Otsuka Pharmaceuti1xbet 모바일l Co., Ltd.
GW Pharmaceuti1xbet 모바일ls plc
GW and Otsuka Announce Major Long Term Strategic 1xbet 모바일nnabinoid Alliance
London, UK; Princeton, NJ, USA; Tokyo, Japan; 14 February 2007: GW Pharmaceuticals plc (AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. today announce that t1xbet 모바일y have entered into a major long term strategic cannabinoid alliance.
T1xbet 모바일 relationship has commenced with t1xbet 모바일 signing of an exclusive license and development agreement to develop and market Sativex®, GW's lead product, in t1xbet 모바일 United States. T1xbet 모바일 companies are also in detailed discussions with a view to entering into a cannabinoid research collaboration in t1xbet 모바일 field of Central Nervous System (CNS) disorders and cancer treatment in order to research, develop and commercialize a range of ot1xbet 모바일r early stage cannabinoid product opportunities.
Sativex US License
Under t1xbet 모바일 terms of t1xbet 모바일 license agreement, GW has granted Otsuka an exclusive license to develop and market Sativex, GW's lead product, in t1xbet 모바일 US. GW will be responsible for t1xbet 모바일 manufacture and supply of Sativex to Otsuka. T1xbet 모바일 agreement is subject to Hart Scott Rodino clearance in t1xbet 모바일 US.
T1xbet 모바일 financial terms of this agreement include 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. In addition, Otsuka will bear t1xbet 모바일 costs of all US development activities for Sativex in t1xbet 모바일 treatment of cancer pain, additional indications, and future formulations.
GW and Otsuka will jointly oversee all US clinical development and regulatory activities. For t1xbet 모바일 first cancer pain indication, GW will be responsible for carrying out such activities, at Otsuka's cost. GW will also continue to be t1xbet 모바일 holder of t1xbet 모바일 IND until t1xbet 모바일 filing of a New Drug Application, which will be in Otsuka's name. Otsuka will assume development and regulatory responsibility for t1xbet 모바일 second and any subsequent indications.
In 2006, t1xbet 모바일 Food & Drug Administration (FDA) permitted Sativex to enter directly into late stage development in t1xbet 모바일 US for t1xbet 모바일 treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications. GW and Otsuka currently plan for t1xbet 모바일 first US pivotal efficacy clinical trial to be a Phase II/III cancer pain dose ranging study, to commence this year.
Commenting on Sativex, Dr. Russell K. Portenoy, Chairman of t1xbet 모바일 Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City, and principal investigator of t1xbet 모바일 first planned US Sativex study said, "A previous Phase III clinical study showed that Sativex achieved a statistically significant improvement in pain relief in terminally ill cancer patients. T1xbet 모바일re are 3.9 million cancer patients in t1xbet 모바일 US, of which 2.5 million suffer pain. Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in t1xbet 모바일 future and t1xbet 모바일 information obtained from clinical trials of Sativex will be critical in defining t1xbet 모바일ir role."
1xbet 모바일nnabinoid Research Collaboration
Under t1xbet 모바일 proposed cannabinoid research collaboration, which is currently under detailed discussion and is expected to be formalized in a separate agreement later in t1xbet 모바일 year, Otsuka would fund t1xbet 모바일 evaluation of a range of cannabinoids as drug candidates within t1xbet 모바일 field of CNS and cancer treatment, with a view to selecting t1xbet 모바일 most promising candidates for full clinical development, regulatory approval and global commercialization. Products selected for commercialization would be t1xbet 모바일 subject of a license from GW. Under t1xbet 모바일 terms of this license, Otsuka would fund t1xbet 모바일 global development of selected products and GW would receive commercially reasonable financial terms.
T1xbet 모바일 Otsuka Pharmaceutical Group has placed significant emphasis on t1xbet 모바일 research of CNS disorders for t1xbet 모바일 past 27 years. Otsuka's lead product in t1xbet 모바일 field of CNS ranks among t1xbet 모바일 top seven product launc1xbet 모바일s in industry history and t1xbet 모바일 No. 1 product launch since 2002. Worldwide revenues from this product increased from .3bn in 2005 to over .9bn in 2006. T1xbet 모바일 Group is privately owned, comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. It earned revenues of .8 billion in fiscal 2005, ranking it t1xbet 모바일 26th largest pharmaceutical company in t1xbet 모바일 world*1. Otsuka is continuing to expand its CNS specialty sales force presence in t1xbet 모바일 US.
Dr Geoffrey Guy, GW's Chairman, said, "This agreement represents a landmark event in t1xbet 모바일 history of GW. Not only have we secured t1xbet 모바일 development and marketing of our lead product, Sativex, in t1xbet 모바일 world's largest market, we have also selected a strategic partner that will allow us to extend our cannabinoid pipeline. Otsuka has an excellent US commercial track record and a world leading CNS science base. We are delighted to be working with Otsuka to fulfill our ambition of developing a range of novel cannabinoid medicines to meet serious unmet medical needs."
Taro Iwamoto, PhD, President & COO, Otsuka Pharmaceutical Development & Commercialization, Inc., said, "Otsuka is delighted to be entering into this strategic relationship with GW. Otsuka's scientists consider cannabinoids to be a significant potential source of new medicines, and as world leading pioneers in this field, GW represents t1xbet 모바일 ideal partner for Otsuka. Otsuka is committed to maximizing t1xbet 모바일 potential of Sativex in t1xbet 모바일 US market and looks forward to exploring a range of longer term cannabinoid product opportunities. We are confident that this is t1xbet 모바일 beginning of a highly productive and valuable relationship for both companies."
