The contract research and manufacturing organization Aptuit (Greenwich, CT) issued a statement that said media reports suggesting that it is discussing a sale of its Indian operations, Aptuit Laurus (Hyderabad, Andhra Pradesh, India), are erroneous. The company said it remains committed to Aptuit Laurus and to the Indian market.
Azopharma’s (Miramar, FL) AniClin Preclinical Services, a provider of early drug-development services, now offers complete pharmacokinetic studies in less than five days. The package offers formulation, dosing, PK sampling, bioanalysis (plasma) of six timepoints, inclusive of quality-control samples, and front and back standard curves.
The chemical company BASF (Ludwigshafen, Germany) joined The Sustainability Consortium, a collaboration of companies that work together to build a scientific foundation that drives innovation and improves consumer-product sustainability.
BioStorage Technologies (Indianapolis, IN), a provider of biomaterials storage, management, and cold-chain logistics, and Biomatrica (San Diego, CA), a biostability company, formed an alliance for sample storage and conversion services. Clients will be able to use Biomatrica’s dry-storage technology and BioStorage’s real-time tracking and monitoring of samples through its inventory-management system.
Eden Biodesign (Liverpool, United Kingdom), a biopharmaceutical company offering contract biologics manufacturing services, and Millipore (Billerica, MA), a provider of tools, technologies, and services for biomanufacturing, formed a partnership to provide biopharmaceutical companies Eden’s current good manufacturing practices (CGMP) manufacturing and Millipore’s Ubiquitous Chromatin Opening Elements (UCOE) expression technology. Eden Biodesign will use Millipore’s UCOE expression technology to undertake mammalian cell-line development projects and CGMP production for third-party clients.
Eli Lilly (Indianapolis, IN) and Thermo Fisher Scientific (Waltham, MA), a provider of equipment, software, and services for research, analysis, discovery and diagnostics, expanded their clinical-trial materials supply-chain relationship. As part of a new five-year agreement, Thermo Fisher’s Clinical Services business will assume responsibility for Lilly's inhouse clinical-trial materials manufacturing, packaging, and labeling operations in Indianapolis. By the end of 2010, Fisher will handle the distribution of clinical-trial materials for Lilly throughout North America.
The European Medicines Agency’s (EMA) recommended the recall of all batches of eight centrally-authorized generic clopidogrel-containing medicines, for which the active substance was manufactured by Glochem Industries (Visakhapatnam, India). In related news, sanofi-aventis (Paris) confirmed that all its clopidogrel-containing products, including Plavix and Iscover, are in full conformity with EMA requirements.
GlaxoSmithKline (London) reported that EMA has no safety concerns with its Rotarix oral vaccine. Despite the presence of material from PCV-1 in the vaccine, EMA and other regulatory agencies have said that the presence of the material does not present a safety risk. GSK says it will continue to manufacture Rotarix in accordance with the approved production methods and quality standards agreed with regulatory authorities worldwide. EMA’s Committee for Medicinal Products for Human Use (CHMP) has requested GSK identify the root cause of PCV-1 in the vaccine and introduce measures to manufacture the vaccine free of PCV1 DNA. PCV-1 is a virus commonly found in certain meat and other food products. CHMP will be reviewing all new data on an ongoing basis and will consider the need for further recommendations at its meetings in April and May 2010 as further data emerges.
The contract-manufacturing organization Lonza (Basel, Switzerland), as part of job cuts announced last year, plans to eliminate 193 positions at its facility in Visp, Switzerland. Lonza says it will initiate immediate discussions with the social partners and employee representation councils at the Visp site to explain the detailed implementation of the measures. The details for the Basel site are still being clarified. Last October, Lonza announced plans to eliminate 450 jobs in its operations across Switzerland.
NextPharma Technologies (Surrey, UK), a contract provider of pharmaceutical development, manufacturing, cold-chain, and distribution services, successfully completed a US Food and Drug Administration inspection of its Braine-l’Alleud site, near Brussels, Belgium.
