April 4, 2007 Notes: Vetter Facility Receives Award, AAI Completes Upgrades to Manufacturing Facility, Codexis Signs Technology Agreement with Merck, more

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Vetter, AAI, Merck, Eli Lilly, More

Company Notes

Ravensburg, Germany (Apr. 2)-Vetter Pharma-Fertigung GmbH & Co.'s (www.vetter-pharma.com) new facility received the Facility of the Year Award in the Process Innovation category. An international jury of experts praised the facility's use of automation and its "high standards of sterility, safety, and quality." The facility, which opened in October 2006, houses filling lines for liquid and lyophilized drugs.

Wilmington, NC (Apr. 3)-AAI Pharma, Inc. (www.aaipharma.com) completed upgrades to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina. The upgrades were done to increase capacity and ensure that both facilities comply with European Union aseptic processing and testing guidelines.

Fort Lee, NJ (Mar. 29)-Specialty pharmaecutical company Alpharma Inc. (www.alpharma.com) entered into a license agreement with drug-delivery research and development company Tris Pharma, Inc. (www.trispharma.com). The agreement gives Alpharma access to Tris's "LiquiXR" technology, which is a drug-delivery platform for the sustained release of products in liquid form. Alpharma plans to use LiquiXR to develop an oral liquid product that complements its existing "Kadian" pain-management solid-dose product line. The companies plan to collaborate to further improve the Kadian product line. Any products that result from the collaboration will be manufactured by Tris and commercialized by Alpharma.

Naarden, The Netherlands (Apr. 2)-BAC BV (www.bac.nl) will collaborate with GE Healthcare (Chalfont St. Giles, UK, www.gehealthcare.com) to develop and market affinity chromatography media to purify therapeutic recombinant FVIII for the treatment of bleeding in patients with Hemophilia A. BAC will provide its "CaptureSelect" affinity ligands, which will enable process-scale purification of FVIII.

Burnaby, BC, Canada (Mar. 20)-Chromos Molecular Systems Inc. (www.chromos.com) entered into an agreement with Pain Therapeutics, Inc. (South San Francisco, CA, www.paintrials.com) to develop a cell line using Chromos's ACE System. Chromos will engineer cell lines for the expression of a monoclonal antibody for Pain Therapeutics. Pain Therapeutics may use the cell lines for scale-up and manufacture of the antibody.

Redwood City, CA (Apr. 3)-Codexis, Inc. (www.codexis.com) signed a technology collaboration agreement with Merck & Co. (Whitehouse Station, NJ, www.merck.com) related to Codexis's "Codex Biocatayst Panels." Merck will become the first subscriber to the product, which enables pharmaceutical manufacturers to use the power of biocatalysts to increase research and development and manufacturing productivity. The three-year agreement gives Merck nonexclusive access to Codexis biocataysts for use in its pipeline.

Buena, NJ (Mar. 30)-Comar, Inc. (www.comar.com) completed the sale of its glass division to Gerresheimer's (Dusseldorf, Germany, www.gerresheimer.com) Kimble Glass, Inc. Kimble gains real estate, manufacturing equipment, plant operations, and management personnnel in the transaction, while Comar retains its glass pipette manufacturing capabilities. All manufacturing equipent and operating personnel associated with glass pipette manufacturing will be relocated to Comar's plastic operations in Buena.

Leiden, The Netherlands (Apr. 3)-Crucell N.V. (www.crucell.com) received a patent from the US Patent and Trademark Office (Washington, DC, www.uspto.gov) related to its PER.C6 cell-line technology. The patent covers the manufacture of influenza vaccines using PER.C6 and provides additional years of patent protection for the use of PER.C6 technology in the influenza field.


Research Triangle Park, NC (Feb. 7)-Diosynth Biotechnology (www.diosynthbiotechnology.com) extended its agreement with PDL BioPharma, Inc. (www.pdl.com) for the commercial manufacture of "Retavase." Retavase, which is used to manage acute myocardial infarctions, is currently manufactured by Diosynth.

Tokyo (Mar. 21)-Eisai Co., Ltd. (www.eisai.co.jp) will acquire Morphotek (Exton, PA, www.morphotek.com) for $325 million. Eisai hopes the acquisition will allow it to expand its capabilities into the biologic therapeutics field. The transaction is expected to close in Eisai's first fiscal quarter of 2007.

