Monday, February 07, 2005

IN BRIEF: BARR LABORATORIES INC.

Barr Laboratories Inc. sued the Food and Drug Administration to gain exclusive rights to sell a generic version of Aventis Pharmaceuticals Inc.'s propiertary pharmaceutical brand name drug, Allegra-D (fexofenadine hydrochloride/pseudoephedrine hydrochloride). The lawsuit challenges the FDA policy that awards generic exclusivity on a patent-by-patent basis rather than solely to the first company to submit a patent challenge. Barr won tentative approval to market a generic version of the allergy drug in July. Barr said it believes the FDA may find that another company filed the first challenge to Aventis' 2002 patent and may force Barr to share its exclusivity.

Thursday, October 28, 2004

ALLEGRA-D 24-HOUR TABLETS APPROVED BY FDA; AAIPHARMA SHARES SOAR

Shares of aaiPharma Inc. surged 59 percent Wednesday after the Sanofi-Aventis Group received Food and Drug Administration approval of the pharmaceutical drug, Allegra-D 24-Hour tablets (fexofenadine hydrochloride/pseudoephedrine hydrochloride), for the treatment of seasonal allergy symptoms with nasal congestion in patients aged 12 years or older.

AaiPharma said Allegra-D 24-Hour is the only approved once-daily prescription antihistamine with a decongestant. Allegra-D 24-Hour was developed using aaiPharma's extended-release drug technology, according to Reuters.

The company will receive a one-time payment from Sanofi-Aventis as well as royalty payments on sales of the pharma product, which will provide aaiPharma with much-needed cash, according to a Thomas Weisel research note cited by CBS MarketWatch. AaiPharma has laid off workers, changed senior management and attempted to sell certain assets this year in an effort to alleviate its financial difficulties. The amount of the upfront and royalty payments was not disclosed.

"Most importantly, we believe this approval further underscores aaiPharma's considerable expertise... said Thomas Weisel analyst Donald Ellis. "As [aaiPharma] has recently disclosed its intention to potentially divest its pharmaceuticals division, we continue to believe the pharmaceutical company is transitioning back to its roots as a clinical research organization."

Ellis said transitioning back to a clinical research organization could help restore aaiPharma to profitability.

Allegra generated approximately $1.6 billion in sales in 2003, according to CBS MarketWatch, while Allegra-D had $461 million in sales.

Shares of aaiPharma closed at $2.64, up $0.98, in heavy trading on the Nasdaq. Shares of Sanofi-Aventis closed at $36.71, up $1.16, or 3.3 percent, in heavy trading on the New York Stock Exchange.

Friday, May 7, 2004

IN BRIEF: MYLAN LABORATORIES INC.

Mylan Laboratories Inc. received tentative approval from the Food and Drug Administration to market a generic drug version of Aventis Pharmaceuticals' brand naming drug, Allegra-D (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg), extended-release tablets. Allegra-D is indicated as a twice-daily therapy for seasonal allergy with nasal congestion in adults and children aged 12 years or older.