GWP.L Regulatory News (GWP)

12 Dec 2005 07:01

GW Pharmaceuticals PLC12 December 2005 Embargoed until 0700 12 December 2005 GW Pharmaceuticals plc ("GW" or "the Company") GW and Almirall Announce European Development and Marketing Agreement for Sativex(R) GW and Almirall Prodesfarma, S.A. ("Almirall") announce that they have enteredinto an exclusive agreement for Almirall to market Sativex(R) in Europe(excluding the UK). Sativex is being developed by GW and is a novel prescription pharmaceuticalproduct derived from components of the cannabis plant. Sativex is administeredvia a spray into the mouth. In April 2005, Canada became the first country inthe world to approve Sativex as a prescription medicine. Under the terms of the agreement, GW has maintained a significant share of longterm product revenues whilst benefiting from a £12 million signature fee. Inaddition, milestone payments are payable on the successful completion of each ofthe ongoing pivotal Phase III trials, as well as on regulatory approvals and inrelation to achievement of sales targets. Including the signature fee,milestones payable under the contract may total up to £46 million. Almirall is Spain's largest pharmaceutical company and one of Europe's leadingprivate pharmaceutical companies, with 2005 sales approaching 1 billion Euros.Almirall is headquartered in Barcelona, and has a staff of over 3,200 people,approximately 500 of whom form part of the R&D team. It is currently present inaround 100 countries worldwide and has a portfolio of proprietary and licensedproducts. The company has a significant presence in Spain, where it is numbertwo by market share, and subsidiary operations in other major European markets,including France, Germany, Italy, Portugal and Belgium. Almirall is currentlystrengthening its direct presence in Europe and Latin America via affiliates,and is actively looking for in-licensing opportunities to support this strategy,medicines for the Central Nervous System being one of its priority areas. Sativex is in Phase III trials for the treatment of Multiple Sclerosis symptoms(neuropathic pain and spasticity), neuropathic pain (peripheral and general) andcancer pain. Under the agreement GW is responsible for completing thedevelopment of Sativex for these three indications. In addition to the three initial target indications, Almirall and GW expect tocollaborate on the development of Sativex in other indications. The parties willbe discussing potential new indications over the coming months. It isanticipated that Almirall will contribute to the cost of development of newindications. The licensed territory includes the members of the European Union (excluding theUK), EU accession countries as well as Switzerland, Norway and Turkey. Incountries where Almirall has no direct presence at the time of product launch,the companies shall jointly agree the appointment of distribution partners. Insuch countries, GW may elect to distribute the product itself. In the UK,Sativex is already licensed to Bayer HealthCare. GW shall be the Marketing Authorisation holder for Sativex. In addition, GW isto be responsible for commercial product supply and will manage the supply ofproduct through a range of contract manufacturing partners, arrangements forwhich are all in place and being utilised to supply commercial product toCanada. Following receipt of the signature fee, GW's financial position has beensignificantly strengthened, with net cash balances now totalling £22 million. Dr Geoffrey Guy, Executive Chairman of GW, said: "We are delighted to haveentered into this agreement with Almirall. As one of the leading specialistEuropean pharmaceutical companies, Almirall is exactly the profile of partnerthat we have been seeking for Sativex. We look forward to working together inbuilding a successful long term collaboration and to realising the marketpotential for Sativex across all its potential indications. GW's commercialstrategy is to maximise the value of Sativex by retaining a significant interestin revenues from product sales whilst at the same time generating sizeable cashpayments in the short term to meet GW's financial requirements. The terms ofthis agreement reflect the merits of this strategy." Dr Jorge Gallardo, President-CEO of Almirall, said: "We are very pleased withthis agreement for Sativex with GW Pharmaceuticals. GW has proven to be aninnovative company with a strong scientific basis. This partnership represents astep forward for Almirall reinforcing our presence in European markets, and is akey milestone in our aim of offering society innovative medicines to fulfillunmet medical needs. Our challenge is to improve the health and quality of lifeof patients suffering from MS and other debilitating conditions." - Ends - Enquiries: GW Pharmaceuticals plc (12/12/05) + 44 20 7067 0700Dr Geoffrey Guy, Executive Chairman (Thereafter) +44 1980 557000Justin Gover, Managing DirectorMark Rogerson, Press and PR + 44 7885 638810 Weber Shandwick Square Mile + 44 20 7067 0700Kevin Smith AlmirallMiriam Paris, Corporate Communication + 34 93 291 3000Gloria Maltas, Corporate Communication Notes to editors: Sativex Sativex is a pharmaceutical product standardised in composition, formulation,and dose. Its principal active cannabinoid components aredelta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). In Canada, Sativex is approved for the symptomatic relief of neuropathic pain inadults with MS. Sativex is currently in Phase III trials in Europe for the following indications: - Spasticity and Neuropathic Pain in MS - Peripheral and General Neuropathic Pain - Cancer Pain About Almirall Almirall is a consolidated international pharmaceutical company that researches,develops and commercialises its own R&D and licensed specialities with the aimof improving health and quality of life. The therapeutic areas on which Almirallfocuses its research resources are related to the treatment of asthma, ChronicObstructive Pulmonary Disease (COPD), psoriasis and rheumatoid arthritis. Almirall is to invest 650 million euros in R&D over the next five years.Forecasted total sales in 2005 amount to 946 million euros. Almirall, whoseHeadquarters are in Barcelona (Spain), has a staff of over 3,200 people,approximately 500 of whom form part of the R&D Team. Almirall is currently present in around 100 countries with its own products andlicensed products from other prestigious companies. The company is strengtheningits direct presence in Europe and Latin America via affiliates, and is activelylooking for in-licensing opportunities to support this strategy, medicines forthe Central Nervous System being one of its priority areas. For more information: www.almirall.es About GW Pharmaceuticals plc GW Pharmaceuticals plc is licensed by the UK Home Office to undertake apharmaceutical research and development program to develop cannabis-basedprescription medicines. GW's shares are publicly traded on AiM, a market on theLondon Stock Exchange. Full details of GW and the company's clinical trials program can be found atwww.gwpharm.com. GW's clinical research program is being carried out by a teamof pharmaceutical professionals experienced in drug development and, inparticular, the development of plant-based medicines and drug delivery systems. This news release may contain forward-looking statements that reflect GW'scurrent expectations regarding future events, including the clinical developmentand regulatory clearance of its products. Forward-looking statements involverisks and uncertainties. Actual events could differ materially from thoseprojected herein and depend on a number of factors, including (inter alia), thesuccess of GW's research strategies, the applicability of the discoveries madetherein, the successful and timely completion of clinical studies, includingwith respect to Sativex and GW's other products, the uncertainties related tothe regulatory process, and the acceptance of Sativex and other products byconsumers and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange