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December 23, 2009 PharmTech.com

News

FDA Opens Mexico City Office
The US Food and Drug Administration opened another foreign office on Dec. 15, 2009, this time in Mexico City. The new post marks the agency’s third in Latin America and its tenth international post to open during the past 13 months.Click Here to Read More

Hospira to Acquire Orchid's Generic Injectable Pharmaceutical Business
Hospira, a specialty pharmaceutical company, agreed to acquire the generic injectable finished dosage-form pharmaceutical business of Orchid Chemicals & Pharmaceuticals for $400 million.
Click Here to Read More

Synthetic Blood Cells Could Deliver Drugs
Scientists from the University of California, Santa Barbara, and the University of Michigan jointly developed synthetic particles that exhibit the characteristics and perform the functions of red blood cells.
Click Here to Read More



PharmTech Talk blog


Product Spotlight

Product image hspace=System automates lyophilization
Telstar (Barcelona) has added a unit to its LyoGistics series of automated loading systems that is designed for the commercial-scale production of freeze-dried active ingredients. The freeze-drying system automatically loads product trays into the lyophilizer without sliding them across the surface of the chamber shelves. The system also fills trays with liquid product and removes lyophilized product using a vacuum system after the drying process is complete.

The setup incorporates a containment isolator between the product and the operator that limits operator exposure to less than 1 µg/m3 during an eight-hour shift. After freeze-dried product has been unloaded, product trays are stored on two independent Tray Storage Carts connected to each side of the main isolator chamber. The isolator system can be broken down easily into modules for inspection and maintenance, according to the company. The product also includes decontamination and cleaning systems.

Company Notes
Ambrilia Biopharma (Montreal), a biopharmaceutical company, has announced cost-cutting actions resulting in the closure of its manufacturing facility and a further reduction in cash consumption and headcount. These actions will further preserve its cash into 2010. The company announced that it has notified its landlord that it is terminating its lease agreement for its facilities in Verdun, Canada, effective Dec. 31, 2009. Ambrilia will relocate to smaller and less expensive facilities given its reduced number of employees and activities.

Amgen (Thousand Oaks, CA) has signed a research agreement with the biopharmaceutical company Array BioPharma (Boulder, CO), which grants Amgen exclusive worldwide rights to Array’s small-molecule glucokinase activator program, including ARRY-403, a drug to treat Type 2 diabetes that currently is in Phase I clinical trials. Amgen will pay Array an upfront payment of $60 million and additional payments for certain clinical and commercial milestones.

The contract research organization Covance (Princeton, NJ) has opened new clinical development offices in Seoul, South Korea, and Mumbai, India, and office expansions in Tokyo and Hong Kong to accommodate growing demand for clinical-development services in the Asia-Pacific region.
 
Merck & Co. (Whitehouse Station, NJ) has agreed to acquire Avecia Biologics (Tees Valley, UK), a contract biologics manufacturer. The deal includes the company’s process development, scale-up, manufacturing, quality, and business-support operations in Billingham, UK. The oligomedicines business of Avecia based in the United States is not part of the transaction.

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MODA Technology (Wayne, PA), a software company specializing in automated environmental monitoring, utility, and product testing for the pharmaceutical industry, launched MODA 3.0, a third-generation mobile data-acquisition platform, which allows quality-control organizations to further automate their manufacturing processes.
 
Myriad Pharmaceuticals (Salt Lake City, UT), a biopharmaceutical company, has agreed to acquire Javelin Pharmaceuticals (Cambridge, MA), a company providing technologies for new drug development and improved formulations of existing drugs. Javelin recently submitted a new drug application for an injectable formulation of diclofenac, a pain-management drug.

Patheon (Toronto), a provider of drug-development and manufacturing services, has successfully released the first commercial shipments of Sumavel DosePro (sumatriptan injection) to the pharmaceutical company Zogenix (San Diego) in anticipation of the planned US commercial product launch scheduled in January 2010.
 
Pfizer (New York) has formed an agreement with the biopharmaceutical company Athersys (Cleveland, OH) to develop and commercialize MultiStem, an investigational stem-cell therapy for treating inflammatory bowel disease. Under the agreement, Pfizer will pay Athersys an upfront payment of $6 million and up to $105 million if certain milestones are met.  
 
sanofi-aventis (Paris) has agreed to acquire the consumer healthcare company Chattem (Chattanooga, TN) for $1.9 billion. The move positions sanofi-aventis in the US consumer healthcare market and is compatible with the company’s goal of using over-the-counter (OTC) and consumer brands as a core growth platform. Sanofi-aventis said it will maintain both of Chattem’s existing manufacturing facilities and will continue construction of a third facility. The transaction is expected to close in the first quarter of 2010. With the move, sanofi-aventis also announced that it will seek to convert its antihistamine product Allegra (fexofenadine hydrogen chloride) in the US from a prescription drug to an OTC product.

In other news, Sanofi Pasteur, the vaccines division of sanofi-aventis, has entered into a worldwide licensing agreement with the biopharmaceutical company Syntiron (St. Paul, MN) to develop and commercialize its prophylactic vaccine against Staphylococcus.

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In other news, the biopharmaceutical company Seattle Genetics Company and Millennium: The Takeda Oncology Company (Cambridge, MA) with its parent company Takeda Pharmaceutical have agreed to globally develop and commercialize brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) in late-stage clinical trials for treating relapsed and refractory Hodgkin lymphoma and systemic anaplastic large-cell lymphoma. Under the collaboration, Seattle Genetics will receive an upfront payment of $60 million and retains full commercialization rights for brentuximab vedotin in the US and Canada. The Takeda Group will have exclusive rights to commercialize the product candidate in all countries other than the US and Canada. Seattle Genetics will be eligible to receive milestones and royalties up to $230 million. Seattle Genetics and the Takeda Group will jointly fund worldwide development costs on a 50/50 basis. Development funding by the Takeda Group during the first three years of the collaboration is expected to be at least $75 million. Takeda Group will be solely responsible for development costs in Japan.
 
Therapure Biopharma (Mississauga, Ontario, Canada), a biopharmaceutical company, will provide aseptic fill–finish services for nimotuzumab, a humanized monoclonal antibody licensed to YM BioSciences. Therapure will formulate and fill nimotuzumab into sterile vials in its facility in Mississauga.

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com


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People Notes

ImmunoGen (Waltham, MA), a biotechnology company, has appointed Suzanne Cadden as vice-president of regulatory affairs and quality. She will be responsible for establishing, in conjunction with the chief medical officer, the registration strategy for the company's product candidates, for directing the development of regulatory submissions, and for managing the company's manufacturing-associated quality functions. Prior to joining ImmunoGen, she was vice-president of Regulatory Affairs & Clinical Development at Sierra Neuropharmaceuticals.

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