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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, recalls for two KV Pharmaceutical subsidiaries; Human Genome Sciences delivers anthrax drug to US Strategic National Stockpile; Akorn president and CEO leaves the company; more...
Ghent, Belgium (Feb. 3)-Ablynx, a biopharmaceutical company, announced that it will receive milestone payments totaling €3 million ($3.9 million) from Boehringer Ingelheim as part of its alliance for the development and commercialization of "Nanobodies," a class of antibody-derived therapeutic proteins. A September 2007 deal between Ablynx and Boehringer Ingelheim covers potential milestone payments of up to €125 million for each “Nanobody” developed as well as undisclosed royalties to Ablynx.
Waltham, MA (Jan. 26)-Altus Pharmaceuticals announced a realignment of product-development priorities to focus on the company's recombinant human growth hormone candidate, “ALTU-238.” Altus will discontinue its “Trizytek” program activities, and will transfer certain Trizytek intellectual property rights and regulatory filings to Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, in accordance with Altus' 2001 agreement with CFFT. Altus will implement a workforce reduction of approximately 75%, primarily in functions related to the Trizytek program. Following the staff reductions, Altus will have approximately 35 employees.
London (Jan. 29)-AstraZeneca announced in its 4th quarter and full-year 2008 report that it will reduce its workforce by an additional 6000 positions by 2013, bringing the total number of reductions to 15,000 jobs. The company did not specify where those cuts will be.
Hollywood, FL (Jan. 21)-Azopharma Product Development Group added microdosing and central laboratory services to its clinical pharmacology research facility, AvivoClin Clinical Services (Daytona Beach, FL).
St. Louis, MO (Feb. 3)-ETHEX, a subsidiary of KV Pharmaceutical, issued a voluntary nationwide recall of several prescription vitamin and supplement products, including “CareNatal” and “Fe-Tinic,” as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current good manufacturing practices. This follows a Jan. 28, 2009 recall announcement of various products at the wholesale and retail. Visit the company's website for details of the recall.
Rockville, MD (Feb. 2)-The pharmaceutical company Human Genome Sciences began delivery of 20,000 doses of its human monoclonal antibody drug “ABthrax” (raxibacumab) to the US Strategic National Stockpile for use in the treatment of inhalation anthrax. ABthrax is being developed under a contract formed in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), US Department of Health and Human Services (HHS).
The Woodlands, Texas (Jan. 22)-Lexicon Pharmaceuticals, a biopharmaceutical company, will restructure its operations to conserve capital and direct resources towards its most advanced drug discovery and development programs. The restructuring will involve a workforce reduction of 102 employees, primarily in basic research, early-stage discovery and support positions, representing approximately 22% of its total workforce.
Billerica, MA (Feb. 2)-Millipore entered into an agreement to acquire Guava Technologies (Hayward, CA), a provider of bench-top cell analysis systems, for $22.6 million. The acquisition follows the distribution and codevelopment partnership the two companies formed in March 2008.
Toronto, Canada (Jan. 30)-Patheon, a provider of drug-development and manufacturing services, will close its Carolina facility in Puerto Rico, effective Jan. 31, 2009. A press release said the company made the decision “after pursuing all reasonable alternatives for the past 12 months.” As previously disclosed, severance and other closure costs are expected to be approximately $3 million.
New York (Jan. 30)-Pfizer announced the discontinuation of a Phase III study of its investigational agent axitinib for the treatment of advanced pancreatic cancer. Based on an interim analysis, an independent Data Safety Monitoring Board found no evidence of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine, compared to gemcitabine alone, the current standard of care for patients with advanced pancreatic cancer.
Princeton, NJ (Feb. 3)-PharmaNet Development Group, a provider of clinical development services, signed a definitive merger agreement with affiliates of JLL Partners. Under the terms of the agreement, JLL will commence a tender offer to purchase all of the outstanding shares of PharmaNet for $5 per share in cash. The transaction values the company's common stock at approximately $100 million. The companies expect the tender offer to close by the end of the first quarter of 2009.
