Statins: The Next Drug Class to Switch to OTC Status?

Main Category: Statins
Article Date: 24 May 2005 - 16:00 PDT

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Industry experts believe the popular cholesterol-lowering statins will be the next class of drugs to go over the counter, according to a study by Cutting Edge Information.

Statins are a complex product because regular office visits are required to monitor cholesterol levels while being treated. Industry observers say that Merck's Mevacor and Bristol-Myers Squibb's Pravachol applications for OTC status were initially rejected because of these complexities. However, Cutting Edge Information found in its recent report, "Cardiovascular Marketing: Budgets, Staffing and Strategy," that with many blockbuster statin products approaching patent expiration, the industry will likely increase its OTC efforts.

While the FDA previously refused to approve statins for OTC use, the administration has now signaled that it may be willing to reconsider its previous stance. Government motivation for the OTC switch is driven by the growing size of the statin market. It is estimated that more than 8 million patients in the US already take statins, and recent federal guidelines estimate that as many as 36 million Americans may need to take a cholesterol- lowering agent to reduce the risk of heart attacks.

As the world statins market grew to over $20 billion last year, pharmaceutical companies are eager to ensure product stability. Boosting drug companies' arguments in favor of OTC approval for statins are years of studies showing the safety of the drugs coupled with years of successful use by millions of patients.

"The cardiovascular market is maturing and yet is still expanding quickly," says Jason Richardson, president of Cutting Edge Information. "Companies have to be ready to move their drugs to OTC as the first generation of statin drugs lose patent protection. This will ensure life for current blockbusters even as the next generation of products expands the number of patients being helped."

Cutting Edge Information's report, "Cardiovascular Marketing: Budgets, Staffing and Strategy," explores the marketing tactics used by brand teams and cardiovascular franchise and therapeutic area leaders to increase market share and remain aggressive in the face of growing generic and competitive pressures. The report reviews product investment and resource allocation, cardiovascular marketing activities, and cardiovascular drug producers.

To download a free summary of this new 139-page report, please visit http://www.PharmaCardio.com . For more information, contact Elio Evangelista at Elio_Evangelista@cuttingedgeinfo.com or 919-433-0214.

Cutting Edge Information
http://www.PharmaCardio.com
http://www.cuttingedgeinfo.com

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