Sept. 28, 2006 Notes: Bentley Receives Patent, Saltigo Invests in Production Complex, More

September 28, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Bentley, Cardinal, Saltigo, Sanofi pasteur

Company Notes

Exeter, NH (Sept. 26)-Bentley Pharmaceuticals (www.bentleypharm.com) announced that the US Patent and Trademark Office issued a patent entitled “Pharmaceutical Compositions and Methods for Insulin Treatment” that covers Bentley's intranasal insulin delivery system and uses where the insulin formulation is administered in the form of a solution or spray. The patent is the first of Bentley's filings to be issued. The patent provides protection for 20 years from the date of filing.

Dublin, OH (Sept. 21)-Cardinal Health (www.cardinal.com) entered a feasibility agreement with Wyeth (Madison, NJ, www.wyeth.com) to develop cell lines using its “Gene Product Expression” (GPEx) cell line engineering technology. The cell lines will be engineered to express two biopharmaceutical molecules in experiments that will determine if the GPEx approach is a feasible augmentation to Wyeth's current production methods.

Foster City, CA (Sept. 22)-Gilead Sciences, Inc. (www.gilead.com) signed eight new nonexclusive license agreements with generic companies in India. The agreements grant Alkem Laboratories Ltd. (Mumbai, www.alkemlabs.com), Aurobindo Pharma Ltd. (Hyderabad, www.aurobindo.com), FDC Ltd. (Mumbai, www.fdcindia.com), J.B. Chemicals & Pharmaceuticals Ltd. (Mumbai, www.uniquepharma.com), Matrix Laboratories Ltd. (Secunderabad, www.matrixlabsindia.com), Medchem International, Ranbaxy Laboratories (Gurgaon, www.ranbaxy.com), and Shasun Chemicals & Drugs Ltd. (Tamil Nadu, www.shasun.com) the rights to produce and distribute generic versions of tenofovir disoproxil fumarate, sold under the brand name “Viread,” to 95 low-income countries around the world, including India. The companies are required to meet certain national and international regulatory standards and include a technology transfer to enable the expeditious production of large volumes of the drug.

Singapore (Sept. 27)-A team of scientists at the Institute of Bioengineering and Nanotechnology (www.ibn.a-star.edu.sg) has developed nanoparticles that can carry both small molecular anticancer drugs and nucleic acids for improved cancer therapy. The new technology relies on a special biodegradable carrier that can enclose drug molecules and allow therapeutic nucleic acids to bind onto it. It can efficiently introduce DNA into a cell to be incorporated into its genetic make-up. Studies have shown that the codelivery of an anitcancer drug and a highly potent anti-tumor messenger molecule using the carrier suppressed cancer growth more efficiently than delivering the drugs separately. The carrier might also be used to codeliver therapeutic nucleic acids to prevent cancer cells from developing resistance to multiple drugs. The study's findings were published online in Nature Materials on Sept. 24.

Huddersfield, Yorkshire, UK (Sept. 25)-NPIL Pharma (www.npilpharma.com) launched a new catalyst-based racemization technology, “Stirling's Catalytic Racemisation Alcohols and Amines” (SCRAM), for producing chiral amines and alcohols. When combined with a resolution technology, the SCRAM racemization catalyst converts inactive enantiomer material back into usable solution. Thus, the new technology could deliver improved process yields. SCRAM could be applied to early or late-phase clinical and launched product manufacturing, and it can be bolted on to existing resolution processes or used as an alternative to asymmetric synthesis.

Leverkusen, Germany (Sept. 26)-Saltigo GmbH (www.saltigo.com) is investing about EUR 10 million (about $12.7 million) in a CGMP production complex in Leverkusen. The investment will be used to convert and expand an existing plant complex into a modern, multifunctional plant structure for CGMP-compliant production, processing, and purification of APIs and intermediates. The complex will comprise four modular multipurpose units, one of which will be used exclusively for the production of intermediates. The units will be set up for the use of solvents and solids and the handling of corrosive APIs. Capacity will be more than 200 metric tons a year. The units could be available as early as mid-2007.

Swiftwater, PA and Lyons, France (Sept. 26)-Sanofi pasteur (www.sanofipasteur.com) initiated its first clinical study with a new generation of seasonal influenza vaccine produced using cell culture technology. The trial, conducted as part of a contract awarded by the US Department of Health and Human Services (HHS, Washington, DC, www.hhs.gov), represents one of the company's initiatives to diversify flu vaccine manufacturing technologies. If successful, it could provide an alternative to traditional egg-based flu vaccines.

Tikva and Karmiel, Israel (Sept. 26)-Teva Pharmaceutical Industries Ltd. (www.tevapharm.com) and Protalix Biotherapeutics Ltd. (www.protalix.com) are collaborating on the development of two proteins using Protalix's plant cell culture platform. According to an agreement signed by both companies, Teva and Protalix will collaborate on research and development of the proteins. Teva will be granted an exclusive license to commercialize the developed products in return for royalty and milestone payments to be made to Protalix upon the achievement of certain pre-defined goals. Protalix will retain certain exclusive manufacturing rights.

London, UK (Sept. 26)-Waters Corporation (www.waters.com) is expanding its research collaboration with Imperial College London (www.imperial.ac.uk) by donating three research instruments: the Waters "Acquity" ultra-performance liquid chromatography system and "Q-Tof Premier" and "GCT Premier" mass spectrometers. The equipment will be used in Imperial College's new NMR facility, which incorporates the Waters Laboratory of Molecular Spectroscopy.


People Notes

Morton Grove, IL (Sept. 25)-Brian Tambi resigned from his position as president and chief executive officer of Morton Grove Pharmaceuticals, Inc. (MGP, www.mgp-online.com) He joined the company nearly 10 years ago as CEO. Tambi will continue to serve as nonexecutive chairman of the board and will manage MGP's partnership initiatives with Indian companies. William Goldberg has been named interim CEO.

Kalamazoo, MI (Sept. 26)-Pfizer Centresource (PCS, www.pfizer.com) appointed Steven Grieve director and team leader of technical development and regulatory affairs. He will be responsible for the development of technical information, regulatory strategy, and continuous technical support of PCS products. Grieve joined Pfizer CentreSource's predecessor company The Upjohn Company in 1980 and has held a number of positions of increasing responsibility.

San Francisco, CA (Sept. 26)-William L. Schary, PhD, was appointed vice-president of regulatory affairs and quality assurance with Sunesis Pharmaceuticals (www.sunesis.com). He previously worked for Valeant Pharmaceuticals International as vice-president of regulatory affairs.

New York, NY (Sept. 22)-ZIOPHARM Oncology, Inc. (www.ziopharm.com) has appointed John Amedio, PhD, vice-president of manufacturing and process development. Amedio previously worked for EPIX Pharmaceuticals and Sandoz Pharmaceuticals. He is also an adjunct professor in the department of Pharmaceutical Sciences at the Massachusetts College of Pharmacy and Health Sciences Boston.

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