Friday August 9, 01:00 PM
British Biotech plc and GeneSoft Inc. announced today that they have signed agreements for a broad-based collaboration to discover and develop novel anti-infective drugs based on British Biotech's proprietary bacterial metalloenzyme inhibitors.
Combining British Biotech's novel targets, chemistry and clinical development with GeneSoft's experience in antibiotic lead optimization and clinical expertise, the collaboration will focus on three specific areas:
"GeneSoft is delighted to partner with British Biotech to discover and develop new antibiotics," said Gary Patou, MD, GeneSoft's President. "The medical community desperately needs new mechanism of action antibiotics to combat multidrug resistant bacteria. We believe that the programs developed within British Biotech have tremendous potential to bring new antibiotics to patients."
Welcoming the agreement, British Biotech Chief Executive Dr Elliot Goldstein said: "Through this collaboration British Biotech has achieved its three key objectives of expanding the Antibiotic Program, while sharing the costs and commercialization rights. GeneSoft is an ideal partner for the program. It specializes in antibiotic drug discovery and development and brings a wealth of clinical and scientific expertise in this field. "
BB-83698 represents a new class of antibiotic and is targeted at hospitalized patients with community-acquired pneumonia. A Phase I clinical study in healthy volunteers, to determine safety and pharmacokinetics of single doses of an intravenous formulation, is expected to begin in October 2002.
Under the first part of the collaboration, British Biotech and GeneSoft have entered into an exclusive agreement to co-develop and commercialize BB-83698. The development costs will be shared equally by British Biotech and GeneSoft, as will the world-wide profits.
PDF research program
In support of BB-83698, British Biotech and GeneSoft have entered into an exclusive research agreement, for an initial period of three years, to identify further PDF inhibitors for clinical development, including oral inhibitors for broader indications. The collaboration will allow increased resource and capabilities to be applied to the PDF program to exploit fully the potential of this novel series of agents. British Biotech will maintain resources on this program at current levels with GeneSoft adding resource equivalent to 170 per cent of British Biotech's. As with BB-83698, development costs and world-wide profits are shared equally.
Other metalloenzyme targets
GeneSoft will select from British Biotech's other anti-microbial metalloenzyme programs, and determine the research projects that it wishes to progress. British Biotech will receive undisclosed milestone and royalty payments on the successful development and commercialization of any products from each research project.
This news release contains forward-looking statements that reflect the Company's current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.
1. The need for new antibiotics
One of the key contributors to morbidity and mortality due to bacterial infections is the increasing prevalence of drug-resistant bacteria. The combination of a limited number of targets, widespread use of prophylactic therapy, empirical treatment with broad-spectrum agents, and the natural evolution of bacteria, has contributed to a resurgence of antibiotic resistance and the creation of a major public health problem. New structural classes of antibiotics that target alternative, essential bacterial processes are likely to make significant inroads into the anti-infectives market.
Bacterial genomes contain a number of metalloenzymes, several of which are believed to be essential to survival, and bacterial polypeptide deformylase (PDF) is now widely recognized as an attractive target for antibacterial chemotherapy (Giglione et al, 2001 Molecular Microbiology, vol 36, 1197-205). Deformylation is a crucial step in bacterial protein biosynthesis and the PDF enzyme is essential for bacterial growth, with the gene encoding PDF (def) found to be present in all sequenced pathogenic bacterial genomes.
In research and pre-clinical studies, British Biotech's PDF inhibitors have shown a microbiological activity profile suitable for respiratory tract pathogens and high potency against antibiotic-resistant organisms. BB-83698, the company's lead PDF inhibitor compound, has now completed the toxicology studies necessary to allow human dosing and a Phase I clinical study in healthy volunteers, to determine the safety and pharmacokinetics of single doses of an intravenous formulation, is expected to begin in October 2002.
2. GeneSoft Inc
GeneSoft is a privately held biopharmaceutical company headquartered in South San Francisco, California. GeneSoft was founded in 1998 by Peter Dervan, Ph.D. and others based on proprietary chemistry technology licensed from the California Institute of Technology. GeneSoft has been using its proprietary technology to discover and develop novel anti-infective products, and currently has a portfolio of lead compounds in late pre-clinical studies. Since its founding, GeneSoft has raised over $60 million in equity capital from investors in the United States, Europe and Asia.
For more information please visit www.genesoft.com
3. British Biotech
British Biotech is a research and development stage pharmaceuticals company aiming to develop and commercialize specialist drugs for serious illnesses, principally cancer. It currently has four products in or near to patient trials, supplemented by focused, collaborative drug discovery research programs.
BB-10901 - A Tumor-Activated Prodrug product, currently in Phase I/II trials in small cell lung cancer. British Biotech acquired exclusive European and Japanese development and commercialization rights to BB-10901 from ImmunoGen Inc. (Boston, USA) in May 2000.
MG98 - A 2nd generation antisense inhibitor of DNA methyltransferase (DNMT), a nuclear enzyme implicated in uncontrolled tumor growth. British Biotech acquired exclusive European development and commercialization rights to MG98 from MethylGene Inc. (Montreal, Canada) in February 2002.
BB-10153 - A novel thrombolytic, about to start a Phase II proof-of-principle study in heart attack patients. The study will be conducted by the Thrombolysis in Myocardial Infarction Study Group, a US-based investigative team at the forefront of clinical research into acute coronary syndromes.
BB-83698 -A peptide deformylase inhibitor targeted at community-acquired pneumonia (hospitalized patients). (See above.)
Antibiotic Program - Now working in collaboration with Genesoft, this research program is focused on the development of bacterial metalloenzyme inhibitors as novel anti-infective drugs (see above).
Anti-Inflammatory Program - In collaboration with Serono SA, this research program is investigating the use of metalloenzyme inhibitors as new treatments for serious inflammatory diseases, particularly multiple sclerosis.
Cancer Program - As part of the collaboration with MethylGene on MG98 (see above) British Biotech has an exclusive option to European development and commercialization rights for compounds from MethylGene's research into small molecule inhibitors of DNMT.
Biodefense Research - As part of the UK Government's biodefense initiative, the Defense, Science and Technology Laboratory (DSTL) of Porton Down is investigating the utility of selected British Biotech metalloenzyme inhibitors against anthrax lethal toxin and botulin toxin.
British Biotech plc
Dr Elliot Goldstein or Tony Weir, 011-44-1865-781166
Media contacts for British Biotech
Hogarth Partnership (UK)
Georgina Briscoe, 011-44-20-7357-9477
GA Kraut (USA)
Gerard Coffey, 1-212-696-5600
David Singer, 1-650-837-1900
Media contact for GeneSoft Inc.
Joanne DelRosario, 1-650-837-1800
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