British Biotech and MethylGene sign agreement on Phase II antisense drug for cancer
[I believed, that this product was heading for the scrapheap. MOGN never talks about it. And then British Biotech picks it up. And even pays for it!]
Oxford, UK and Montreal, Quebec – British Biotech plc (LSE: BBG, Nasdaq: BBIOY) and MethylGene Inc., a privately-held Canadian biopharmaceuticals company, today announced that they have entered into a collaboration granting British Biotech the European development and commercialisation rights for MG98, MethylGene’s leading experimental anti-cancer drug, currently in Phase II clinical development in North America.
In addition, British Biotech has been granted an exclusive one-year option, renewable for a second year, to license preclinical compounds that emerge from MethylGene’s complementary small molecule DNA Methyltransferase (DNA MT) inhibitor programme for cancer.
MG98 is a novel, second-generation, antisense compound. It is designed to disrupt the production of DNA MT, an enzyme that is implicated in uncontrolled tumour growth, by inhibiting its expression.
MG98 is currently in two Phase II trials in North America, in head and neck cancer and renal cell carcinoma (kidney cancer), and one Phase I trial in advanced myelodysplasia (MDS) and relapsed/refractory acute myeloid leukaemia. These trials are being conducted by MethylGene and MGI PHARMA Inc., to whom the North American development and commercialisation rights for MG98 were granted by MethylGene in August 2000. MG98 is one of the first second-generation antisense compounds to advance into Phase II clinical trials. MG98 was well tolerated in Phase I, dose-escalation trials in a variety of solid tumours and a partial response and prolonged stable disease were observed in several patients.
British Biotech will expand the MG98 Phase II programme by funding additional studies in cancers in which expression of DNA MT is implicated and will work closely with MGI PHARMA and MethylGene on further development of MG98. British Biotech and MGI PHARMA expect to share the Phase III development costs equally.
British Biotech and MethylGene have also formed an agreement on MethylGene’s research programme for the design and synthesis of small molecule inhibitors of DNA MT. This complementary programme aims to produce drugs that directly inhibit the action of DNA MT, rather than inhibiting the production of the enzyme as is the case for MG98. Under the agreement between the two companies, British Biotech has secured a one-year option, renewable for a second year, to the European development and commercialisation rights for compounds emerging from this research.
Transaction terms
Under the Licence, Development and Commercialisation Agreement, British Biotech will make an initial research and development payment to MethylGene of US$1.7 million. This will be followed by milestone payments of up to US$12.8 million based on successful regulatory approval and commercialisation for MG98 in Europe. MethylGene will also receive undisclosed royalties on sales. British Biotech will make additional equity investments, research and development payments and milestone payments to MethylGene if the option to further participate in the small molecule research programme is exercised. In addition, under a separate Stock Purchase Agreement, British Biotech will make an equity investment of US$2 million in MethylGene.
Dr Elliot Goldstein, chief executive officer of British Biotech, said: “This transaction allows us to accomplish two important objectives. First, acquisition of the development and commercialisation rights to MG98 in Europe adds a fifth compound, already in Phase II, to our clinical portfolio and takes British Biotech into an exciting new approach to cancer treatment. Second, the research agreement provides British Biotech with access to MethylGene's strong intellectual property position and rational drug discovery capabilities and a second approach to this novel cancer target.”
Donald F. Corcoran, MethylGene's president and chief executive officer, said: “MethylGene chose British Biotech as our European partner based on the quality and experience of its clinical development in cancer. By establishing this relationship with British Biotech we can capitalize on the progress already made with MGI PHARMA. We look forward to this new collaboration allowing us to aggressively pursue the clinical development of MG98 in North America and Europe as well as further expand our drug discovery efforts for additional DNA methyltransferase inhibitors.” |
