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  • GW Appoints Senior US Experts to Support US Market Entry

GW Appoints Senior US Experts to Support US Market Entry

 

GW Appoints Senior US Experts to Support US Market Entry

28  February  2005

US Founder Investors increase stake with approx $5m additional investment

GW announces that it is accelerating its strategy to enter the United States market by retaining experts in pharmaceutical development and regulatory affairs.

In its preliminary results statement of 19 January 2005, GW announced that it would embark on a regulatory programme 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 Food & Drug Administration (FDA) for an Investigational New Drug application in the US.

In order to advance these efforts, GW has engaged the services of the Apjohn Group LLC, based in Michigan. The Apjohn Group is a 10 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 (“the Investors”) have increased their equity position in the Company. The Investors have invested a further $4.8m (£2.5m) to increase their shareholding from 7.79% to 9.62%. This has been achieved through the issue for cash of 2,034,894 new ordinary shares (“the New Shares”). The New Shares, which represent 1.83% of GW’s issued share capital prior to the issue, were issued at a price of £1.235 per share. The Investors have agreed to be subject to certain lock-up provisions in relation to the New Shares, which apply for a period of 12 months. In addition, GW has issued to the Investors warrants to subscribe for 203,493 GW shares at £1.35 per share which can be exercised at any time prior to the fifth anniversary of their issue. GW will apply the proceeds arising from the subscription for the New Shares to fund its US activities and for general corporate purposes.

Dr Geoffrey Guy, Executive Chairman of GW, commented: “The US is the world’s most significant pharmaceutical market. In order for GW to be successful in this market, it is important for the Company to gather together an appropriate team and resource. 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. 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.”

Application will be made for the New Shares to be admitted to AiM, a market of the London Stock Exchange.

- Ends -

Enquiries:

GW Pharmaceuticals plc(28/02/05) 020 7067 0700
Dr Geoffrey Guy, Executive Chairman(Thereafter) 01980 557 000
Justin Gover, Managing Director
David Kirk, Finance Director
Weber Shandwick Square Mile020 7067 0700
Kevin Smith

This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including the clinical development and regulatory clearance of the Company's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and the Company's other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.

 
 
 

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