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Almac’s (Craigavon, Northern Ireland) Clinical Technologies division passed one of the UK’s first joint routine good clinical practice/good manufacturing practice inspections by the Medicines and Healthcare Products Regulatory Agency (MHRA) at its Craigavon, UK, site. The inspection focused on the ability of Almac’s integrated phone and web response system to adequately ensure that expired products were not shipped to sites or dispensed to patients at clinical-trial sites.
Anchor Therapeutics (Cambridge, MA) entered into a collaboration and license agreement with Ortho-McNeil-Janssen Pharmaceuticals (OMJPI, Raritan, NJ) to develop G protein coupled receptor (GPCR)–targeted therapeutic compounds using Anchor's proprietary pepducin technology. Pepducins are lipidated peptides designed to be allosteric modulators for GPCR targets. Under the agreement, Anchor and OMJPI will work jointly to discover and optimize preclinical development candidates, and OMJPI assumes responsibility for development and commercialization. Anchor will receive an upfront payment and milestone payments up to $480 million.
Bionovo (Emeryville, CA) announced that the US Food and Drug Administration accepted the company's chemistry, manufacturing, and controls (CMC) plan for its lead drug candidate, Menerba, in a Type "B" or "End of Phase 2" meeting. According to a company press release, this is the first time that FDA's botanical drug development CMC guidance has been applied to an oral drug in a major indication. Bionovo is now in final discussions with FDA to complete the design of its Phase III trials.
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Cyanta Analytical Services (Maryland Heights, MO), an analytical service provider, formed an agreement with Global BioDevelopment (Clearwater, FL), a consulting firm for life science companies, in which each organization would share sales, marketing, and technical capabilities to help grow each other's business. Cyanta will use its sales and marketing team to promote the capabilities of the relationship, as well as perform analytical work and medical device testing. Global BioDevelopment will leverage its industry connections to support the partnership and will provide regulatory and development support to clients.
Delphi Genetics (Charleroi, Belgium) signed a licensing agreement with GlaxoSmithKline (London) for the use of its StabyExpress technology for the production of protein vaccines for human use. The StabyExpress system is designed to improve the efficiency of protein production and increase protein yield in the manufacture of recombinant vaccines without the use of antibiotics. Financial details were not disclosed.
Eli Lilly and Company (Indianapolis) announced that approximately 140 of its scientists have begun working at its new cancer-research facility in New York City. Lilly occupies 90,000 ft2 of office/laboratory space in the new Alexandria Center for Life Science—New York City, located along Manhattan's East Side Medical Corridor just north of Bellevue Hospital and adjacent to New York University's Langone Medical Center. The Alexandria Center now houses the research activities of ImClone Systems, a subsidiary of Lilly.
Japanese conglomerate Mitsui & Co. (Tokyo) agreed to acquire a 5% stake in contract research and manufacturing organization Arch Pharmalabs (Mumbai) for 1.2 billion Yen ($13 million).
NextPharma (Surrey, UK), a provider of product development, contract manufacturing, and cold-chain services, received inspection accreditation from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) at its Braine-l’Alleud site, located near Brussels. Work at the site focuses on aseptic production and packaging, including the manufacture of cytotoxic products.
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Novartis (Basel) sold the US rights to market Enablex (darifenacin) extended release tablets, a drug to treat adults with symptoms of overactive bladder, to Warner Chilcott (Ardee, Ireland), a pharmaceutical company. Novartis will receive an upfront payment of $400 million and potential milestone payments up to $20 million. Novartis retains the rights to darifenacin worldwide except in the US. Warner Chilcott expects to assume manufacturing of the drug for the US once it is transferred to Warner Chilcott's manufacturing facility. The transaction is expected to close by the end of October 2010.
In other Novartis news, the company received approval from the US Food and Drug Administration for its oral multiple sclerosis (MS) treatment Gilenya (fingolimod) 0.5 mg daily, which is a first-line treatment for relapsing forms of multiple sclerosis—the most common forms of the disease. The FDA approval makes Gilenya the first oral treatment indicated for relapsing forms of MS available in the US.