Pfizer Venture Investments, the venture capital arm of Pfizer (New York) leads a $15 million investment in biotechnology company Nodality (South San Francisco, CA), which specializes in personalized medicine tests for cancer and autoimmune disease. The money will be used to support marketing activities associated with Nodality’s test in acute myelogenous leukemia and to advance ongoing and new research and development programs in other hematologic malignancies, autoimmune diseases, and solid tumors.
Pfizer (New York) is collaborating with the Juvenile Diabetes Research Foundation (JDRF), Hadassah Medical Organization, and The Hebrew University of Jerusalem to replicate and regenerate insulin-producing cells in people with Type I diabetes. The collaboration, jointly funded by JDRF and Pfizer, will focus on the preclinical evaluation of certain proprietary Pfizer compounds as candidates to promote beta cell replication and regeneration.
The contract-research organization PPD (Wilmington, NC) launched the PPD Vaccines & Biologics Center of Excellence, a network of integrated, laboratory services focused on vaccine and biologic drug development. The center will offer comprehensive laboratory services to support development of products such as vaccines, monoclonal antibodies, peptides, protein-drug conjugates, and other biologics.
Ranbaxy Laboratories (Gurgaon, Haryana, India), a pharmaceutical and generic-drug company, will collaborate with protein production company Pfenex (San Diego, CA) to develop an undisclosed biosimilar therapeutic. Pfenex will receive maintenance fees, milestone payments, and royalty payments on any product sales derived from the agreement.
The custom pharmaceutical services business of Dr. Reddy’s Laboratories (Hyderabad, Andhra Pradesh, India) commissioned a commercial-scale manufacturing facility for pharmaceutical-grade methoxypoly (ethylene glycol) (mPEG) alcohols at its facility in Cuernavaca, Mexico. mPEG alcohols are used as raw materials for activated mPEGs, which are used in pegylation of biologics and small molecules. The facility will manufacture a wide range of molecular-weight mPEGs and has an annual capacity of multiple metric tons. The mPEG alcohol manufactured in Mexico will be supplied to Dr. Reddy’s facility in Mirfield, United Kingdom, where commercial-scale activation will be performed.
The Society of Chemical Manufacturers and Affiliates (SOCMA) announced that its board of governors approved eight new members at its Mar, 23 meeting. The new members are: Harrell Industries (Rock Hill, SC), Myriant Technologies (Quincy, MA), G4S Wachenhut (Palm Beach Gardens, FL), SiVance (Gainesville, FL), RPI BioChemicals (Mt. Prospect, IL), CS Bio Company (Menlo Park, CA), Savage Safe Handling (Auburn, ME), and Fuji Chemical (Toyama, Japan).
Transgene (Parc d’Innovation d’Illkirch, France) signed an exclusive agreement with Novartis (Basel) for the development and marketing of Transgene’s targeted immunotherapy product, TG4010 (MVA-MUC1-IL2), a vaccine for the treatment of non-small cell lung cancer and other potential cancer indications. Under the deal, Transgene granted Novartis an option to acquire an exclusive worldwide license for TG4010, and Novartis will pay Transgene a $10-million nonrefundable option fee. If Novartis exercises the option, and contingent on successful development, regulatory, and commercial milestones, Transgene is eligible to receive up to approximately EUR 700 million ($948 million) from Novartis. Novartis will assume all development, regulatory, and commercialization costs related to TG4010 across all indications. Transgene will retain primary manufacturing rights for TG4010 to supply Novartis’ clinical and commercial requirements.
The contract manufacturer DPT Laboratories (San Antonio) named Michael Curry as its director of sterile operations at the company’s Center of Excellence for Sterile & Specialty Products in Lakewood, New Jersey.
Catalent Pharma Solutions (Somerset, NJ), a provider of advanced dose form and packaging technologies, appointed Lois Johnson as its vice-president of quality, development, and clinical services, and Alex Eslava as its vice-president of quality and sterile technologies.
Encap Drug Delivery (Livingston, United Kingdom) appointed Jane Fraser as its research and development director.