Abbott Laboratories (Abbott Park, IL) and AstraZeneca (London) received a complete response letter (CRL) from the US Food and Drug Administration for their new drug application for Certriad (rosuvastatin/fenofibric acid delayed release) capsules. The companies are evaluating the CRL and said they would respond to the agency’s request for additional information.
Avid Bioservices (Tustin, CA), a provider of current good manufacturing practice (CGMP) manufacturing services for the biotechnology and biopharmaceutical industries, expanded its commercial-supply relationship with the biopharmaceutical company Halozyme Therapeutics (San Diego). Halozyme designated Avid a preferred supplier for future products requiring Avid's process-development and biomanufacturing capabilities and expertise. Avid has manufactured commercial products for Halozyme since 2005 in the company's CGMP facility. Financial terms were not disclosed.
Boehringer Ingelheim (Ingelheim, Germany) launched its corporate venture capital fund, the Boehringer Ingelheim Venture Fund (BIVF). The company said BIVF wll invest in biotech and startup companies that provide therapeutic approaches and technologies to help drive innovation in medical science.
The contract analytical services provider Celsis Analytical Services (Chicago, IL) expanded the analytical chemistry capabilities of its accredited current good manufacturing practice laboratories to include mass spectrometry and ion chromatography.
The US District Court for the Southern District of Indiana upheld the validity of Eli Lilly’s (Indianapolis, IN) compound patent on Gemzar (gemcitabine HCl for injection), which maintains Lilly's US exclusivity for Gemzar through November 15, 2010. In a separate case, a second patent for Gemzar, related to its FDA-approved uses, has a 2013 expiration date and was ruled invalid by the US District Court for the Eastern District of Michigan. Lily is appealing that decision.
GlaxoSmithKline (London) and Isis Pharmaceuticals (Carlsbad, CA) formed a strategic alliance to apply Isis’ antisense drug-discovery platform to seek out and develop new therapeutics against targets for rare and serious disease, including infectious diseases and some conditions causing blindness. The alliance covers six programs and Isis will receive an upfront $35 million payment from GSK and is eligible to receive on average up to $20 million in milestones per program. Isis will be eligible to receive license fees and milestone payments, totaling nearly $1.5 billion, if all six program are successfully developed for one or more indications and commercialized through to pre-agreed sales targets.
Hospira (Lake Forest, IL), a specialty pharmaceutical company, completed its acquisition of Orchid Chemicals & Pharmaceuticals (Chennai, Tamil, Nadu, India) for $400 million. The newly appointed managing director of Hospira India, C.B. Rao, will oversee the 450 former Orchid employees and report to CEO Terry Kearney. The acquisition includes Orchid's beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin, penicillin, and carbapenem facilities) and pharmaceutical research and development (R&D) facility at Irungattukottai, Chennai, as well as its generic injectable dosage-form product portfolio and pipeline. In addition, the companies signed a long-term agreement for Orchid to supply active pharmaceutical ingredients for the acquired generic injectable pharmaceuticals business. The two companies also formed transitional services agreements for approximately 15 months to support various alliances and distribution arrangements of the acquired business.
The drug discovery and development company MDRNA (Bothell, WA) announced a study effort with Pfizer (New York). The study effort will focus on the evaluation of MDRNA's proprietary di-alkylated amino acids (DiLA2) platform and UsiRNA constructs for RNA interference. In other news, MDRNA signed a definitive agreement to acquire Cequent Pharmaceuticals (Cambridge, MA), a biopharmaceutical company, in an all stock transaction valued at approximately $46 million.
The biopharmaceutical company Medivation (San Francisco) announced plans to reduce its workforce and operating costs in order to focus on prioritized-dimebon trials and the continued development of MDV3100, a drug candidate for treating prostate cancer. The company will reduce the number of staff by 23, or approximately 20%. The reduction is effective March 29, 2010.
Merck & Co. (Whitehouse Station, NJ) announced that Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) for treating frequent heartburn will be available in drug stores, grocery stores, mass merchandisers, and club stores nationwide. The drug, a proton pump inhibitor, was approved by FDA for over-the-counter use in December 2009.
The bioscience company Penn Pharma (Tredegar, UK)) started construction on a cold-storage facility at its good manufacturing practice warehouse in South Wales. The facility is scheduled to be completed by June 2010.
The contract research organization Ricerca Biosciences (Concord, OH) announced a business-development agreement with Life Science Partner (LSP, Tokyo). LSP was granted the ability to market the full spectrum of services offered by Ricerca to those companies represented by LSP.
SAFC, part of the life-sciences chemical company Sigma-Aldrich (St. Louis), announced the opening of a $30-million expansion to its manufacturing facility in Verona, Wisconsin. The expansion is designed to significantly increase SAFC’s capacity to produce commercial-scale high potency active pharmaceutical ingredients.
sanofi-aventis (Paris) settled US patent-infringement lawsuits related to generic versions of Eloxatin (oxaliplatin) with certain defendants involved in the litigation. Sanofi and Debiopharm (Lausanne, Switzerland), licensor of the involved patent rights, signed settlement agreements with generics makers Teva Pharmaceuticals (Jerusalem), Fresenius Kabi (Bad Homburg Germany), and Sandoz (Holzkirchen, Germany). Under terms of the settlement, the generic manufacturers will cease selling their generic oxaliplatin products on June 30, 2010, and will resume selling generic oxaliplatin products on August 9, 2012, under a license to re-enter the market.
Simcere Pharmaceutical Group (Nanjing, China), which specializes in the development, manufacturing, and marketing of branded-generic and proprietary pharmaceuticals, reported that China's State Food and Drug Administration (SFDA) issued a statement on its investigation into the human-use rabies vaccine manufactured by Jiangsu Yanshen Biological Technology Stock Co., of which Simcere has an interest. SFDA found that the four batches of human-use rabies vaccine manufactured by Jiangsu Yanshen and released had an insufficient amount of the active compound. The responsible employees of Jiangsu Yanshen are under criminal investigation.
The medical-device company Unilife received FDA clearance for the Unitract 1mL insulin syringes assembled at its Lewisberry, Pennsylvania, manufacturing facility.
The biotechnology company Genzyme (Cambridge, MA) created the position of chief operating officer and appointed executive vice-president David Meeker to the position.
Ranbaxy Laboratories (New Delhi) plans to hire approximately 1500 marketing executives. The move will expand the company's sales team by at least 50%, according to various industry sources.