OR WAIT null SECS
Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.
AVI BioPharma (Bothell, WA), a developer of RNA-based therapeutics, was awarded a new contract with the United States Department of Defense for the development of the company's hemorrhagic fever virus therapeutic candidates, AVI-6002 and AVI-6003, for Ebola and Marburg viruses, respectively. AVI will receive an initial payment of $80 million and up to $291 million if the products are approved by FDA.
CSL (Melbourne, Australia) will build a biotechnology facility at its manufacturing site in Broadmeadows, Australia. The new facility will focus on the late-stage development of therapies for cancer, bleeding disorders, inflammation,and infection.
Encorium Group (Wayne, PA), a clinical research organization (CRO), acquired Progenitor Holdings (Zurich), a CRO providing services in emerging market regions. Encorium acquired Progenitor for cash and stock valued at EUR 1.7 million ($2.2 million), plus earn-out consideration of cash and stock with a value of up to EUR 1.5 million ($1.9 million).
GlaxoSmithKline (GSK, London) said it expects to record a legal charge for the second quarter of 2010 of £1.57 billion ($2.36 billion) (equating to an after-tax cost of £1.35 billion). The charge includes settlements, agreements in principle to settle, and other provisioning for long-standing legal cases involving an investigation by the US government into the company’s former manufacturing site at Cidra, Puerto Rico; product-liability and antitrust litigation relating to Paxil (paroxetine); and product-liability cases regarding Avandia (rosiglitazone) and other products.
Johnson & Johnson (J&J, New Brunswick, NJ) said on the company’s blog that it would eliminate 300 of the 400 jobs at the Fort Washington, Pennsylvania, plant that manufactured the recently recalled children’s and infants’ medications. Reutersreported early this week that J&J and Merck (Whitehouse Station, NJ) received a Form 483 letter from the US Food and Drug Administration after an inspection of a Lancaster, Pennsylvania, plant owned by a joint venture between the two companies called Johnson & Johnson–Merck Consumer Pharmaceuticals. Reuters said that an FDA spokeswoman confirmed the agency had issued the inspection report.
LyoTechnica (Carlsbad, CA) was launched to provide contract drug development services for injectable pharmaceuticals. The company offers analytical and formulation development, manufacturing of sterile stability batches, stability testing services, and regulatory support services.
Mylan (Pittsburgh, PA), a generic-drug company, agreed to acquire Bioniche Pharma (Galway, Ireland), a pharmaceutical company focused on injectables, for $550 million in cash. Mylan will gain entry into the North American injectables market through the acquisition.
Pfizer (New York) suspended its chronic low back pain and painful diabetic peripheral neuropathy clinical program for the investigational compound tanezumab. Pfizer previously announced the suspension of tanezumab studies in patients with osteoarthritis on June 23. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain, according to a company release.
Samsung Medical Center (Seoul, Korea) and Pfizer (New York) formed a research partnership to analyze tumors from Korean patients to generate gene-expression profiles. The companies said the research may lead to therapies for liver cancer.
Tekmira Pharmaceuticals (Vancouver, Canada), a company focused on RNA interference (RNAi) therapeutics, was awarded a new contract with the United States Department of Defense to advance an RNAi therapeutic using Tekmira's lipid nanoparticle technology, SNALP (stable nucleic acid-lipid particle) to treat Ebola virus infection. Tekmira is eligible to receive up to $34.7 million over the next three years for development through the completion of a Phase I clinical trial. Tekmira could receive up to $140 million if an Ebola therapeutic is approved by FDA.
AcuTemp Thermal Systems (Dayton, OH), a manufacturer of temperature-controlled packaging, appointed Rick Lenhard lead engineer of passive systems. Lenhard will be responsible for expanding the company’s line of AcuTemp Qualified Shippers and for developing custom passive shippers.
Amgen (Thousand Oaks, CA) appointed Jonathan M. Peacock chief financial officer, effective Sept. 1, 2010. Peacock will report to Kevin W. Sharer, Amgen's chairman and chief executive officer, and will succeed Michael A. Kelly, who served as acting CFO since May 2010.
Mary Foster, vice-president of quality for Catalent (Somerset, NJ), was elected chair of the United States Pharmacopeia (USP) Packaging, Storage, and Distribution Expert Committee for the 2010–2015 USP cycle. The Committee will focus on the following areas: supply chain, including drug pedigrees and anticounterfeiting; testing for extractables and leachables; and testing of glass, plastic, and metal container-closure systems. The Committee will continue the work on current chapters under revision such as General Chapter <1079> Good Storage and Transportation Practices. Foster also serves on the USP Advisory Panel for bulk pharmaceutical excipients.
Phage Pharmaceuticals (San Diego) appointed David Jackson vice-president of operations planning. Jackson is responsible for overseeing the company’s therapeutic-protein manufacturing facility in San Diego. He will report to Robert J. Beckman, the company’s CEO.
Contract research organization PPD (Wilmington, NC) appointed Henrietta Ukwu senior vice-president of global regulatory affairs. Ukwu previously served as vice-president of global regulatory affairs at Wyeth Pharmaceuticals, now Pfizer (New York).
Spectrum Pharmaceuticals (Irvine, CA), a biotechnology company, appointed George Tidmarsh senior vice-president, chief scientific officer, and head of research and development operations. Tidmarsh will report directly to Rajesh C. Shrotriya, CEO, president, and chairman of the board of directors of Spectrum Pharmaceuticals.