Alnylam Pharmaceuticals (Cambridge, MA), an RNAi therapeutics company, presented new clinical data from its ALN-VSP Phase I liver cancer trial in a presentation at the Dana-Farber Cancer Institute in Boston and provided human proof of concept for its efforts in advancing RNAi therapeutics. Results from molecular analysis of human biopsy samples showed achievement of pharmacologically relevant siRNA drug levels in tissues. In addition, using a highly precise polymerase chain reaction (PCR)-based technique known as 5'- rapid amplification of cDNA ends (5'-RACE), analysis of human tissue samples showed proof of RNAi-mediated target mRNA cleavage, and thus RNAi in man with the systemically delivered RNAi therapeutic. These results provide significant human proof of concept for Alnylam's efforts in advancing RNAi therapeutics to patients. "These data provide conclusive evidence that RNAi can be harnessed in man and, as such, represent a notable and important milestone in the advancement of RNAi therapeutics as a potential new class of medicines," said Phillip Sharp, PhD, institute professor at The Koch Institute for Integrative Cancer Research at MIT, chairman of Alnylam’s scientific advisory board, and Alnylam director, in a press release.
AstraZeneca (London) announced that FDA extended the time to complete its review of the new drug application for the investigational anticancer drug vandetanib. As part of the review process, FDA required that AstraZeneca submit a Risk Evaluation and Mitigation Strategy (REMS). A proposed REMS was submitted by AstraZeneca and the FDA accordingly extended the Prescription Drug User Fee Act (PDUFA) date from Jan. 7, 2011 to Apr. 7, 2011.
Aurobindo Pharma (Hyderabad, India) agreed to divest its subsidiary company, Aurobindo (Datong) Bio Pharma, China, to China National Pharmaceutical Group (Sinopharm, Shanghai), subject to regulatory approvals. Sinopharm will acquire the shares through its subsidiary company, Sinopharm Weiqida Pharmaceutical.
Eli Lilly and Company (Indianapolis) and Boehringer Ingelheim (BI, Ingelheim, Germany) agreed to develop and commercialize a portfolio of diabetes compounds currently in mid- and late-stage development. Included are BI’s two oral diabetes agents—linagliptin and BI10773—as well as Lilly's two basal insulin analogues—LY2605541 and LY2963016—as well as the option to co-develop and co-commercialize Lilly's anti-TGF-beta monoclonal antibody. BI will receive an up-front payment of EUR 300 million ($390 million) and is eligible to receive up to EUR 625 million ($812 million) in milestone payments for linagliptin and BI10773. Lilly is eligible to receive up to $650 million in milestone payments on its two basal analogue insulins. Should Boehringer Ingelheim elect to opt-in to the Phase III development and potential commercialization of the anti-TGF-beta monoclonal antibody, Lilly would be eligible for up to $525 million in milestone payments. The companies will share ongoing development and commercialization costs equally. Each company will also be entitled to potential performance payments on sales of the molecules they contribute to the collaboration.
Epizyme (Cambridge, MA) formed an alliance with GlaxoSmithKline (GSK, London) to discover, develop, and market small-molecule therapeutics targeting histone methyltransferases (HMTs), a class of epigenetic enzymes, for the treatment of cancer and other diseases. Epizyme is eligible to receive an up-front payment of $20 million, research funding, more than $630 million in total milestone payments if medicines are commercialized for all targets in the collaboration, and up to double-digit royalties on product sales.
Contract research organization PPD (Wilmington, NC) established a joint venture with Taijitu Biologics Limited (TBL) for the discovery of biotherapeutics. The joint venture, named BioDuro Biologics, will develop and commercialize an innovative technology platform for the discovery of first- and best-in-class monoclonal antibody therapies in collaboration with MAB Discovery (Munich, Germany). Singapore-based BioDuro Biologics will provide drug-discovery services based on this technology platform to global biopharmaceutical companies.
A US District Court in Delaware granted an injunction preventing Teva Pharmaceuticals USA (North Wales, PA) and Barr Laboratories (Pomona, NY) from commercializing generic versions of Amgen's (Thousand Oaks, CA) Sensipar (cinacalcet) until expiration of the drug's US patents in 2018. Sensipar is approved for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma.
Biopharmaceutical company UCB (Brussels) will build in-house biotech microbial manufacturing capacity in Bulle, Switzerland, to secure demand for its core product, Cimzia (certoluzimab pegol). The new manufacturing unit should be operational in 2015 and requires an investment of EUR 250 million.
4-Antibody (Basel), a biotechnology company focused on therapeutic antibody technology and antibody drug development, appointed Robert F. Burns as its CEO. Burns previously served as CEO at Affitech (Copenhagen) and Celldex Therapeutics (Needham, MA).
Biopharmaceutical company Affymax (Palo Alto, CA) appointed John Orwin, the company’s president, to succeed Arlene Morris as CEO and member of the board of directors, effective Feb. 1, 2011. Morris will remain a consultant until September 2011.
Alfa Laval Inc. (Richmond, VA), a technology provider focused on heat transfer, separation, and fluid handling, and the US branch of the equipment manufacturer Alfa Laval (Lund, Sweden), appointed John Atanasio president and CEO. He joined the company in 1982 as part of the company’s Food and Dairy Group. Atanasio will be based in the company’s Richmond, Virginia, facility.
Service provider Cambrex (East Rutherford, NJ) named Shawn Cavanagh its executive vice-president and COO, effective Jan. 17, 2011. Cavanagh will report to Steve Klosk, president and CEO.
Catalent Pharma Solutions (Somerset, NJ) made the following appointments: Jochen Rohe was named country general manager for softgel manufacturing for Catalent Japan; David Bricker was named general manager of sterile technologies at Catalent’s Woodstock, Illinois, facility; and Sergio Alter was named general manager of softgel manufacturing in the company’s Buenos Aires location.
DSM Pharmaceutical Products (Parsippany, NJ), the pharmaceutical ingredients and contract manufacturing organization of Royal DSM, appointed Alexander R. Wessels president and CEO. He will report to Stephan Tanda, member of the DSM managing board. Wessels was previously president and CEO of DSM Food Specialties.
SOHM (Buena Park, CA), a generic-drug manufacturer, promoted Shailesh Shah, former vice-president of corporate strategy, to the position of president and CEO of SOHM's US, India, and global operations. Shah's promotion will be effective Jan. 15, 2011.
West Pharmaceutical Services (Lionville, PA), a manufacturer of components and systems for injectable drug delivery, appointed Jeffrey C. Hunt president of the company's Pharmaceutical Packaging Systems business. Hunt will replace Steven A. Ellers, the company's president and CEO, who is planning to retire. Warwick Bedwell was appointed president of the Pharmaceutical Packaging Systems unit’s Asia-Pacific region, succeeding Ronald Van Dijk, who has concluded his assignment in Asia. Bedwell will report to Hunt.