Almirall and GW announce European development and marketing agreement for Sativex®
This medication is already approved in Canada for the relief of neuropathic pain in adults with multiple sclerosis and is currently in Phase III trials in Europe
Barcelona, December 12 2005 - Almirall and the UK based pharmaceutical company GW Pharmaceuticals announce that they have entered into an exclusive agreement for Almirall to market Sativex® in Europe.
The licensed territory includes the members of the European Union (EU) countries, EU accession countries as well as Switzerland, Norway and Turkey. In the UK, Sativex is already licensed to Bayer HealthCare.
Sativex® is being developed by GW and is a novel prescription pharmaceutical product derived from components of the cannabis plant. Sativex® is administered via a spray into the mouth. In April 2005, Canada became the first country in the world to approve Sativex® as a prescription medicine for neuropathic pain in Multiple Sclerosis (MS). Sativex® is a pharmaceutical product standardised in composition, formulation, and dose. Its principal active cannabinoid components are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). In Europe it is in Phase III trials for the treatment of MS symptoms (neuropathic pain and spasticity), neuropathic pain (peripheral and general) and cancer pain. Under the agreement, GW is responsible for completing the development of Sativex® for these three indications. In addition to the three initial target indications, Almirall and GW expect to collaborate on the development of Sativex® in other indications.
"We are very pleased with this agreement for Sativex® with GW Pharmaceuticals. GW has proven to be an innovative company with a strong scientific basis. This partnership represents a step forward for Almirall reinforcing our presence in European markets, and is a key milestone in our aim of offering society innovative medicines to fulfill unmet medical needs. Our challenge is to improve the health and quality of life of patients suffering from MS and other debilitating conditions" said Dr Jorge Gallardo, President-CEO of Almirall.
Dr Geoffrey Guy, Executive Chairman of GW, said: "We are delighted to have entered into this agreement with Almirall. As one of the leading specialist European pharmaceutical companies, Almirall is exactly the profile of partner that we have been seeking for Sativex®. We look forward to working together in building a successful long term collaboration and to realising the market potential for Sativex® across all its potential indications."
Under the terms of the agreement, GW has maintained a share of long term product revenues whilst benefiting from a £12 million signature fee. In addition, milestone payments are payable on the successful completion of each of the ongoing pivotal Phase III trials, as well as on regulatory approvals and in relation to achievement of sales targets. Including the signature fee, total milestones payable under the contract may total up to £46 million.
About Almirall
Almirall is a consolidated international pharmaceutical company that researches, develops and commercialises its own R&D and licensed specialities with the aim of improving health and quality of life. The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, Chronic Obstructive 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, whose Headquarters 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 and licensed products from other prestigious companies. The company is strengthening 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.
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development program to develop cannabis-based prescription medicines.GW's shares are publicly traded on AiM, a market on the London Stock Exchange.
Full details of GW and the company's clinical trials program can be found at www.gwpharm.com.GW's clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems.