PHARMACY

GPhA urges removal of 12-year exclusivity amendment from healthcare-reform bill

BY Alaric DeArment

NEW YORK Either reduce the amount of time that a drug company would have to wait before submitting an approval application to the Food and Drug Administration for a biosimilar from the 12 years provided under pending healthcare legislation, or strike the biosimilars language from the bill altogether, an organization representing the generic drug industry has called on President Barack Obama to tell Congress.

In a letter to president Obama Tuesday, Generic Pharmaceutical Association president and CEO Kathleen Jaeger asked Obama to urge Congress to lower the data exclusivity period from 12 years to one that would “ensure timely entry of safe and affordable biosimilars and biogenerics to the market.” Either that, Jaeger wrote, or do away with the biosimilars provision.

“The inclusion of the current fatally flawed language is arguably worse than the effective monopoly that the biotech industry enjoys because it represents an empty promise to Americans who may falsely believe that the legislation will provide for meaningful competition,” Jaeger wrote. “This simply will not increase access or contain drug spending costs; rather, it represents little more than camouflaged protection of the unacceptable and unsustainable status quo.”

The GPhA wants biotech drugs to have five years’ data exclusivity – as pharmaceutical drugs already do – while the biotechnology has called for up to 14 years, saying that the unique properties of biotech drugs would allow potential biosimilar manufacturers to engineer around their patents. The White House has suggested a seven-year exclusivity period.

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Pleio’s medication adherence program yields positive results

BY Alaric DeArment

PHILADELPHIA A company that runs a medication adherence program said its program had a “highly significant” effect.

Pleio Health Support Systems announced Monday results of the Pleio GoodStart program, analyzing data from 1,776 patients taking a chronic cardiovascular medication between May 2008 and 2009 that showed patients refilled an average of two additional 30-day prescriptions during their initial nine-month period of taking the medication.

Patients in the GoodStart program also refilled their prescriptions an average of 10 days sooner than those in the control group, Pleio said.

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Deloitte report: Pharmaceutical companies’ ‘patent cliff’ could bolster mergers, acquisitions

BY Alaric DeArment

NEW YORK A wave of acquisitions indicates a trend of consolidation in the drug industry, as companies seek ways to build up their research and development pipelines while reducing overhead costs, according to a report released Tuesday by professional services firm Deloitte.

One of the factors driving mergers is that drugs representing more than $74 billion in sales will lose patent protection by 2012, which many analysts have come to call the “patent cliff.”

“With so many rapidly changing dynamics – the patent cliff, healthcare reform and still-dry capital markets – the trends in life sciences industry consolidation are almost certain to continue with a growing emphasis on those deals with companies involved with late-stage developed compounds,” Deloitte & Touche partner Phil Pfrang said in a statement. “Healthy companies have good cause to pursue deals that promise faster revenue streams and profits.”

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