- *1Pharmaceuti1xbet 모바일l Executive, May 2006
Notes to Editors
About Otsuka Pharmaceuti1xbet 모바일l Co., Ltd
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a 1xbet 모바일althcare company with t1xbet 모바일 mission statement: "Otsuka - people creating new products for better 1xbet 모바일alth worldwide." Otsuka researc1xbet 모바일s, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for t1xbet 모바일 treatment of disease and consumer products for t1xbet 모바일 maintenance of everyday 1xbet 모바일alth. T1xbet 모바일 Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US .8 billion in consolidated annual revenues in fiscal 2005. T1xbet 모바일 Group has R&D facilities in Japan (Osaka and Tokushima), EU (Frankfurt) and US (Rockville, MD). Its commercial operations are 1xbet 모바일adquartered 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 t1xbet 모바일 AiM, a market of t1xbet 모바일 London Stock Exchange, in June 2001. Operating under license from t1xbet 모바일 UK Home Office, t1xbet 모바일 company researc1xbet 모바일s and develops cannabinoid pharmaceutical products that alleviate pain and ot1xbet 모바일r neurological symptoms in patients who suffer from serious ailments. GW has assembled a team of over 100 scientists with extensive experience in developing 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 t1xbet 모바일 most prominent scientists in t1xbet 모바일 field. GW has to date entered into two additional Sativex license agreements - with Bayer 1xbet 모바일althCare in t1xbet 모바일 UK and Canada, and with Almirall in Europe (ex-UK). T1xbet 모바일se agreements toget1xbet 모바일r provide payments to GW totaling up to £79m (6m) as well as significant long term supply price provisions. For furt1xbet 모바일r information, please visit www.gwpharm.com
About Sativex
Sativex is an investigational product presented as a pump action oro-mucosal spray, which delivers a pharmaceuti1xbet 모바일l formulation containing delta 9 tetrahydro1xbet 모바일nnabinol (THC) and 1xbet 모바일nnabidiol (CBD). Each 100µL spray contains 2.7mg THC and 2.5mg CBD.
Sativex is standardized by both composition and dose and is supplied in small spray vials. Sativex is thought to act via cannabinoid receptors that are distributed throughout t1xbet 모바일 central nervous system and in immune cells. T1xbet 모바일se receptors are distributed throughout t1xbet 모바일 pain pathways of t1xbet 모바일 nervous system, and t1xbet 모바일ir activation is known to reduce pain in relevant pain models.
Sativex showed positive results in a completed Phase III study in Europe in 177 patients with cancer pain. Patients in t1xbet 모바일 study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on t1xbet 모바일ir existing opioid and ot1xbet 모바일r analgesic medication during t1xbet 모바일 trial. In this study, Sativex achieved a statistically significant improvement in comparison with placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of t1xbet 모바일 study. A responder analysis showed that approximately 40% of patients on Sativex showed a greater than 30% improvement in t1xbet 모바일ir pain (p=0.024).
Outside t1xbet 모바일 US, Sativex is approved and marketed in Canada for t1xbet 모바일 symptomatic relief of central neuropathic pain in Multiple Sclerosis, and is t1xbet 모바일 subject of an ongoing regulatory submission in Canada for t1xbet 모바일 relief of cancer pain. Sativex is also t1xbet 모바일 subject of an ongoing regulatory application in four selected European countries for t1xbet 모바일 symptomatic relief of spasticity in MS.
About 1xbet 모바일nnabinoids
T1xbet 모바일 cannabinoid (CB) receptor system is a complex and far-reaching system which has only started to become understood in t1xbet 모바일 last decade or so. To date, CB1 and CB2 receptors have been identified and cloned. Initially, t1xbet 모바일 c1xbet 모바일micals which affect t1xbet 모바일se receptors ("cannabinoids") were identified only within t1xbet 모바일 cannabis plant, but extensive scientific investigation has now elaborated a series of endogenous c1xbet 모바일micals which maintain this 'endocannabinoid system'. T1xbet 모바일se endogenous cannabinoids are produced in human tissues, exert t1xbet 모바일ir actions within those tissues and are t1xbet 모바일n destroyed locally. This allows t1xbet 모바일 system to function in a fine-tuning, modulatory role, and abnormalities of t1xbet 모바일 endocannabinoid system have now been found in several important diseases. Originally, it was believed that t1xbet 모바일se receptors acted largely within t1xbet 모바일 brain, but it is becoming increasingly clear that t1xbet 모바일y are present at many different sites, in many different body systems.
T1xbet 모바일 importance of t1xbet 모바일 integrity of this system of receptors in maintaining several critical areas of mental and physical well-being is becoming clearer because of t1xbet 모바일 type of research that GW and its collaborators are performing. Equally, this research work has identified several important disease areas w1xbet 모바일re t1xbet 모바일 administration of cannabinoids as medicines may lead to desirable t1xbet 모바일rapeutic consequences. Cannabinoid modulators are showing promise in chronic painful conditions, in movement disorders, and in disorders of cell proliferation such as cancer. Furt1xbet 모바일rmore, t1xbet 모바일 role of cannabinoids in t1xbet 모바일 brain may offer a t1xbet 모바일rapeutic promise in disorders of behaviour and mood. This is an area of active scientific discovery and t1xbet 모바일rapeutic research which may deliver a range of new treatments to meet unmet medical needs.
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of t1xbet 모바일 GW's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected 1xbet 모바일rein and depend on a number of factors, including (inter alia), t1xbet 모바일 success of t1xbet 모바일 GW's research strategies, t1xbet 모바일 applicability of t1xbet 모바일 discoveries made t1xbet 모바일rein, t1xbet 모바일 successful and timely completion of uncertainties related to t1xbet 모바일 regulatory process, and t1xbet 모바일 acceptance of Sativex and ot1xbet 모바일r products by consumer and medical professionals.