Business briefs: GSK, Vivus, Biogen Idec, Astellas, Myriad

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GlaxoSmithKline said in a statement Monday that some of its executives stationed in China “appear to have acted outside of our processes and controls which breaches Chinese law.” The statement followed reports over the last few weeks that China's government alleges GSK employees have bribed doctors, hospitals, and government reps to help facilitate high-priced sales. The allegations tally the financial impact at around $489 million in what Bloomberg describes as “spurious travel and meeting expenses as well as trade in sexual favors,” according to China's Ministry of Public Safety. GSK's situation, however, is not unique: Bloomberg notes that Amgen, Merck, Novartis, Roche and Sanofi have stopped using the travel agency that is implicated in the accusations. GlaxoSmithKline said in Monday's statement that it is working with the Chinese Ministry of Public Safety and that operational changes the two have been discussing “will be passed on in the form of price reductions, ensuring our medications are more affordable to Chinese patients.”

Vivus has dropped its CEO and taken on another: PMLive reports that AstraZeneca's former commercial operations EVP Tony Zook is taking on the biotech's lead role, bumping Leland Wilson. The move follows what Reuters says has been called one of the biotech's ugliest proxy fights. This one was won and led by investment firm First Manhattan, which Reuters notes held 9.9% of the company, and the group lobbying for a leadership change included First Manhattan and Sarissa Capital Management. Zook's CEO nomination was not a surprise: Bloomberg noted July 2 that First Manhattan wanted the executive to head up the company. Bloomberg posted a statement at the time from First Manhattan's senior managing partner Sam Colin that explained its choice, saying Zook “has an extraordinary track record of launching blockbuster drugs in the US primary care market” and he “will allow us to further attract the best talent to commercialize the best obesity drug ever.” The prescription weight loss category as a whole has been a slow build, despite high expectations. Among the challenges: payer buy-in, and a lack of messaging for the marketplace that shifts obesity from being considered a condition that is the result of poor discipline to a medical condition that is free-standing medical problem of its own. Vivus' marketing approach has been criticized as being anemic: Unlike Arena, which is paired up with Eisai for its approved medication Belviq and Orexigen which has teamed up with Takeda for its pipeline drug, Contrave, Vivus has stuck by its going-alone approach, limiting even its consumer outreach for Qsymia largely to HCP-friendly channels.

Biogen Idec and the University of Edinburgh are teaming up to study new treatments for neurodegenerative conditions, including multiple sclerosis, reports PMLive. The three-year collaboration will be based in what's called the Edinburgh BioQuarter, where the university has research relationships with industry peers including GlaxoSmithKline and Galecto Biotech.

The FDA approved Astellas' anti-organ-rejection treatment Astagraph XL (tacrolimus extended release capsules). The drug maker reported the news Friday. The treatment is for kidney-transplant patients and is the first daily oral tacrolimus treatment.

Myriad's patent woes are not over: Vermont Sen. Patrick Leahy (D-VT) has asked the NIH to leverage its “March-in” rights provided under the 1980 Bayh-Dole Act which carves out certain rights for research that has benefited from government funding. At issue is Myriad's BRCA gene test, which focuses on a biomarker that is linked with an 87% risk of breast cancer and 44% risk for developing ovarian cancer. Actress Angelina Jolie's prophylactic double mastectomy brought attention to the test after she announced her decision to pursue surgery after testing positive for the gene. The Supreme Court ruled in June that Myriad's patents are not all patentable—specifically those that related to naturally occurring DNA. The decision gave potential competitors room, but the company still has patents that will hold through 2018, which means the $3,000 to $4,000 cost associated with the test will remain a market force. The Bayh-Dole Act gives the government the right to require patent holders to license their IP on what Leahy calls “reasonable terms.” Failing that, the law allows the government to license technology that has benefited from federal funds if “action is necessary to alleviate health or safety needs which are not reasonably satisfied.” Leahy argues in his July 12 note that BRCA testing falls into this category because of the health benefits. And potential savings of widespread use are clear, but “the health needs of the public are not reasonably satisfied by the patentee in this situation because testimony presented to the USPTO made clear that many women are not able to afford the testing provided by Myriad.”

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