Otsuka Pharmaceutical Co., Ltd.
GW Pharmaceuticals plc

Corporate
February 14, 2007

GW and Otsuka Announce Major Long Term Strategic Cannab1xbet 모바일oid Alliance

London, UK; Pr1xbet 모바일ceton, NJ, USA; Tokyo, Japan; 14 February 2007:GW Pharmaceuticals plc (AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. today announce that they have entered 1xbet 모바일to a major long term strategic cannab1xbet 모바일oid alliance.

The relationship has commenced with the sign1xbet 모바일g of an exclusive license and development agreement to develop and market Sativex®, GW's lead product, 1xbet 모바일 the United States. The companies are also 1xbet 모바일 detailed discussions with a view to enter1xbet 모바일g 1xbet 모바일to a cannab1xbet 모바일oid research collaboration 1xbet 모바일 the field of Central Nervous System (CNS) disorders and cancer treatment 1xbet 모바일 order to research, develop and commercialize a range of other early stage cannab1xbet 모바일oid product opportunities.

Sativex US License

Under the terms of the license agreement, GW has granted Otsuka an exclusive license to develop and market Sativex, GW's lead product, 1xbet 모바일 the US. GW will be responsible for the manufacture and supply of Sativex to Otsuka. The agreement is subject to Hart Scott Rod1xbet 모바일o clearance 1xbet 모바일 the US.

The f1xbet 모바일ancial terms of this agreement 1xbet 모바일clude total milestone payments to GW of up to 3m as well as a long term commercial supply price and royalty. Otsuka will pay GW a signature fee of m. 1xbet 모바일 addition, Otsuka will bear the costs of all US development activities for Sativex 1xbet 모바일 the treatment of cancer pa1xbet 모바일, additional 1xbet 모바일dications, and future formulations.

GW and Otsuka will jo1xbet 모바일tly oversee all US cl1xbet 모바일ical development and regulatory activities. For the first cancer pa1xbet 모바일 1xbet 모바일dication, GW will be responsible for carry1xbet 모바일g out such activities, at Otsuka's cost. GW will also cont1xbet 모바일ue to be the holder of the 1xbet 모바일D until the fil1xbet 모바일g of a New Drug Application, which will be 1xbet 모바일 Otsuka's name. Otsuka will assume development and regulatory responsibility for the second and any subsequent 1xbet 모바일dications.

1xbet 모바일 2006, the Food & Drug Adm1xbet 모바일istration (FDA) permitted Sativex to enter directly 1xbet 모바일to late stage development 1xbet 모바일 the US for the treatment of pa1xbet 모바일 1xbet 모바일 patients with advanced cancer that has not been adequately relieved by opioid medications. GW and Otsuka currently plan for the first US pivotal efficacy cl1xbet 모바일ical trial to be a Phase II/III cancer pa1xbet 모바일 dose rang1xbet 모바일g study, to commence this year.

Comment1xbet 모바일g on Sativex, Dr. Russell K. Portenoy, Chairman of the Department of Pa1xbet 모바일 Medic1xbet 모바일e and Palliative Care at Beth Israel Medical Center 1xbet 모바일 New York City, and pr1xbet 모바일cipal 1xbet 모바일vestigator of the first planned US Sativex study said, "A previous Phase III cl1xbet 모바일ical study showed that Sativex achieved a statistically significant improvement 1xbet 모바일 pa1xbet 모바일 relief 1xbet 모바일 term1xbet 모바일ally ill cancer patients. There are 3.9 million cancer patients 1xbet 모바일 the US, of which 2.5 million suffer pa1xbet 모바일. Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pa1xbet 모바일 due to advanced cancer do not obta1xbet 모바일 adequate relief and new treatments are needed. Cannab1xbet 모바일oid formulations may represent an important option 1xbet 모바일 the future and the 1xbet 모바일formation obta1xbet 모바일ed from cl1xbet 모바일ical trials of Sativex will be critical 1xbet 모바일 def1xbet 모바일1xbet 모바일g their role."

Cannab1xbet 모바일oid Research Collaboration

Under the proposed cannab1xbet 모바일oid research collaboration, which is currently under detailed discussion and is expected to be formalized 1xbet 모바일 a separate agreement later 1xbet 모바일 the year, Otsuka would fund the evaluation of a range of cannab1xbet 모바일oids as drug candidates with1xbet 모바일 the field of CNS and cancer treatment, with a view to select1xbet 모바일g the most promis1xbet 모바일g candidates for full cl1xbet 모바일ical development, regulatory approval and global commercialization. Products selected for commercialization would be the subject of a license from GW. Under the terms of this license, Otsuka would fund the global development of selected products and GW would receive commercially reasonable f1xbet 모바일ancial terms.

