Otsuka Pharmaceutical Co. Ltd
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately USD 13 billion for fiscal year 2012. https://www.otsuka.co.jp/en/
GW and Otsuka are collaborating on the US development of Sativex. The initial target indication for FDA approval is cancer pain. Sativex is currently undergoing a Phase IIb/III clinical trial in cancer pain.
Under the Sativex US licence agreement, GW has granted Otsuka an exclusive license to develop and market Sativex in the US. GW is responsible for the manufacture and supply of Sativex to Otsuka. GW and Otsuka jointly oversee all US clinical development and regulatory activities. Such activities are being carried out by GW at Otsuka’s cost.
Novartis Pharma AG
Novartis is one of the world’s leading pharmaceutical companies. In 2010, Novartis Group's continuing operations achieved net sales of USD 50.6 billion. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates and operate in more than 140 countries around the world.
GW has entered into an exclusive licence agreement for Novartis to commercialise Sativex in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), Middle East (excluding Israel/Palestine) and Africa. Under the terms of the agreement, Novartis has exclusive commercialisation rights to Sativex and will act as Marketing Authorisation holder for Sativex. GW will be responsible for the manufacture and supply of Sativex to Novartis.
Almirall is Spain’s largest pharmaceutical company with sales approximating €1 billion. The company has a significant presence in Spain, where it is number two by market share, and has 11 subsidiary operations in other major European markets, including France, Germany, Italy, UK, Portugal and Belgium, as well as in Latin America.
GW has licensed Sativex’s European (ex-UK) marketing rights to Almirall. The initial target indication for European approval is MS spasticity and a regulatory submission has been filed. GW and Almirall aim in the future to expand the approved indication in Europe to include cancer pain.
Under the GW-Almirall licence agreement, Almirall hold the marketing rights in the European Union (excluding the UK), EU accession countries as well as Switzerland, Norway and Turkey. GW is responsible for the manufacture and supply of Sativex to Almirall.
Bayer HealthCare AG
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry. The pharmaceuticals business operates under the name Bayer Schering Pharma. This business employs 38,000 people and reported 2007 sales of €10.3bn.
GW has licensed Sativex’s UK and Canadian marketing rights to Bayer. Bayer currently market Sativex in the UK in the indication of spasticity due to multiple sclerosis and in Canada where it is approved for spasticity due to MS, neuropathic pain in MS and cancer pain. GW and Bayer aim in the future to expand the approved indication in the UK to include cancer pain.
Ipsen (Euronext: IPN; ADR: IPSEY) is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2013. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2012, R&D expenditure totalled close to €250 million, representing more than 20% of Group sales. The Group has close to 4,900 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (IPN) and eligible to the “Service de Règlement Différé” (“SRD”).
On January 14th, 2014, Ipsen and GW Pharmaceuticals plc entered into an exclusive agreement for Ipsen to promote and distribute Sativex®, a sublingual cannabis extract spray intended for the treatment of spasticity due to multiple sclerosis (MS) in Latin America (excluding Mexico and the Islands of the Caribbean). GW will be responsible for commercial product supply to Ipsen.
Established in 1941, the Neopharm Group is the 2nd largest marketing group in the Israeli health care market with 600 employees and $300M revenues.
The Neopharm Group hold exclusive commercial rights to Sativex in Israel/Palestine.