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Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Company and People Notes: Genentech Tells Shareholders to Reject Roche's Tender Offer; Cryoport Appoints President and CEO; More...
Craigavon, Northern Ireland (Feb. 13)—Almac Clinical Services has increased its capacity for specialist storage of controlled and refrigerated clinical supplies with the opening of an additional storage facility. The new facility contains a 1277-m³ vault, holding an additional 150 pallet spaces for controlled-drug storage. The facility provides 450 extra pallet spaces for storage of refrigerated material, with room for an additional future expansion of 400 pallets.
Tokyo (Feb. 17)—Asahi Kasei Medical agreed to acquire TechniKrom’s (Glenview, IL) biopharmaceutical manufacturing equipment business. The integration of operations, scheduled for Mar. 1, 2009, will expand Asahi Kasei Medical’s business further into the field of bioprocess equipment and separation media.
Tokyo, Japan (Feb. 23)—Astellas Pharma issued a statement saying it “remains committed” to acquiring CV Therapeutics (Palo Alto, CA) despite CV’s rejection of a proposal by Astellas to acquire it for $16 per share in cash. The proposal represents a premium of 41% to CV Therapeutics’ closing price on January 26, 2009, the last day of trading before the proposal was made public, and a 69% premium to CV Therapeutics’ 60-day average closing price prior to the public disclosure of the offer.
Seattle (Feb. 20)—Cell Therapeutics, a biopharmaceutical company, announced today that it exercised its option to sell its 50% ownership interest in the Zevalin joint venture to Spectrum Pharmaceuticals for $18 million. Cell Therapeutics and Spectrum established a joint venture in December 2008 to develop and commercialize "Zevalin" (ibritumomab tiuxetan) a cancer therapy. At that time Cell Therapeutics contributed all of the Zevalin-related assets to the joint venture and sold to Spectrum a 50% membership interest in the joint venture for $15 million, plus certain milestone payments. Cell Therapeutics will focus its resources on the approval of pixantrone for relapsed aggressive non-Hodgkin's lymphoma and "Opaxio" (paclitaxel poliglumex) for nonsmall cell lung and ovarian cancer.
Branford, CT (Feb. 18)—CuraGen, a biopharmaceutical company, announced it is exploring strategic alternatives to enhance shareholder value, including a possible sale of the company. The company said in a press release, “There is no assurance that this process will result in any changes to the company's current business plans or lead to any specific action or transaction.”
South San Francisco, CA (Feb. 23)—Genentech announced that a special committee of its board of directors unanimously recommended that shareholders reject the tender offer from Roche to acquire all of the outstanding shares of Genentech not owned by Roche for $86.50 cash per share. Roche commenced the tender offer on Feb. 9, 2009, and the offer will expire on March 12, 2009. In August 2008, Genentech rejected a proposal by Roche to acquire the outstanding shares for $89 per share, saying it “substantially undervalues the company.” Roche currently owns approximately 55.8% of Genentech's outstanding shares.
Cambridge, MA (Feb. 19)—Genzyme announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the company’s variation to produce “Myozyme” (alglucosidase alfa) at the 4000-L bioreactor scale at its manufacturing facility in Geel, Belgium. The positive CHMP opinion is the final step before formal approval to produce and market Myozyme manufactured at the 4000-L bioreactor scale in the European Union, Norway, and Iceland. Myozyme is the only approved treatment for Pompe disease, a progressively debilitating disease that manifests as a broad spectrum of clinical symptoms.
Martinsried/Munich, Germany and Houston, TX (Feb. 18)—GPC Biotech AG and Agennix announced that the two oncology-focused biotechnology companies have signed an agreement to merge their businesses. In the transaction, GPC Biotech is to be merged into a new German company, which will hold all of the shares of Agennix and a EUR 15 million ($19.2 million) cash contribution by dievini Hopp BioTech holding, an investment company of Dietmar Hopp and one of the largest shareholders of GPC Biotech. The merger combines GPC Biotech’s and Agennix’s oncology pipelines, including Agennix’s Phase III oncology therapy, talactoferrin, with the clinical development and financial resources of GPC Biotech and dievini Hopp BioTech holding. The deal will be subject to customary closing conditions and is expected to be completed by the end of 2009.
Houston, TX (Feb. 19)—Introgen Technical Services (ITS) signed manufacturing agreements to produce biological materials for two new customers: Advantagene, and the H. Lee Moffitt Cancer Center. Additionally, ITS has expanded its ongoing collaborative relationship with Oncolys BioPharma through completion of additional good-manufacturing-practices production services for that company.
