Business Briefs: Novo, FDA, Biologics

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Monday's news that Novo Nordisk's diabetes medication helped obese patients scuttle between 5% and 6% of their weight over 56 weeks hasn't helped the company's reputation on Wall Street, reported Reuters, which cited the company's failure to get the FDA to approve Tresiba in February as one of the reasons. The near-miss approval is a notable one: in its 2012 annual report, the company called out the GLP-1 as one of the key products driving projected sales growth of 8-10% for 2013. The anticipated Tresiba approval also spurred the company to up its sales and distribution spend by 13%, to $4 billion, while it revved up its sales force to support the drug's market introduction. Bloomberg noted Tuesday that JP Morgan told investors that the company is stumbling, and cut its stock recommendations from neutral to underweight. “Novo's recent share price rally suggests investors remain in denial that Novo's fundamentals have deteriorated,” JP Morgan analyst Richard Vosser told Bloomberg. Diabetes products, which include human an analog insulins as well as GLP-1s like Victoza and Tresiba, account for about 80% of Novo's sales. The company puts its share of the global diabetes market at 26%.

Almost a week after the FDA took to the NEJM's pages to talk about uncoupling the cognitive and functional improvement requirements for Alzheimer's Disease therapies, the Alzheimer's Association released a study finding that a third of seniors die with Alzheimer's or another form of dementia. The Association's report notes that Alzheimer's-related deaths are on the rise even as death rates from other major killers fall, up 68% between 2000 and 2010. The dismal data comes as TransTech Pharma celebrates an FDA fast track designation for its experimental Alzheimer's therapy TTP488 -- one of several that help the regulator speed approvals. TransTech's approach targets interactions between amyloid beta, which is found in Alzheimer's patients, and an immunoglobulin family of molecules.

Even as FDA commissioner Peggy Hamburg frets that sequester cuts will slow approvals, the Government Accountability Office is encouraging the regulator to do a bit more when it comes to dietary supplement oversight. The GAO noted that the FDA has improved monitoring, but said in a report that the agency could do more -- for example, by tapping into poison center data and implementing a systematic collection of adverse event reports. GAO said the latter could help FDA “assess whether AERs are being used to their fullest extent.” GAO also recommended the FDA make potential safety concerns public – something it is not required to do – in the interest of consumer awareness of the impact supplements may have on health.

Biologics were major earners last year, according to Genetic Engineering & Biotechnology News, which reported that eight of last year's top-selling drugs were biologics, including: Amgen's Neulasta ($4 billion); Roche's Avastin ($6 billion); Roche's Herceptin ($6 billion); Sanofi's Lantus ($7 billion);  Roche's Rituxan ($7 billion); Amgen/Pfizer's Enbrel ($8 billion); J&J/Merck's Remicaid ($8 billion); and Abbott/Abbvie's Humira ($9 billion).
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