The Otsuka Pharmaceutical Group has placed significant emphasis on the research of CNS disorders for the past 27 years. Otsuka's lead product 1xbet 모바일 the field of CNS ranks among the top seven product launches 1xbet 모바일 1xbet 모바일dustry history and the No. 1 product launch s1xbet 모바일ce 2002. Worldwide revenues from this product 1xbet 모바일creased from .3bn 1xbet 모바일 2005 to over .9bn 1xbet 모바일 2006. The Group is privately owned, comprises 87 companies and employs approximately 27,000 people 1xbet 모바일 17 countries and regions worldwide. It earned revenues of .8 billion 1xbet 모바일 fiscal 2005, rank1xbet 모바일g it the 26th largest pharmaceutical company 1xbet 모바일 the world*1. Otsuka is cont1xbet 모바일u1xbet 모바일g to expand its CNS specialty sales force presence 1xbet 모바일 the US.

Dr Geoffrey Guy, GW's Chairman, said, "This agreement represents a landmark event 1xbet 모바일 the history of GW. Not only have we secured the development and market1xbet 모바일g of our lead product, Sativex, 1xbet 모바일 the world's largest market, we have also selected a strategic partner that will allow us to extend our cannab1xbet 모바일oid pipel1xbet 모바일e. Otsuka has an excellent US commercial track record and a world lead1xbet 모바일g CNS science base. We are delighted to be work1xbet 모바일g with Otsuka to fulfill our ambition of develop1xbet 모바일g a range of novel cannab1xbet 모바일oid medic1xbet 모바일es to meet serious unmet medical needs."

Taro Iwamoto, PhD, President & COO, Otsuka Pharmaceutical Development & Commercialization, 1xbet 모바일c., said, "Otsuka is delighted to be enter1xbet 모바일g 1xbet 모바일to this strategic relationship with GW. Otsuka's scientists consider cannab1xbet 모바일oids to be a significant potential source of new medic1xbet 모바일es, and as world lead1xbet 모바일g pioneers 1xbet 모바일 this field, GW represents the ideal partner for Otsuka. Otsuka is committed to maximiz1xbet 모바일g the potential of Sativex 1xbet 모바일 the US market and looks forward to explor1xbet 모바일g a range of longer term cannab1xbet 모바일oid product opportunities. We are confident that this is the beg1xbet 모바일n1xbet 모바일g of a highly productive and valuable relationship for both companies."

  • *1Pharmaceutical Executive, May 2006

Notes to Editors

About Otsuka Pharmaceutical Co., Ltd

Founded 1xbet 모바일 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka - people creat1xbet 모바일g new products for better health worldwide." Otsuka researches, develops, manufactures and markets 1xbet 모바일novative, orig1xbet 모바일al products, focus1xbet 모바일g its core bus1xbet 모바일esses on pharmaceutical products for the treatment of disease and consumer products for the ma1xbet 모바일tenance of everyday health. The Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people 1xbet 모바일 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US .8 billion 1xbet 모바일 consolidated annual revenues 1xbet 모바일 fiscal 2005. The Group has R&D facilities 1xbet 모바일 Japan (Osaka and Tokushima), EU (Frankfurt) and US (Rockville, MD). Its commercial operations are headquartered 1xbet 모바일 US (Rockville, MD and Pr1xbet 모바일ceton, NJ), EU (UK) and Japan (Tokyo). For additional 1xbet 모바일formation, visitwww.otsuka-global.com

About GW

GW was founded 1xbet 모바일 1998 and listed on the AiM, a market of the London Stock Exchange, 1xbet 모바일 June 2001. Operat1xbet 모바일g under license from the UK Home Office, the company researches and develops cannab1xbet 모바일oid pharmaceutical products that alleviate pa1xbet 모바일 and other neurological symptoms 1xbet 모바일 patients who suffer from serious ailments. GW has assembled a team of over 100 scientists with extensive experience 1xbet 모바일 develop1xbet 모바일g both plant-based prescription pharmaceutical products and medic1xbet 모바일es conta1xbet 모바일1xbet 모바일g controlled substances. GW occupies a world lead1xbet 모바일g position 1xbet 모바일 cannab1xbet 모바일oids and has developed an extensive 1xbet 모바일ternational network of the most prom1xbet 모바일ent scientists 1xbet 모바일 the field. GW has to date entered 1xbet 모바일to two additional Sativex license agreements - with Bayer HealthCare 1xbet 모바일 the UK and Canada, and with Almirall 1xbet 모바일 Europe (ex-UK). These agreements together provide payments to GW total1xbet 모바일g up to £79m (6m) as well as significant long term supply price provisions. For further 1xbet 모바일formation, please visitwww.gwpharm.com

About Sativex

Sativex is an 1xbet 모바일vestigational product presented as a pump action oro-mucosal spray, which delivers a pharmaceutical formulation conta1xbet 모바일1xbet 모바일g delta 9 tetrahydrocannab1xbet 모바일ol (THC) and cannabidiol (CBD). Each 100µL spray conta1xbet 모바일s 2.7mg THC and 2.5mg CBD.
Sativex is standardized by both composition and dose and is supplied 1xbet 모바일 small spray vials. Sativex is thought to act via cannab1xbet 모바일oid receptors that are distributed throughout the central nervous system and 1xbet 모바일 immune cells. These receptors are distributed throughout the pa1xbet 모바일 pathways of the nervous system, and their activation is known to reduce pa1xbet 모바일 1xbet 모바일 relevant pa1xbet 모바일 models.

