Healthy Skepticism Library item: 10743

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Publication type: news

Von Schaper E.
Bayer to Battle FDA to Sell Heart Drug to Consumers
Bloomberg News 2007 Jun 28
http://www.bloomberg.com/apps/news?pid=20601202&sid=atV7vJ3m7.3E&refer=healthcare

Full text:

Headquarters of Bayer Schering Pharma June 28 (Bloomberg) — Bayer AG plans to succeed where Merck & Co. and Bristol-Myers Squibb Co. failed: Selling U.S. consumers a cholesterol drug without a prescription.

The company that gave the world aspirin 100 years ago is talking to U.S. regulators about a low-dose version of Bristol- Myers’s Pravachol, a member of the statin drug class that includes Pfizer Inc.‘s Lipitor. At stake is a slice of the more than $22 billion spent worldwide on cholesterol-lowering pills.

While Bayer expects to market the drug to consumers alongside aspirin, doctors and analysts say the Leverkusen, Germany-based company may not succeed. The Food and Drug Administration, which blocked earlier attempts to make statins into consumer products, may balk at approving over-the-counter sales for long-term use without a doctor’s direct supervision.

``The FDA generally seems to be more difficult,’‘ said Ulle Woerner, an analyst at Landesbank Baden-Wuerttemberg in Stuttgart. ``This could be a good step to strengthen Bayer’s profile in the U.S., but it won’t come easy.’‘

Bayer is second to Johnson & Johnson in the $75 billion global consumer-drug market with 2.5 billion euros ($3.4 billion) in revenue. Its consumer sales have outgrown the market in eight of the last 10 years.

The drugmaker wants Pravachol to fuel growth of the consumer care division, Gary Balkema, who runs the unit, said at an investor conference last week. Bayer executives declined to discuss plans for persuading the FDA to approve the drug.

Joint Pain, Stomach Upset

Bayer shares have soared 38 percent this year and may rise further when the company releases a study on its experimental blood-thinning drug on July 8, analysts say. They rose 83 cents, or 1.5 percent, to 56.06 euros in Frankfurt. The company this month raised its profit forecast for the next three years after finding ways to squeeze more administrative and research costs from the Schering purchase.

The stock has outperformed Germany’s benchmark DAX Index this year, which has risen 19 percent as the company has benefited from purchasing Schering AG. Of the 31 analysts who cover Bayer and are tracked by Bloomberg, 20 rate the company a ``buy,’‘ eight have ``hold’‘ recommendations and three rate Bayer a ``sell.’‘

Drugs sold without a prescription tend to treat short-term illness that patients can feel, like joint pain or stomach upset — not high cholesterol, a condition that can’t be easily identified or monitored.

In 2000, the FDA rejected requests by two statin makers, Whitehouse Station, New Jersey-based Merck, which sells the drug Mevacor, and New York-based Bristol-Myers, which owns Pravachol. Both companies sought to sell low doses of their products without prescriptions.

In 2005, regulators rejected a second attempt by Merck and New Brunswick, New Jersey-based J&J, saying research didn’t show that an over-the-counter pill would be used safely.

Safety Issues

The FDA has come under pressure to be cautious after approving Merck’s painkiller Vioxx, which was withdrawn in 2004 after evidence that the drug doubled the risk of heart attacks. The agency has also been criticized in the past month about its oversight of the safety of Avandia, a diabetes medicine sold by London-based GlaxoSmithKline Plc.

Bayer ranks fifth in the U.S. consumer healthcare market, and turning prescription medicines into over-the-counter products is part of a plan to break into the top three, according to Balkema.

``The most recent dialogues we’ve had with the FDA in the spring are the most encouraging we’ve seen thus far, and we’ll continue those,’‘ Balkema said. Bayer bought the rights to the U.S. consumer version of Pravachol from Bristol-Myers and will shoulder the cost of the product’s development.

Playing Catch-up

``This is a very good drug, it’s just not the kind you want to take without a prescription,’‘ said Brian Strom, a professor at the University of Pennsylvania School of Medicine in Philadelphia.

Statins work by drawing cholesterol out of the blood, keeping some of the waxy substance from blocking arteries. The class is associated with a rare side effect called rhabdomyolysis, a muscle-wasting condition that forced Bayer to pull its prescription statin, Baycol, from the market in 2001.

Balkema touted aspirin, the company’s longest-selling drug, as a model for taking prescription drugs to over-the-counter use. ``Bayer has got this fantastic brand; it has the enormous consumer base with Bayer aspirin, and a very, very powerful OTC health-care business,’‘ William Kridel, managing director of Ferghana Partners, said in a televised interview today.

Some doctors are pointing to the U.K. when it comes to non- prescription sales of heart pills.

Glaxo’s Diet Pill

A drug similar to Pravachol, Merck’s Zocor, has been available there since 2004, with pharmacists having the ability to decide whether a customer gets the medicine. Those deemed at high risk, like diabetics or men with a family history of heart disease, are referred to a doctor.

Bayer isn’t the only drugmaker trying to sell less powerful versions of prescription medicines over the counter. Glaxo won approval of a lower-dose version of Roche Holding AG’s Xenical diet pill in the U.S. in February.

To prepare consumers for its version, called Alli, Glaxo issued 250 pages of educational materials to accompany a starter pack, a Web site, 200,000 copies of a diet plan and 800,000 copies of a book to help dieters combine the pill with weight- loss programs. Sales of the Alli pack reached as high as No. 2 among health and personal care products on the Amazon.com Web site their first week.

Bayer will also have to educate consumers and pharmacists, analysts said.

``I think approval will depend more on how much the company can put a pharmacist education plan in place to show the FDA that patients won’t be left alone with their high cholesterol,’‘ said Evguenia Rossikhina, a Zurich-based analyst for Datamonitor, the consumer and health-care consultant.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net .