Retailers sue Pfizer, charge generic Lipitor delay

Five large drug and grocery chains are suing Pfizer Inc. and a second drugmaker, alleging they conspired to delay sales of cheap generic versions of the blockbuster cholesterol drug Lipitor.

Lipitor, the world's top-selling drug ever, had peak sales of nearly $13 billion a year several years ago. Sales dropped sharply after it got U.S. generic competition on Nov. 30.

The lawsuit, filed Thursday by Walgreen Co., the Kroger Co. and three other retailers in U.S. District Court in Trenton, N.J., claims generics should have been available nearly two years earlier, when Lipitor's original patent expired.

The suit accuses Pfizer of patent fraud as well as "illegal, anti-competitive conduct" with generic drugmaker Ranbaxy Laboratories of India to block other generic drugmakers from selling versions of Lipitor, called atorvastatin calcium, until recently.

The suit also accuses New York-based Pfizer of making deals with companies that manage prescription benefits, giving them big discounts on brand-name Lipitor in exchange for those companies limiting sales of generic versions. Generic pills generally bring pharmacies higher profit margins than brand-name medicines do.

Pfizer denies the lawsuit claims and said Friday that it "will defend itself vigorously." A spokesman for Ranbaxy said the company had not been served with the lawsuit and has a policy against commenting on pending litigation.

The plaintiffs, which include Safeway Inc., Supervalu Inc. and HEB Grocery Co. LP, claim the original patent for the active ingredient in Lipitor expired in March 2010 and that Pfizer fraudulently got the U.S. Patent and Trademark Office to grant a follow-on patent that extended Pfizer's monopoly on Lipitor sales.

According to Pfizer, Lipitor has additional patents that run until 2017, in addition to the patent in question in the lawsuit.

The plaintiffs also accuse Pfizer and Ranbaxy of striking a deal to delay competition from other generic versions of Lipitor. Ranbaxy got a six-month window through the end of May when it sold generic Lipitor and the only other generic version on the market was an authorized one

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CDC recommends expanded use of Pfizer vaccine

Reuters – Wed, Jun 20, 2012 (Reuters) - An advisory committee for the Centers for Disease Control and Prevention voted on Wednesday to recommended expanded use of Pfizer Inc's Prevnar 13 vaccine to include adults 19 and older with compromised immune systems due to conditions such as HIV infection, cancer and advanced kidney disease.

The Advisory Committee on Immunization Practices (ACIP)favored the expanded use by a vote of 14-0 with one abstention, the CDC said.

Prevnar 13, one of Pfizer's most important products, prevents pneumococcal pneumonia or invasive disease. Wall Street analysts, on average, have forecast Prevnar 13 sales will reach $6.75 billion by 2016. The company reported sales of $941 million in the first quarter.

"While we view this (recommendation) as an incremental positive, we think the Street expected a positive outcome," ISI Group analyst Mark Schoenebaum said in a research note.

Pfizer shares were off 9 cents at $22.62 in midday trading on the New York Stock Exchange.

Prevnar 13 was initially approved by the U.S. Food and Drug Administration in 2010 for the prevention of invasive pneumococcal disease caused by the 13 serotypes included in the vaccine in infants and children from 6 weeks through 5 years old.

The FDA in December approved Prevnar 13 for adults age 50 and older. ACIP has not yet recommended the vaccine for that patient population.

"We are committed to continuing discussions with the ACIP with the aim of expanding the recommendations to include all adults 50 years of age and older - a population rapidly increasing in the United States and at risk for developing vaccine-type pneumococcal pneumonia and invasive disease," Pfizer said in a statement.

Pfizer is expecting data next year from a Prevnar 13 trial of more than 84,000 subjects 65 and older to determine if the vaccine is effective in preventing the first episode of community-acquired pneumonia caused by the 13 pneumococcal serotypes in the vaccine.

ACIP is likely awaiting results from that trial, called CAPITA, before making a recommendation for the vaccine's use in older adults.

"The key event for Prevnar 13 remains the data readout in 2013 from the CAPITA adult outcomes study," Schoenebaum said.

The vaccine is not approved for those between the ages of 6 and 49.

(Reporting By Bill Berkrot; editing by Maureen Bavdek and Andre Grenon)

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FDA panel urges approval for Pfizer arthritis drug

"An advisory committee to the US Food and Drug Administration on Wednesday urged US regulators to approve a new treatment for rheumatoid arthritis made by the pharmaceutical giant Pfizer. (AFP Photo/Timothy A. Clary)" title

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Nestle wins pricey battle for Pfizer baby food unit

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