Five things for pharma marketers to know: Wednesday, August 26
Gilead Sciences' Harvoni received FDA approval after Sovaldi.
Federal and state Medicaid officials should allow more people to be treated with new high-priced hepatitis-C drugs, an advisory panel told the White House, according to The New York Times. The recommendations revolve around such options as Sovaldi and Harvoni, which can cost $84,000 for a full course of treatment. Several states have imposed restrictions for when Medicaid will cover use of such drugs. Those restrictions run counter to sound medical practice, the Presidential Advisory Council on HIV/AIDs said, as did officials from the Public Health Service.
Irish drugmaker Perrigo Co. apparently does not plan to go quietly into the arms of suitor Mylan NV, reported Bloomberg Business. Perrigo CEO Joseph Papa continues to pursue takeover deals of his own while trying to convince his shareholders to reject Mylan's takeover offer. Perrigo is searching out deals with companies in the $100 million to $1 billion annual revenue range.
The FDA gave priority review status to Sarepta Therapeutics' eteplirsen, an experimental therapy developed to treat a rare genetic disorder, Duchenne muscular dystrophy. The disease, which affects one of every 3,500 boys worldwide, destroys muscle tissue and often kills patients by the time they reach their 30s, reported The Wall Street Journal. The FDA previously granted Fast-Track, orphan-drug and rare pediatric disease designations to eteplirsen.
Novo Nordisk, the world's largest maker of diabetes drugs, plans to begin a Phase-III trial for oral semaglutide, its protein-based GLP-1 analogue treatment for diabetes, after reporting “encouraging” results in earlier trials. Novo said it will conduct seven trials of roughly 8,000 people with type-2 diabetes. The company plans to invest $2 billion over the next five years in production facilities in North Carolina and in its native Denmark.
Pfizer plans to sell the US rights to four pharmaceutical drugs to New Jersey–based Alvogen. The agreement includes clindamycin injection and acetylcysteine inhalation solution as well as two pending abbreviated new drug applications for voriconazole injection and melphalan injection. Robert Wessman, Alvogen's chairman and CEO, said, “This acquisition supports our strategy to gain exposure to the high growth, injectable segment in the US market."