Generic News

Pharmacy Times, February 2011 Infectious Disease, Volume 77, Issue 2

Some Physicians Still Don’t Trust Generic Drugs

Although most physicians agree that generic drugs are as effective as their brand counterparts, a new study found that many still have negative perceptions about their quality and efficacy. Researchers from Harvard, Brigham and Women’s Hospital, and CVS Caremark say those lingering doubts could be driving up the cost of health care. Their report was published in The Annals of Pharmacotherapy online on January 4, 2011.

“These beliefs could represent an important barrier to greater generic use and could contribute to elevated prescription costs for patients, insurance providers, and society,” wrote the lead author of the study William Shrank, MD, MSHS, of Brigham and Women’s Hospital and Harvard Medical School.

Dr. Shrank and colleagues analyzed survey responses of 506 physicians to determine their attitudes regarding generic drugs. More than 23% of physicians surveyed expressed negative perceptions about the efficacy of generic drugs, and nearly 50% reported negative perceptions about their quality.

In addition, more than 25% said they did not prefer to use generics as firstline therapy for themselves or their families. Physicians 55 years and older were 3.3 times more likely to have negative perceptions about generics than those aged 25 to 34 years.

The researchers also asked the participants how they received information about new generics entering the market. Pharmaceutical company representatives were by far the most common source of information: 75% of physicians said they relied on drug reps for updates on generics.

To boost the generic prescribing rate, the researchers recommend educational initiatives that target physicians who are more likely to harbor misgivings about generic drugs. “Payors and policy makers attempting to stimulate cost-effective medication use should consider educating physicians, particularly older ones, to improve their comfort with generics,” they concluded.

Perrigo Buys Paddock Labs for $540 Million

Generic drug maker Perrigo announced in January that it agreed to acquire assets of Minneapolis-based Paddock Laboratories for $540 million. Perrigo expects to receive a tax benefit estimated at $95 million from the deal, which is scheduled to close in the 4th fiscal quarter of 2011.

The acquisition “expands the breadth of Perrigo’s product offerings and adds a strong new product pipeline,” the company said in a statement. During its first fiscal year, the deal will add more than $200 million in sales and bolster Perrigo’s portfolio with the addition of 35 new drug products.

It will also add more than 25 Abbreviated New Drug Applications to the company’s product pipeline. Of those drug applications, 2 are first-tofile, giving Perrigo 180 days of marketing exclusivity for the products following their final FDA approval and launch.

Joseph C. Papa, Perrigo’s chairman and chief executive officer, said Paddock Labs has “a proven record for quality manufacturing with great customer service,” and that “this strategic acquisition will help to further grow our existing Rx business and continue to add value for our shareholders.”

Blockbuster Blood Thinner Gets Patent Extension

Big pharma companies will be busy tallying their losses in 2011 as patents on blockbuster drugs expire by the dozen. The outlook is less grim for the makers of the top-selling blood thinner Plavix, who announced in January that the FDA granted the drug an additional 6 months of exclusivity.

The decision to extend the patent was made after Bristol-Myers Squibb and partner sanofi-aventis conducted additional studies of Plavix in infants. The research consisted of 2 studies—a dose-ranging study and a trial in children undergoing heart surgery.

The results of the latter study, presented at the American Heart Association meeting in 2010, “showed no benefit of the drug in the prevention of thrombotic events in infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonaryartery shunt,” reported.

Although no new indications are approved, the extension will delay generic competition for Plavix in the United States, giving Bristol-Myers Squibb and sanofi-aventis the right to market it exclusively until May 17, 2012. Generic versions of the drug have been available in Europe since 2009, and global sales of Plavix totaled $9.1 billion in 2009, according to IMS Health.