GWP.L Regulatory News (GWP)

28 Feb 2005 14:05

GW Pharmaceuticals PLC28 February 2005 For Immediate Release 28 February 2005 GW Pharmaceuticals plc ("GW" or "the Company") GW Appoints Senior US Experts to Support US Market Entry US Founder Investors Increase Stake With Approx $5m Additional Investment GW announces that it is accelerating its strategy to enter the United Statesmarket by retaining experts in pharmaceutical development and regulatoryaffairs. In its preliminary results statement of 19 January 2005, GW announced that itwould embark on a regulatory programme in the US for its lead product, Sativex.The Company considers that the breadth of data now available will enableinitiation of discussions with the Food & Drug Administration (FDA) for anInvestigational New Drug application in the US. In order to advance these efforts, GW has engaged the services of the ApjohnGroup LLC, based in Michigan. The Apjohn Group is a 10 member partner group offormer major US pharmaceutical company executives with extensive experience inUS clinical development, regulatory affairs, and public policy. In addition, GWhas recruited as consultants a number of key medical opinion leaders as well asexperts with experience in related regulatory areas. These initiatives willenable GW to draw support and guidance broadly within the scientific and medicalcommunity. In response to these US strategic developments, GW's US founder investors andtheir associates ("the Investors") have increased their equity position in theCompany. The Investors have invested a further $4.8m (£2.5m) to increase theirshareholding from 7.79% to 9.62%. This has been achieved through the issue forcash of 2,034,894 new ordinary shares ("the New Shares"). The New Shares, whichrepresent 1.83% of GW's issued share capital prior to the issue, were issued ata price of £1.235 per share. The Investors have agreed to be subject to certainlock-up provisions in relation to the New Shares, which apply for a period of 12months. In addition, GW has issued to the Investors warrants to subscribe for203,493 GW shares at £1.35 per share which can be exercised at any time prior tothe fifth anniversary of their issue. GW will apply the proceeds arising fromthe subscription for the New Shares to fund its US activities and for generalcorporate purposes. Dr Geoffrey Guy, Executive Chairman of GW, commented: "The US is the world'smost significant pharmaceutical market. In order for GW to be successful in thismarket, it is important for the Company to gather together an appropriate teamand resource. Over the last few years, GW has been working to build a supportbase in the US and we are excited about the prospect of working alongside arange of experts to assist our efforts. We are delighted that our plans have metwith such a positive response from our founder US shareholders, who haveextensive experience in this sector, and welcome their increased equityparticipation in the Company." Application will be made for the New Shares to be admitted to AiM, a market ofthe London Stock Exchange. - Ends - Enquiries: GW Pharmaceuticals plc (28/02/05) 020 7067 0700Dr Geoffrey Guy, Executive Chairman (Thereafter) 01980 557 000Justin Gover, Managing DirectorDavid Kirk, Finance Director Weber Shandwick Square Mile 020 7067 0700Kevin Smith This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events, including the clinicaldevelopment and regulatory clearance of the Company's products. Forward-lookingstatements involve risks and uncertainties. Actual events could differmaterially from those projected herein and depend on a number of factors,including (inter alia), the success of the Company's research strategies, theapplicability of the discoveries made therein, the successful and timelycompletion of clinical studies, including with respect to Sativex and theCompany's other products, the uncertainties related to the regulatory process,and the acceptance of Sativex and other products by consumers and medicalprofessionals. This information is provided by RNS The company news service from the London Stock Exchange