GW Pharmaceuticals clinched a deal with a US investor yesterday to raise £8.6m, which will enable the fledgling biotech company to develop its pioneering cannabis-based drug Sativex in the United States. GW is placing 6.2 million new shares at 139.61p apiece with Polygon Investment Partners, a New York-based fund manager.
The company also announced it had won the go-ahead from the US Food and Drug Administration for a Phase III trial - the last of three stages required to file for approval of the drug - with 250 patients. The trials will start in the second half of the year and the company hopes to file for approval of Sativex in two or three years' time.
The trials will cost $15m (£8.5m) but additional research will take the total US cost to more than $20m, Justin Gover, GW's managing director, said. He said the newly raised funds will enable GW to start testing Sativex in the US without being under pressure to find a partner quickly. The company has started looking for a licensing partner to shoulder most of the US development costs.
Sativex, a mouth spray, is already sold in Canada to treat nerve pain associated with multiple sclerosis, but the US tests will focus on its use as a treatment for pain in terminally ill cancer patients.
The company recently won Spain's Almirall as a marketing partner for European countries excluding the UK, while the German drug maker Bayer is GW's marketing partner in Canada and Britain. Canada became the first country to approve Sativex for sale in April last year but the company has suffered delays in Britain, where regulators asked for a second Phase III trial to test the efficacy of the drug. Mr Gover said the study should be completed by the spring and that regulatory approval would come at the end of the year at the earliest. Even so, the Home Office recently agreed to requests from doctors and patients to allow imports of Sativex from Canada.
GW suffered a setback recently when Sativex was linked to the development of an illness that killed a pensioner suffering from severe diabetes. But Mr Gover said the case had occurred in 2003, adding that UK regulators were fully aware of it but had no safety concerns.Reuse content