GWP.L Regulatory News (GWP)

14 Feb 2007 07:01

GW Pharmaceuticals PLC14 February 2007 GW and Otsuka Announce Major Long Term Strategic Cannabinoid Alliance London, UK; Princeton, NJ, USA; Tokyo, Japan; 14 February 2007: GWPharmaceuticals plc (AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. todayannounce that they have entered into a major long term strategic cannabinoidalliance. The relationship has commenced with the signing of an exclusive license anddevelopment agreement to develop and market Sativex(R), GW's lead product, inthe United States. The companies are also in detailed discussions with a view toentering into a cannabinoid research collaboration in the field of CentralNervous System (CNS) disorders and cancer treatment in order to research,develop and commercialize a range of other early stage cannabinoid productopportunities. The Otsuka Pharmaceutical Group has placed significant emphasis on the researchof CNS disorders for the past 27 years. Otsuka's lead product in the field ofCNS ranks among the top seven product launches in industry history and the No. 1product launch since 2002. Worldwide revenues from this product increased from$1.3bn in 2005 to over $1.9bn in 2006. The Group is privately owned, comprises87 companies and employs approximately 27,000 people in 17 countries and regionsworldwide. It earned revenues of $6.8 billion in fiscal 2005, ranking it the26th largest pharmaceutical company in the world (1). Otsuka is continuing toexpand its CNS specialty sales force presence in the US. Sativex US License Under the terms of the license agreement, GW has granted Otsuka an exclusivelicense to develop and market Sativex, GW's lead product, in the US. GW will beresponsible for the manufacture and supply of Sativex to Otsuka. The agreementis subject to Hart Scott Rodino clearance in the US. The financial terms of this agreement include total milestone payments to GW ofup to $273m as well as a long term commercial supply price and royalty. Otsukawill pay GW a signature fee of $18m. In addition, Otsuka will bear the costs ofall US development activities for Sativex in the treatment of cancer pain,additional indications, and future formulations. GW and Otsuka will jointly oversee all US clinical development and regulatoryactivities. For the first cancer pain indication, GW will be responsible forcarrying out such activities, at Otsuka's cost. GW will also continue to be theholder of the IND until the filing of a New Drug Application, which will be inOtsuka's name. Otsuka will assume development and regulatory responsibility forthe second and any subsequent indications. In 2006, the Food & Drug Administration (FDA) permitted Sativex to enterdirectly into late stage development in the US for the treatment of pain inpatients with advanced cancer that has not been adequately relieved by opioidmedications. GW and Otsuka currently plan for the first US pivotal efficacyclinical trial to be a Phase II/III cancer pain dose ranging study, to commencethis year. Commenting on Sativex, Dr. Russell K. Portenoy, Chairman of the Department ofPain Medicine and Palliative Care at Beth Israel Medical Center in New YorkCity, and principal investigator of the first planned US Sativex study said, "Aprevious Phase III clinical study showed that Sativex achieved a statisticallysignificant improvement in pain relief in terminally ill cancer patients. Thereare 3.9 million cancer patients in the US, of which 2.5 million suffer pain.Although opioids are highly effective analgesics, studies suggest that as manyas one-third of patients with pain due to advanced cancer do not obtain adequaterelief and new treatments are needed. Cannabinoid formulations may represent animportant option in the future and the information obtained from clinical trialsof Sativex will be critical in defining their role." Cannabinoid Research Collaboration Under the proposed cannabinoid research collaboration, which is currently underdetailed discussion and is expected to be formalized in a separate agreementlater in the year, Otsuka would fund the evaluation of a range of cannabinoidsas drug candidates within the field of CNS and cancer treatment, with a view toselecting the most promising candidates for full clinical development,regulatory approval and global commercialization. Products selected forcommercialization would be the subject of a license from GW. Under the terms ofthis license, Otsuka would fund the global development of selected products andGW would receive commercially reasonable financial terms. Dr Geoffrey Guy, GW's Chairman, said, "This agreement represents a landmarkevent in the history of GW. Not only have we secured the development andmarketing of our lead product, Sativex, in the world's largest market, we havealso selected a strategic partner that will allow us to extend our cannabinoidpipeline. Otsuka has an excellent US commercial track record and a world leadingCNS science base. We are delighted to be working with Otsuka to fulfill ourambition of developing a range of novel cannabinoid medicines to meet seriousunmet medical needs." Taro Iwamoto, PhD, President & COO, Otsuka Pharmaceutical Development &Commercialization, Inc., said, "Otsuka is delighted to be entering into thisstrategic relationship with GW. Otsuka's scientists consider cannabinoids to bea significant potential source of new medicines, and as world leading pioneersin this field, GW represents the ideal partner for Otsuka. Otsuka is committedto maximizing the potential of Sativex in the US market and looks forward toexploring a range of longer term cannabinoid product opportunities. We areconfident that this is the beginning of a highly productive and valuablerelationship for both companies." There will be a conference call for analysts today at 8.30am GMT. Analystsshould contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113for details. There will be a live audio web cast of this call, which will beaccessible on the press releases page in the investor relations section of theGW website (www.gwpharm.com). A recording of this call will be available on theGW website later today. Enquiries:For GW: GW Pharmaceuticals plc Today: +44 20 7831 3113 Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000 Justin Gover, Managing Director Mark Rogerson, Press and PR Tel: + 44 7885 638810 Financial Dynamics