SOURCE: Five Star Equities

Five Star Equities

May 24, 2012 08:20 ET

Merck and Mylan Look to Benefit From Plan to Speed up FDA Reviews

Five Star Equities Provides Stock Research on Merck and Mylan

NEW YORK, NY--(Marketwire - May 24, 2012) - Lost revenues as a result of expiring patents have been a growing problem for the big pharmaceutical companies. New products that are being introduced into the market place are not expected to generate the same levels of revenues of top selling drugs that have lost patent protection, but a plan to speed up reviews of new drugs and medical devices will look to benefit the industry. Five Star Equities examines the outlook for companies in the Drug Manufacturers Industry and provides equity research on Merck & Co., Inc. (NYSE: MRK) and Mylan Inc. (NASDAQ: MYL).

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A $6.4 billion plan to speed up FDA reviews of new drugs and medical devices is now a step closer to becoming law as it has now been moved to the Senate. The Senate was expected to vote earlier this week on roughly $2 billion in new fees that drug and medical device companies will pay to regulators over the next 5 years for review of their products according to a recent Bloomberg article. Generic-drug companies, who were previously exempt from such fees, make up $1.56 billion. Fees for brand-name drug companies over the five-year period will increase 6 percent to $4.1 billion, and more than double for device makers to 609 million, according to the Congressional Budget Office's cost estimate.

"To get lifesaving drugs and devices to the patients that need them as quickly as possible, Congress must give the Food and Drug Administration the tools it needs to review and approve these products," Senate Majority Leader Harry Reid stated on the Senate floor.

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Merck, known as MSD outside the United States and Canada, provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. Worldwide sales of SINGULAIR, a once-a-day oral medicine for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, grew 1 percent from the first quarter of 2011 to $1.3 billion. The U.S. patent for SINGULAIR will expire in Aug. 2012, and the company expects a significant decline in sales thereafter.

Mylan has recently announced that it has launched Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg in France, Belgium, the UK, the Netherlands and Ireland. Mylan has received marketing authorization from each country's respective health authority to begin selling its product immediately. Atorvastatin Calcium is the generic version of Pfizer's Lipitor Tablets.

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