Shire receives market exclusivity for ADHD drug
DUBLIN, Ireland A new drug for treating attention-deficit hyperactivity disorder properly received its five-year market exclusivity from the Food and Drug Administration, the drug’s manufacturer announced.
British drug maker Shire said the FDA confirmed the new chemical entity exclusivity given to Vyvanse (lisdexamfetamine dimesylate). The drug’s exclusivity period will last until February 2012, and its patents will remain in effect until June 2023.
Generic drug maker Actavis had sued the FDA in the District Court of the District of Columbia challenging the agency’s decision to grant Vyvanse status as a new chemical entity following its refusal to file Actavis’ approval application for a generic version of the drug. The court case was stayed pending the outcome of the FDA’s review.
Pleio’s medication adherence program yields positive results
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.
Deloitte report: Pharmaceutical companies’ ‘patent cliff’ could bolster mergers, acquisitions
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.”