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Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.
Aesica (Newcastle upon Tyne, UK), a contract services provider, will invest £3 million ($4.7 million) in a new high-containment manufacturing facility at its Queenborough, UK, site.The new high-containment unit will include suites for granulation, tableting, and blister packing. The new facility will also include security measures that will ensure it can manufacture Schedule II controlled drugs such as opiates. The company expects that the facility will be completed by May 2011.
AMRI (Albany, NY) received the Pfizer Route Design Innovation Award, which recognizes innovative ideas for process chemistry and large-scale active pharmaceutical ingredient production. Pfizer (New York) will present the company with the award at the AMRI 2010 Integrated Drug Discovery Symposium to be held in Albany, New York, on Oct. 13–14. AMRI will also receive an honorarium for its win.
BioMarin Pharmaceutical (Novato, CA) acquired ZyStor Therapeutics (Milwaukee, WI), a biotechnology company developing enzyme replacement therapies for the treatment of lysosomal-storage disorders. ZyStor's lead product candidate is ZC-701, a fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for Pompe disease. Under the terms of the agreement, BioMarin acquired ZyStor for $22 million upfront and up to an additional $93 million if certain milestones are achieved. FDA has accepted an investigational new drug application for ZC-701. Investigational product has been manufactured, and a clinical study is expected to start in early 2011.
Eli Lilly (Indianapolis) will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease. Eli Lilly said in a press release that it made the decision because preliminary results from two Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. The company stated that the decision on semagacestat does not affect the ongoing clinical trials of solanezumab, Eli Lilly's other compound in Phase III trials as a potential Alzheimer's treatment.
In other Eli Lilly news, the company announced that the US District Court for the District of New Jersey has ruled against Eli Lilly in its patent litigation for Strattera (atomoxetine), the company’s ADHD medication. In the case of Eli Lilly and Company v. Actavis Elizabeth LLC, et al., the court ruled that Lilly's '590 patent, or method-of-use patent, for Strattera is invalid. The patent had been set to expire in May 2017. Robert A. Armitage, senior vice-president and general counsel for Lilly, said in a press statement that the company will appeal the court’s decision.
Biopharmaceutical company Emergent BioSolutions (Rockville, MD) agreed to acquire Trubion Pharmaceuticals (Seattle), also a biopharmaceutical company, for $96.8 million in cash and stock, and, depending on certain milestones, up to a total of $135.5 million. The companies expect the acquisition of Trubion to close in the fourth quarter of 2010.
Selecta Biosciences (Watertown, MA), a biopharmaceutical company, was awarded a $3-million grant from the National Institute on Drug Abuse (NIDA), an institute within the US National Institutes of Health (NIH), to develop a therapeutic nicotine vaccine for the treatment of smoking cessation and relapse prevention. The grant will support the advancing of a clinical-drug candidate from Selecta's pipeline for a nicotine vaccine from preclinical through early clinical evaluation.
Alexza Pharmaceuticals, a pharmaceutical company focused on central nervous system conditions, appointed Darl Moreland vice-president of quality. He will have responsibility for quality assurance, quality control, and quality system regulatory compliance.
Amarin (Dublin), a biopharmaceutical company, appointed Colin W. Stewart president, CEO, and a member of the company's board of directors. Declan Doogan, who has been serving as the company's interim CEO, will continue to support the company as chief medical officer.
Human Genome Sciences (HGS, Rockville, MD), a biotechnology company, appointed Tuomo Pätsi vice-president of HGS Europe. Pätsi will report to Barry A. Labinger, executive vice-president and chief commercial officer.
Ricerca Biosciences (Concord, OH), a contract research organization, appointed Carlos Martínez Manchado to its analytical chemistry department.
Selecta Biosciences (Watertown, MA), a biopharmaceutical company, appointed Werner Cautreels president, CEO, and a member company's board of directors. Cautreels previously served as CEO and global head of R&D at Solvay Pharmaceuticals until its acquisition by Abbott Laboratories (Abbott Park, Illinois) in February 2010.
SkyePharma (London) appointed Axel Müller CEO, effective Aug. 23, 2010. Müller will be based principally in Muttenz, Switzerland, where SkyePharma has its main research and development activities.