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Antigenics, Gilead, Inyx, KVD Pharma, MedImmune, Novartis, Solvias
Antigenics Inc. (NewYork, NY, www.antigenics.com)signed anexpanded license and supply agreements with GlaxoSmithKline Biologicals(GSK, Rixensart, Belgium, www.gsk-bio.com) for the use of its "QS-21Stimulon"adjuvant system. Under the terms of the agreement,GSK will purchase a percentage of its QS-21 supply requirements fromAntigenics through 2014 and Antigenics will transfer the manufacturingtechnologies to GSK.
AshtonPharmaceuticals Ltd., a wholly owned subsidiary of Inyx, Inc. (New York, NY, www.inyxinc.com),wasselected by a leading Indian specialty pharmaceutical company tomanufacture several generic drugs for the United Kingdom and otherEuropean countries. Ashton will provide process transferservices for the production of tablet products at commercial batchsizes and then will manufacture and package the generic products.
Indian drug manufacturer Aurobindo Pharma (Hyderabad, India, www.aurobindo.com)acquired an FDA-compliant facility in Dayton, New Jersey for $19million. The 20-acre facility will serve as the company's USheadquarters andwill comprise 100,000 ft2 of R&D,formulation manufacturing, and distribution facilities.
Specialtypharmaceutical company AuxiliumPharmaceuticals, Inc. (Malvern, PA, www.auxilium.com)signed an agreement with UK-based CobraBiologics Ltd. (UK) tomanufacture additional CGMP and biologics license application batchesfor AA4500, a drug candidate for the treatment of Peyronie's disease,hypogonadism, and overactive bladder. Auxilium anticipates thismanufacturing activity will be completed by the end of 2006.
GileadSciences, Inc. (Foster City, CA, www.gilead.com) agreed to exercise its option topurchase Corus Pharma(Seattle, WA, www.coruspharma.com)for $365 million. Gilead expects the deal to close in the third quarterof 2006, subject to regulatory approvals. Concurrently, Gilead and Novartis Vaccine and Diagnostics, Inc. (Basel,Switzerland, www.novartis.com)have entered into an agreement whereby Novartis has agreed, for anundisclosed payment, to dismiss its ongoing litigation with Corus.
Generic drug developer and manufacturer KVD Pharma (Branchburb, NJ, www.kvdpharma.com)entered into a product development agreement with Alembic Limited (Baroda, India).Under the terms of the agreement, Alembic Limited and KVD Pharma willdevelop nine products that represent more than $1.4billion in US market sales. Products will be manufactured andsold under the KVD Pharma label.
MedImmune, Inc.(Gaithersburg, MD, www.medimmune.com)received a complete response letter for a supplemental biologicslicense application (sBLA) related to a new formulation of its "FluMist"live-virus, intranasal influenza vaccine. With the sBLA, MedImmune isseeking approval to use a refrigerator-stable, cold-adapted, trivalentinfluenza vaccine. FDA has requested clarification and additionalinformation about previously submitted data. MedImmune plans to submita separate sBLA to FDA within the next few weeks requesting an expandedlabel for FluMist.
Solvias(Basel, Switzerland, www.solvias.com)licensed the rights to manufacture, market, and distribute the"MeOBIPHEP" catalyst technology from Roche(Basel, Switzerland, www.roche.com).The licensing includes all of the relevant catalysis applications andcompound matter intellectual property as well as manufacturingprocesses for commercial-scale quantities. The MeOBIPHEP technologysupports thedevelopment and manufacture of single-enantiomer drug substances andchemical intermediates.
Sigma-Genosys (St. Louis, MO, www.sigma-genosys.com)installed new mass-based purification systems in support of itsportfolio of technologies to support its rapidly growing custom peptidebusiness. The use of this technology in the Sigma-Genosys manufacturingprocess will increased throughput, according to the company. Inaddition, the company expanded its analytical capabilities with theintroduction of mass spectroscopy?mass spectroscopy detection.
Aileen Ryanhas joined Vion Pharmaceuticals, Inc.(New Haven, CT, www.vionpharm.com)as vice-president of regulatory affairs. She will be in charge ofglobal regulatory strategies for the company's anticancer products anddirect the group responsible forn the interaction between Vion and FDAandother regulatory agencies worldwide.