Indianapolis, IN (Apr. 3)-Eli Lilly and Company (www.lilly.com) completed its acquisition of Hypnion, Inc. (Lexington, MA, www.hypnion.com). The acquisition, valued at $315 million, gives Lilly sevaral new early-stage drug candidates as well as insomnia molecule HY10275, which is currently in Phase II of development.

Strasbourg, France (Mar. 20)-The Council of Europe inaugurated the new building for the European Directorate for the Quality of Medicines & HealthCare (EDQM, www.edqm.eu). EDQM controls the Technical Secretariat of the European Pharmacopoeia, which provides users with official standards for the manufacture and quality control of medicines. In addition, EDQM coordinates the network of Official Medicines Control Laboratories. The new building houses laboratories, offices, and meeting rooms.

Rockville, MD (Mar. 29)-The US Food and Drug Administration (FDA, www.fda.gov) announced that manufacturers of peroglide drug products for use in the treatment of Parkinson's disease will voluntarily remove the drugs from the market. FDA requested that the drugs be withdrawn after multiple studies found that pergolide could seriously damage patients' heart valves. The products being withdrawn are Valeant Pharmaceuticals's (Aliso Viejo, CA, www.valeant.com) "Permax" and two generic versions manufactured by Par (Woodcliff Lake, NJ, www.parpharm.com) and Teva (Tikva, Israel, www.tevapharm.com).

Chalfont St. Giles, UK (Mar. 27)-GE Healthcare (www.gehealthcare.com) introduced its custom radiolabeling service for the manufacture of carbon-14 labeled compounds. The new service is designed to help support the GMP requirements of pharmaceutical researchers in clinical trials and to allow for complete documented traceability and accountability of drug products. The service is provided from GE's newly commissioned facility in Cardiff, United Kingdom.

Princeton, NJ (Mar. 28)-Laureate Pharma (www.laureatepharma.com) opened its new pilot plant in Princeton, NJ. The plant is designed for process development and production and purification of early-phase preclinical proteins.

Gaithersburg, MD (Mar. 29)-MedImmune, Inc. (www.medimmune.com) licensed its reverse genetics intellectual property to Sanofi Pasteur (Lyon, France, www.sanofipasteur.com). Sanofi will use the property to develop and construct new vaccine strains for seasonal, pre-pandemic, and pandemic inflluenza.

San Diego, CA (Apr. 3)-Drug-delivery platform developer MediVas, LLC (www.medivas.com) achieved a milestone related to its agreement with Merck & Co., Inc. (Whitehouse Station, NJ, www.merck.com). The milestone is connected to one of the orally available biologics that are the focus of the collaboration.

Whitehouse Station, NJ (Mar. 28)-Merck & Co. (www.merck.com) and H. Lundbeck A/S (Copenhagen, Denmark, www.lundbeck.com) discontinued their joint development program for gaboxadol. Gaboxadol, an investigational new medicine for the treatment of insomnia, was in Phase III development.

Basel, Switzerland (Mar. 30)-Following a request from the US Food and Drug Administration (Rockville, MD, www.fda.gov), Novartis (www.novartis.com) suspended US marketing and sales of irritable bowel syndrome treatment "Zelnorm." The action comes after Novartis found a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking Zelnorm. The findings were reported to FDA, which then requested that Novartis discontinue marketing the drug.

Perth, Australia (Apr. 4)-pSivida Limited (www.psivida.com) signed a collaborative research and license agreement with Pfizer Inc. (New York, NY, www.pfizer.com) for pSivida's controlled drug-delivery technologies. pSivida will receive $155 million in development and sales-related milestones, and the two companies will work together on a joint research program to develop opthalmic products using pSivida's drug-delivery technology. In addition, Pfizer will invest $5 million in ordinary shares of pSivida.

Basel, Switzerland (Apr. 4)-Roche (www.roche.com) announced two acquisitions. The company acquired Therapeutic Human Polyclonals, Inc. (THP, Sunnyvale, CA) for $56.5 million. Roche plans to integrate THP into the Roche Pharma Center of Excellence for Protein Research in Penzberg, Germany. Roche also signed a difinitive merger agreement with BioVeris Corporation (Gaithersburg, MD, www.bioveris.com). Roche agreed to acquire 100% ownership of BioVeris for $21.50 per share in cash for a total of $600 million.

