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Barr starts shipping OTC Plan B pills

Barr started shipping its „morning after” birth-control pill to US pharmacies to begin over-the-counter (OTC) sales for the first time.

Barr Pharmaceuticals Inc. won US regulatory approval on August 24 to sell the drug without a doctor's prescription to women ages 18 and older. The drug, called Plan B, will be available in pharmacies across the country by mid-November, the Woodcliff Lake, New Jersey-based company said yesterday in a statement. Plan B, which is designed to prevent pregnancy when taken within 72 hours after sex, was cleared in 1999 for US sales with a prescription. Barr's application to sell the pills over the counter ignited a three-year political debate between people who wanted more timely access to the drug and those who argued that it might promote sexual promiscuity among teenagers.

„Patient demand is going to warrant that it is going to be stocked by lots of retail outlets,” Will Sawyer, an analyst at Leerink Swann & Co. in New York, said yesterday in a telephone interview. OTC availability may help Barr triple annual sales of Plan B to as much as $90 million within three to four years, Sawyer said. Barr's CEO, Bruce Downey, said in August that Plan B made about $30 million last year, or about 3% of the company's sales. Shares of Barr rose $1.47, or 3%, to $51.36 at 4 p.m. on Monday in New York Stock Exchange composite trading. The stock has dropped 18% this year.

The US Food and Drug Administration granted Barr three years of exclusivity to sell the OTC pills without generic competition until August 2009, the company said yesterday. Women ages 17 and younger will still need a prescription. Sawyer said Barr's timing of the OTC shipments and its marketing plans have met analysts' projections so far. Pharmacies will pay about $27.95 per treatment when the pills are purchased wholesale, Barr spokeswoman Carol Cox said yesterday in an e-mail. Prescription-only versions of the drug were less expensive to make and were sold to pharmacies for $18.89 per treatment, she said.

The price that consumers pay will vary depending on what stores charge. Barr buys Plan B as a finished product from Budapest-based Gedeon Richter Nyrt, Eastern Europe's biggest maker of gynecological drugs. Cox declined to comment about how the two companies split profit from the drug. Richter shares rose Ft 1,095, or 2.6%, to 42,595 forint in Budapest. About 250 Barr sales representatives who had been responsible for marketing the prescription pills will promote Plan B to doctors and pharmacists as an over-the-counter drug as well, the company said.

Barr has also started an information campaign for consumers and health-care providers about the drug and the federal age restrictions. Barr derives about two-thirds of its revenue from selling cheaper copies of brand-name medications. The company bought Croatian drugmaker Pliva d.d. last month to become the second-largest US maker of generic drugs. Corona, California-based Watson Pharmaceuticals Inc., which completed its acquisition of Andrx Corp. on Sunday, ranks first by 2005 revenue. (Bloomberg)