Glenmark gets nod to conduct crofelemer Phase II trials

Mumbai, August 03, 2006: Glenmark Pharmaceuticals Limited [Glenmark], the research-led global pharmaceutical company, received approval from The Drug Controller General of India [DCGI] to initiate Phase II trials for its novel, in-licensed anti-diarrhoeal product, crofelemer. 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.

Glenmark signed a development and commercialization alliance with Napo Pharmaceuticals, Inc. [Napo] in July 2005. Under the terms of the agreement, Glenmark 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 Glenmark 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. Glenmark expects to launch the drug in 2008 in the first territory. The Company is also working on a development plan for the other indications of AIDS related diarrhoea and paediatric diarrhoea.

On the occasion, Glenn Saldanha, Managing Director & CEO, Glenmark Pharmaceuticals Limited, commented, "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.

About Glenmark Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The Company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.

The Company in also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. Its first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively. This compound subsequently completed Phase I clinical trials successfully and has recently entered Phase II clinical trials in the US. The Company's second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes, is in Phase II clinical trials in South Africa. Glenmark's third lead is a compound named GRC 10389, a CB-I receptor antagonist for the treatment of Obesity. This compound is completing pre-clinical studies and is expected to be filed for a Phase I trial in H1 FY07. The Company has three other programmes across inflammation and pain management at the pre-clinical stages. [www.glenmarkpharma.com]

For further information, please contact Ms. Vaijayanti Karande Senior Manager [Corporate Communications] Email: vaijayantik@glenmarkpharma.com