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news.UK-based GW Pharmaceuticals has revealed that it is accelerating its strategy to introduce its cannabis-based pain drug Sativex into the US market and has received almost $5 million from investors to help fund this move.
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In its preliminary results statement of January 19 2005, GW announced that it would embark on a regulatory program in the US for its lead product, Sativex. The company considers that the breadth of data now available will enable initiation of discussions with the FDA for an investigational new drug application (IND) in the US.
In order to advance these efforts, GW has engaged the services of the Apjohn Group, based in Michigan. The Apjohn Group is a ten-member partner group of former major US pharmaceutical company executives with 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. These initiatives will enable GW to draw support and guidance broadly within the scientific and medical community.
In response to these US strategic developments, GW’s US founder investors and their associates have increased their equity position in the company, investing a further $4.8 million. GW will apply the proceeds to fund its US activities and for general corporate purposes.
“Over the last few years, GW has been working to build a support base in the US and we are excited about the prospect of working alongside a range of experts to assist our efforts,” commented Dr Geoffrey Guy, executive chairman of GW. “We are delighted that our plans have met with such a positive response from our founder US shareholders, who have extensive experience in this sector, and welcome their increased equity participation in the company.”