Company Notes

Alnylam Pharmaceuticals, a company specializing in RNA interference (RNAi) drug development, has announced plans to implement a corporate restructuring, including an approximate 33% reduction in its workforce, in order to align resources with its clinical-development program. The company is focusing on its Alnylam 5x15 RNAi therapeutic product strategy, which is a company strategy launched in January 2011 to develop and commercialize novel RNAi therapeutics. Two lead programs are ALN-TTR, to treat transthyretin-mediated amyloidosis, and ALN-APC to treat hemophilia. Read More

FDA has issued a complete response letter to AstraZeneca and Bristol-Myers Squibb regarding the companies’ new drug application for the investigational compound dapagliflozin for treating Type II diabetes in adults. The complete response letter requests additional clinical data to allow a better assessment of the risk–benefit profile for dapagliflozin. This includes clinical-trial data from ongoing studies and may require information from new clinical trials. Read More

The International Society of Pharmaceutical Engineers (ISPE) and Interphex have recognized the 2012 recipients of the Facility of the Year Awards, an annual recognition of innovation and accomplishments in facility design, construction and operation. Awards were given in the following categories:

• Equipment Innovation: Rentschler Biotechnologie for its REX III manufacturing facility in Laupheim, Germany
• Sustainability: Chiesi Farmaceutici for its R&D center in Parma, Italy
• Project Execution: Eisai Pharmatechnology & Manufacturing for its integrated R&D and manufacturing complex in Visakhapatnam, India
• Facility Integration: Merck & Co. for its vaccine bulk manufacturing facility in Durham, North Carolina
• Operational Excellence: Roche Diagnostics for its expansion of its therapeutic proteins project
• Special Recognition for Novel Collaboration: National Institute for Bioprocessing Research and Training (NIBRT) for its medium-scale bioprocessing plant in Dublin, Ireland.

For additional details of the project work, Read More

Merck & Co. has agreed to resolve all claims related to its nonsteroidal anti-inflammitory drug Vioxx (rofecoxib) in Canada. The agreement was signed by Merck and plaintiffs’ representatives and is pending approval by courts in Canada’s provinces. If the agreement is approved and specified conditions are met, Merck will pay a total amount of at least C$21.8 million ($21.7 million) but not more than C$36.9 million ($36.7 million). This would resolve all Vioxx certified class actions, putative class actions, other litigation and claims related to Vioxx in Canada. The amount to be funded for Vioxx users in Canada will be between C$11.3 million ($11.2 million) and C$26.4 million ($26.2 million) and will be determined by the final number of eligible claimants. Read More

In other news:

Abbott’s Starlims laboratory information-management system technology will be installed in FDA testing laboratories.

Almac has successfully completed MHRA inspections at its facilities in Craigavon, Northern Ireland, and Elvingston, Scotland.

Congresswoman Mary Bono Mack (R-CA) has written a letter criticizing FDA for lack of oversight of Novartis’s Novartis’s consumer-healthcare manufacturing facility in Lincoln, Nebraska.

Novo Nordisk has established a Type I diabetes R&D center in Seattle, Washington.

Patheon adds soft-gel capsule capabilities through new partnership with Procaps.

Pharmaceutics International has begun construction of a new aseptic fill–finish manufacturing facility.

Roche has agreed to acquire Illumina, a provider of DNA sequencing systems, for $5.7 billion, as part of its genetic testing, diagnostics, and drug-development efforts.

Sartorius Stedim Biotech and Refine Technology have announced an agreement to develop a high-density cell-cultivation platform.

Sartorius Stedim Biotech and G-Con partner to provide advanced and flexible biopharmaceutical production platforms.

People Notes

Oliver Mueller has been appointed as president of Suzhou Pharma Services, effective Jan. 3, 2012. Suzhou Pharma Services, an affiliate of Amerigen Pharmaceuticals, is a CDMO focused on oral solid-dose forms.

In other news:

Bristol-Myers Squibb has named Gerald L. Storch to its board of directors.

Coldstream Laboratories has appointed Sholto Maclean as its manager of technology transfer.

Lonza CEO Stefan Borgas steps down; Rolf Soiron, current chairman of the board of Lonza, becomes interim head.

Patheon appoints Antonella Mancuso as president of global commercial operations and chief manufacturing officer.