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Novo Nordisk Drops Inhaled Insulin Product, Neurocrine Appoints CEO and President, More...
Verna, India (Jan. 10)-Bosch Packaging Technology inaugurated its new manufacturing facility in Verna Industrial Estate in Goa early in December. The new 2600-m2 facility produces and assembles packaging technology equipment for packing vials, ampuls and syringes as well as candy wrapping, solid food and biscuit packaging. Bosch Packaging Technology has sold more than 400 packaging machines and process equipment in India for use in the pharmaceutical, confectionery and food processing industries. The facility employs 80 people and has an initial installed capacity of 120 machines a year with plans to increase this to 240 machines in three years.
Incheon, South Korea (Jan. 10)-Celltrion, a biopharmaceutical company focused on contract manufacturing, and CSL Limited (Parkville, Australia), a biopharmaceutical company, signed an agreement to develop and supply “CSL 360,” an experimental monoclonal antibody therapy for the treatment of acute myeloid leukemia. Phase I clinical trials for CSL 360 are currently being conducted by CSL in Australia. Celltrion will provide process development services and supply clinical and commercial material for development and commercialization, with the potential for a longer-term manufacturing relationship between the companies in the future.
London, UK (Dec. 10)-GlaxoSmithKline (GSK) and OncoMed Pharmaceuticals (Redwood City, CA) formed an alliance to discover, develop and market novel antibody therapeutics to target cancer stem cells, which are believed to play a key role in the establishment, metastasis and recurrence of cancer. OncoMed will focus on the discovery and development of cancer stem cell antibody therapeutics and will provide GSK with an option to license four product candidates from OncoMed’s library of monoclonal antibodies. OncoMed will receive an undisclosed initial cash payment and equity investment, and it is eligible to earn milestone payments up to $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory and commercial goals. OncoMed will also receive double-digit royalties on all collaboration product sales. Furthermore, GSK will have an option to invest in a future initial public offering by OncoMed.
Carlsbad, CA (Jan. 10)-Invitrogen entered into a definitive agreement to purchase privately held CellzDirect (Research Triangle Park, NC) in a cash transaction for approximately $57 million. CellzDirect provides hepatocyte-based cell products and related services used in the testing of new drugs. These types of cells are the most accepted model for predicting a compound’s effects on enzymatic metabolism in the liver. Such testing, recommended by the US Food and Drug Administration, can prevent costly failures in clinical trials.
New York (Jan. 14)-Novo Nordisk will discontinue development of its “AERx” inhaled insulin product and will lay off most of the approximately 300 company employees developing the product, based primarily in Hayward, California. After reviewing the commercial potential of the product, the company decided to halt work on AERx and research other potential inhaled insulin products. In October 2007, Pfizer dropped its inhaled insulin project, “Exubera,” due to a lack of consumer interest.
Carmiel, Israel, (Jan. 14)-Protalix BioTherapeutics signed a lease agreement for the expansion of its manufacturing and research facility in Carmiel. The expansion will triple the the company’s manufacturing space in anticipation of the potential commercialization of Protalix’s lead product candidate, “prGCD,” a therapeutic protein for the treatment of Gaucher disease. The term of the lease agreement is 7.5 years with options to extend the life of the lease for up to 15 additional years.
St. Louis, MO (Jan. 14)-SAFC Pharma, a member of the Sigma-Aldrich group , is planning a $12 million expansion at its niche biologics production facility in Carlsbad, California. Two new viral product manufacturing suites will increase the company’s viral manufacturing to commercial-scale quantities. Due to become operational in the second half of 2009, the new suites will add 8,000 ft2 of manufacturing space and enable 100 L batch production in stirred tank bioreactors and 1,000 L batch manufacturing in disposable bioreactors. The expansion will add to the current 44,000-ft2 site and be Biosafety Level 2 compliant, allowing manipulation of human pathogens.
Washington DC (Jan. 14)-The Supreme Court of the United States declined to hear a case concerning the issue of whether terminally ill patients have the right to be treated with investigational drugs. In August 2007, the US Court of Appeals for the District of Columbia ruled that terminally ill patients do not have a constitutional right to access experimental drugs that have not been approved by the US Food and Drug Administration. Read Editor in Chief Michelle Hoffman’s October 2007 column “Who's in Charge?” on the subject.
Redwood City, CA (Jan. 15)-A.P. Pharma, a specialty pharmaceuticals company, announced that Michael O’Connell, its chief operating officer and chief financial officer, will be leaving the company on January 18, 2008. The company will search for a new chief financial officer. Gregory Turnbull, the company’s current president and chief executive officer, will handle the duties of the CFO on an interim basis.
Wilmington, DE (Jan. 14)-DuPont named Nicholas C. Fanandakis group vice-president of DuPont Applied BioSciences, which includes the following businesses: BioFuels, BioMaterials, BioSpecialties and BioMedical.
Vancouver, Canada (Jan. 10)-Inflazyme Pharmaceuticals announced that effective January 1, 2008, Michael Liggett was appointed chief operating officer, president, and a director of the company.
San Diego (Jan. 14)-Neurocrine Biosciences announced that its chief operating officer, Kevin Gorman, PhD, was appointed president and chief executive officer and a member of the company’s board of directors. Gary Lyons will step down as president and CEO of Neurocrine and will continue to serve as a member of the board.
Jerusalem, Israel (Jan. 10)-Teva Pharmaceutical Industries announced the resignation of George S. Barrett, chief executive officer, Teva North America, corporate executive vice-president, global pharmaceutical markets. William S. Marth, currently president and chief executive officer of Teva USA, will replace Barrett and assume the additional role of CEO of Teva North America effective immediately. Barrett will remain with Teva through the end of January 2008 to assist in the transition.