Business briefs: Eisai, Merck, plus another ACA delay
Eisai is lobbying the FDA to give it more time on its Belviq patents, reports BioCentury, which says the regulator was wrong to start the five-year patent clock while the DEA was figuring where its weight-loss drug should live on the DEA's schedule of controlled substances. Even though the FDA approved Belviq in June 2012, the DEA schedule designation wasn't decided until June 2013, and Eisai is looking to have that date be considered the patent start date. In addition to giving more time for exclusivity, it could provide a necessary cushion while doctors and patients get used to the idea of prescription weight-loss drugs. Despite apparent need—over 35% of adults are obese—the prescription meds like Vivus' Qsymia and Belviq, which is made by Arena but marketed by Eisai, have not taken off. Payers have given the drugs a lukewarm reception, and category watchers say this may be a contributing factor behind lackluster sales.
A federal judge ruled that Paula Deen's racial bias accuser Lisa Jackson could not sue the now-former Food Network star over racial discrimination, reports the New York Times. The judge said Jackson, who once ran one of Deen's businesses, could not sue because she was “an accidental victim of the alleged racial discrimination,” as opposed to a victim of the alleged misconduct. Jackson is white. NYT notes that Monday's decision does not affect Jackson's sexual-harassment suit against Deen's brother Earl Hiers. Loss of reputation and endorsement deals have made a major dent in Deen's celebrity chef reputation, but USA Today says Monday's decision will not be able to temper the backlash from the allegations accusing Deen of racist remarks. The swirl of negative publicity unwound several lucrative Deen deals, including her endorsement deals with Wal-Mart, QVC, Smithfield Farms and other.
Avanir's sales force will be touting Merck's diabetes medication Januvia to long-term care facilities. On Monday Avanir announced the arrangement, which includes the 25mg, 50mg and 100mg sitagliptin tablets. The sales push kicks off in October, and Avanir's compensation will include a fixed fee and incentive payments.Another healthcare reform measure has been delayed. The initiative that would cap consumer out-of-pocket costs by eliminating a payer's ability to have separate deductibles for prescriptions and medical care will become a uniform measure in 2015, not 2014 as initially scheduled, reports the New York Times. The paper notes that the Labor Department has had the rollback information posted on its website since February, but this “was obscured in a maze of legal and bureaucratic language that went largely unnoticed.” The delay means that employers with 50 or fewer employees will not have to provide health insurance by 2014. The administration announced in July that this measure won't go into effect until 2015.