Biobusiness in INDIA -Q3 2008

BIO-BUSINESSES IN INDIA

Sun Pharma Received FDA Approval for Generic Fosamax (R) Tablets
In September, Sun Pharmaceutical Industries Ltd. announced that the company received approval from FDA to market Alendronate sodium tablets (generic Fosamax). Alendronate sodium tablets are indicated for the treatment and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget's disease of the bone in men and women.
Fosamax (R) tablets have annual sales of approximately US$ 560 million in the US alone.

Diakron and Orchid Pharma to Develop Anti-coagulant Drug
In August, Diakron Pharmaceuticals, Inc. announced the signing of an exclusive license agreement for a novel investigational oral anticoagulant drug candidate discovered and developed through Phase I clinical trials by Merck & Co. Inc. Under the terms of the agreement, Diakron has the exclusive rights to develop, and, if approved, market and distribute the compound worldwide.
In a simultaneous transaction, Orchid Chemicals & Pharmaceuticals Ltd., the Chennai (India) based pharmaceutical major ("Orchid Pharma"), has signed an agreement to partner with Diakron as a significant shareholder and developer for the anticoagulant drug candidate. Orchid will be undertaking the next stages of development.

Codexis and Arch Pharmalabs in Strategic partnership
In August, Codexis, Inc., a leader in biocatalysis technology, and Arch Pharmalabs Limited, a leading Indian active pharmaceutical ingredients (APIs) and intermediates manufacturer, announced a major new strategic collaboration, expanding their three-year partnership in pharmaceuticals manufacturing.
Codexis, based in Redwood City, CA, will offer multiple pharmaceutical intermediates and active pharmaceutical ingredients (APIs) made with its proprietary biocatalytic processes to both innovator and generic drug manufacturers. Sales in India will be through its subsidiary, Codexis Laboratories India Private Limited. Arch, which is based in Mumbai, India and has ten facilities throughout the country, will be Codexis' exclusive manufacturer for these products. The two companies will also co-market products.

Satyam Computer Service Ltd partners with Sciformix, Inc to Provide Comprehensive Drug Safety Management Services.

In June – Satyam Computer Services Ltd, a leading global consulting and information technology services provider, announced that it formed an strategic partnership with Sciformix, Inc., a Westborough, Massachusetts-based, Life Science Knowledge Process Outsourcing (KPO) company, to data management services in "Pharmacovigilance." Several high-profile withdrawals of popular drugs from the marketplace made this partnership more important. Pharmaceutical companies presently are looking for ways to manage risk and taking a more proactive approach toward collection and assessment of drug safety information.

This partnership addresses the worldwide increase in focus on drug safety, which is leading to increased volumes of adverse events being reported to the regulatory authorities. Satyam and Sciformix will collaborate to enable pharmaceutical and biotechnology companies to better monitor safety of the products they market by offering services across the safety management spectrum, ranging from case intake to international regulatory reporting.

Ranbaxy Received a Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets

In June - Ranbaxy Laboratories Limited announced that it received a tentative approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. It will be launched by Ranbaxy upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte.

Valganciclovir HCl I used for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.

Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).

Ranbaxy Laboratories Limited, one of the largest pharmaceutical companies in India, manufactures and markets a wide range of generic drugs. The Company is doing businesses in over 125 countries and has extenssive international affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

FDA Approved Escitalopram Oxalate Tablets (generic)
In June - Lupin Pharmaceuticals, Inc. (LPI) announced that received a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (FDA).

Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) tablets, used for the treatment of major depressive disorder. According to the IMS-Health Sales data the brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008,

Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry."

Lupin intends to introduce the products in the market through its network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.

Ryan Baidya

California Takshila University