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Also, AstraZeneca announces changes to its supply chain operations; Christian Velmer appointed head of Wyeth Canada; More...
Albany, NY (Nov. 19)-Albany Molecular Research, Inc. (AMRI) and its wholly owned subsidiary, AMR Technology, Inc., announced that a settlement regarding US patent infringement litigation involving “Allegra” (fexofenadine HCl) and “Allegra D-12” (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) has been reached among several companies, including Aventis Pharmaceuticals, Inc., sanofi-aventis US LLC (SA), Teva Pharmaceuticals, USA, Inc., and Barr Laboratories, Inc. The settlement agreement and related licensing arrangements are subject to review by the Federal Trade Commission and US state attorneys general. As part of the settlement, AMRI will amend its licensing agreement with SA to allow SA to sublicense patents related to Allegra and Allegra D-12 to Teva and Barr in the United States. AMRI will receive an upfront sublicense fee from SA of $10 million. SA will also provide royalties to AMRI on the sale of products containing fexofenadine HCl and products containing fexofenadine HCl and pseudoephedrine HCl by Teva and Barr through 2015, along with additional considerations. AMRI will continue to receive royalties from SA for the sale of products containing Allegra, Allegra D-12, and authorized generics for the remaining term of the patents. Royalties for the sale of products containing Allegra outside of the US were not part of this litigation.
Atlanta (Nov. 16)-The American Association of Pharmaceutical Scientists (AAPS) recognized researchers in the pharmaceutical sciences at the AAPS Annual Meeting and Exposition in Atlanta last month. Hayat Onyuksel, PhD, professor of pharmaceutics and bioengineering and associate head of the Department of Biopharmaceutical Sciences in the College of Pharmacy at the University of Illinois at Chicago, received the AAPS Lipid-based Drug Delivery Outstanding Research Award. Onyuksel has been working on lipid-based drug delivery systems for almost two decades. She is using phospholipid self-assemblies, liposomes and micelles as nanocarriers for hydrophobic small molecules and peptide/proteins to improve solubility and stability of the drugs. Udaya Toti, PhD, was awarded the AAPS Postdoctoral Fellow Award. Other award winners may be found here.
London (Nov. 20)-AstraZeneca announced proposed changes to its global manufacturing and supply chain operations as part of its plans to improve efficiency. The company introduced new manufacturing processes, and it will also establish a regional packing strategy to improve its ability to respond to customer requirements. AstraZeneca will exit three sites: Porriño in Spain, Destelbergen in Belgium, and Umeå in Sweden. The company also announced that roles will be affected at its facilities in Macclesfield, UK, and Södertälje, Sweden. These moves will result in a net reduction across the business of 1400 positions by 2013, subject to local consultation. AstraZeneca is further investing in its Wuxi plant in China. Part of this investment will provide additional packing and formulation capabilities.
Riverside, PA (Nov. 12)-Cherokee Pharmaceuticals, a subsidiary of PRWT Services, broke ground at its Riverside, Pennsylvania, plant to commence a $2-million expansion project. Expansion plans consist of a three-story building addition that will house new process equipment to be used for the manufacture of active pharmaceutical ingredients. The company plans to add 20 jobs when the expansion is completed, which is expected by the end of 2009.
Redwood City, CA (Nov. 17)-Codexis and Dyadic International (Jupiter, FL) announced a license agreement covering use of Dyadic’s C1 expression system for large-scale production of enzymes in certain fields including biofuels and chemical and pharmaceutical intermediate production. The agreement includes an upfront payment by Codexis of $10 million provided that certain performance criteria are satisfied. Additional financial terms were not disclosed.
Indianapolis (Nov. 24)-Eli Lilly has completed its acquisition of ImClone Systems. ImClone is now a wholly owned subsidiary of Lilly. ImClone's chief executive officer, John Johnson, will retain his current position and will report directly to John Lechleiter, Lilly’s president and chief executive officer.
Essen, Germany (Nov. 28)-Evonik Industries AG sold its Seal Sands, UK, site and related business to the management team at Evonik Degussa Seal Sands, Middlesbrough, UK. Financial terms were not disclosed. The management buyout team established the new company Fine Organics Limited, led by Keith Hanson, the current general manager. The total transfer of the site incorporates all assets, the employees and ongoing operations based at the Seal Sands site. Fine Organics will continue to manufacture products on behalf of Evonik Degussa GmbH on a custom manufacturing basis.
