Week of Dec. 14, 2009: Company Notes: Sanofi Pasteur recalls H1N1 vaccine; Patheon consolidates Puerto Rico operations.

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Abbott to acquire Starlims Technologies; GSK Biologicals to form alliance with Intercell.

Company Notes

Abbott (Abbott Park, IL) has agreed to acquire Starlims Technologies, a provider of laboratory-information management systems, for $123 million. The acquisition will support the company’s diagnostics business. The transaction is expected to close in the first quarter of 2010.
Cubist Pharmaceuticals (Lexington, MA) has agreed to acquire Calixa Therapeutics (San Diego, CA) for $92.5 million in cash and potential payments of $310 million if the company achieves certain milestones relating to CXA-101, Calixa’s antipseudomonal cephalosporin product. The acquisition is expected to close in the fourth quarter of 2009.
Codexis (Redwood City, CA), a biocatalysis firm, has expanded its agreement with the generic drug company Teva Pharmaceutical Industries (Petach Tikva, Israel), under which Teva will use Codexis biocatalysis technology for key process steps in the manufacture of select generic drugs.
The biopharmaceutical company Cytokinetics (South San Francisco, CA) has terminated its collaboration and license agreement with GlaxoSmithkine (London), effective Feb. 28, 2010. As a result, the rights for GSK-923295, an anticancer therapy, will revert back to Cytokinetics.
Dynavax Technologies (Duesseldorf, Germany) reported that its good manufacturing practice (GMP) manufacturing facility in Duesseldorf has been approved for the commercial production of the hepatitis B surface antigen, a component of Heplisav, the company’s investigational adult hepatitis B vaccine.
Generex Biotechnology (Worcester, MA) has signed a long-term agreement with sanofi-aventis Deutschland GmbH (Frankfurt, Germany) for the manufacture and supply of recombinant human insulin crystals for commercial and clinical trial use in Generex’s proprietary buccal insulin spray product, Generex Oral-lyn. Financial terms of the arrangement were not disclosed.

