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news.GW Pharmaceuticals has given Otsuka Pharmaceutical the rights to develop and market the cannabis-based drug Sativex for cancer pain in the US.
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The financial terms of this agreement include total milestone payments to GW of up to GBP273 million as well as commercial supply price and royalty. Otsuka will pay GW a signature fee of GBP18 million.
In addition, Otsuka will bear the costs of all US development activities for Sativex in the treatment of cancer pain, additional indications, and future formulations. GW and Otsuka will jointly oversee all US clinical development and regulatory activities.
A previous phase III clinical study showed that Sativex achieved a statistically significant improvement in pain relief in terminally ill cancer patients. GW and Otsuka said they expect a phase II/III cancer pain dose ranging study with Sativex to commence this year.
Separately, the companies are also in discussions with a view to entering into a collaboration in the field of central nervous system disorders and cancer treatment in order to develop a range of other early stage cannabinoid product opportunities.
Under the proposed cannabinoid research collaboration, which is expected to be formalized in a separate agreement later in the year, Otsuka would fund the evaluation of a range of cannabinoids as drug candidates.
Products selected for commercialization would be the subject of a license from GW. Under the terms of this license, Otsuka would fund the global development of selected products and GW would receive commercially reasonable financial terms.