Genzyme-Isis cholesterol drug Kynamro wins FDA approval

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January 30, 2013 BIO has teamed up with FedEx to offer member companies discounts of up to 35% off select FedEx Express, FedEx Ground and FedEx Home Delivery services through the BIO Business Solutions cost-savings program. Learn more. The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.   Today's Top Story    Genzyme-Isis cholesterol drug Kynamro wins FDA approval Isis Pharmaceuticals and Sanofi unit Genzyme obtained FDA approval to market Kynamro, or mipomersen, as an add-on treatment to lipid-lowering drugs and diet for patients with homozygous familial hypercholesterolemia. Due to risks of liver problems, the once-weekly injectable drug will carry a boxed warning. The approval triggers the payment of a $25 million milestone fee from Genzyme to Isis. Bloomberg Businessweek/The Associated Press (1/29), Fox Business/Dow Jones Newswires (1/29)      Anthera Approaches Phase III, Prices $40M Public Offering With launch of its Phase III registration studies for Lupus drug blisibimod imminent, Anthera Pharmaceuticals Inc., of Hayward, Calif., priced an unwritten public offering worth $40 million in gross proceeds to support operations as it goes forward. Find out the details.   Health Care & Policy  States face lobbying from drugmakers to restrict biosimilars Amgen and Genentech are among the drugmakers pushing state legislatures to restrict substitution of biosimilar drugs for branded biologic therapies. Bills under consideration would require patient consent and doctor notification before a biosimilar may be substituted and would mandate that only drugs deemed "interchangeable" by the FDA could be substituted. The New York Times (tiered subscription model) (1/28)      Afraxis licenses compounds to Genentech for up to $187.5M Afraxis, which specializes in developing drugs for central nervous system diseases, granted Genentech exclusive, worldwide rights to develop and market several compounds against an undisclosed target. The deal entitles Afraxis to as much as $187.5 million in upfront and milestone fees. Genetic Engineering & Biotechnology News (1/29), American City Business Journals/San Francisco/Bay Area BizTalk blog (1/29)      FDA panel supports approval of Boehringer's olodaterol for COPD An FDA advisory panel endorsed the approval of Boehringer Ingelheim's olodaterol as a once-daily bronchodilator treatment for chronic obstructive pulmonary disease including chronic bronchitis and emphysema. Boehringer plans to market the drug in a soft mist inhaler under the name Striverdi Respimat. Bloomberg Businessweek (1/29), MedPage Today (free registration) (1/29)      Endo enters into R&D agreement with CRO GVK Biosciences and Endo Pharmaceuticals agreed to collaborate in the discovery and development of small molecules targeting a certain protein. GVK, an Indian contract research organization, will deliver a clinical candidate. Endo will handle development and marketing. Genetic Engineering & Biotechnology News (1/28), Pharmaceutical Business Review Online (1/29)      Crowdfunding is poised to disrupt biotech investing Most crowdfunding campaigns to date have not raised nearly enough to finance development of a new drug, but the method is nonetheless poised to shake up biotech investing, Luke Timmerman writes. Globally, crowdfunding could surpass $1 trillion, Poliwogg CEO Greg Simon says. Questions remain as to how crowdfunding will work, how it will be regulated and whether venture capitalists will cede control of their porfolios. Xconomy (1/28)      Lechleiter: R&D breakthroughs on the horizon The push for personalized medicine, an emphasis on scientific advances and flourishing research into rare diseases suggest that the U.S. biopharmaceutical industry could be on the brink of a renaissance in drug research and development, writes PhRMA chairman and Eli Lilly and Co. CEO John Lechleiter. An all-time high number of new drugs are in human testing, and more drugs are being developed for diseases without approved therapies in the past 10 years, Lechleiter writes. Forbes (1/28)          Company & Financial News  $10M goes to Acceleron as midstage tests of anemia drug begin Celgene paid partner Acceleron Pharma a $10 million milestone fee for initiating a midstage trial of anemia drug candidate ACE-536. The trial will evaluate the drug's safety, efficacy and tolerability in patients with low-risk or intermediate-1 risk myelodysplastic syndrome. American City Business Journals/Boston/bioflash blog/Mass High Tech (1/29)        Food & Agriculture  BASF ends push for biotech potato approval in Europe BASF is no longer seeking approval in Europe for its Fortuna, Modena and Amadea biotech potatoes "due to uncertainty in the regulatory environment and threats of field destructions." The decision follows the European Commission's announcement that it will halt the approval process for biotech crops until next year while it works towards a agreement with member countries. IndustryWeek/Agence France-Presse (1/29), Fox Business/Dow Jones Newswires (1/29)        Industrial & Environmental  Miss., Ohio universities win USDA grant for biomass research Mississippi State University and Ohio State University will work together to research processes for different types of biomass to produce biofuels in an effort to determine which is most efficient. The project will be funded by a $6.5 million grant from the Department of Agriculture. WJTV-TV (Jackson, Miss.) (1/28)        News from BIO  BIOtechNOW BIOtechNOW is the first in a number of new products from BIO intended to enhance our communications with the biotech community -- not only with our members, but with other stakeholders as well. This e-newsletter, combined with its website, serves as our flagship in that effort. BIOtechNOW will offer original content that emphasizes the business needs of the industry; highlight BIO's advocacy efforts; and provide a portal to all BIO activities and events. Most importantly, it will spotlight for those outside the industry the value of biotechnology. 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