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BioConvergence, PharmaFab, Johnson & Johnson, More
Bloomington, IN (Apr. 18)-BioConvergence LLC (www.bioconvergencellc.com), a provider of parenteral product development, CGMP materials management, and consulting services, is adding 20,000 ft2. to its existing 50,000-ft2 facility to accommodate growing demand, particularly in its CGMP materials management business unit. The expansion also adds 15 employees to its existing base of 21 full-time employees and includes a multimillion-dollar investment in facilities and equipment.
Rockville, MD (Apr. 25)-The US Food and Drug Administration (www.fda.gov) entered a consent decree of permanent injunction against contract manufacturer PharmaFab Inc. (www.pharmafab.com), its subsidary, PFab LP, andPharmaFab's president and vice-president of scientific affairs to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products were not produced according to current good manufacturing practice (CGMP) and may not have FDA approval. According to FDA, PharmaFab did not investigate manufacturing failures or record and justify why it deviated from written manufacturing procedures. Also, the company did not have an effective quality-control unit and did not establish reliable expiration dates for products. The decree requres PharmaFab to destroy certain drugs and bars them from distributing all drugs until they obtain FDA approval and comply with CGMP.
Spring House, PA (Apr. 19)-Johnson & Johnson Pharmaceutical Research & Development, LLC., part of Johnson and Johnson (New Brunswick, NJ, www.jnj.com), started construction of a new building on its Spring House, Pennsylvania, campus, that will add approximately 150,000 square feet in new laboratory, clinical development, and office space to its existing facilities. The site will become Johnson & Johnson Pharmaceutical Research & Development's East Coast hub for discovery research and early clinical development upon its completion in 2009. Under the plan, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., will retain 680 existing jobs at the site, and expects to add another 120 jobs over the next three years.
Basel, Switzerland (Apr. 19)–Lonza (www.lonza.com) announced plans for the groundbreaking of its expansion at its Portsmouth, New Hampshire mammalian biopharmaceutical manufacturing facility. The company will break ground for the 330,000-ft2 facility on May 17, 2007. Lonza is investing roughly $300 million for the project. The Portsmouth site is the company's largest scale mammalian cell culture plant commissioned to date, with total suite capacity of 93,000 L. Lonza is adding a 5000-L bioreactor to the existing facility that is expected to come on stream in mid-2008.
Basel, Switzerland (Apr. 19)-Novartis (www.novartis.com) acquired the rights to a development compound that combines medicinal and vaccine technology to help smokers overcome their addiction to nicotine. The compound, CYT002-NicQb, is being developed by Cytos Biotechnology AG (Schlieren, Switzerland, www.cytos.com) and is set to enter Phase III trials in late 2008. Under the agrement, Novartis acquires the worldwide development, manufacturing, and commercialization rights to NicQb.
Leiden, Netherlands (Apr. 25)-Drug-delivery and development company OctoPlus N.V. (www.octoplus.nl) obtained additional rights to IsoTis, Inc.'s (Irvine, CA, www.isotis.com) "PolyActive" drug-delivery technology. PolyActive is used in OctoPlus's product "Locteron," a controlled-release formulation of interferon alfa for the treatment of chronic hepatitis C. The new agreement gives OctoPlus control over the use and manufacture of PolyActive in the areas of controlled-release pharmaceuticals, medical coatings, and orthopedics.
St. Louis, MO (Apr. 26)-SAFC (www.safcglobal.com) completed the construction of two new protein active pharmaceutical ingredient (API) facilities at its St. Louis manufacturing campus. The new biologics manufacturing facility includes a 25,000-ft2 CGMP purification manufacturing suite for nonanimal-derived protein APIs and a 6000 ft2 facility for purifying animal-derived protein APIs. Validation of the two facilities is expected by mid-2007.
Basking Ridge, NJ (Apr. 17)–VioQuest Pharmaceuticals (www.vioquestpharm.com) agreed to sell its subsidiary, Chiral Quest, Inc. (Monmouth Junction, NJ, www.chiralquest.com), to Chiral Quest Acquisition Corp. (CQAC), a corporation formed by Chiral Quest's management and others. ChiralQuest specializes in asymmetric chemocatalysis and custom synthesis. The sale is valued at $3 million; $1.7 million in cash is expected to be paid to VioQuest Pharmaceuticals upon closing, plus CQAC will assume Chiral Quest's liabilities of as much as $1.3 million. The deal is expected to close in the second quarter of 2007.
Kvistgard, Denmark (Apr. 19)-Peter Wulff will step down after 13 yeasr as president and chief excecutive officer of Bavarian Nordic (www.bavarian-nordic.com). Wulff will be replaced by Anders Hedegarrd, who will assume his position on or before November 1. Hedegaard previously held executive positions with Aga, Foss, and Novo Nordisk.
New York, NY (Apr. 26)-Bristol-Myers Squibb Co. (www.bms.com) appointed James M. Cornelius chief executive officer for a term through the date of the company's annual meeting of stockholders in 2009. Cornelius has been acting as interim chief executive officer for the past eight months. He joined the board of Bristol-Myers Squibb in 2005 and previously served as chairman and chief executive officer of Guidant Corporation, chief financial officer of Eli Lilly, and president and chief executive officer of IVAC Corporation.
San Francisco, CA (Apr. 23)-DiObex, Inc. (www.diobex.com) named David Cory, RPh, chief executive officer and a member of the board of directors. Cory was president and chief operation officer of Prestwick Pharmaceuticals, and he also held positions with CoTherix and InterMune, Inc.
Phoenix, AZ (Apr. 24)-David Coffin-Beach, PhD, was named presiedent and chief operating officer of Synovics Pharmaceuticals, Inc. (www.synovics.com). Coffin-Beach was a consultant with VCG & A, INc. and also worked for Schering-Plough, Goldline Laboratories, and DuPont Pharmaceuticals.