Shares in GW Pharmaceuticals of the UK enjoyed a good day on the markets after the company announced that it is speeding up plans to get its cannabis-derived treatment Sativex (tetrahydrocannabinol plus cannabidiol) which treats the symptoms of multiple sclerosis and neuropathic pain), onto the lucrative US market.
The company issued a statement saying that it has hired Apjohn Group, a Michigan, USA-based firm which is run by former major pharmaceutical executives who have extensive experience in US clinical development, regulatory affairs, and public policy.
In addition, GW has recruited as consultants a number of key medical opinion leaders as well as experts with experience in related regulatory areas. The aforementioned initiatives have prompted GW’s US founder investors to put in a further $4.8 million into the company, increasing their shareholding from 7.79% to 9.62%.
Geoffrey Guy, executive chairman at GW, noted that the US is the world’s most significant pharmaceutical market and in order to be successful there: “It is important for the company to gather together an appropriate team and resource.” He added that GW has been working to build a support base in the US over the last few years ‘and we are excited about the prospect of working alongside a range of experts to assist our efforts”.
The news of US expansion comes hot on the heels of GW announcing positive preliminary results from a Phase III clinical trial using Sativex in patients with severe cancer pain [[20/01/05d]]. The firm is also on the verge of winning a first approval for the treatment, which is sprayed under the tongue, in Canada as the regulatory authorities have issued a qualifying notice [[21/12/04d]].
However, approval of Sativex has been repeatedly delayed at home and GW’s share price took a hammering at the end of last year after the UK’s drug regulatory agency, the MHRA, requested an additional efficacy trial of the drug [[06/12/04e]].