Basel, Switzerland (Jan. 30)-Roche intends to commence a cash tender offer to acquire all outstanding publicly held shares of Genentech for $86.50 per share. The offer replaces the Roche’s July 21, 2008 proposal to acquire all of the shares of Genentech for $89 per share in cash by means of a negotiated merger. Genentech’s board of directors rejected that offer on Aug. 13, 2008. Roche, which currently owns 55.8% of the Genentech outstanding shares, said it expects to commence the tender offer to Genentech’s shareholders within approximately two weeks. Genentech issued a statement urging shareholders to take no action, and that the board of directors would evaluate the offer once it is made by Roche.
Marlborough, MA (Jan. 28)-The specialty pharmaceutical company Sepracor announced a corporate restructuring and workforce reduction plan. The company will eliminate about 530 positions, roughly 20% of its workforce; 350 field-based positions and 180 corporate positions. Sepracor will also eliminate approximately 410 contract sales organization sales representative positions. The company’s sales positions after the restructuring will total approximately 1325.
St. Louis, MO (Feb. 3)-Ther-Rx, a subsidiary of KV Pharmaceutical, issued a voluntary nationwide recall of several prescription vitamin and supplement products, including “Chromagen” and “Repliva,” as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current good manufacturing practices. The announcement follows a January 28, 2009, recall announcement that included its “Gynazole-1,” “Clindesse,” and “microK Extencaps” products. See the company’s website for details of the recalls.
Milford, MA (Feb. 2)-Waters announced it has acquired all of the remaining outstanding capital stock of Thar Instruments (Pittsburg, PA), the supercritical fluid chromatography (SFC) manufacturer, for an undisclosed amount. Waters made an equity investment in Thar in June 2007.
Lake Forest, IL (Jan. 29)-The specialty pharmaceutical company Akorn announced that Arthur Przybyl, president and CEO, left the company. A committee of three board members, Chairman John Kapoor and directors Randall Wall and Jerry Ellis, will oversee operations and identify Przybyl’s replacement.
Waltham, MA (Jan. 26)-Altus Pharmaceuticals announced that as part of its restructuring plan, Chief Medical Officer Burkhard Blank, Chief Financial Officer Jonathan Lieber, and Vice-President of Business Development John M. Sorvillo will leave the company.
Albany, NY (Feb. 3)-AMRI named Richard A. Saffee general manager of large-scale manufacturing. Saffee will report to Steven Hagen, vice-president of pharmaceutical development and manufacturing.
Liverpool, UK (Jan. 28)-Eden Biodesign, a contract manufacturing organization, reorganized its management team. Derek Ellison was appointed chief operating officer, Anita Bate was promoted to chief scientific officer from science director, Phil Ball moved from the UK to the US offices and was appointed technical director, David Simpson was appointed process development manager, Mandy Shipman was appointed biopharm development consultant, Gina Wenham took on responsibility for the analytical development team alongside quality control, and Alison Justice was promoted to quality assurance director. Eden Biodesign Inc, the company's US subsidiary, relocated to North Carolina’s biotech hub, Research Triangle Park, last week.
Indianapolis, IN (Jan. 30)-Eli Lilly and Company promoted Enrique Conterno to president of Lilly USA, LLC, effective immediately. Conterno was formerly senior vice-president of health care professional markets for Lilly in the US. He will report to Bryce Carmine, executive vice president of global marketing and sales. Conterno succeeds Deirdre Connelly, who had led Lilly's US operations since 2005.
London (Jan. 30)-GlaxoSmithKline (GSK) announced that Deirdre Connelly will join the company as president of North American Pharmaceuticals, effective Feb. 9, 2009. She will report to Andrew Witty, CEO, and will become a member of GSK’s corporate executive team. Connelly had served as president of US operations at Eli Lilly and Company since 2005.