Dr Reddy's shrugged off recent volatility on Wednesday and moved tenaciously on filing new gernerics with the US FDA.
The scrip of the domestic pharma major nudged up 0.6% to Rs 905.65 on BSE in early trades today. Dr Reddy's Laboratories hit a high of Rs 910 earlier. Around 1,890 DRL shares changed hands on BSE in just a few minutes since trading commenced today.
Some degree of volatility has marked the counter of late - moving between the Rs 980- and the Rs 860-mark. This was preceded by a rally, as the scrip surged 43% from Rs 696.60 on 8 November 2002 to Rs 1,000.45 on 16 January 2003.
DRL today said that it has filed with the US Food and Drug Administration to market a generic version of Aventis Pharmaceuticals' anti-allergy drug Allegra.
DRL has filed an Abbreviated New Drug Application with the USFDA for Fexofenadine HC1 Tablets, equivalent to 30 mg, 60 mg and 180 mg of base, with Paragraph IV certifications on all seven Orange Book patents listed for Allegra® tablets. Fexofenadine HC1 Tablets are the generic version of Aventis' Allegra® tablets. The product is indicated for the relief of symptoms associated with seasonal allergic rhinitis. The brand has annual sales in the United States of approximately $1.35 billion. Dr Reddy's notified Aventis Pharmaceuticals, Inc upon which the latter filed a lawsuit against the Company in the United States District Court for the District of New Jersey alleging patent infringement on six Orange Book patents.
The last three months of 2002 saw a spate of filings by DRL in the US. These included five DMF (Drug Master File) filings, essentially permission to enter the US bulk actives market with the objective of either supplying to a large US generics player or captive consumption, and three ANDAs (Abbreviated New Drug Applications). Like the other four ANDAs filed in 2002-03, these three also took the Para IV route. An application filed under Para IV challenges the patents on a product. If successful, a Para IV filing will make it possible for a company to launch its product even before the expiry of the patent. The company also gets a 180-day exclusive marketing window for its generic offering. DRL has 19 approvals pending with the FDA. This includes 14 patent challenge cases.
DRL has been beset by negative developments of late. One of these was that the company dropped three new compounds (DRF 4848, DRF 3188 and DRF NPPC) from its research pipeline. The same were undergoing/ completed pre-clinical development or animal trials. The company did not cite any reason for this move.
In early February 2003, Novo Nordisk said it had decided not to pursue further development of DRL's insulin sensitizer Ragaglitazar (DRF2725; NN622). The decision was taken after Novo performed a renewed benefit/risk assessment of the compound, including analysis of both the clinical phase III data and the tumour findings in the long-term animal studies. The financial terms and conditions of the original agreement remain unchanged, DRL said in a statement.
This compound was out-licensed by DRL to Novo Nordisk in August 1998. Ragaglitazar (DRF 2725; NN622) is an insulin sensitizer that acts as a dual PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist. In July 2002, Novo Nordisk had announced that it was suspending phase 3 clinical trials of Ragaglitazar (DRF 2725; NN622) after it found tumors in one mouse and several rats in long-term animal studies.
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