London (Nov. 21)-GlaxoSmithKline signed an exclusive cooperation agreement with Shenzhen Neptunus Interlong Bio-Technique (Shenzhen, Guangdong, China) as a preliminary step in forming a joint venture (JV) between the two companies. The JV company will seek to codevelop seasonal influenza vaccines and prepandemic/pandemic influenza vaccines, by first targeting against strains of the virus specific to China, Hong Kong, and Macau.
Geneva, Switzerland (Nov. 12)-Merck Serono, a division of Merck KGaA (Darmstadt, Germany), expanded the Merck Serono Biotech Center (MSBC), its production site in Corsiersur-Vevey, Switzerland. The expansion will enable the production of greater quantities of “Erbitux” (cetuximab), the monoclonal antibody for the treatment of colorectal and head and neck cancers.
London (Nov. 14)-Pfizer launched a new research unit known as Pfizer Regenerative Medicine. Scientists at Pfizer Regenerative Medicine will explore the use of stem cells to develop future treatments that may prevent disability, repair failing organs, and treat degenerative diseases. The ultimate goal will be to deliver new medicinal products that can pave the way for the use of cells as therapeutics.
Haninge, Sweden (Nov. 17)-Recipharm, a contract development and manufacturing organization, announced that AstraZeneca has divested its AstraZeneca Biotech Laboratory (ABL) in Södertälje, Sweden, to the company. Recipharm will lease the ABL from AstraZeneca for an initial period of 12 years; all associated equipment and the majority of the existing ABL staff were transferred to Recipharm.
Heerlen, The Netherlands (Nov. 19)-Royal DSM N.V., a life sciences and materials sciences company, will divest DSM Deretil in a management buyout. DSM Deretil is a business unit of DSM Anti-Infectives. Financial details were not disclosed.
Washington, DC (Nov. 14)-The United States Department of Justice is seeking a permanent injunction to bar Actavis Totowa LLC (Morristown, NJ), and Actavis Inc. (Hafnarfjordur, Iceland) from the manufacturing and distribution of generic drug products until they demonstrate compliance with the good manufacturing practice (GMP) requirements of the federal Food, Drug and Cosmetic Act. The complaint stems from findings of five FDA inspections of Actavis Totowa's facilities over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of GMP requirements. FDA also found that the company continued to manufacture and distribute unapproved new drug products. In a press release, Actavis said it "remains confident that the actions it has taken to remedy the compliance and manufacturing issues at Actavis Totowa will exceed FDA's expectations and will more accurately represent Actavis standards for good manufacturing practices than what FDA previously observed."
Buffalo, NY (Dec. 1)-Cleveland BioLabs, a drug discovery and development company, appointed Michelle Ross senior vice-president of public health and government services, with responsibility for commercialization of military and public health medical emergencies applications. Ross joins Cleveland BioLabs while remaining a senior partner for biodefense and public health programs with Martin, Blanck & Associates, a federal health services consulting firm.
Lexington, MA (Dec. 2)-Cubist Pharmaceuticals, a biopharmaceutical company, appointed Santosh J. Vetticaden senior vice-president of clinical development and chief medical officer. Vetticaden will be a member of Cubist’s executive team and will report to Mike Bonney, Cubist’s president and CEO.
Fort Worth, TX (Nov. 25)-Healthpoint, a DFB Pharmaceuticals company, appointed Travis E. Baugh president and chief operating officer. Healthpoint focuses on the research, development, and marketing of branded pharmaceuticals, over the counter drugs, and medical devices for tissue management and surgical indications.
Stockholm, Sweden (Dec. 1)-The board of directors of Meda, a specialty pharmaceutical company, reached agreement with CEO Anders Lönner in which his employment will be extended until mid-2012.
San Diego, CA (Nov. 25)-Alan J. Lewis, currently president and chief executive officer of Novocell, a cell and drug therapy company focused on diabetes, was named president and CEO of The Juvenile Diabetes Research Foundation (New York). Lewis will leave Novocell effective Jan. 1, 2009.
Markham, Ontario, Canada (Nov. 26)-Wyeth Pharmaceuticals appointed Christian Velmer to the position of president and managing director of Wyeth Canada, effective November 17, 2008. Velmer replaced Arnout Ploos Van Amstel, who took a position as senior vice-president and general manager of the institutional business unit for Wyeth.