Company and People Notes: Avid Bioservices Signs Manufacturing Supply Pact with Catalyst Biosciences; Pfizer Named Mace L. Rothenberg Senior VP of Development for its Oncology Unit, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Maxygen looks to costs, jobs; Receptor BioLogix appoints Dale R. Pfost CEO; more...

Company Notes

San Diego, CA (Oct. 21)-Amylin Pharmaceuticals, a biopharmaceutical company, and Eli Lilly (Indianapolis) entered into a product-supply agreement for exenatide once weekly, a development compound that, if approved, would become the first once-weekly therapy to treat type 2 diabetes. Under terms of the agreement, Lilly will make an upfront cash payment of $125 million to Amylin, and Amylin will supply product for sales in the US and to Lilly for sales outside of the US. In addition, Lilly will reimburse Amylin for its share of the more than $500 million capital investment in the West Chester, Ohio, facility through the cost of goods sold for exenatide once weekly. As part of the overall supply arrangement, Lilly will provide Amylin with a $165 million line of credit that Amylin can draw upon beginning in the fourth quarter of 2009 through the second quarter of 2011.

Tustin, CA (Oct. 27)-Avid Bioservices, a manufacturing services provider, signed a manufacturing supply agreement with Catalyst Biosciences (South San Francisco, CA), a biotechnology company. Avid will produce clinical-grade material in support of Catalyst’s clinical candidate, CB 813, an improved version of factor VIIa for the treatment of acute bleeding in hemophilia patients. Under the terms of the agreement, Avid will begin CGMP manufacturing to provide cell bank preparation, process development, and preparation of the manufacturing portion of the FDA investigational new drug application. Further terms of the agreement were not disclosed.

Phoenixville, PA (Oct. 24)-Bilcare Global Clinical Supplies, a provider of clinical trial supplies and services, expanded its global distribution and warehousing capabilities for clinical trial supplies by signing a service agreement with World Courier (Stamford, CT), a specialty courier company, to use depots in Argentina, Brazil, Colombia, Chile, Mexico, Peru, and Russia. The new locations supplement Bilcare’s existing network with locations in India, the UK, Singapore, and the US. Bilcare is planning additional global depot locations are planned for the near future.

Taian City, Shandong, China (Oct. 16)-China Biologic Products, a plasma-based pharmaceutical company, announced that its subsidiary, Shandong Taibang Biological Products, entered into an agreement to acquire 35% of the equity interest in Xi'an Huitian Blood Products (Xi'an, Shaanxi Province), a biopharmaceutical company, for RMB 44,000,000 (approximately $6.44 million). The companies expect the transaction to be completed within two months.

Mansfield, MA (Oct. 17)-Covidien will commence a $100-million, five-year plant expansion of its St. Louis facilities, according to a report in the St. Louis Business Journal. The company expects the expansion to add 30 new research jobs and enhance its pharmaceutical development capabilities.

Indianapolis (Oct. 27)-Eli Lilly introduced a color differentiation system for U-100 insulin products marketed in the US, including vials, pens and individual packaging for “Humalog” (insulin lispro injection [rDNA origin]) and “Humulin” (regular insulin human injection, USP [rDNA origin)]). Lilly’s color differentiation system, also used for Humalog and Humulin formulations marketed in Europe, is designed to help patients, health care providers and pharmacists accurately identify the insulin that has been prescribed. Click here for more details about the color system.

London (Oct. 23)-GlaxoSmithKline Biologicals (GSK) and AFFiRiS (Vienna, Austria), a biotechnology company, signed a collaboration agreement granting GSK exclusive rights to AFFiRiS’s Alzheimer’s disease vaccine programs, which are aimed at treating Alzheimer’s by targeting beta-amyloid. As part of the agreement, GSK gains exclusive rights to develop and commercialize two Alzheimer’s disease vaccine candidates that are based on "AFFiRiS AFFiTOPE" technology and are currently in Phase I clinical development, and other Alzheimer’s disease vaccine candidates that are in preclinical development. Under the terms of the agreement, AFFiRiS will receive an up-front payment of €22.5 million ($29 million) and could be eligible for milestone payments and royalties. The total potential value of the agreement could reach €430 million ($550 million). This agreement is subject to customary regulatory approval.

