Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Strategies & Market Trends : India Coffee House -- Ignore unavailable to you. Want to Upgrade?

To: Mohan Marette who wrote (4677)	6/21/1999 11:35:00 AM
From: Mohan Marette	Respond to of 12475

Cheminor Drugs seeks US FDA's approval for anti-depressant drug Cheminor Drugs Website cheminor.com Dr.Reddy's Laboratories drreddys.com --------------------------------------------------------------------- Anju Ghangurde ---------------------------------------------------------------------- Mumbai, June 20: The Hyderabad-based Cheminor Drugs has filed an abbreviated new drug application (ANDA) in the US for fluoxetine hydrochloride, an anti-depressant. Cheminor's efforts to tap the US generics market would require big brother Dr Reddy's Laboratories to secure a US Food and Drug Administration (FDA) approval for its bulk drugs unit. In a faxed response to The Financial Express, Dr Reddy's Laboratories official spokesperson said, "For marketing the formulation of fluoxetine hydrochloride in the US, Cheminor's pharma division requires US FDA approval on the facility where the material for the formulation is manufactured, which is Dr Reddy's Lab's bulk drugs unit 1 (pilot plant)". Dr Reddy's bulk drugs unit was inspected for the anti-depressant by the US FDA on June 2, 1999, as part of the regulatory requirement, based on Cheminor's ANDA for the product. Dr Reddy's Lab does not export generics to the US market directly. A FDA approval for the facility will allow Cheminor's Pharma divisionto market the formulation in the US, though American multinational Eli Lilly & Co had earlier filed a complaint against the Indian company over its ANDA. Eli Lilly markets its fluoxetine hydrochloride brand in the US as Prozac (which registered sales of over $2 billion in 1998), though the latest position on the complaint against Cheminor could not be ascertained.Analysts also say that Cheminor's ANDA's prospects may be eclipsed by a recent $4 million partial settlement reached between Eli Lilly and three generic companies--Barr Laboratories, Geneva Pharmaceuticals and Apotex Inc --for fluoxetine hydrochloride. A US district court has also prohibited the US FDA from approving their ANDAs before Lilly's patents expire. Meanwhile, analysts say that "such synergies" between Dr Reddy's Lab and Chemnior Drugs can be best encashed via a merger. "A merger would allow both companies capitalise on their strengths for collective benefits. Besides Cheminor has a strategic equity alliance with Schein Pharma and thisis expected to boost its generics thrust," an analyst with an Indian stock-broking firm said. Schein Pharma holds an 18.04 per cent equity stake in Cheminor Drugs. Dr Reddy's Lab chairman K Anji Reddy had in April announced an intent to merge both companies though no definite time frame had been set. The Reddy family holds approximately 49 per cent of Cheminor drug's equity capital and an equity satke of over 27 per cent in Dr Reddy's Laboratories. financialexpress.com