|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
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.
Week of June 13, 2011: Company and People Notes: Biogen Idec Receives Approval for the Avonex Pen; Xceleron Makes Several Senior Appointments; and More.
Biogen Idec, a biotechnology company, has received approval from the European Commission for the Avonex Pen, a prefilled, once-a-week, single-use intramuscular autoinjector for delivering the injectable multiple sclerosis drug, Avonex (interferon beta-1a).
The US District Court for the Southern District of California vacated a temporary restraining order and denied a request by Amylin Pharmaceuticals for a preliminary injunction that sought to impose restrictions on the Lilly Diabetes sales force with regard to the sale of exenatide, the active ingredient in Eli Lilly's Byetta and Boehringer Ingelheim's (BI) competing drug, linagliptin. Amylin recently filed litigation involving the two companies' diabetes collaboration agreement for exenatide, which was formed in 2002. Earlier this year, Lilly formed a pact with BI for linagliptin and other diabetes treatments.
In other news, Eli Lilly and the biomaterials manufacturer Synthes have formed a drug-development and collaboration agreement to focus on treatment for bone conditions such as osteoporosis. The agreement allows for the joint development and licensing of early-stage compounds from Lilly to Synthes for use within orthopedic trauma, spine, craniomaxillofacial, and reconstructive areas. The two companies will jointly develop site-specific osteoinductive (i.e., bone healing) products based on Synthes' biomaterials combined with Lilly's biologics or pharmaceuticals and will also evaluate additional orthopedic uses for Lilly's osteoporosis drug, Forteo (teriparatide [RDNA origin] injection).
The biopharmaceutical company Gilead Sciences was subpoenaed by the US Attorney's Office for the Northern District of California which requested documents related to the manufacture and related quality and distribution practices of Gilead's Atripla, Emtriva, Hepsera, Letairis, Truvada, Viread, and other investigational fixed-dose combinations of Truvada and Edurant. Gilead said in a press statement that it is cooperating in the civil and criminal investigation.
In response to a UNICEF request for a rotavirus vaccine, GlaxoSmithKline (GSK) has offered its medication, Rotarix, to the GAVI Alliance at $2.50 per dose. If accepted by UNICEF, large-scale immunization could begin later this year.
The PATH Malaria Vaccine Initiative (MVI) has entered into a collaboration with GSK and the biopharmaceutical company Crucell, part of Johnson & Johnson, for developing a malaria vaccine. In this collaborative effort, a single dose of Crucell's weakened recombinant adenovirus Ad35.CS.01malaria vaccine approach will be administered, followed by two doses of GSK's RTS,S malaria vaccine candidate in a Phase I/IIa clinical trial that is expected to begin later this year.
The contract development and management organization Hovione and Particle Sciences, a producer of drug-development services, have agreed to combine their technologies to begin work on several development projects targeting poorly water-soluble drugs. Particle Sciences will develop the solubilization process and resulting drug products, and Hovione will manage the scale-up and industrialization of the spray-drying process.
The contract manufacturing organization (CMO) Lonza is investing CHF 10 million ($11.92 million) to expand its biopharmaceutical development services platform in Singapore. The expansion includes the addition of 1858-m2 (20,000-ft2) of laboratory space and associates equipment and will support cell-line construction, upstream and downstream process development, and analytical services. The facility is expected to come on line in the first half of 2012.
Merck Serono, a division of Merck KGaA, has signed an exclusive licensing agreement with the biopharmaceutical company Affectis Pharmaceuticals for the development and commercialization of oral compounds targeting P2X7 receptors for treating neurodegenerative diseases. Under the terms of the agreement, Merck Serono will have worldwide exclusive rights to develop and commercialize selected compounds. The contract also includes a research collaboration focusing on P2X7 antagonist optimization. Affectis will receive EUR 2.4 million ($3.46 million) in upfront payment and research funding and could receive up to EUR 277 million ($400 million) in milestones for the first three products to come out of the collaboration, as well as undisclosed royalties.
