "This is a significant approval milestone and will enable the first NCE launch by Glenmark across emerging markets. Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on anti-retovirals who experience non-infectious diarrhea, which often can lead to reduced treatment compliance. This will also help us accelerate filing across countries and also propel our development in additional diarrhea indications including the acute indications."

Glenmark is now working on other indications, including treatment of patients with cholera and acute, adult diarrhoea, with the same drug.

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