GWP.L Regulatory News (GWP)

11 May 2005 07:00

GW Pharmaceuticals PLC11 May 2005 For Immediate Release 11 May 2005 GW Pharmaceuticals plc ("GW" or "the Company") Re: Sativex Marketing Agreement GW and Bayer Healthcare AG announce certain amendments to their marketingagreement for Sativex in the UK and Canada. The amendments have been made inlight of the recent regulatory approval of Sativex in Canada, and reflect thefact that approval was granted in Canada before the UK, and not vice versa aswas envisaged at the time that the marketing agreement was entered into in May2003. Under the original terms of the marketing agreement, as a consequence of theapproval of Sativex in Canada last month, Bayer became obliged to make amilestone payment to GW. Bayer has now agreed to make an immediate additionalpayment to GW of £1m in further recognition of this approval. With respect to the UK, the original terms provided, upon regulatory approval,for Bayer to be able to elect to utilise £10m of the total payment to subscribefor GW shares. Under the amended terms, the total payment to be received by GWon UK approval shall be £10m and this entire amount shall be paid in the form ofa milestone payment (i.e. Bayer shall no longer be entitled to utilise any partof the payment to subscribe for GW shares). In addition, further milestonesshall be payable to GW during the first three years following launch dependenton sales performance. The total milestone payments due to GW under the Bayer agreement of £32.75mremain unchanged. In addition, GW and Bayer have agreed a revised timeframe for their discussionson extending Bayer's rights to other countries. These discussions will takeplace during the second half of 2005. Dr Geoffrey Guy, Executive Chairman of GW, said, "We believe that theseamendments are a positive development for GW shareholders. While the total valueof our potential receipts under the marketing agreement remains unchanged, wehave increased our short term cash position by £1m, whilst at the same timeensuring that the substantial UK approval payment will not be dilutive to ourshareholders. With the successful approval of Sativex in Canada as well as ourcontinued close collaboration in the UK, the GW-Bayer partnership remainsstrong." - Ends - Enquiries: GW Pharmaceuticals plc 01980 557 000Justin Gover, Managing DirectorDavid Kirk, Finance Director Weber Shandwick Square Mile 020 7067 0700Kevin Smith/Rachel Taylor/Yvonne Alexander 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