The expression technology provider Pfenex has entered into a nonexclusive strategic partnership with the SAFC, the custom manufacturing and business services arm of Sigma-Aldrich. Under the agreement, Pfenex will manage production strains and processes for SAFC's contract manufacturing customers, and the developed processes will ultimately be transferred to SAFC's recently-expanded fermentation facility in Jerusalem, Israel for cGMP production.
Pfizer's network of translational research partnerships, called the Centers for Therapeutic Innovation, has launched in Boston with Beth Israel Deaconess Medical Center, Boston University School of Medicine, Children's Hospital Boston, Harvard University, Partners HealthCare, Tufts Medical Center, Tufts University, as well as the University of Massachusetts Medical School in Worcester. These organizations follow on previously announced partnerships with academic medical institutions in California and New York City.
In other news, Pfizer and the biopharmaceutical company Clovis Oncology have entered into an agreement for the development and commercialization of Pfizer's oral and IV Poly (ADP-ribose) polymerase (PARP) inhibitor, PF-01367338, currently in Phase I/II development for treating solid tumors. Under the terms of the agreement, Clovis Oncology will take over responsibility for global product development and commercialization. Pfizer will receive an upfront license fee from Clovis, payable in equity in Clovis Oncology, and will be eligible to receive further payments totaling up to $255 million upon Clovis Oncology's successful attainment of development, regulatory and sales milestones. Pfizer will also receive royalties on any product sales. In addition, Pfizer Venture Investments, the venture capital arm of Pfizer, will make a separate equity investment in Clovis Oncology.
The biotechnology company Seattle Genetics and Agensys, an affiliate of Astellas Pharma, have agreed to codevelop a second antibody-drug conjugate (ADC) under the companies' existing ADC collaboration agreement. The ADC, known as ASG-22ME (formerly AGS-22M6E), targets the Nectin-4 antigen, which is expressed on multiple solid tumors. During the first quarter of 2011, Agensys submitted an investigational new drug application to FDA for a Phase I trial of ASG-22ME. Seattle Genetics and Agensys are also codeveloping another ADC, ASG-5ME, which is currently in Phase I clinical trials for pancreatic and prostate cancer.
Selecta Bioscienes, a biopharmaceutical company, and the Juvenile Diabetes Research Foundation (JDRF) have established a research collaboration to support Selecta's development of a diabetes vaccine. Through the research partnership, JDRF will provide milestone-based financial support and expertise, with the goal of applying Selecta's vaccine technology toward the development of vaccines for Type I diabetes.
The CMO Senn Chemicals has opened a new office at Menlo Labs, in Menlo Park, California.
The contract testing and analytical services company SGS Life Science Services has announced that its facility in Wavre, Belgium, has achieved a prequalified status from the World Health Organization (WHO). WHO prequalification demonstrates that a laboratory has met established global quality guidelines on GMP and Good Practices for National Pharmaceutical Control Laboratories. This facility has passed inspection by FDA and EMA, and operates under Good Laboratory Practices, Good Clinical Practices, cGMP, and ISA 17025. The prequalification of the SGS Belgium laboratory follows the recent prequalification of the SGS Chennai, India, facility in January 2011.
The Pharmaceutical Research and Manufacturers of America has named Matthew D. Bennett senior vice-president of communications and public affairs. He previously worked for GolinHarris, where he served as senior vice-president of the firm's healthcare communications and advocacy group.
Xceleron, a bioanalytics company, has appointed David Roblin to its board of directors in a nonexecutive capacity and Stuart Best as senior director of operations. Roblin was most recently senior vice-president of research and development (R&D), research head, and site developer at Pfizer Global R&D. Best was most recently head of bioanalysis at Merck.
The drug-development company XOMA has named Paul Rubin, MD, as vice-president and chief medical officer. He previously held senior positions with Sepracor and Abbott Laboratories.