Agreements and contracts - Pharmaceutical Technology

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Agreements and contracts

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 3, Issue 1

Washington, DC (Jan. 17)—The US Department of Health and Human Services (HHS, Washington, DC, www.hhs.gov) awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million doses of the vaccine or enough adjuvant for 150 million doses within six months of the onset of an influenza pandemic. GlaxoSmithKline (Philadelphia, Pennsylvania, www.gsk.com) and Novartis Vaccines and Diagnostics (Emeryville, CA, www.novartis.com) each were granted five-year contracts totaling $63.3 million and $54.8 million, respectively. Iomai Corporation (Gaithersburg, MD, www.iomai.com) will receive a 15-month grant of $14.4 million to complete Phase I clinical trials of its vaccine. Upon successful completion of these trials, the company will receive an additional $114 million.

Ramonville-Saint-Anne, France (Jan. 16)—French biotechnology company Affichem appointed SAFC Pharma (St. Louis, MO, www.sigmaaldrich.com/SAFC/Pharma.html) to provide chemical-development services relating to "Dendrogenine A," a potential cancer treatment.

Mumbai, India (Jan. 12)Nicholas Piramal India Limited (NPIL, www.nicholaspiramal.com) and Eli Lilly and Company (Indianapolis, IN, www.lilly.com) signed an agreement to develop and commercialize certain of Lilly's preclinical drug candidates that span multiple therapeutic areas. NPIL will design and execute the global clinical-development program, including IND-enabling nonclinical studies and human clinical trials to Phase III.

Redmond, WA (Jan. 10)Univar USA (www.univarusa.com) will be named the exclusive US distributor for SPI's (New Castle, DE, www.spipharma.com) "Mannogem," "Barcroft," "Advantose," "Effer Soda," and "Sorbitol Special" product lines for over-the-counter and prescription applications.

Buffalo Grove, IL (Jan. 9)Akorn, Inc. (www.akorn.com) signed an agreement with Azad Pharma (Toffen, Switzerland, www.azad.ch) to develop and supply latanoprost, bimatoprost, and travoprost abbreviated new drug application (ANDA) drug products for the treatment of glaucoma. The products will be manufactured by Taejoon Pharmaceutical Co. Ltd., (Seoul, South Korea). Both Taejoon and Azad will complete the regulatory dossiers and will manufacture and supply the products to Akorn upon ANDA approval.

Brisbane, CA (Jan. 9)InterMune, Inc. (www.intermune.com) completed large-scale synthesis and delivery to its partner Roche (Basel, Switzerland, www.roche.com) of an active pharmaceutical ingredient for drug candidate ITMN-191. As a result, InterMune received a $10-million milestone payment from Roche.

South San Francisco, CA (Jan. 8)Genentech (www.gene.com) entered into an exclusive worldwide license agreement with Seattle Genetics, Inc. (Bothell, WA, www.seattlegenetics.com) for the development and commercialization of the humanized monoclonal antibody SGN-40. Seattle Genetics will receive an upfront payment of $60 million as well as potential milestone payments exceeding $800 million and royalties on annual net sales of SGN-40. Genentech will fund future research, development, manufacturing, and commercialization costs.

Cambridge, MA (Jan. 8)Alkermes, Inc. (www.alkermes.com) signed a commercial manufacturing agreement with Eli Lilly and Company (Indianapolis, IN, www.lilly.com) for "AIR" inhaled insulin. Under the agreement, Alkermes will manufacture insulin powder for the system. The agreement also provides for an additional investment by Lilly for the construction and operation of a second manufacturing line at Alkermes's commercial-scale production facility.

Aurora, ON, Canada (Jan. 5)Helix BioPharma Corp (www.helixbiopharma.com) signed an agreement with BioVectra (Charlottetown, PEI, Canada, www.biovectra.com) to manufacture L-DOS47 bulk drug product for clinical testing in patients with adenocarcinoma of the lung.

Toronto (Jan. 5) IntelliPharmaCeutics Corp. (www.intellipharmaceutics.com) concluded an agreement with Par Pharmaceutical Companies, Inc. (Woodcliff Lake, NJ, www.parpharm.com) to develop a generic, controlled-release drug product for the US market.

Bridgewater, NJ (Jan. 4) Enzon Pharmaceuticals, Inc. (www.enzon.com) entered into an agreement with Ovation Pharmaceuticals, Inc. (Deerfield, IL, www.ovationpharma.com) to supply the active ingredient, L-asparaginase, which is used in the production of Enzon's "Oncaspar" treatment for acute lymphoblastic leukemia.

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