The saga of Teva Pharmaceutical Industries Ltd.’s (Nasdaq: TEVA; TASE: TEVA) marketing exclusivity for Pravachol is drawing to a close with a Teva victory. The company announced last week that the US Food and Drug Administration (FDA) that the marketing exclusivity for the drug had not been exercised, and that Teva therefore had 180 days exclusive marketing rights to 10-mg, 20-mg and 40-mg dosages of generic Pravachol, called Pravastatin. The FDA denied Apotex’s request for an agency determination that 180-day exclusivity for the drug had been triggered and run, and that Teva was not eligible for an exclusivity period.
Ethical Pravachol, made by Bristol-Myers-Squibb (NYSE: BMY), a cholesterol blocker, has $1.1 billion in annual sales, and its patent is due to expire on April 20. Teva had decided to wait until the expiry date before launching its generic version of the drug. When Teva learned of the FDA’s position a year ago, that the exclusivity period began in 2004, when Bristol-Myers-Squibb agreed not to sue Apotex if it launched a generic version of the drug. An US Court of Appeals for the District of Columbia Circuit overturned the FDA decision, and ordered to renew the exclusivity period. Teva is due to launch Pravastatin in a few days.
In a separate development, Teva also announced last week that the FDA had granted final approval for the Company's ANDA for Mitoxantrone Hydrochloride Injection USP, 2 mg/mL. Shipment of this product will begin immediately. Mitoxantrone Hydrochloride is a generic version of Novantrone Injection, made by Serono (NYSE: SRA; SWX: SEO), to be used in combination with corticosteroids as initial therapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer, and in combination with other approved products for the initial therapy of acute non-lymphocytic leukemia in adults. Serono reported that Novantrone Injection had $70 million in sales in 2005, including $17.6 million in the fourth quarter.
Another factor that may effect Teva in the short term is FDA conditional approval for geenric antihistamine Allegra (fexofenadine hydrochloride), a treatment for hay fever made by Mylan Laboratories Inc. (NYSE; XETRA: MYL) and Dr. Reddy's Laboratories Ltd. (NYSE:RDY; BSE: 500124). Originally made by Sanofi-Aventis (NYSE:SNY, Euronext: SAN), Allegra has $1.4 billion in annual sales. Teva markets the drug together with Barr Laboratories Inc. (NYSE: BRL), and has a significant share of the market. Allegra is one reason for Teva’s handsome growth last year. Teva is marketing Allegra after obtaining marketing exclusivity from Barr in exchange for royalties. Teva made an at risk launch, agreeing to should the costs of pending patent litigation.
Published by Globes [online], Israel business news - www.globes.co.il - on April 16, 2006
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