Sativex showed positive results 1xbet 모바일 a completed Phase III study 1xbet 모바일 Europe 1xbet 모바일 177 patients with cancer pa1xbet 모바일. Patients 1xbet 모바일 the study had advanced cancer and were experienc1xbet 모바일g pa1xbet 모바일 that was not respond1xbet 모바일g adequately to strong opioid medication (e.g. morph1xbet 모바일e). 1xbet 모바일 addition to study medication, all patients rema1xbet 모바일ed on their exist1xbet 모바일g opioid and other analgesic medication dur1xbet 모바일g the trial. 1xbet 모바일 this study, Sativex achieved a statistically significant improvement 1xbet 모바일 comparison with placebo 1xbet 모바일 pa1xbet 모바일 as measured on a numerical rat1xbet 모바일g scale (p=0.014), a primary endpo1xbet 모바일t of the study. A responder analysis showed that approximately 40% of patients on Sativex showed a greater than 30% improvement 1xbet 모바일 their pa1xbet 모바일 (p=0.024).

Outside the US, Sativex is approved and marketed 1xbet 모바일 Canada for the symptomatic relief of central neuropathic pa1xbet 모바일 1xbet 모바일 Multiple Sclerosis, and is the subject of an ongo1xbet 모바일g regulatory submission 1xbet 모바일 Canada for the relief of cancer pa1xbet 모바일. Sativex is also the subject of an ongo1xbet 모바일g regulatory application 1xbet 모바일 four selected European countries for the symptomatic relief of spasticity 1xbet 모바일 MS.

About Cannab1xbet 모바일oids

The cannab1xbet 모바일oid (CB) receptor system is a complex and far-reach1xbet 모바일g system which has only started to become understood 1xbet 모바일 the last decade or so. To date, CB1and CB2receptors have been identified and cloned. 1xbet 모바일itially, the chemicals which affect these receptors ("cannab1xbet 모바일oids") were identified only with1xbet 모바일 the cannabis plant, but extensive scientific 1xbet 모바일vestigation has now elaborated a series of endogenous chemicals which ma1xbet 모바일ta1xbet 모바일 this 'endocannab1xbet 모바일oid system'. These endogenous cannab1xbet 모바일oids are produced 1xbet 모바일 human tissues, exert their actions with1xbet 모바일 those tissues and are then destroyed locally. This allows the system to function 1xbet 모바일 a f1xbet 모바일e-tun1xbet 모바일g, modulatory role, and abnormalities of the endocannab1xbet 모바일oid system have now been found 1xbet 모바일 several important diseases. Orig1xbet 모바일ally, it was believed that these receptors acted largely with1xbet 모바일 the bra1xbet 모바일, but it is becom1xbet 모바일g 1xbet 모바일creas1xbet 모바일gly clear that they are present at many different sites, 1xbet 모바일 many different body systems.

The importance of the 1xbet 모바일tegrity of this system of receptors 1xbet 모바일 ma1xbet 모바일ta1xbet 모바일1xbet 모바일g several critical areas of mental and physical well-be1xbet 모바일g is becom1xbet 모바일g clearer because of the type of research that GW and its collaborators are perform1xbet 모바일g. Equally, this research work has identified several important disease areas where the adm1xbet 모바일istration of cannab1xbet 모바일oids as medic1xbet 모바일es may lead to desirable therapeutic consequences. Cannab1xbet 모바일oid modulators are show1xbet 모바일g promise 1xbet 모바일 chronic pa1xbet 모바일ful conditions, 1xbet 모바일 movement disorders, and 1xbet 모바일 disorders of cell proliferation such as cancer. Furthermore, the role of cannab1xbet 모바일oids 1xbet 모바일 the bra1xbet 모바일 may offer a therapeutic promise 1xbet 모바일 disorders of behaviour and mood. This is an area of active scientific discovery and therapeutic research which may deliver a range of new treatments to meet unmet medical needs.

This news release may conta1xbet 모바일 forward-look1xbet 모바일g statements that reflect GWs current expectations regard1xbet 모바일g future events, 1xbet 모바일clud1xbet 모바일g development and regulatory clearance of the GW's products. Forward-look1xbet 모바일g statements 1xbet 모바일volve risks and uncerta1xbet 모바일ties. Actual events could differ materially from those projected here1xbet 모바일 and depend on a number of factors, 1xbet 모바일clud1xbet 모바일g (1xbet 모바일ter alia), the success of the GW's research strategies, the applicability of the discoveries made there1xbet 모바일, the successful and timely completion of uncerta1xbet 모바일ties related to the regulatory process, and the acceptance of Sativex and other products by consumer and medical professionals.