Glenmark gets nod from DCGI for Phase II trials on 'Crofelemer'

Mumbai, Aug 03 (UNI) Glenmark Pharmaceuticals Ltd has received approval from the Drug Controller General of India [DCGI] to initiate Phase II trials for its novel, in-licensed anti-diarrhoeal product, crofelemer.

Annoucing this, the company said the trial is expected to commence in calendar 2006 and will involve sixty adult patients suffering from acute diarrhoea in a prospective, randomized, parallel group using a controlled double-blind placebo method. The trial will be concluded within three months from the start of dosing.

The Company signed a development and commercialization alliance with Napo Pharmaceuticals, Inc. [Napo] In July 2005. Under the terms of the agreement, the Company will be responsible for marketing crofelemer in over 140 countries, including India, for 3 indications, viz. AIDS diarrhoea, infectious diarrhoea and paediatric diarrhoea.

In return the Company will provide low-cost and large-scale manufacturing in FDA approved manufacturing facilities and upon marketing will pay royalties ranging from high single digits to early teens on net sales to Napo. It expects to launch the drug in 2008 in the first territory.

Glenmark is also working on a development plan for the other indications of AIDS related diarrhoea and paediatric diarrhoea.

Commenting, Mr Glenn Saldanha, Managing Director&CEO, of the Company said, ''We are happy with the progress that crofelemer is showing; if approved, the drug has the potential to meet a large and unsatisfied need for safe and effective medication for the treatment of diarrhoea.'' Napo Pharmaceuticals Inc. is focused on developing and commercializing proprietary Pharmaceuticals for the global marketplace, in collaboration with local partners. In order to address major global unmet medical needs in developed and developing countries. The Company is based in California, USA with a subsidiary in Mumbai, India and recently made its debut in the main market of the London Stock Exchange.

UNI SN PM AW1751