AMRI received approval from the Italian Medicines Agency (AIFA) for its facility in Burlington, Massachusetts, to manufacture the commercial drug product octreotide for a customer in the European Union. This approval specifically applies to laboratories and manufacturing areas at the company's Burlington facility designed for the production of aseptic and lyophilized vials, affirming the facility's compliance with EU GMP standards.
Bayer HealthCare plans organizational and personnel changes following its earlier announcement of restructuring. The pharmaceuticals business (previously Bayer Schering Pharma) will operate as a division called Bayer HealthCare Pharmaceuticals. The headquarters of the pharmaceuticals business will remain in Berlin. In the United States, Bayer HealthCare will consolidate the four East Coast sites it currently maintains into one this year, as part of the announced efficiency program. The new center for the approximately 2500 employees will be built near one of the existing sites in the New Jersey/New York region. Details of the personnel changes are included in the company’s press release.
Bayer HealthCare and Zydus Cadila agreed to form the joint venture (JV) company Bayer Zydus Pharma. Each party will hold 50% of the shares of Bayer Zydus Pharma, and be equally represented on its management board. The JV will help Bayer HealthCare strengthen its presence in the emerging markets, according to a company press release. The JV will focus on women’s healthcare, diagnostic imaging, and general medicines, and oncology. The new company will be headquartered in Mumbai.
Dalton Pharma Services, a pharmaceutical services provider, entered into a supply contract with Oncovir, a specialty-pharmaceutical company, to provide active pharmaceutical ingredient manufacturing and aseptic fill/finish services under current GMP. The agreement covers products for Oncovir’s collaboration with the Cancer Vaccine Acceleration Fund, a joint initiative between the Cancer Research Institute and the Ludwig Institute for Cancer Research.
DSM Biologics, a business unit of DSM Pharmaceutical Products, formed a development pact with NKT Therapeutics, a biotechnology company that focuses on developing therapeutics based on unique immune cells called natural killer T (NKT) cells. The pact covers the process development and current GMP manufacturing by DSM of NKT’s lead product, iNKT mAb. Financial terms were not disclosed.
Genzyme completed the sale of its diagnostic-products business to Sekisui Chemical for $265 million in cash. Genzyme’s approximately 575 employees in the business were offered similar positions with Sekisui, which plans to maintain operations in each of the business’s current locations. Sekisui also agreed to supply Genzyme with certain enzymes needed for the production of Cerezyme (imiglucerase for injection). In addition, Genzyme entered into a purchase agreement with an affiliate of International Chemical Investors Group to acquire Genzyme’s pharmaceutical-intermediates business. The acquired pharmaceutical intermediates business will be renamed Corden Pharma Switzerland and will operate within the Corden Pharma platform. The companies expect to close the transaction during the first quarter of 2011. Financial terms were not disclosed.
NextPharma, a provider of product development, contract manufacturing, and cold-chain logistics services, entered into partnership for technological innovation with Bone Therapeutics, a bone-cell therapy company based in Belgium; Université Libre de Bruxelles; and Université de Liège. The first product to be developed will be a sterile depot (sustained release) formulation in prefilled syringes for intra-articular administration. Product development and manufacture of the sterile investigational medicinal product in prefilled syringes will be undertaken in NextPharma’s Sterile Product Development Center (SPDC) in Belgium, and laboratory work has already begun. In a separate announcement, NextPharma said it will add a prefilled-syringe capability at the SPDC. The facility will be equipped with semiautomatic syringe fillers with automatic stoppering units under vacuum in the cytotoxic and noncytotoxic units.
Nitto Denko, a diversified materials manufacturer, acquired Avecia Biotechnology, a provider of therapeutic nucleic acid manufacturing and development services. Avecia provides services for DNA- and RNA-based therapeutics to customers from preclinical through commercial launch.
Oxford BioMedica, a gene-therapy company, agreed to acquire a manufacturing facility based in Oxford, United Kingdom, from RecipharmCobra Biologics, the specialist biologics division of Recipharm, for £1.9 million ($3 million). The 16,000-ft2 facility includes 4400 ft2 of cleanrooms, and was previously approved by the Medicines and Healthcare products Regulatory Agency to GMP standards.
Pfizer agreed to purchase Ferrosan’s consumer-healthcare business, which includes dietary supplements and lifestyle products. The Copenhagen-based consumer healthcare company serves the Nordic region, Russia, the Ukraine, Poland, Turkey, and many countries throughout Central and Eastern Europe.
Specialty-pharmaceutical company ProStrakan awarded contract manufacturing organization SCM Pharma a five-year contract for the ongoing supply of its licensed product, Ketensin. SCM Pharma will be responsible for the filling of the 2- and 10-ml vial presentations, sterilization, finished-product testing, and supply of the product. Ketensin is indicated for the treatment of hypertensive crisis during and after surgery, and is marketed by ProStrakan in the Netherlands.
Sigma-Aldrich acquired the assets of Resource Technology Corporation (RTC), a provider of analytical standards and certified reference materials. Terms of the purchase were not disclosed.
Valeant Pharmaceuticals International agreed to acquire PharmaSwiss, a generic-drug and over-the-counter pharmaceutical company for EUR 350 million ($478 million). Up to an additional EUR 30 million ($41 million) more may be payable to certain stockholders of PharmaSwiss based on achievement of certain milestones.
Contract manufacturing organization Aesica Pharmaceuticals appointed a team to direct and manage its new European operations following the purchase of three manufacturing sites from UCB in Monheim and Zwickau, Germany and Pianezza, Italy. Simon Clough was appointed managing director of the formulated-products business unit and will be based at the Monheim site. He will be supported by Katy Lineker, finance director of the formulated-products business unit, who will also be based in Monheim. Furthermore, three Aesica ambassadors have been appointed to support and facilitate the transition following the completion of the acquisition in early 2011. Janette Waterhouse will be based at Zwickau for three months, Edd Wood will spend three months at Pianezza, and Helen Taylor will relocate to Monheim for three months.
Gary Balkema, head of the consumer-care division of Bayer HealthCare will retire, effective Apr. 1, 2011. In addition, Ulrich Köstlin, member of the board of management of Bayer Schering Pharma AG, will leave the company on June 30, 2011.
John M. Coster will join the Generic Pharmaceutical Association (GPhA) as senior vice-president for government affairs, effective Feb. 14, 2011. Coster comes to GPhA from the National Community Pharmacists Association.
NextPharma, a provider of product development, contract manufacturing, and cold-chain logistics services, appointed Brigitte Genard as quality director at its sterile contract development and manufacturing site in Braine-l’Alleud, Belgium.
Patheon appointed James C. Mullen as its CEO and as a member of the board of directors. Mullen was previously CEO and president of Biogen Idec. Peter Bigelow, president of Patheon’s North American operations, has served as interim CEO since Wesley Wheeler left the company in December 2010.