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Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...
Copenhagen, Denmark (Aug. 5)-CMC Biologics, a contract manufacturing organization, entered into an agreement with the biopharmaceutical company Symphogen (Lyngby, Denmark) for process development and CGMP manufacture of an undisclosed Symphogen polyclonal antibody product candidate. Terms of the agreement were not disclosed.
Warrington, PA (Aug. 6)-Discovery Laboratories made progress in addressing key remaining requirements identified by an FDA approvable letter for “Surfaxin” (lucinactant) for the prevention of respiratory distress syndrome in premature infants. The company’s response, available here, reviews steps taken to move toward marketing approval, including an update on the company’s steps toward satisfying International Conference of Harmonization (ICH) guidelines for the proposed specifications for certain lipid-related impurities in the two phospholipids used in Surfaxin.
Indianapolis, IN(Aug. 6)-Eli Lilly announced that Covance, a provider of drug development services, will buy and operate Lilly's Greenfield Laboratories located in Greenfield, Indiana, for an up-front payment of $50 million. The two companies also will sign a 10-year service agreement. The agreement expands their existing collaboration, with Covance assuming responsibility for Lilly's toxicology testing and other research and development support activities at the site. This collaboration, which also includes expanded early-stage clinical work and Phase II/III clinical trial support, will help Lilly to lower drug development costs.
Bridgewater NJ, (Aug. 11)-Enzon Pharmaceuticals, a biopharmaceutical company, is considering selling its entire specialty pharmaceuticals business, or selling one or more of its products, and its Indianapolis, Indiana, manufacturing facility. The company received confidential, nonbinding, preliminary indications of interest for the purchase of all or a portion of the specialty pharmaceutical business. Enzon intends to continue evaluating the sale process, and does not intend to comment further on the possible sale until a definitive agreement has been reached, or a determination is made not to pursue such a transaction.
Mechelen, Belgium (Aug. 12)-The drug discovery company Galapagos announced that its service division, BioFocus DPI (Saffron Walden, UK), signed a contract with the biopharmaceutical company UCB (Brussels, Belgium) for the provision of chemistry services. UCB will transfer a team of chemists to BioFocus DPI, and chemistry work will continue toward candidate selection stage. Under the contract, UCB will provide biology support for the program. The total contract value for Galapagos could potentially exceed €4 M. Additionally, Galapagos is eligible to receive up to €500,000 in milestone payments.
Rockville, MD (July 24)-FDA recently posted a July 24 warning letter to G&W Laboratories citing significant current good manufacturing practices (CGMP) deviations during an inspection of the company’s facilities in South Plainfield, New Jersey, in December 2007. The CGMP deviations pertain to the company’s hemorrhoidal ointment product, and some violations include failure to reject drug products that did not meet established quality standards, a lack of process procedures during scale-up, and failure to clean equipment used in production. The warning letter also addresses misbranded and unapproved new prescription drugs, in reference to two rectal suppositories produced by G&W. Read the full warning letter here.
South San Francisco, CA (Aug. 13)-Genentech announced its special committee of the board of directors unanimously concluded that Roche's offer of $89.00 per share “substantially undervalues the company,” according to a company press release. Therefore, Roche’s offer to acquire Genentech was rejected. The special committee says it would consider another proposal. Roche’s bid for Genentech was reported in ePT’s July 24 edition.
Basel, Switzerland (Aug. 6)-The contract manufacturer Lonza will form a new business unit based in China: Lonza Engineering. This new business unit will provide engineering, facility design, and maintenance services for the Chinese market. The initial geographic focus will be on the market in China, and the company may later expand to global markets.
Bridgewater, NJ (Aug. 5)-Ortho Biotech is voluntarily recalling one manufacturing lot (P114942A) of “Procrit” (Epoetin alfa) after having identified cracks in the necks of a small number of vials upon post-manufacturing inspection. No other lot of this product is affected by this recall. Approximately 44,292 vials of lot P114942A were distributed between April 15, 2008 and July 17, 2008. See the announcement on Ortho Biotech’s website for more details.
Kenilworth, NJ (Aug. 12)-Schering-Plough expanded its presence in China and established Shanghai Schering-Plough Pharmaceutical Co. Ltd., a wholly owned operation based in Shanghai through the acquisition of the shares of its former joint venture partners. Schering-Plough in China serves Chinese healthcare professionals and customers in the areas of allergy/respiratory, cardiovascular, central nervous system, skin care, oncology, infectious diseases, and women's health.
Washington, DC (Aug. 4)-The US Patent and Trademark Office published a notice in the Federal Register that alerted the public to a new applicability date of regulatory provisions dealing with related applications in the “Claims and Continuations” Final Rule. This Final Rule was permanently enjoined by the district court in Tafas v. Dudas on April 1, 2008, and the decision is currently on appeal to the US Court of Appeals for the Federal Circuit. The Federal Register notice states that should the injunction be removed, the requirements of the rule that deal with related applications [37 CFR 1.78(f)(1) and (f)(2)] will apply only to applications filed on or after any new future effective date. Previously, these requirements were also to be applied to patent applications that had been filed prior to the effective date, but that is no longer the case.
Hafnarfjordur, Iceland (Aug. 12)-One week after Sigurdur Oli Olafsson took over as chief executive officer (CEO), Actavis appointed Gudbjorg Edda Eggertsdottir deputy CEO. Other appointments include Valur Ragnarsson as executive vice-president of third-party sales, and Doug Boothe as CEO of Actavis United States. Ragnarsson will join the executive board with immediate effect, while Eggertsdottir and Boothe are currently board members.
Hyderabad, India (Aug. 8)-Biological E., a biopharmaceutical company, appointed Rayasam Prasad as chief operating officer for global biologics. Prasad has more than 25 years of experience in management roles at such companies as Genentech (South San Francisco, CA), MedImmune (Gaithersburg, MD) and Genzyme (Cambridge, MA).
Adelaide, Australia (Aug. 8)-Bionomics, a biopharmaceutcial company, extended the employment contract of Deborah Rathjen, as CEO and managing director until August 7, 2011. Bionomics discovers and develops treatments for cancer and diseases of the central nervous system.
Boston, MA (Aug. 11)-The pharmaceutical company Cortria appointed Gene Cefali, PhD, as senior vice-president of clinical pharmacology and formulation development. Cefali specializes in the field of niacin metabolism and pharmacokinetics.
Basking Ridge, NJ (Aug. 6)-Millennium Biotechnologies, Inc., a wholly owned subsidiary of Millennium Biotechnologies Group, Inc., named Mark C. Mirken its new CEO and chairman of its board of directors. Mirken has been president and chief operating officer of Millennium since he joined the company in September of 2007. Mirken will replace Jerry Swon, who has been chief executive officer and board chairman since 2001. Swon will be retiring from these positions to pursue other business interests.
La Jolla, CA (Aug. 11)-TorreyPines Therapeutics, a biopharmaceutical company, announced that Neil Kurtz will resign as president, chief executive officer, and a director of the company, effective August 31, 2008. Evelyn Graham will replace Kurtz as acting chief executive officer. She has been the company's chief operating officer since 2006.