GW and Almirall strengthen strategic collaboration
Financial terms amended to provide for near term €12m (£10m) milestone payment to GW
Almirall granted commercial rights to Sativex® for Mexican market
GW and Almirall strengthen strategic collaboration
15 March 2012
Porton Down, UK; 15 March 2012: GW Pharmaceuticals plc (AIM: GWP) announces that it has signed an amendment to its Sativex® licence agreement with Almirall S.A. As part of the revised agreement, Almirall has been granted rights to market Sativex® in Mexico and GW will receive a new near term milestone payment of €12 million (£10 million).
Under the terms of the original licence agreement signed in December 2005, Almirall was granted exclusive rights to market Sativex®in Europe (excluding the UK). With Sativex®now approved and launched by Almirall in certain European countries and with further launches planned, GW and Almirall have revisited the financial terms in order to optimise the agreement to best suit the current strategic interests of both companies.
In return for Almirall agreeing to pay to GW a new milestone payment of €12m (£10m) based on a near term cancer pain trial recruitment target, GW has agreed to reduce the Sativex®supply price charged by GW to Almirall over the next few years until the launch of Sativex®in the cancer pain indication in Europe and has agreed to cancel future cancer pain launch milestones of £5.5m. In addition, Almirall has been granted exclusive rights to commercialise Sativex®in Mexico, a country in which Almirall has had an affiliate in place for more than a decade.
Luciano Conde, Chief Operating Officer of Almirall, said “We have been very pleased with our partnership with GW and the initial market response to Sativex®. Sativex®is a new therapeutic option to alleviate suffering from the physical impairment caused by muscle spasticity and Almirall has been committed to ensuring its availability across Europe and now also in Mexico.”
Justin Gover, Managing Director of GW, said “We are delighted to expand our long term relationship with Almirall. We have been impressed with their commitment to the product and pleased with their success to date. The new near term milestone payment will further strengthen our balance sheet at a time when we are supporting multiple European Sativex®launches as well as planning to expand manufacturing for the United States market and for the future cancer pain indication. A further consequence of this new near term milestone payment is that GW now expects to report a small profit in the current financial year ending 30 September 2012.”
Sativex®is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada and New Zealand. Launches are expected during 2012 in Italy, Sweden, Austria and the Czech Republic. In addition, a Mutual Recognition Procedure (MRP) regulatory filing is currently underway to expand Sativex®approvals to ten additional European countries. It is expected that this new MRP process should complete around mid 2012.
Sativex®is approved as a treatment for spasticity in people with Multiple Sclerosis. The product is also in Phase III clinical development as a treatment for cancer pain.
GW Pharmaceuticals pl:(Today)+ 44 20 7831 3113
Dr Geoffrey Guy, Executive Chairman: (Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Financial Dynamics:+ 44 20 7831 3113
Ben Atwell / John Dineen
GW Nominated Adviser: Peel Hunt LLP:+44 (0)20 7418 8900
James Steel / Vijay Barathan
Notes to Editors
Sativex®is indicated for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. Sativex®is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue) and has a flexible dosing regime, particularly appropriate given the variable nature of both spasticity and multiple sclerosis from patient to patient.
Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.
Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), gastrointestinal disorders, psoriasis and other dermatological conditions. Almirall’s products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 12 affiliates. For further information please visit the website at: www.almirall.com
GW was founded in 1998 and listed on the AIM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. For further information, please visit www.gwpharm.com
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW’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 GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex®and other products by consumer and medical professionals.