Healthy Skepticism Library item: 5939

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Publication type: news

Heher AM.
Plavix Patent Fight May Hurt Lilly
Yahoo Finance 2006 Aug 16
http://biz.yahoo.com/ap/060816/lilly_generic_plavix.html?.v=1

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Plavix Patent Fight May Hurt Lilly
Wednesday August 16, 3:57 pm ET
By Ashley M. Heher, AP Business Writer
Patent Fight Over Plavix Could Spell Problems for Lilly

INDIANAPOLIS (AP) — The outcome of a federal court fight over a generic version of the popular blood-thinning drug Plavix could threaten one of Eli Lilly and Co.‘s most promising pipeline medications.

Lilly’s own blood-thinner, prasugrel, will face heightened competition if the cheaper, generic form of Plavix stays on the market. Lilly officials have said they expect to submit the medication to the Food and Drug Administration in late 2007.

Plavix’s marketers Bristol-Myers Squibb Co. and Sanofi-Aventis SA are slated to square off against Apotex Inc. in a New York federal court Friday, in the hopes of forcing the Canadian generic company to halt sales of its version of the drug and recall product already sold.

Apotex’s generic form of Plavix hit drug store shelves last week.

Prasugrel, which experts say could generate $1.2 billion in sales in 2012, is part of a partnership between Lilly and Daiichi-Sankyo Co.

But it will be more difficult for prasugrel to reach that goal if Bristol-Myers and Sanofi-Aventis lose their injunction request, forcing Lilly’s drug to compete against a cheap, generic version of Plavix.

Analysts said the research must show a significant difference between the two products to convince cost-cautious insurers that prasugrel merits a higher price tag.

“I think we’re in an area where you have to be materially better to justify the cost,” said George Farra, a principal with Woodley Farra Manion Portfolio Management in Indianapolis. “If there isn’t that much differentiation between the two, the cheaper version will be recommended by the insurance companies.”

To make sure the medication can sway hard-to-impress physicians and insurance companies, Lilly is enrolling 13,000 patients in a head-to-head study that pits Plavix against prasugrel.

If Lilly can prove its drug is better at preventing major cardiovascular problems among a high-risk population, that should help the pharmaceutical maker retain patients that might otherwise take the generic version of Plavix.

“The possibility that generic clopidogrel (Plavix) will become available earlier than expected underscores the validity of our clinical trial strategy,” J. Anthony Ware, vice president and global brand development leader for prasugrel, told The Associated Press in a statement. “We chose this strategy chiefly because we had anticipated that clopidogrel (generic Plavix) would be available on a generic basis for most of prasugrel’s life cycle.”

Bear Stearns analyst John Boris called prasugrel Lilly’s most important pipeline drug.

“If you’re launching into a market, it’s a lot better to launch into a market that’s dominated by branded products,” he said. “It’d be much better for Lilly to compete head-to-head with Bristol, because the economics are based on a branded price.”

The generic form of Plavix costs around $124 for 30 tablets, compared with about $148 for the Bristol-Myers branded version.

Meanwhile, Bristol-Myers and Sanofi-Aventis are offering discounts on Plavix, hoping the drug will maintain its market share.

Sales of Plavix, the second-best selling drug in the world behind Pfizer Inc.‘s cholesterol drug Lipitor, totaled $5.9 billion last year.

Plavix is made by Sanofi-Aventis but is sold in the U.S., Canada and other countries by Bristol-Myers. The medicine is Bristol-Myers’ top-selling product.

A ruling on the injunction is expected to take several weeks.

http://www.lilly.com