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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Pfizer to close Indiana "Exubera" facility, executive appointments at Patheon, more...
Rockville, MD (May 14)-The US Food and Drug Administration announced that Bayer HealthCare Pharmaceuticals (Wayne, NJ) notified the agency that the company will begin removing the remaining "Trasylol" (aprotinin) stock from the US market, most of which is in warehouses and hospitals or physicians' stock. The FDA will work with Bayer to ensure a smooth and complete process. In November 2007, Bayer agreed to FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, after preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.
Germantown, WI (May 14)-Contract manufacturer Cambridge Major Laboratories will expand its capabilities in large-scale active pharmaceutical ingredient (API) manufacturing with a new 120,000-ft2 manufacturing suite. The facility is designed with multiple GMP manufacturing suites capable of producing multi-ton quantities of API. The facility will initially feature six manufacturing suites with reactors up to 2000-gallon scale with complete isolation and containment, several vessels for hydrogenation and cryogenic reactions, and the potential to accommodate additional manufacturing suites up to 4000-gallon scale. Completion is scheduled for August of 2009.
Cranbury, NJ (May 13)-Palatin Technologies, a biotechnology company, reported its financial results for the third quarter ended March 31, 2008 and announced new strategic objectives as part of a restructuring. Palatin will continue to develop products targeting melanocortin and natriuretic receptors in the sexual dysfunction, obesity, and cardiovascular fields, including acute hospital care products for use in treatment of acute systemic hypertension, congestive heart failure and hemorrhagic shock. The company discontinued development of bremelanotide for the treatment of male and female sexual dysfunction, but will develop bremelanotide for treatment of hemorrhagic shock and related indications. Palatin will implement an immediate reduction in force of 30% of its employees.
Terre Haute, IN (May 13)-Pfizer will close its Terra Haute, Indiana, manufacturing plant by the middle of next year. The plant was used to manufacture the inhaled insulin product “Exubera,” and had received an investment of more than $300 million since 1999 to prepare for Exubera production. The closure will eliminate the remaining 140 jobs at the plant. IN January, Pfizer cut 660 jobs and warned that more layoffs would come later.
Rockville, MD (May 16)-The US Food and Drug Administration announced that Scientific Laboratories, and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a consent decree of permanent injunction and are barred from manufacturing and distributing drug products until they bring the company's manufacturing operations into compliance with law and obtain approval for their products. Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The complaint alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP). The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: "B-Vex Suspension," "Ben-Tann Suspension," "D-Tann Suspension," "D-Tann AT Suspension," "D-Tann CT Suspension," "D-Tann DM Suspension," "D-Tann HC Suspension," "Dur-Tann DM Suspension," "Duratan DM Suspension," "L-All 12 Suspension," "Nazarin Liquid," and "Nazarin HC Liquid." Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.
Tampa, FL (May 6)-Xcelience, a contract research organization, launched a new service in preformulation and formulation development with X-ray diffraction (XRD) capabilities. The XRD is the key technique for solid-state drug analysis benefiting all stages of drug development, testing, production and stability.
East Rutherford, NJ (May 15)-Cambrex, a contract manufacturing organization, appointed Steven M. Klosk president and chief executive officer and a member of the board of directors, effective May 14, 2008. James A. Mack, president and CEO since 1995 and chairman since 1999, has announced he will step down. Mack will remain a board member and advisor until his retirement on June 30, 2008. The company will separate the positions of board chairman and CEO, and John R. Miller will assume the position of non-executive chairman of the board.
East Hills, NY (May 15)-Pall Corporation, a company focused on filtration, separation, and purification technologies, appointed Senior Vice-President Felix M. Negron to lead global manufacturing and supply chain operations for the company’s life sciences business. Negron joined the company in 2003 as general manager for Pall Life Science’s operations in Puerto Rico.
Toronto, Canada (May 14)-Contract manufacturer Patheon announced the following executive management appointments: Eric W. Evans as chief financial officer, Paul M. Garofolo as senior vice-president and chief information officer, Warren A. Horton as vice-president of global quality operations, and Doaa A. Fathallah as senior vice-president of general counsel Europe and global pharmaceutical development services.
Paris, France, and Nes Ziona, Israel (May 14)-The privately held biotechnology company Sepal Pharma, appointed Frédéric Revah as chief executive officer. Revah joined Sepal Pharma in May 2008 and is based in Paris.
Boston, MA (May 15)-Surface Logix, a biopharmaceutical company, announced that Jim Mahoney, president & chief executive officer, will be stepping down from his current position to pursue other interests. Mahoney will maintain a consulting relationship with the company. Steven Gillis, PhD, Managing Director at ARCH Venture Partners will assume the role of Executive Chairman until a new CEO is appointed.
Ravensburg, Germany (May 14)-Vetter Pharma-Fertigung announced that as of June 1, 2008, Peter Soelkner will be heading a number of divisions at the company, which specializes in the filling of prefilled injection systems. Soelkner’s new tasks will include global key account management, corporate marketing, supply chain management and project management. Soelkner will join the current Managing Directors Max Horn and Thomas Otto in handling company business.