Tel: +44 20 7831 3113 David Yates, Nicola Daley For Otsuka: US Enquiries Debbie Kaufmann Tel: +1 240 683 3568 Europe Enquiries Alison Ross Tel: +44 1895 207 7122 Japan Enquiries Hideki Shirai Tel: +81 3 3292 0021 Notes to Editors About Otsuka Pharmaceutical Co., Ltd Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company withthe mission statement: "Otsuka - people creating new products for better healthworldwide." Otsuka researches, develops, manufactures and markets innovative,original products, focusing its core businesses on pharmaceutical products forthe treatment of disease and consumer products for the maintenance of everydayhealth. The Otsuka Pharmaceutical Group comprises 87 companies and employsapproximately 27,000 people in 17 countries and regions worldwide. Otsuka andits consolidated subsidiaries earned US $6.8 billion in consolidated annualrevenues in fiscal 2005. The Group has R&D facilities in Japan (Osaka andTokushima), EU (Frankfurt) and US (Rockville, MD). Its commercial operations areheadquartered in US (Rockville, MD and Princeton, NJ), EU (UK) and Japan(Tokyo). For additional information, visit www.otsuka-global.com About GW GW was founded in 1998 and listed on the AiM, a market of the London StockExchange, in June 2001. Operating under license from the UK Home Office, thecompany researches and develops cannabinoid pharmaceutical products thatalleviate pain and other neurological symptoms in patients who suffer fromserious ailments. GW has assembled a team of over 100 scientists with extensiveexperience in developing both plant-based prescription pharmaceutical productsand medicines containing controlled substances. GW occupies a world leadingposition in cannabinoids and has developed an extensive international network ofthe most prominent scientists in the field. GW has to date entered into twoadditional Sativex license agreements - with Bayer HealthCare in the UK andCanada, and with Almirall in Europe (ex-UK). These agreements together providepayments to GW totaling up to £79m ($156m) as well as significant long termsupply price provisions. For further information, please visit www.gwpharm.com About Sativex Sativex is an investigational product presented as a pump action oro-mucosalspray, which delivers a pharmaceutical formulation containing delta 9tetrahydrocannabinol (THC) and cannabidiol (CBD). Each 100(micro)L spraycontains 2.7mg THC and 2.5mg CBD. Sativex is standardized by both composition and dose and is supplied in smallspray vials. Sativex is thought to act via cannabinoid receptors that aredistributed throughout the central nervous system and in immune cells (2).These receptors are distributed throughout the pain pathways of the nervoussystem, and their activation is known to reduce pain in relevant pain models. Sativex showed positive results in a completed Phase III study in Europe in 177patients with cancer pain. Patients in the study had advanced cancer and wereexperiencing pain that was not responding adequately to strong opioid medication(e.g. morphine). In addition to study medication, all patients remained on theirexisting opioid and other analgesic medication during the trial. In this study,Sativex achieved a statistically significant improvement in comparison withplacebo in pain as measured on a numerical rating scale (p=0.014), a primaryendpoint of the study. A responder analysis showed that approximately 40% ofpatients on Sativex showed a greater than 30% improvement in their pain (p=0.024). Outside the US, Sativex is approved and marketed in Canada for the symptomaticrelief of central neuropathic pain in Multiple Sclerosis, and is the subject ofan ongoing regulatory submission in Canada for the relief of cancer pain.Sativex is also the subject of an ongoing regulatory application in fourselected European countries for the symptomatic relief of spasticity in MS. About Cannabinoids The cannabinoid (CB) receptor system is a complex and far-reaching system whichhas only started to become understood in the last decade or so. To date, CB1 andCB2 receptors have been identified and cloned. Initially, the chemicals whichaffect these receptors ("cannabinoids") were identified only within the cannabisplant, but extensive scientific investigation has now elaborated a series ofendogenous chemicals which maintain this 'endocannabinoid system'. Theseendogenous cannabinoids are produced in human tissues, exert their actionswithin those tissues and are then destroyed locally. This allows the system tofunction in a fine-tuning, modulatory role, and abnormalities of theendocannabinoid system have now been found in several important diseases.Originally, it was believed that these receptors acted largely within the brain,but it is becoming increasingly clear that they are present at many differentsites, in many different body systems. The importance of the integrity of this system of receptors in maintainingseveral critical areas of mental and physical well-being is becoming clearerbecause of the type of research that GW and its collaborators are performing.Equally, this research work has identified several important disease areas wherethe administration of cannabinoids as medicines may lead to desirabletherapeutic consequences. Cannabinoid modulators are showing promise in chronicpainful conditions, in movement disorders, and in disorders of cellproliferation such as cancer. Furthermore, the role of cannabinoids in the brainmay offer therapeutic promise in disorders of behaviour and mood. This is anarea of active scientific discovery and therapeutic research which may deliver arange of new treatments to meet unmet medical needs. Footnotes: (1) Pharmaceutical Executive, May 2006 (2) Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Last accessed 16 December 2005. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html. This news release may contain forward-looking statements that reflect GWscurrent expectations regarding future events, including development andregulatory clearance of the GW's 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 the GW's research strategies, the applicability of the discoveriesmade therein, the successful and timely completion of uncertainties related tothe regulatory process, and the acceptance of Sativex and other products byconsumer and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange