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Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...
Morristown, NJ (Apr. 25)-Actavis Totowa, a US manufacturing division of the international generic pharmaceutical company Actavis Group (Hafnarfjordur, Iceland), is initiating a Class 1 nationwide recall of "Digitek" (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals under a "Bertek" label and by UDL Laboratories under a "UDL" label. The voluntary all-lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.
Hayward, CA (Apr. 30)-Aradigm announced that review of the clinical data by Novo Nordisk, with whom Aradigm collaborated on inhaled insulin, revealed no occurrence of primary lung cancer in patients inhaling insulin using the “AERx” insulin diabetes management system (iDMS). AERx iDMS uses an aqueous formulation of insulin delivered by a hand-held electronic inhaler. Review of the clinical trial data for AERx iDMS revealed no cases of primary lung cancer either in the 2307 patients treated with AERx iDMS or in the 1218 patients treated with comparator treatments.
New York, (May 2)-Bristol-Myers Squibb signed a definitive agreement to sell its ConvaTec business unit to Nordic Capital Fund VII and Avista Capital Partners for $4.1 billion subject to adjustments based on ConvaTec’s audited 2007 financial statements and closing working capital. ConvaTec develops and markets wound therapeutics and ostomy care products. The closing is anticipated in the third quarter of 2008.
Hyderabad, India (May 1)-Dr. Reddy’s Laboratories completed two acquisitions: The Dow Chemical Company’s Dowpharma Small Molecules Business associated with its Mirfield and Cambridge, United Kingdom, sites, as well as BASF’s manufacturing facility in Shreveport, Louisiana, and related contract manufacturing business for finished pharmaceuticals. Further financial terms and conditions of the transaction are not being disclosed. The acquisition of Dowpharma Small Molecules includes customer contracts, associated products, process technology, intellectual property, and trademarks as well as the transfer of the Mirfield and Cambridge facilities. Employees directly related to the business located at the two facilities will become part of Dr Reddy’s. Dr. Reddy’s will also have a nonexclusive license to Dow’s “Pfenex Expression Technology” for biocatalysis development. The BASF acquisition includes relevant business, customer contracts, related abbreviated new drug applications and new drug applications, trademarks, as well as the Shreveport facility and related contract manufacturing activities. It also includes a tolling and supply agreement. Employees directly related to the business located at Shreveport site will become part of Dr Reddy’s.
Heerlen, The Netherlands (Apr. 28)-DSM, the life sciences and materials sciences company, agreed to acquire The Polymer Technology Group (PTG, Berkeley, CA). Through the acquisition of privately held PTG, DSM obtains a position in the field of biomedical polymers. The acquisition is subject to regulatory approvals and is expected to close in the second quarter of 2008. The acquisition price, which will not be disclosed as agreed between the parties, consists of a payment at closing and an earn-out.
Skokie, IL (May 5)-NanoInk, a technology company specializing in nanometer-scale manufacturing, created a new business unit called “NanoGuardian.” Anchored by NanoInk’s novel “NanoEncryption” technology, NanoGuardian will focus on delivering brand protection solutions for combating the global counterfeiting and product diversion problems in the life science industry and other highly counterfeited markets.
Shanbally, Ireland (May 2)-Pfizer will invest €190 million ($293 million) to establish a biologics facility at Shanbally, Ireland. The new plant will create approximately 100 jobs over three years, and up to 500 construction and service jobs during the peak of building activity. It will be located on a 30-acre site adjacent to Pfizer’s existing facility in Ringaskiddy, and will be completed and fully commissioned by the end of 2009. This facility will focus on process development and production of small-scale quantities of Pfizer Global Research & Development products entering Phase II–III clinical trials.
Swiftwater, PA and Lyon, France (Apr. 28)-Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, announced that the US Department of Health and Human Services (HHS) accepted H5N1 bulk vaccine antigen to produce approximately 38.5 million doses of vaccine to protect against a new strain of avian influenza. Sanofi Pasteur has a multiyear contract with HHS as part of its pandemic program and will receive a payment of $192.5 million, in the second quarter of 2008, for acceptance of the bulk vaccine lot. In 2007, Sanofi Pasteur received $126.9 million for its bulk pandemic vaccine.
South San Francisco, CA (May 5)-VaxGen, a biopharmaceutical company, completed the sale of all assets and rights related to its recombinant protective antigen (rPA) anthrax vaccine product candidate and related technology to Emergent BioSolutions. Under the terms of the transaction, Emergent BioSolutions paid VaxGen $2 million upon execution of the definitive agreement and could pay up to an additional $8 million in milestone payments, plus specified percentages of future net sales.
Corona, CA (Apr. 29)-Watson Pharmaceuticals, a specialty pharmaceutical company, announced that FDA has completed the inspection of the company's Florida manufacturing facilities and has removed the Official Action Indicated ("OAI") status at Watson's Davie, Florida, site. As a result of this action, and subject to satisfying other FDA approval criteria, Abbreviated New Drug Applications (ANDAs) for products at this site are now eligible for FDA approval. FDA completed the onsite portion of its inspection on April 10, 2008, at which time it issued a Form 483 List of Inspectional Observations. Watson responded to the Form 483 Inspectional Observations on April 17, 2008. Since 2005, the Davie, Florida, manufacturing facility has been under OAI status. During that time, Watson has continued to file ANDAs for product candidates to be manufactured at this site. However, FDA approval of pending ANDAs has been withheld pending positive resolution of the OAI status. Watson is working closely with FDA to obtain approval of pending ANDAs eligible for final approval.
Newcastle upon Tyne, UK (Apr. 21)-Aesica, a supplier of active pharmaceutical ingredients and formulated products, appointed Anthony Higham as operations director. He will be responsible for operations for the company’s three manufacturing sites in Northumberland, Enfield and Queenborough in the UK. The sites provide primary and secondary manufacturing capabilities. Higham joins the company from GlaxoSmithKline, where he was a divisional technical head within global manufacturing and supply.
Schaumburg, IL (Apr. 30)-APP Pharmaceuticals, specialty drug company focused on injectable pharmaceutical products, named Thomas H. Silberg as president and chief executive officer, succeeding Patrick Soon-Shoing, who will remain chairman of the board. The company appointed Richard J. Tajak as chief financial officer, succeeding Lisa Gopala.
Woodcliff Lake, NJ (May 5)-Eisai Corporation of North America appointed Cynthia Schwalm president of Eisai Inc. Schwalm will have full operating responsibility for leading Eisai Inc., the US commercial operation of Eisai Co., Ltd. She will report to Lonnel Coats, president and chief operating officer of Eisai Corporation of North America.
London, UK (Apr. 30)-GlaxoSmithKline announced a number of changes to its corporate executive management team. In a message to employees, Andrew Witty detailed new appointments to the management team, which will take effect on May 22 when he assumes the role of chief executive officer. In addition to Witty becoming CEO effective May 22, some of the new appointments include Julian Heslop as chief financial officer, Moncef Slaoui as chairman of research & development, Chris Viehbacher as president of North American Pharmaceuticals, and David Pulman as president of global manufacturing and supply. For a complete list of the senior management team, read the full press release.
Quakertown, PA (Apr. 16)-RCD Technology, a developer and manufacturer specialized RFID tag solutions, appointed Philip Lazo as the company’s chief executive officer. Lazo has previously lead the development, deployment, and management of RFID and related automatic data capture technologies in various industries including healthcare, federal, travel and transportation and retail supply chain.
Madison, NJ (Apr. 30)-Wyeth’s Robert R. Ruffolo, Jr., PhD, will retire as president of Wyeth Research and senior vice-president of Wyeth later this year. He will be succeeded by Mikael Dohlsten, PhD. Ruffolo joined Wyeth in November 2000 and has been responsible for pharmaceutical research and development for the company.