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Week of Sept. 20, 2010: Company and People Notes: DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.
Cleveland BioLabs (Buffalo, NY) received a $45-million federal grant from the US Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to develop and stockpile its investigational drug CBLB502 as a medical radiation countermeasure. Under the terms of the contract, the CBMS-MITS will provide $14.8 million for Cleveland BioLabs' development of CBLB502 through US Food and Drug Administration approval, after which the grant allows for the purchase of $30,000,000 worth of troop-equivalent doses.
DSM BioSolutions (Delft, The Netherlands), DSM’s microbial fermentation contract manufacturing organization business unit, and PolyTherics (London), a company focused on engineering proteins, entered into an agreement for the process development and manufacture of PolyTherics’ lead biobetter product, HiPEG IFN α-2a. PolyTherics has applied its HiPEG site-specific PEGylation technology to interferon alpha to produce a product (HiPEG IFN α-2a) that has eight-fold higher activity than a marketed PEGylated interferon in vitro and a comparable half-life in a preclinical study. DSM has successfully started development, scale-up, and manufacture of the recombinant his-tagged IFN α-2a, and the companies will work toward producing sufficient material for preclinical and clinical development.
Elan (Dublin) held a meeting of its board of directors and members unanimously accepted a report prepared by the United States law firm of McKenna Long & Aldridge based upon a review it conducted, according to an Elan press release. McKenna Long, serving as independent counsel to the board, reviewed a number of matters brought to the board's attention by certain directors and found no legal breaches or other wrongdoing of any nature by Elan management, any member of its board, or its advisors. Directors Vaughn Bryson and Jack Schuler have expressed their satisfaction with the outcome of the McKenna process and plan to resign from the board. They will do so within 90 days, upon the election of a new chairman or otherwise at the request of the chairman, according to the press release.
Forest Pharmaceuticals (New York) has agreed to plead guilty to charges relating to obstruction of justice, the distribution of Levothroid, which at the time was an unapproved new drug, and the illegal promotion of Celexa for use in treating children and adolescents suffering from depression, according to a press release from the US Department of Justice. Forest also agreed to settle pending False Claims Act allegations that the company caused false claims to be submitted to federal healthcare programs for the drugs Levothroid, Celexa, and Lexapro. As a result, Forest has agreed to pay more than $313 million.
Galapagos (Mechelen, Belgium) will acquire GlaxoSmithKline’s (GSK, London) research center in Zagreb, Croatia. Galapagos will provide research and development services to GSK under a three-year fee-for-service contract for EUR 14 million ($18.6 million). The acquisition arrangement provides for ongoing employment of the 130 staff. Further terms were not disclosed.
Genmab (Copenhagen) and Seattle Genetics (Bothell, WA) formed an antibody-drug conjugate (ADC) research collaboration pact. Under the agreement, Genmab may use Seattle Genetics’ ADC technology with its HuMax-TF antibody targeting the Tissue Factor antigen, which is expressed on numerous types of solid tumors. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a codevelopment option for any resulting ADC products at the end of Phase I clinical development.
GlaxoSmithKline (GSK, London) and Genmab (Copenhagen) will shift the formulation and drug-delivery strategy of ofatumumab in autoimmune indications. After review of the program, GSK will focus development efforts on the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development work on the intravenous route of administration in autoimmune disease.
Biotechnology company Gentronix (Manchester, UK) partnered with Charles River Laboratories (Wilmington, MA), a preclinical contract research organization, to offer BlueScreen HC Screening services for the early detection of genotoxicity. The services are designed to offer accurate, low-compound use and rapid results generation to identify genotoxic problem compounds earlier in discovery and preclinical development.
L.B. Bohle (Warminster, PA) opened its US service center in Warminster, Pennsylvania. The center provides demonstration and training on operation of tablet-coating equipment, containment applications, process development and optimization, blending, milling, and more. The center will also accommodate workshops and seminars.
RTS Life Science (Manchester, UK), a supplier of automated sample management and pharmaceutical testing systems, formed a new Pharmaceutical Testing Group. The group will focus on products for inhaler and tablet testing as well as dissolution and content-uniformity testing.
AAIPharma Services (Wilmington, NC), a provider of pharmaceutical product-development services, appointed Philippe M. Maitre executive vice-president and chief financial officer. Maitre was previously chief financial officer at Oscient Pharmaceuticals (Waltham, MA), a commercial-stage pharmaceutical company.
Jeffrey A. Winton was named vice-president of communications at Eli Lilly (Indianapolis), effective Oct. 11, 2010. Winton will report to Bart Peterson, senior vice-president of corporate affairs and communications.
Kite Pharma (Los Angeles), a biopharmaceutical company focused on developing immunotherapies for cancer, named Aya Jakobovits its president and CEO.
Mallinckrodt Baker (Phillipsburg, NJ) appointed Robert Harrer executive vice-president, chief financial officer, and chief administrative officer. Harrer will oversee the company’s financial operations as well as its information technology, human resources, legal department, and global shared services.
Contract research organization Velesco Pharmaceutical Services (Plymouth, MI) appointed Shirley Smith director of quality and Yuan Chen senior pharmaceutical scientist.