The contract development and manufacturing organization (CDMO) Althea Technologies has entered into a commercial supply agreement with Biotest Pharmaceuticals, a manufacturer of biotherapeutic products. Under the terms of the agreement, Althea will fill commercial drug products to supply the US market. The products will be filled in Althea's new commercial manufacturing facility in San Diego, California.
AstraZeneca, GlaxoSmithKline, and the University of Manchester in the United Kingdom, have formed the Manchester Collaborative Center for Inflammation Research (MCCIR), a translational research center. The new center will direct research in diseases associated with chronic inflammation (i.e., asthma, chronic obstructive pulmonary disease, rheumatoid arthritis, and inflammatory bowel disease). The center is scheduled to open later this year.
In other news, AstraZeneca has ended its development and option agreement with the specialty healthcare company BTG, relating to CM-3, a GLP-1 analogue being developed by BTG's CellMed subsidiary for use in Type II diabetes and other indications.
Biovest, a biopharmaceutical company developing personalized immunotherapies, has completed its new BiovaxID cancer vaccine manufacturing site as part of an expansion of its 35,000-ft2 cell culture center in Coon Rapids, Minnesota. This new production space will accommodate manufacturing for Biovest’s late-stage, autologous, active immunotherapy for the treatment of non-Hodgkin’s lymphoma.
Bristol-Myers Squibb has expanded its RNA interference pact with the biopharmaceutical company Tekirma Pharmaceuticals. The expansion will include evaluation of newly-developed Tekmira proprietary lipid nanoparticle formulations designed for delivery to tumors and other tissues outside the liver.
Cambridge Major Laboratories, a contract manufacturing organization (CMO), reports that its large-scale active pharmaceutical ingredient (API) manufacturing facility in Germantown, Wisconsin, successfully passed FDA inspection, which included a pre-approval inspection and a general quality-systems inspection.
Cancer Research UK, a United Kingdom-based cancer charity, has awarded the CMO Onyx Scientific a project to develop and manufacture GMP synthesis of an API for use in a Phase I clinical trial.
EMD Millipore, the life-science division of Merck KGaA, has opened a biopharmaceutical technical and training center in Shanghai. This 8200-ft2 facility will provide support, training, and validation services to EMD Millipore’s biopharmaceutical customers with operations in China.
The biopharmaceutical companies Halozyme Therapeutics and ViroPharma have signed of an exclusive licensing agreement for the use of rHuPH20 (recombinant human hyaluronidase) in the development of a subcutaneous formulation of Cinryze (C1 esterase inhibitor [human]). Under the agreement, Halozyme may receive up to $83 million, with an upfront payment of $9 million and total potential future milestone payments of $74 million dependent upon the achievement of clinical and regulatory targets, plus a 10% royalty on future sales of the combination of Cinryze with rHuPH20. The license provides ViroPharma with exclusivity to C1 esterase inhibition and to the hereditary angioedema indication, along with three additional orphan indications. ViroPharma will fund all development and commercialization expenses for the program.
The CMO Hovione successfully completed six inspections by regulatory agencies during the past eight months, which included inspections of the company’s sites in China and Portugal by Japanese authorities, multiple FDA inspections of the companiy’s sites in Loures, Portugal, and New Jersey, and an inspection by the Portuguese authorities.
Immunologix, a supplier of humanized monoclonal antibodies, has partnered with DavosPharma, a manufacturing representative of custom chemistry and formulation services, whereby DavosPharma will represent and market the human antibodies produced by Immunologix.
The CMO Lonza is investing CHF 24 million ($27 million) to expand cytotoxic manufacturing capabilties at its fine-chemicals facilities in Visp, Switzerland. The investment will add multikilogram-scale cytotoxic capacity for clinical and commercial production.
Merck has completed its previously announced acquisition of Inspire Pharmaceuticals, a specialty pharmaceutical company, for $430 million.
In other news, Merck received FDA approval for Victrelis (boceprevir), a drug to treat chronic hepatitis C.
Pfenex, a provider of expression technology, has formed a three-year collaboration with MedImmune, the biotechnology arm of AstraZeneca. The agreement provides MedImmune with nonexclusive access to Pfenex Expression Technology and scientific resources for the development of bioprocesses for human therapeutic proteins and vaccines. Additionally, Pfenex will engineer production strains and develop early-production processes for MedImmune’s proprietary molecules, and a joint steering committee will be established to oversee the collaboration and facilitate the decision-making process.
The Pain and Sensory Disorders and Regenerative Medicine Unit of Pfizer has partnered with Cellzome, a drug-discovery and development company, for characterizing epigenetic factors involved in stem-cell differentiation using Cellzome’s Episphere technology. Under the agreement, Pfizer will provide its know-how in stem-cell handling and regenerative medicine, and Cellzome will apply its chemoproteomics platform to chart the changes of epigenetic factors during stem-cell differentiation.
The contract research organization PPD has established four new practice areas as part of its ongoing strategy: biosimilars, adaptive trial design, a China regulatory strategy, and cardiovascular outcomes studies.
SAFC, a CMO, has entered into a commercial supply pact with the biotechnology company Oncolytics Biotech. Under the terms of the agreement, SAFC will perform process validation of products, and will continue to supply clinical requirements as well as supplying commercial material upon approval of products.
Sanofi Pasteur, the vaccines division of Sanofi, has launched Fluzone Intradermal, an influenza vaccine with intradermal microinjection delivery. The vaccine will be used for active immunization of adults, age 18–64, against influenza disease caused by influenza virus subtypes A and B.
Aphena Pharma Solutions, a provider of pharmaceutical packaging, has appointed Mary Foster as corporate vice-president of quality and regulatory affairs. Foster’s new role will include planning long-term goals and ensuring compliance to regulatory standards. She was previously vice-president of quality for the CDMO Catalent Pharma Solutions.
BASi, a contract analytical services firm, named Michael Zhou as senior director of research and development (R&D). Zhou was formerly a director of bioanalytical chemistry at Synta Pharmaceuticals, a biopharmaceutical company.
The CMO Cambridge Major Laboratories appointed Richard Proehl as vice-president of manufacturing. Proehl will be responsible for all plant-scale manufacturing operations within the organization as well as all engineering and environmental, health, and safety functions.
Catalent Pharma Solutions has appointed Rao Tatapudy as vice-president of scientific affairs, innovation, and growth. Tatapudy will be responsible for strategic programs in R&D and technology platforms with a focus on advances in bioavailability enhancement, taste-masking, modified release, and particle engineering. He was previously with Pfizer as new product leader and director of new product and process development.
The CDMO Irvine Pharmaceutical Services appointed Dorla Mirejovsky as senior director of formulation development. Mirejovsky was most recently responsible for the development and manufacture of several proprietary drug candidates at the biopharmaceutical company, Spectrum Pharmaceuticals.
Premier Research Group, a provider of pharmaceutical and biotechnology services, named Ronald Kershner as vice-president of biostatistics and data operations for North America. Kershner has more than 25 years of experience in various operational aspects of clinical-trial planning, execution, and delivery within the pharmaceutical, biotechnology, and contract-research industries.