PHARMACY

Mylan files second suit against newspaper

BY Alaric DeArment

MORGANTOWN, W. Va. Generic drug maker Mylan has sued the Pittsburgh Post-Gazette again, this time for libel.

According to court documents obtained by Drug Store News, Mylan filed a complaint against the Post-Gazette and reporters Patricia Sabatini and Len Boselovic Friday in the Circuit Court of Monongalia County, W.Va., over a series of articles the newspaper published alleging pervasive manufacturing misconduct at the company’s plant in Morgantown, W.Va.

In its complaint, Mylan accused the newspaper of “the sort of sensationalism, exaggeration and outright falsehood that typifies the worst kind of tabloid journalism,” and seeks unspecified damages and compensation for legal fees.

Mylan also noted that the day after the publication of the initial article, the company’s stock price experienced dramatic fluctuations and was traded at an unusually high volume.

“The Post-Gazette and its staff writers intentionally and misleadingly omitted, juxtaposed and distorted the facts to persuade readers that, among other things, Mylan engages in activity that would result in adverse Federal Food and Drug Administration action, destroys evidence, has a culture that is cavalier about quality control, and produces products that pose a danger to patients,” the complaint read.

The Post-Gazette had reported that employees at the plant ignored and deleted computerized warnings of problems with the manufacturing equipment, based on confidential internal documents, anonymous sources and third-party commentary. A subsequent investigation by the Food and Drug Administration found “minor” deviations in standard operating procedures, but determined that the problem had been corrected, and that there was no evidence of widespread misconduct.

Mylan sued the Post-Gazette in August seeking compensation and the return of the documents, saying that the newspaper had obtained them improperly and without Mylan’s knowledge or consent.

Mylan and the Post-Gazette declined to comment.

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PHARMACY

BIO responds to GPhA letter to Obama

BY Alaric DeArment

WASHINGTON The Biotechnology Industry Organization has asked the Obama administration and members of Congress to disregard a request by the Generic Pharmaceutical Association to strike biosimilars language from the healthcare-reform bill.

In a letter to President Barack Obama Tuesday, GPhA president Kathleen Jaeger asked Obama to urge Congress to either reduce the 12-year period of market exclusivity provided in the bill’s language, determining the amount of time a potential manufacturer would have to wait before making a biosimilar to compete with the innovator company’s product, or eliminate the biosimilars language from the bill altogether.

“GPhA’s request to the administration is a cruel trick to the millions of patients who are awaiting the benefits of biosimilars,” a BIO statement in response to the letter read. “GPhA is asking the Obama administration to hold patients and consumers hostage unless it gets its way on this critical provision of healthcare reform.”

BIO has stated that it prefers an exclusivity period of 14 years, saying that the unique properties of biosimilars would allow a potential biosimilar manufacturer to circumvent an innovator company’s patents and arguing that additional time is needed to determine whether a biosimilar would have the same safety and efficacy as its innovated counterpart. GPhA, meanwhile, wants five-year exclusivity periods, similar to the ones that pharmaceutical drugs have before facing generic competition. GPhA says that 14-year exclusivity periods would deprive patients of more affordable alternatives to biotech drugs, which can cost tens of thousands of dollars per year. The Obama administration has called for a seven-year exclusivity period.

“Biosimilars, often erroneously referred to as ‘generic biologics,’ can bring the benefits of expanded competition to biologics, breakthrough medicines that are extending and saving the lives of patients living with diseases such as cancer, diabetes, Parkinson’s and Alzheimer’s,” BIO’s statement read.

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Warner Chilcott completes acquisition of P&G’s pharmaceutical arm

BY Allison Cerra

ARDEE, Ireland Warner Chilcott has completed its acquisition of a global brand’s pharmaceutical business.

Procter & Gamble’s branded prescription pharmaceutical business complements Warner Chilcott’s existing presence in women’s health care and adds new therapeutic and geographic markets. At closing, approximately 1,900 employees of P&G’s pharmaceuticals business joined Warner Chilcott and the company added manufacturing facilities in Germany and Puerto Rico.

“This is a transformational acquisition that extends our presence to include many of the major pharmaceutical markets around the World and significantly enhances the scale and diversity of our business,” said Roger Boissonneault, president and CEO Warner Chilcott. “Importantly, the increased scale afforded by this deal provides us with the ability to pursue a broader range of R&D projects to fuel our long-term growth.”

To finance the acquisition, the company used a combination of cash on hand and borrowings under new senior secured credit facilities.

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