Posted on December 19, 2006 @ 08:55 am
Bridge Pharmaceuticals, Inc. has acquired
Gene Logic Labs (GLL), based in Gaithersburg, MD. Bridge will retain the services of all GLL employees, and the acquired unit’s name will become Bridge Global Development Services, Inc. (a subsidiary of Bridge Pharmaceuticals, Inc). Also, the two companies have entered into a preferred services agreement for preclinical drug development.
The acquisition of the Gene Logic Labs Gaithersburg facility enables Bridge to offer a complete IND suite of toxicology and pharmacology services on a global scale, according to the company. Combining the experience, technical staff and resources of U.S. operations with existing scientific staff in its new, purpose-built facility in Beijing, China, Bridge will provide the pharma industry with the high quality data required for worldwide regulatory submissions with "very significant cost savings."
“Many clients see the economies associated with performing preclinical work in Asia and want the assurances that work done there would be performed under the strict guidelines of U.S. level GLP regulatory requirements,” said Glenn Rice, Ph.D., chief executive officer and president of Bridge. “The GLL acquisition allows us to offer the unique benefits of our China facilities with the assurance of the regulatory compliance that clients require.”
Posted on December 19, 2006 @ 08:53 am
Avid Bioservices, Inc., a subsidiary of Peregrine Pharmaceuticals, Inc., has extended its commercial manufacturing supply agreement with
Halozyme Therapeutics, Inc. Under the terms of the contract amendment, Avid could manufacture as many as 20 runs per year during the next five years of a recombinant human enzyme that is the active ingredient in Halozyme's marketed products, Hylenex and Cumulase. Avid began manufacturing commercial product for Halozyme under cGMP in 2004.
"We are pleased to extend our contract with Avid to manufacture our recombinant human enzyme that is a key ingredient in Hylenex and Cumulase," said William Fallon, vice president of manufacturing and operations at Halozyme. "Avid's proven capabilities in cGMP manufacturing support our ability to increase sales of both marketed products."
"We are delighted that Halozyme has re-confirmed their confidence in Avid's capabilities by extending the term of the agreement for five additional years, while also significantly expanding its potential scope," said Richard Richieri, senior vice president of bioprocess development and manufacturing at Avid. "We have had a very productive relationship with Halozyme over the past few years and are pleased to be the primary manufacturer for this important commercial product and technology."
Posted on December 19, 2006 @ 08:51 am
GlaxoSmithKline and
Genmab have entered a worldwide agreement to co-develop and commercialize HuMax-CD20, a human monoclonal antibody in late stage development for CD20 positive B-cell chronic lymphocytic leukemia (B-CLL) and follicular non-Hodgkin's lymphoma (NHL) and in Phase II for rheumatoid arthritis (RA). The agreement is subject to review under the Hart-Scott-Rodino Act.
Under the terms of the agreement, Genmab will receive a license fee of approximately $102 million, and GSK will invest approximately $357 million in Genmab. The potential value of this agreement, in the event of commercial success in cancer and various autoimmune and inflammatory diseases, could exceed $2.1 billion. Genmab will also be entitled to receive tiered royalties on global sales of HuMax-CD20.
GSK will receive an exclusive worldwide license to HuMax-CD20 as well as other antibodies with affinity for the CD20 antigen, which Genmab may develop. GSK will also have an exclusive option to a CD20 UniBody to be developed in collaboration with Genmab. The two companies will co-develop HuMax-CD20. Genmab will be responsible for development costs until 2008, including two ongoing late-stage oncology studies after which development costs will be shared. GSK will be solely responsible for the manufacturing and commercialization of HuMax-CD20.
Genmab will have an option to co-promote HuMax-CD20 in a targeted oncology setting in the U.S. and in the Nordic region. Should this be undertaken, Genmab will have the option co-promote Bexxar and Arranon in the U.S. and Atriance in the Nordic region.
Dr. Moncef Slaoui, chairman of R&D, GSK, commented, "We believe that this alliance is a significant step for GSK and Genmab. By combining the skills and knowledge of Genmab in developing fully human antibodies, such as HuMax-CD20, and the substantial experience of GSK in clinical and commercial development, we hope to be able to bring this innovative and potentially valuable medicine to patients as soon as possible."