Posted At Yahoo.com

BY : PRNewswire

t is not often that a change from prescription to nonprescription status creates an entirely new category of over-the-counter medications, but that is what is set to occur as pharmaceutical companies are attempting to switch their cholesterol-lowering drugs to OTC status in many of the largest markets around the world. Two recently released studies by Kline & Company examine this imminent shift and its implications for the healthcare systems of the United States, Germany, and other countries.

"A shift in this class definitely brings significant regulatory and consumer marketing challenges, but there are practical and financial reasons to make the switch for the drug companies and the national health care agencies around the world," says Laura Mahecha, industry manager for the healthcare practice of Kline's research division.

Cardiovascular disease represents significant health and financial burdens for most Westernized countries and has created an impetus to prevent cardiovascular deaths and reduce costly prescription drug expenditures.

"The health care agencies want to shift drug costs toward consumers where they can, and OTC drugs will be cheaper for consumers to buy than the original prescription version. And the drug companies want Rx-to-OTC switches to extend the patent life of their products and offset declines from generic competition," Mahecha notes.

Prime switch candidates in the cholesterol reducer category for the U.S. market include Merck's Zocor and Mevacor and Bristol-Myers Squibb's Pravachol, according to Kline's U.S. CHOLESTEROL-LOWERING DRUGS 2005: Rx MARKET ANALYSIS AND SWITCH FORECASTS market study. These drugs have already proven their ability to generate large profits as top-selling prescription medications and have already seen--or will soon see--their patents expire in a number of major national markets.

The greatest hurdle the drug marketers face is convincing regulatory agencies that consumers will be able to use the drugs safely and correctly without the direction and monitoring of a physician. In this instance, they may be able to cite a precedent: Merck's 10 mg Zocor Heart-Pro has been available for sale in Great Britain since July 2004 as a behind-the-counter medication. Consumers must first consult with a pharmacist before purchasing the drug.

"Countries like the U.K. and Canada that have the behind-the-counter class have a greater chance of seeing more switches in general," says Mahecha. "It's effectively a middle ground between Rx and OTC, but there's still a good chance that cholesterol reducers will soon switch in the U.S. and other countries that don't have a BTC class."

Another recently released study by Kline, INTERNATIONAL RX-TO-OTC-SWITCH FORECASTS, identifies Germany as a likely contender to be the next country to switch cholesterol-reducing drugs to OTC status.

"While there hasn't been a great push for a switch in this area, Germany is in the middle of enacting significant healthcare reforms, and the German Health Ministry is looking for ways to reduce the costs associated with all drugs covered by socialized medicine," says Mahecha. "This could move them off of the wait-and-see approach that they've adopted to this point--waiting for actual use data to come out of the Heart-Pro switch in the U.K."

Kline's study points to New Zealand as another country that may switch a cholesterol reducer. Merck's Lipex, its version of Zocor for the New Zealand market, is set to lose its patent protection there this year, so Merck is seeking a switch.

"With the number of patients that suffer from high cholesterol in most Western nations, the national markets represent hundreds of millions of dollars in annual sales for OTC treatments," says Susan Babinsky, vice president and head of Kline's healthcare consulting practice. "The major challenge facing these OTCs is proving that consumers can safely and effectively use the drugs as OTCs without physician monitoring."

In order to identify likely candidates for Rx-to-OTC switch among the cholesterol reducers, Kline has published U.S. CHOLESTEROL-LOWERING DRUGS 2005: Rx MARKET ANALYSIS AND SWITCH FORECASTS. The study provides an overview of the prescription market segment in the U.S., including regulatory issues and the sales potential of OTCs, as well as a forecasting model to help subscribers identify opportunities according to different retail scenarios.

Statins and other cholesterol-reducing prescription drugs are also covered in Kline's INTERNATIONAL RX-TO-OTC-SWITCH FORECASTS, which provides predictions of switches in major national markets in Europe, the Asia-Pacific region, and North America. The report covers nine major national markets and analyzes switch activity across 14 therapeutic classes, including cholesterol- lowering drugs.

For information on either of these studies, go to www.klinegroup.com/sslife.htm and scroll to view Kline's Health Care titles, or contact Laura Mahecha at +1-973-435-3446 or laura_mahecha@klinegroup.com. In Europe, contact Pilar Pardo at +32 2 776 0737 or pilar.pardo@kline-europe.com.

To learn more about Kline's customized consulting capabilities for the healthcare field, contact Susan Babinsky at +1-973-435-3365 or susan_babinsky@klinegroup.com.

Established in 1959, Kline & Company (www.klinegroup.com) is an international business consulting and market research firm serving the life sciences, consumer products, specialty chemicals, and energy industries.