Royal DSM (Heerlen, The Netherlands), a life sciences and materials sciences company, and biopharmaceutical company Crucell (Leiden, The Netherlands) will expand the activities of their existing joint venture, the PERCIVIA PER.C6 Development Center, located in Cambridge, Massachusetts. The companies plan to transform the joint venture, which will be known as PERCIVIA LLC, from a development center into a full biopharmaceutical company for the development of PER.C6-based biobetter proteins and monoclonal antibodies, as well as global licensing of the PER.C6 human cell line for production of third-party monoclonal antibodies and other proteins.
Sanofi Pasteur (Lyon, France), the vaccines division of the sanofi-aventis group (Paris), agreed to acquire VaxDesign (Orlando, FL), a biotechnology company that develops, manufactures, and markets in vitro models of the human immune system. Under the terms of the agreement, Sanofi Pasteur will make an upfront payment of $55 million and an additional $5-million milestone payment. The closing of the transaction is expected to occur by the end of 2010, subject to regulatory approval.
Scarab Genomics (Madison, WI), a company focused on E. coli genomics and production strains, formed a preferred marketing and sales agreement with contract manufacturing organization Lonza (Basel). Under the agreement, Lonza will support Scarab’s business-development activities and will become the preferred marketing provider for the Clean Genome technology, giving Lonza customers access to the platform for protein and plasmid DNA production. In addition, Lonza and Scarab will codevelop new microbial expression technologies. Financial details of the contract were not disclosed.
Valeant Pharmaceuticals International (Mississauga, Canada) completed the merger with Biovail following the approval by shareholders of both companies. The combined company is called Valeant Pharmaceuticals International, Inc. Under the terms of the merger agreement, Valeant stockholders will receive, for each share of Valeant common stock outstanding immediately prior to the merger, 1.7809 Biovail common shares.
Xcelience (Tampa, FL), a contract research organization, has expanded its solid oral-dosage form development and manufacturing capabilities in granulation with the addition of a Vector TFC-220 Roller Compactor in its good manufacturing practice area.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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ClinTec International (London), a contract research organization, appointed Dianne Kikta executive vice-president. Kikta is based in ClinTec’s Philadelphia location and will offer the company’s clients guidance on their drug-development and resourcing strategies.
Discovery Laboratories (Warrington, PA), a biotechnology company, appointed Thomas C. Hoy as vice-president of manufacturing operations. In addition, the company announced that Charles F. Katzer, senior vice-president and chief technical officer, resigned to pursue another opportunity.
INC Research (Raleigh, NC), a contract research organization, appointed Hans-Peter Guler vice-president of clinical development of endocrine. Guler’s clinical-research experience includes research in areas such as metabolism, diabetes mellitus, and obesity.
Biopharmaceutical company Prolong Pharmaceuticals (South Plainfield, NJ) named Glenn Kazo as its president. Kazo has been a consultant to the company since 2007. He succeeds Prolong founder Abraham Abuchowski, who remains CEO.
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Reliable Biopharmaceutical (St. Louis), a manufacturer of active pharmaceutical ingredients (APIs) and high purity ingredients, appointed David Feldker president and CEO, effective Oct. 23, 2010. Feldker previously served as vice-president of SAFC at Sigma-Aldrich (St. Louis) with responsibility for the API contract development and manufacturing segment.
Ricerca Biosciences (Concord, OH), a preclinical contract research organization, appointed Lawrence (Bob) Lima III director of analytical chemistry. Lima will manage one of the company’s largest and most diversified departments, according to a company press release.
Contract research organization Velesco Pharmaceutical Services (Plymouth, MI) named Shirley Smith as its director of quality. In addition, Yuan Chen was appointed senior pharmaceutical scientist.
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Last week, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) met to review and discuss drug marketing authorization applications. Several decisions were made (see full press release) including the committee’s recommendation to harmonize globally the prescribing information for Lipitor (atorvastatin).
Next week, in Bethesda, Maryland, ISPE and PDA will cohost a workshop on the implementation of pharmaceutical development, risk management, and quality systems as part of the ICH quality-trio workshop series. The workshop will feature members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and include breakout sessions on design space, control strategy, quality system, and risk management. Industry is encouraged to attend. |
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| Survey Says... |
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Michelle Hoffman
New data provide insight into pharma-industry professionals' daily lives.
Coming Soon: Editor-in-Chief Michelle Hoffman’s column focuses on embryonic-stem-cell research in the October issue of Pharmaceutical Technology. |
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Small-Molecule Outsourcing
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