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ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.
The European Patent Office issued the RNAi therapeutics company Alnylam Pharmaceuticals (Cambridge, MA) a notice of intent to grant the company’s "Manoharan II" patent series. The new patent includes 16 claims covering compositions and methods, including pharmaceutical compositions, for chemically modified small interfering RNA (siRNAs) containing phosphorothioate and 2-O-alkyl modifications without any siRNA length restrictions. These chemical modifications are broadly used to achieve potency, stability, and selectivity of siRNAs.
Althea Technologies (San Diego, CA), a provider of services for biopharmaceutical development and manufacturing, acquired the assets and intellectual property (IP) portfolio of Altus Pharmaceuticals (Cambridge, MA), a developer of protein therapeutics. The IP portfolio includes Altus' cross-linked enzyme crystal and controlled-release injectable technologies. Financial terms were not disclosed.
Anacor Pharmaceuticals (Palo Alto, CA) entered a research agreement with the nonprofit organization Medicines for Malaria Venture (MMV, Geneva, Switzerland) to explore Anacor's boron chemistry platform for developing new therapeutics for the treatment of malaria. Under the agreement, Anacor will be responsible for leading the research effort and MMV will contribute its extensive malaria drug research expertise as well as financial support.
The US Food and Drug Administration approved AstraZeneca’s (London) and the pharmaceutical company Pozen’s (Chapel Hill, NC) Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug-associated gastric ulcers. Vimovo, codeveloped by Pozen and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole, a proton pump inhibitor (PPI).
Biotage AB (Uppsala, Sweden), a provider of tools and technology for medicinal and analytical chemistry, agreed to acquire all outstanding shares in MIP Technologies (Lund, Sweden), a privately held developer of molecularly imprinted polymers and other novel polymers. Under the terms of the agreement, an upfront payment corresponding to an enterprise value for MIP Technologies will be made. In addition, further payments based on sales performance will be made until the end of 2015.
FDA issued a complete response letter to Bristol-Myers Squibb (Princeton, NJ) regarding its the biologics license application for belatacept in kidney transplantation. The letter requests the 36-month data from the ongoing Phase III studies to further evaluate the long-term effect of belatacept. The company said it will work with the FDA to provide the data as soon as it is available.
FDA approved the biotechnology company Dendreon’s (Seattle ) Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. Provenge is designed to induce an immune response against prostatic acid phosphatase, an antigen expressed in most prostate cancers. Dendreon intends to make Provenge available through approximately 50 centers, all of which were approved Provenge clinical trial sites, and expects to increase capacity over the next year. The increased capacity will be a result of the anticipated licensures of its expanded facilities in New Jersey, Atlanta, and Orange County, California in mid-2011.
DSM Biologics, a division of DSM Pharmaceutical Products (Parsippany, NJ) signed preliminary agreements with the Australian government to design, build, and operate a mammalian biopharmaceutical manufacturing facility in Brisbane. The facility, scheduled to be operational in 2010, will offer mammalian process development and current good manufacturing practices clinical and commercial manufacturing services. The Australian government will provide the funding for the facility. In other news, DSM Biologics announced the acquisition of the assets and associated business of the Rhobust technology from Upfront Chromatography A/S (Denmark) for pharmaceutical and other applications. Financial terms were not disclosed.
EyeGate Pharma (Waltham, MA), a provider of noninvasive ocular-drug delivery, established a research collaboration with GlaxoSmithKline (GSK, London) to evaluate the delivery of several GSK therapies to the anterior and posterior tissues of the eye using the EyeGate II delivery system. Specific terms of the agreement were not disclosed.
The contract manufacturing company Goodwin Biotechnology (Plantation, FL) and Hyprocell (Branford, CT), a developer of clinical cell-line development, agreed to a collaboration designed to streamline current good manufacturing practices manufacturing services.
The contract manufacturer Norwich Pharmaceuticals (Norwich, NY) announced the formation of Norwich Clinical Services to provide clinical testing capabilities that will further expand the company’s third-party services. The new division will offer a complete range of clinical research capabilities, bioanalytical studies, and pharmacovigilance monitoring services.
Purdue Research Park (West Lafayette, IN) announced that its Chao Center for Industrial Pharmacy and Contract Manufacturing will discontinue operations in the coming months. The Chao Center is a pharmaceutical manufacturing facility that produces and distributes legacy and small-volume drugs.
Vetter (Ravensburg Germany), a provider of aseptically prefilled injection systems, and Sentry BioPharma Services (Indianapolis, IN), a provider of supply chain management and clinical packaging services, signed a partnership agreement. Vetter will fill early-stage, high-value biopharmaceuticals at its Chicago facility. Sentry will label, package, and ship the clinical supplies from its site in Indiana. Financial terms were not disclosed.
The pharmaceutical company Celgene (Summit, NJ) announced its senior-management succession plan. As of June 16, 2010, CEO Sol Barer will be appointed executive chairman of the board of directors through December 31, 2010. Robert J. Hugin, president and COO, will become CEO.
Merck & Co. (Whitehouse Station, NJ) announced changes in responsibilities for three of its top leaders. Richard Clark, chairman, CEO, and president, will continue as chairman and CEO. Kenneth Frazier, president of the company's global human health worldwide sales and marketing division, was elected company president. Adam Schechter, who leads the company's pharmaceutical business in the United States, was elected to succeed Mr. Frazier as president of global human health.
The European Medicines Agency appointed Alexis Nolte as its head of quality of medicines sector, effective May 3, 2010. He replaces the former head of sector, John Purves, who retired after 14 years of service. EMA appointed Jean-Claude Brival as head of its product data management sector, effective May 3.