FDA panel backs Contrave
SAN DIEGO — A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.
Orexigen Therapeutics and Takeda Pharmaceutical announced Tuesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.
“We are encouraged by the panel’s view of the risk-benefit profile of Contrave,” Orexigen president and CEO Michael Narachi said. “We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting today in preparation for our [Prescription Drug User Fee Act] action date in January.”
Diet pills for treating overweight and obese patients have been a tough sell for the FDA. The agency declined to approve such drugs as Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin) while requesting that Abbott’s Meridia (sibutramine) be removed from the market due to safety concerns.
J&J’s bid to acquire Crucell gains full support
NEW BRUNSWICK, N.J. — Johnson & Johnson made its courtship with Dutch biotech company Crucell official by acquiring all of the company for $2.3 billion, the two companies said Wednesday.
In a deal that won the full support of Crucell’s management, J&J will pay $32.74 per share for the remainder of Crucell that it doesn’t already own; J&J indirectly controls around 18% of Crucell’s stock through a Dutch affiliate, while Delta Lloyd Asset Management, Robeco and the Van Herk Group control around 15.5%, according to published reports.
J&J said it would maintain Crucell’s headquarters in Leiden, Netherlands, and keep it as the center for vaccines within J&J’s pharmaceuticals division; it also would keep the company’s senior management and “generally” keep its current staff intact.
J&J originally announced its intention to buy the remainder of Crucell in September, receiving backing from Crucell in early October. Prior to its acquisition by Pfizer, Wyeth also had considered buying Crucell in January 2009.
Graymark sets its sights on sleep disorders
OKLAHOMA CITY — Following the sale of ApothecaryRx pharmacies to Walgreens, Graymark Healthcare said it is shifting its focus to sleep disorders, including obstructive sleep apnea.
Graymark is one of the largest providers of sleep medicine diagnosis and treatment, owning and operating diagnostic sleep centers that treat a wide range of sleep disorders, and also operates a medical equipment supply company that provides disposable and durable medical equipment.
"Millions of Americans suffer from obstructive sleep apnea, and many aren’t aware they have a problem or that treatment is available in their communities," said Stanton Nelson, chairman and CEO of Graymark Healthcare. "As a pure-play sleep disorders company focused primarily on obstructive sleep apnea, we believe Graymark is better able to help people sleep better."
Graymark announced its sale of ApothecaryRx pharmacies, which operates 18 pharmacies across five states, to Walgreens in late August.