Sydney, Australia (Feb. 13)—Australian pharmaceutical research and development company Novogen plans to focus its activities on its oncology program. Along with this decision, Novogen has taken several steps to reduce costs such as outsourcing scale-up manufacturing of clinical stage compounds, putting on hold its cardiovascular and anti-inflammatory programs, reducing worldwide staff from 62 to 51, and implementing fee and income reductions of 20% for the board and executive management.
Uppsala, Sweden (Feb. 23)—The pharmaceutical company Orexo acquired PharmaKodex (Cambridge, England), a drug-delivery company focused on the reformulation and development of prescription and consumer health medicines containing small-molecule drugs. PharmaKodex has a number of preclinical and early clinical projects focused on improving oral, sublingual, and transdermal medications.
High Point, NC (Feb. 12)—PharmaCore, a contract manufacturer focused on small-molecule chemistry for drug discovery and development, added a new 16,000-ft2 pilot plant to its existing facility. The lab and kilo-scale capacity are augmented with the addition of several new synthesis suites with reactor sizes up to 2000 L and follow current good manufacturing practices.
Basingstoke, England (Feb. 20)—Shire, a specialty biopharmaceutical company, signed an agreement with UCB, a biopharmaceutical company, to acquire the worldwide rights, excluding the United States, Canada and Barbados, to "Equasym" IR and XL (methylphenidate hydrochloride), used for the treatment of attention deficit hyperactivity disorder. Shire will make a cash payment to UCB of EUR 55 million ($70.2 million) for the acquisition of the rights on completion of the transaction. In addition, small milestone payments may become payable in 2009 and 2010 if certain net sales targets are met. As part of this transaction, approximately 20 sales and sales management personnel will transfer to Shire. The acquisition is subject to standard closing conditions.
Toronto, Canada (Feb. 18)—Therapure Biopharma signed a pact with LFB Biotechnologies (Les Ulis, France), a subsidiary of LFB SA, for the development of a manufacturing method for a plasma therapeutic protein. The project, which is being jointly managed by research and development teams from the two companies, is expected to yield a novel treatment for a serious illness that currently has limited treatment options.
Brussels, (Feb. 19)—The biopharmaceutical company UCB plans to build a biologics pilot plant on its site of Braine-l'Alleud in Belgium. This planned investment should amount to EUR 65 million ($83 million). The company expects the biologics pilot plant to become operational in early 2012, and approximately 100 new jobs will be created.
West Lafayette, IN (Feb. 17)—BASi, a provider of contract research services, appointed Anthony S. Chilton chief operating officer of scientific services. Chilton has responsibility for the services provided to customers in North America and Europe.
Lake Forest, CA (Feb. 23)—CryoPort, a provider of shipping and storage products for the biopharmaceutical cold chain, appointed Larry G. Stambaugh president and CEO in addition to his current position as chairman of the board. Stambaugh succeeds Peter Berry, who resigned as president and CEO of CryoPort and now serves as an advisor. He will also remain on the board of directors.
Cambridge, MA (Feb. 19)—Genocea Biosciences, a vaccine discovery and development company, appointed executive director Staph Leavenworth Bakali as its new chief executive officer. Leavenworth Bakali replaces Genocea cofounder Robert Paull, who will remain on the company’s board of directors.
Beijing (Feb. 20)—Kiwa Bio-Tech Products Group appointed Steven Ning Ma chief financial officer and chief operating officer. Ma's most recent position was managing director of SAS Conserve de Provence (Camaret sur Aguy, France), where he was in charge of overall operation of a French subsidiary for Chalkis Group.
Martinsried, Germany (Feb. 20)—MorphoSys, a biotechnology company, appointed Ulrich Moebius head of preclinical development and project management. Moebius joins MorphoSys from the biopharmaceutical company Medigene (Martinsried, Germany).
Pittsburgh, PA (Feb. 19)—Mylan, a generics and specialty pharmaceutical company, announced that Edward J. Borkowski, its chief financial officer, will leave the company in the next several months. Borkowski will remain with Mylan until a successor is named and in place.
Albuquerque, NM (Feb. 20)—OSO BioPharmaceuticals Manufacturing, contract manufacturing organization, appointed Rick Lapointe vice-president of technology and acquisitions. Prior to joining OsoBio, Lapointe served as head of contract manufacturing at HollisterStier Laboratories and as director of manufacturing at Bayer Corp.