GlaxoSmithKline Biologicals (London) and the biotechnology company Intercell (Vienna, Austria) have formed a strategic alliance to accelerate the development and commercialization of needle-fee patch-based vaccines. The agreement includes Intercell’s candidate for traveler’s diarrhea and an investigational single-application pandemic influenza vaccine as well as the use of patch technology for other vaccines. GSK will make an up-front cash contribution of EUR 33.6 million ($48.8 million) in addition to an equity investment of EUR 84 million ($122 million) through a staggered shareholding purchase option of up to 5% in Intercell.
Pfizer (New York) has formed a research and development (R&D) collaboration with Crown Bioscience (Santa Clara, CA), a US-based drug-discovery services company with R&D facilities in China, to develop treatments for Asian cancers. The work will take place at Crown’s research facility in Taicang, Jiangsu Province, China.  
The contract manufacturer Lonza (Basel, Switzerland) has formed a manufacturing-services agreement with Femta Pharmaceuticals (San Diego, CA), a biopharmaceutical company. The agreement covers the development and current good manufacturing practice (CGMP) manufacturing of FM101, a monoclonal antibody in late preclinical development. The agreement allows Femta to access Lonza’s glutamine synthease gene-expression system, along with cell line, purification, and process development for a CGMP process.
The biotechnology company Merrimack Pharmaceuticals (Cambridge, MA) has acquired Hermes Biosciences (South San Francisco, CA), a biopharmaceutical company specializing in drug-delivery technologies using lipidic nanocarriers and antibodies as targeting agents.
Particle Sciences (Bethlehem, PA), a contract-research organization, has expanded its high-potency compound (HPC) handling capabilities through a relationship with IES Engineers (Blue Bell, PA), an engineering and environmental, health, and safety consulting firm. Under the agreement, IES Engineers will be responsible for evaluating incoming materials and placing them into exposure control bands and for specific design and implementation of HPC-related procedures.
Patheon (Toronto), a provider of contract development and manufacturing services, plans to consolidate its Puerto Rico operations at its manufacturing site in Manatí and either close or sell its plant in Caguas. The company estimates that the consolidation will result in total repositioning expenses of approximately $7.0 million, of which $2.4 million will be booked in the first quarter of fiscal 2010. Patheon also expects to book an impairment charge of approximately $1.3 million in the first quarter of fiscal 2010 in connection with the consolidation plan. The consolidation is expected to be completed by the end of fiscal year 2011.
sanofi-aventis (Paris) launched new production units at its site in Le Trait, France. The Le Trait site specializes in sterile injectable products, primarily for export. The lines include new filling, inspection, and packaging systems, enabling the manufacturing plant to double the production of prefilled syringes to meet growing demand for Lovenox (enoxaparin), which is used to prevent deep-vein thrombosis. The investment will also allow the company to diversify its vaccine production in partnership with Sanofi Pasteur. The site currently manufactures the seasonal flu vaccine Vaxigrip, and from December 2009, will also handle packaging of an infant meningitis vaccine for the Japanese market, and production of the new intradermal flu vaccine Intanza beginning in early 2010.
sanofi-aventis also announced that it has formed a collaboration agreement and option for a license for a preclinical monoclonal antibody targeting infectious diseases with Alopexx Pharmaceuticals (Cambridge, MA). Alopexx will receive upfront payment and research funding and potential milestones payments up to $375 million.
sanofi pasteur (Lyon, France), the vaccines division of the sanofi-aventis Group (Paris), is voluntarily recalling about 800,000 doses of its prefilled H1N1 swine flu vaccine meant for children between the ages of 6 months and 35 months. According to the US Centers for Disease Control and Prevention (CDC), the recall is based on the drug product’s lack of potency rather than a safety issue. On Dec. 7, the company notified CDC and the US Food and Drug Administration that the potency in one distributed batch of pediatric syringes had dropped below a prespecified limit, and subsequently found three other lots with a low prespecified limit. Additional information is on the CDC website.
The biotechnology company Seattle Genetics (Bothell, WA) has been notified by Genentech (South San Francisco, CA), part of Roche (Basel, Switzerland), that Genentech has decided to terminate the companies’ collaboration agreement for dacetuzumab, a monoclonal antibody to treat non-Hodgkin lymphoma and multiple myeloma.
The Society of Chemical Manufacturers and Affiliates (SOCMA) reports that Bio-Process Systems Alliance, an industry group that promotes the implementation of single-use biopharmaceutical manufacturing, has joined SOCMA as an affiliate. SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceutical ingredients and intermediates. 


The biopharmaceutical company Unigene Laboratories (Boonton, NJ) announced a restructuring plan that included a company workforce reduction of one-third and salary reductions. The company will continue production of Fortical, a nasal calcitonin product, and will maintain its core operations by decreasing expenses by $9–10 million for 2010. The company says it maintains an adequate inventory of calcitonin and enzyme to support Fortical and will temporarily suspend manufacturing of those materials at the Boonton facility, but will maintain the CGMP status of the facility and the ability to make peptides at that location.
People notes
Bristol-Myers Squibb (New York) has appointed Charles Bancroft as acting chief financial officer, effective Jan. 1, 2010. Jean-Marc Huet, current executive vice-president and chief financial officer, will leave the company at the end of 2009. Bancroft was most recently vice-president of finance for Bristol-Myers Squibb’ global biopharmaceutical business.
Pfizer (New York) has appointed Adele Gulfo as US president of the company’s primary-care business. Gulfo will be responsible for the company’s US primary care business, including its five regional business units, commercial operations, marketing, and corporate and government customer relationships. She will report to Olivier Brandicourt, president and general manager of Pfizer’s worldwide primary-care business. Gulfo joins Pfizer from AstraZeneca (London), where she was most recently vice-president of business development and design for launch.