Waltham, MA (Mar. 20)-Thermo Fisher Scientific Inc. (www.thermofisher.com) formed a joint venture with the Gerresheimer Group (Dusseldorf, Germany, www.gerresheimer.com) to create a manufacturer of disposable and reusable glass labware for scientific laboratories. The new company, which will be called Kimble/Chase Life Scienceware, LLC, will be based in New Jersey. Thermo Fisher will own 49% of the company and contribute its Chase Scientific, Scherf, and Pfeiffer glassware lines. Gerrresheimer will own the remainder of the company and contribute certain Kimble, Kontes, and Bomex brand life science research products.

Madison, NJ (Apr. 3)-Wyeth (www.wyeth.com) purchased the final 20% stake in Wyeth K.K. (Tokyo, www.wyeth.jp) from Takeda Pharmaceuticals Company Limited (Osaka, Japan, www.takeda.com). Wyeth now owns 100% of Wyeth K.K.


People Notes

Cambridge, MA (Mar. 29)-Robert Steininger was appointed senior vice-president of manufacturing for Acceleron Pharma, Inc. (www.acceleronpharma.com). Steininger previously served as vice-president of process sciences at Millennium Pharmaceuticals.

London (Apr. 3)-Amarin Corporation plc (www.amarincorp.com) appointed Paul F. Duffy president of US commercial operations. Duffy previously held positions with Novartis Pharmaceuticals and Validus Pharmaceuticals.

Birmingham, AL (Apr. 2)-BioCryst Pharmaceuticals, Inc. (www.biocryst.com) named David S. McCullough vice-president, strategic planning and commercialization and Philip P. Breitfeld, MD, executive director, oncology development and associate chief medical officer. McCullough joins the company after serving as director, global corporate development at Merck KGaA. Breitfeld was medical director, oncology at EMD Pharmaceuticals, Inc.

Coral Gables, FL (Apr. 4)-Catalyst Pharmaceuticals Partners, Inc. (www.catalystpharma.com) appointed Steven R. Miller, PhD, vice-president of pharmaceutical development and project management. Miller will be responsible for the company's product development program, including all aspects of chemistry and manufacturing controls, quality systems, contract operations, and development planning. Miller previously was executive director of R&D operationsn with Watson Laboratories.

Parsippany, NJ (Apr. 3)-Joseph Marchese joined DSM Pharmaceuticals Inc. (www.dsm.com) as senior director, business manager, sterile injectables. Marchese served as vice-president of sales and marketing at West-Ward Pharmaceutical Corp.

Strasbourg, France (Mar. 27)-The European Pharmacopoeia Commission (www.edqm.eu) elected Hendrick Jan de Jong chair for the term running from June 2007 to June 2010. He succeeds Michael Morris, who was named chair in 2004. de Jong served as a professor of pharmaceutical analysis at Leiden University before joining French pharmaceutical company Servier in 1984. He is a member of the Dutch, French, and European Pharmacopoeia Commissions.

Paris (Apr. 3)-Ipsen (www.ipsen.com) named Eric Drape executive vice-president, manufacturing and supply organization. Drape succeeds Peter Wilson, who is retiring from teh company.

San Francisco, CA (Apr. 3)-Philip J. Young was appointed president and chief executive officer of Osteologix Inc. (www.osteologix.com). Young joins the company from Insmed, Inc., where he was chief business officer and executive vice-president.

San Diego, CA (Apr. 3)-Somaxon Pharmaceuticals, Inc. (www.somaxon.com) appointed James L'Italien, PhD, senior vice-president, regulatory affairs and quality assurance. L'Italien assumes the newly created position after serving as senior vice-president, regulatory affairs and complaince at Ligand Pharmaceuticals. He also held positions at Baxter BioScience, Amylin, Ortho Biotech, and SmithKline Beecham.

Mississauga, ON, Canada (Apr. 3)-YM BioSciences Inc. (www.ymbiosciences.com) named John Waterfall interim head of program management and Dianne Harris consulting project manager for the "AeroLEF" program. Waterfall previously served as divisional vice-president, global project management at Hoffman La-Roche Inc. Harris previously was general manager at Elan Medical Technologies.