Glenmark makes 1st batch of crofelemer API for clinical trials in USA

Mumbai, November 17, 2006 - Glenmark Pharmaceuticals Limited [Glenmark], the research-led global pharmaceutical company, today announced the successful production of crofelemer active pharmaceutical ingredient [API] for use in a pivotal Phase III trial by Napo Pharmaceuticals, Inc. [Napo] in the US for chronic diarrhoea in persons living with HIV/AIDS. Glenmark is manufacturing this API at a dedicated unit at its US FDA approved facility in Ankleshwar.

"We see this as an important product for India and Glenmark's licensed territories," said Glenn Saldanha, Managing Director & CEO, Glenmark Pharmaceuticals Ltd. "Many diarrhoea diseases are resistant to antibiotics; crofelemer's mechanism of action treats the symptom of dehydration regardless of cause. Furthermore, a strong safety database including over 1200 patients to date will help us target successful registration and launch of crofelemer by 2008/2009."

Glenmark signed a development and commercialisation 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, acute 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 recently received approval from the Drug Controller General of India [DCGI] to initiate a Phase II trial for acute infectious diarrhoea. The Company is also working on a development plan for the other indications of AIDS related diarrhoea and paediatric diarrhoea.

Napo Pharmaceuticals, Inc. is focused on developing and commercialising 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, Diabetes and Oncology.

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 and India, and was recently out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. Glenmark has four other programmes across obesity, inflammation and pain management at the pre-clinical stages; three of which will enter the clinics in FY 2007.