Alnylam Pharmaceuticals (Cambridge, MA), a developer of RNAi-based therapeutics, granted Tekmira Pharmaceuticals (Vancouver) a new target-specific InterfeRx license to discover, develop, and commercialize an RNAi therapeutic for the treatment of Ebola virus infection (TKM-Ebola). Detailed financial terms were not disclosed, but Alynylam will receive royalties on sales of any resulting product under the licensing agreement.
In a separate announcement, Alnylam described a colloboration with Medtronic (Minneapolis), a medical device company, and CHDI Foundation (New York), a virtual biotech company focused on Huntington's disease treatments. The companies will advance ALN-HTT, a drug-device combination for the treatment of Huntington's disease. ALN-HTT consists of an RNAi therapeutic targeting huntingtin, the gene responsible for Huntington's disease, that is being developed for delivery to the central nervous system using an implantable infusion system developed by Medtronic.
ATW (Warwick, RI), a provider of custom manufactured metal components and services, announced the opening of Parmatech-Proform’s, a subsidiary of ATW, new manufacturing facility in East Providence, Rhode Island. The company focuses on metal injection molding for the medical, telecommunications, firearms, hand tools, semiconductor, and electronic packaging markets. The new facility will serve as Proform’s headquarters.
Biocon (Bangalore, India), a biotechnology company, plans to invest $161 million in Malaysia in a biomanufacturing and research and development facility. Through a partnership with Biotechcorp (Ampang, Malaysia), an agency of Malaysia’s Ministry of Science, Technology and Innovation, the facility will be established in Bio-Xcell, a biotechnology park in Iskandar. The facility, targeted to be operational by 2014, will focus on the research and development and production of biosimilars and other biopharmaceutical products.
Bristol-Myers Squibb (New York) and AstraZeneca (London) received approval for their combination therapy Kombiglyze XR (saxagliptin and metformin HCl extended-release) for the treatment of Type II diabetes in adults. According to a company press release, the drug is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG), and post-prandial glucose (PPG).
Bristol-Myers Squibb (New York) and Simcere Pharmaceutical Group (Nanjing, China), a pharmaceutical company, formed a pact to codevelop BMS-817378, a preclinical small molecule MET/VEGFR-2 inhibitor. Under the terms of the agreement, Simcere receives exclusive rights to develop and commercialize BMS-817378 in China while Bristol-Myers Squibb retains exclusive rights in all other markets. Financial terms were not disclosed.
The US Food and Drug Administration determined that additional time is required to complete the review of Bristol-Myers Squibb’s (New York) biologics license application (BLA) for ipilimumab in pretreated advanced melanoma, and has moved its decision date from December 25, 2010, to March 26, 2011. In response to an FDA request, the company submitted further analysis of data for review and the agency considers this to be a major amendment to the drug’s BLA.
Contract manufacturing organization Cambrex (East Rutherford, NJ) acquired a 51% stake in Zenara Pharma (Hyderabad, India), a pharmaceutical company focused on the formulation of final dosage form products. Cambrex’s CEO, Steve Klosk, said in a company statement that he was excited to partner with Zenara and provide products for the approximately $1.5-billion nicotine replacement therapy market. Zenara will be renamed Cambrex Zenara.
Catalent Pharma Solutions (Somerset, NJ), a service provider, added the Xcelodose microdosing system to its Research Triangle Park, North Carolina, facility. This system is designed to provide metering of powder active pharmaceutical ingredients into capsules, which eliminates the need for upfront formulation activities.
Contract research organization Covance announced its third-quarter financial results and said it will implement restructuring actions such as consolidating its North American toxicology services by closing its toxicology facility in Vienna, Virginia; reducing spending across the company, including corporate overhead; realizing savings from process improvements and automation investments; and restructuring the executive management team.
Eli Lilly (Indianapolis) agreed to acquire Avid Radiopharmaceuticals (Philadelphia), a company developing molecular imaging compounds intended for the detection and monitoring of chronic diseases. Lilly will acquire all outstanding shares of Avid for an upfront payment of $300 million, subject to adjustment based on existing cash on hand at closing. Avid stockholders will also be eligible for up to $500 million in milestone payments for the performance of the company’s lead candidate florbetapir F 18 (18F-AV-45), a molecular imaging agent designed to detect amyloid plaque in the brain. Upon completion of the acquisition, Avid will continue to operate from its facility in Philadelphia, Pennsylvania.
Sanofi Pasteur (Lyon, France), the vaccines division of sanofi aventis (Paris) reported that its dengue vaccine is in final stage of clinical development. The vaccine candidate, developed to prevent dengue disease in children and adults, entered its first Phase III clinical study in Australia. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur, according to a company press release.
Specialty pharmaceutical company Valeant Pharmaceuticals International (Mississauga, Canada), formerly known as Biovail, and S.A.C. Capital Advisors (SAC) have agreed to settle SAC's Connecticut action against Valeant for vexatious litigation. As part of the settlement, Valeant will pay SAC $10 million, a portion of the costs SAC expended in defending two earlier actions filed by Biovail and its shareholders.
Waters (Milford, MA) launched its Centers of Innovation Program, an initiative designed to support scientific innovation in the fields of health and life-science research, sports science, food safety, clinical research, and environmental protection. Through the program, Waters is partnering with research scientists using ultraperformance liquid chromatography and mass spectrometry in their studies.
The European Medicines Agency is seeking a new executive director. Interested candidates have until Nov. 24, 2010, to submit their applications to the European Commission. Thomas Lönngren, the current executive director, will leave the agency on Dec. 31, 2010, following the expiration of his second five-year mandate. EMA appointed Andreas Pott, the current head of administration, to serve as acting executive director from Jan. 1, 2011, until a permanent successor is named.
BioStorage Technologies (Indianapolis), a provider of sample management, cold-chain logistics, and biomaterial storage, appointed Gregory Swanberg as its CEO. F. John Mills will vacate his current position as CEO but will continue as chair of the board.
Codexis (Redwood City, CA) appointed William Rothwell to the new position of vice-president and general manager of biobased chemicals. Rothwell will report to Alan Shaw, the company’s president and CEO.
Cyanotech (Kailua Kona, HI), a developer of microalgae technology, named Brent Bailey as a member of the board of directors, effective immediately, and as president and CEO, effective Jan. 11, 2011. He will replace David I. Rosenthal, who has served as interim president and CEO since Feb. 27, 2010. Rosenthal will remain as a director.
IBA Molecular North America (Dulles, VA), a provider of radiopharmaceutical products, appointed Michael Hickey president of IBA’s molecular tracers North America division. He will be based in Dulles, Virginia, and will report to Renaud Dehareng, president of IBA molecular tracers worldwide. Hickey previously spent 24 years with AstraZeneca Pharmaceuticals (Wilmington, DE) in a wide range of roles spanning marketing, sales, and general management.
Metamark Genetics (Cambridge, MA), an oncology molecular diagnostics company, appointed Mark R. Straley as the company's president, CEO, and as a member of its board of directors. Kenneth E. Weg, a Metamark cofounder who previously served as interim CEO, will continue as chair of the board.
OctoPlus (Leiden, The Netherlands), a drug-delivery company, appointed Jan Hendrik Egberts as its CEO. He will replace OctoPlus's current CEO, Simon Sturge, who will leave the company on Jan. 1, 2011.