European Marketing Agreement for Sativex Between GW and Almirall
Dec 12, 2005, 15:52, Reviewed by: Dr. Priya Saxena
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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 Canada, Sativex is approved for the symptomatic relief of neuropathic pain in adults with MS. Sativex is currently in Phase III trials in Europe for Spasticity and Neuropathic Pain in MS, Peripheral and General Neuropathic Pain and Cancer Pain.
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By GW Pharmaceuticals,
GW and Almirall Prodesfarma, S.A. (�Almirall�) announce that they have entered into an exclusive agreement for Almirall to market Sativex� in Europe (excluding the UK).
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.
Under the terms of the agreement, GW has maintained a significant 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, milestones payable under the contract may total up to �46 million.
Almirall is Spain�s largest pharmaceutical company and one of Europe�s leading private 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 in around 100 countries worldwide and has a portfolio of proprietary and licensed products. The company has a significant presence in Spain, where it is number two by market share, and subsidiary operations in other major European markets, including France, Germany, Italy, Portugal and Belgium. Almirall is currently 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.
Sativex is in Phase III trials for the treatment of Multiple Sclerosis 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. The parties will be discussing potential new indications over the coming months. It is anticipated that Almirall will contribute to the cost of development of new indications.
The licensed territory includes the members of the European Union (excluding the UK), EU accession countries as well as Switzerland, Norway and Turkey. In countries where Almirall has no direct presence at the time of product launch, the companies shall jointly agree the appointment of distribution partners. In such 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 is to be responsible for commercial product supply and will manage the supply of product through a range of contract manufacturing partners, arrangements for which are all in place and being utilised to supply commercial product to Canada.
Following receipt of the signature fee, GW�s financial position has been significantly strengthened, with net cash balances now totalling �22 million.
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. GW�s commercial strategy is to maximise the value of Sativex by retaining a significant interest in revenues from product sales whilst at the same time generating sizeable cash payments in the short term to meet GW�s financial requirements. The terms of this agreement reflect the merits of this strategy.�
Dr Jorge Gallardo, President-CEO of Almirall, said: �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.� 
- GW Pharmaceuticals plc
www.gwpharm.com
Sativex
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 Canada, Sativex is approved for the symptomatic relief of neuropathic pain in adults 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 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.
For more information: http://www.almirall.es
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.
This news release may contain forward-looking statements that reflect GW's current expectations regarding future events, including the clinical development and regulatory clearance of its 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 GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW's other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.
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