|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Week Of March 22, 2010: Company And People Notes: Merck Ends Partnership With Dynavax; PhRMA Elects Officers; And More.
Biopharmaceutical company Dynavax Technologies (Berkeley, CA) and Merck & Co. (Whitehouse Station, NJ) ended its partnership regarding the clinical development and marketing of Heplisav, Dynavax's hepatitis B vaccine. Merck agreed to pay Dynavax $4 million to cover final expenses. In a separate release, Dynavax says it plans to file a biologics application for Heplisav in the third quarter of 2011.
Formatech (Andover, MA), a contract development and manufacturing organization, as part of its Fillanthropy program, agreed to donate the services required to aseptically fill and finish one lot of biopharmaceutical company Tracon Pharmaceuticals’ (San Diego, CA) anticancer drug.
GlaxoSmithKline (London) notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine Rotarix. PCV-1 does not multiply in humans and is not known to cause illness in humans. The material was first detected following work done by a research team in the US and then confirmed by additional tests conducted by GlaxoSmithKline. FDA issued a statement that said there is no evidence that this finding poses a safety risk. FDA, however, is recommending that US clinicians and public health professionals temporarily suspend the use of Rotarix as a precautionary measure. FDA intends to convene an advisory committee within approximately four to six weeks to review the available data and make recommendations on rotavirus vaccines licensed in the US. FDA will also seek input on the use of new techniques for identifying viruses in vaccines.
FDA issued a Complete Response Letter to the pharmaceutical company MannKind (Valencia, CA) regarding its new drug application for Afrezza (insulin human [rDNA origin) inhalation powder for the treatment of adults with Type 1 and Type II diabetes. The letter requested information and currently available clinical data that support the clinical utility of Afrezza and information about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in clinical trials. The letter cited no safety concerns, but requested updated safety data related to Afrezza. The letter also requested changes to the proposed labeling of the cartridges, foil pouches, and cartons.
Merck & Co. (Whitehouse Station, NJ), in response to FDA’s ongoing safety review of the risk of skeletal muscle effects from high-dose simvastatin, said in a release that it would continue to share data with the FDA and other regulatory agencies from completed and ongoing clinical studies of simvastatin. Merck said it supported FDA's recommendation that patients continue taking their medication as prescribed, and that patients speak to their physician if they have symptoms or questions.
The European Commission granted Novartis (Basel) marketing authorization for Menveo, a conjugate vaccine available in Europe that helps protect against four major groups of meningococcal disease. Menveo is indicated for the active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135, and Y, to prevent invasive disease.
Contract-research organization PPD (Wilmington, NC) and collaborative-research organization Southern Research Institute (Birmingham, AL) signed an agreement to provide pandemic and seasonal influenza vaccine research. Southern Research will transfer its seasonal assays and reagents to PPD, which will help build Southern Research's preclinical influenza and clinical pandemic/highly pathogenic avian influenza (HPAI) testing business through client referrals.
Sigma-Aldrich (St. Louis) agreed to sell approximately 100 of Pfizer’s (New York) small-molecule compounds to life-science researchers for target characterization, assay development, screening, and in vivo animal-model applications. Financial terms of the agreement were not disclosed.
Biopharmaceutical company Tekmira Pharmaceuticals (Vancouver, Canada) and Pfizer (New York) agreed to collaborate on evaluating Tekmira’s stable nucleic acid-lipid particle technology to deliver small interfering RNA (SNALP) molecules provided by Pfizer. Tekmira will be responsible for preparing the SNALP formulations, and Pfizer will evaluate the formulations in preclinical models. Financial terms of the collaboration were not disclosed.
The generic-drug company Teva Pharmaceutical (Jerusalem) agreed to acquire the German generic-drug maker Ratiopharm for EUR 3.6 billion ($4.8 billion). The pro forma sales of the combined company would be $16.2 billion, and the move would increase Teva’s European sales from $3.3 billion in 2009 to joint pro forma sales of $5.2 billion. Teva expects to complete the transaction by the end of 2010.
Specialty pharmaceutical company Valeant Pharmaceuticals International (Aliso Viejo, CA) agreed to acquire a private-branded generics and over-the-counter company in Brazil for $28 million. The Brazilian company had annual sales of approximately $19 million in 2009, and a large portion of its product portfolio is in dermatology. Valeant said it also plans to buy a new manufacturing plant to produce solids, semisolids, and liquids for approximately $28 million. Both transactions are expected to close in the second quarter of 2010.