Redwood City, CA (Oct. 22)-Maxygen, a biotechnology company focused on the development of optimized protein drugs, announced plans to reduce spending, cut its workforce and explore strategic options such as a sale of one or more corporate assets, a strategic business combination, or other transactions. The company plans to reduce its spending on MAXY-G34 by delaying Phase III manufacturing until it identifies a partner who can share manufacturing costs. MAXY-G34 is the company’s next-generation long-acting G-CSF for the treatment of chemotherapy-induced neutropenia. Maxygen also plans to reduce headcount by terminating approximately 30% of its workforce, with staggered terminations from January 1 through the end of April 2009. The company has retained the investment bank Lazard to assist in exploring strategic options.

Basel (Oct. 20)-Novartis announced in its third quarter report issued last week it has a new commercial model for its US general medicines business. The "Customer Centric Initiative" will implement a new regional US business model consisting of five new regional units that have cross-functional responsibility for the full primary care product portfolio, replacing the nationally managed sales forces. About 550 full-time equivalent positions in the US sales force are planned to be reduced, with more than half of the cuts planned from not filling already vacant positions. The new organization will start on January 1, 2009. Novartis plans to take a one-time charge of approximately $20 million in the 2008 fourth quarter, with annual cost savings of $80 million anticipated from 2010.


Bagsværd, Denmark (Oct. 23)-Novo Nordisk, Cellartis (Göteborg,
Sweden), a stem cell biotechnology company, and the Lund University Stem Cell Center (Lund, Sweden) signed a collaborative research agreement to develop insulin-producing cells from human stem cells. The collaboration aims to develop a cell therapy for the treatment of insulin-dependent diabetes and, in the longer term, a cure for diabetes, according to a press release.

Toronto (Oct. 23)-Patheon, a provider of drug development and manufacturing services, opened a new pharmaceutical development services (PDS) suite at its Whitby Development Centre (Whitby, Ontario, Canada). The 2500-ft2 suite is GMP-compliant and is designed to manufacture products for Phase I–II clinical studies. The new facility will also add early-phase pharmaceutical development and manufacturing capacity, with a manufacturing scale of 1 kg to 10 kg.

People Notes

Longmont, CO (Oct. 23)-Chemizon, the drug-discovery division of Optomagic (Ansan, Gyeonggi, South Korea), announced today the addition of three new members to its senior management team. Xin Bu was named director of biology and Haihong Ni has been named director of computational chemistry. Both Bu and Ni will be based in Chemizon’s Beijing research and development facility. In addition, Albert Gyorkos was named director of strategic planning and will be based in the company’s Longmont, Colorado, office.

Cambridge, MA (Oct. 24)-Hydra Biosciences, a privately held biopharmaceutical company, appointed David Kimball, PhD, chief scientific officer. Kimball most recently served as senior vice-president of discovery at Pharmacopeia (Cranbury, NJ). Hydra also appointed Christine Bellon, PhD, vice-president of intellectual property and legal affairs. Bellon joins Hydra from Infinity Pharmaceuticals (Cambridge, MA), where she served as assistant general counsel, intellectual property.

Paris (Oct. 24)-Novexel, a specialty pharmaceutical company, appoint Kenneth Coleman as its chief scientific officer. Coleman joined Novexel on October 1, 2008.

Waltham, MA (Oct. 23)-The board of directors of OXiGENE, a clinical-stage biopharmaceutical company, appointed John A. Kollins, the company's current chief operating officer, to the positions of chief executive officer and director. The board accepted the resignation of Richard Chin as president and chief executive officer and as a member of the Board of Directors, effective October 22, 2008.

New York (Oct. 22)-Pfizer named Mace L. Rothenberg senior vice-president of clinical development and medical affairs for its Oncology Business Unit. Rothenberg joins Pfizer from Vanderbilt University in Nashville, Tennessee, where he was professor of medicine at the Vanderbilt University Medical Center and Ingram Professor of Cancer Research at the Vanderbilt-Ingram Cancer Center.

Palo Alto, CA (Oct. 28)-Receptor BioLogix, a biotechnology company, appointed Dale R. Pfost, PhD, chief executive officer. The company also announced that current investors committed an additional $6 million to the company in an equity and debt financing.