+++++++++++++++++++++++++ Biota Holdings Limited (ASX:BTA) announced today that it has signed a letter of intent with Japanese pharmaceutical company, Sankyo Co, Ltd ("Sankyo") covering Biota's second-generation, long-acting influenza drugs (FLUNET) and a similar Sankyo compound. The letter of intent anticipates an agreement that will see the two companies pooling their long-acting influenza drug pipelines and jointly seeking development and commercialisation partnerships.
Sankyo is a leading Japanese pharmaceutical company, and has been co-marketing Relenza(TM) with GlaxoSmithKline (GSK) in Japan for several years. Sankyo has also developed its own long-acting neuraminidase inhibitor (LANI) which is already in human clinical trials. Under the proposed agreement, Biota and Sankyo will pool their LANI pipelines, cross-license their relevant patents, and share equally all future licensing and royalty revenues.
"This is an important strategic alliance for Biota," said Group CEO, Peter Molloy, who noted that discussions have been underway with Sankyo for several months. "The agreement effectively accelerates our FLUNET program and gives us a major boost in the partnering process. It also gives us a potential new source of revenues, bridging our marketed products (Relenza and FLU OIA(R)) and our discovery stage programs."
Once the agreement is finalised, the combined pipeline of the Biota-Sankyo alliance will include Sankyo's LANI compound and Biota's FLUNET compounds. The Biota compounds are at the predinical stage, while the Sankyo compound has successfully completed Phase I studies in Europe. Further Phase I work studies may be required, but subject to securing a development partner, the Company expects that it could enter Phase II trials in 2004. The combined portfolio of LANI compounds will be offered to prospective partners as a joint package.
"We expect it to be an attractive licensing package," said Mr Molloy. "It combines a strong patent estate, with a suite of compounds, the first of which is already in human trials. Both parties have been talking to potential partners about their respective programs. Now we will pool those prospects and seek to close a development deal quickly." Under the proposed agreement, the companies will jointly manage the partnering process, with the intention that all further clinical development work would be funded by the licensing partners.
The letter of intent provides for a 90-day negotiation period, during which the companies intend to prepare and execute a detailed agreement.
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