Date: 2014-01-14
Type of information: Distribution agreement
Compound: Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)
Company: Ipsen (France) GW Pharmaceutical (UK)
Therapeutic area: Neurodegenerative diseases
Type agreement: promotion
distribution
Action mechanism: Sativex® is an endocannabinoid modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). As part of the human endocannabinoid system (ECS), cannabinoid receptors, CB1 and CB2 receptors are found predominantly at nerve terminals where they have a role in retrograde regulation of synaptic function. THC acts as a partial agonist at both CB1 and CB2 receptors, mimicking the effects of the endocannabinoids, which may modulate the effects of neurotransmitters (e.g. reduce effects of excitatory neurotransmitters such as glutamate).
Disease: spasticity due to multiple sclerosis
Details: * On January 14, 2014, Ipsen and GW Pharmaceuticals have announced that they have entered into an exclusive agreement for Ipsen to promote and distribute Sativex®1, a sublingual cannabis extract spray intended for the treatment of spasticity due to multiple sclerosis in Latin America (excluding Mexico and the Islands of the Caribbean). GW will be responsible for commercial product supply to Ipsen.
Sativex® is already approved in 24 countries (principally in Europe) as a treatment of spasticity due to multiple sclerosis. GW Pharmaceuticals and Ipsen aim to start regulatory filings in selected countries in Latin America during 2014 for the MS spasticity indication. The rights granted to Ipsen cover spasticity due to MS and also cover the future cancer pain indication. Financial terms include an upfront payment to GW Pharmaceuticals, regulatory and commercial milestone payments, and a long term supply price. Christophe Jean, Executive Vice-President, Strategy and Business Development, Ipsen stated: “Ipsen is delighted to enter into partnership with GW for Latin America, as Sativex® is a good complement to our neurology franchise portfolio in this region. Sativex® will bring added value to patients with spasticity due to multiple sclerosis. Furthermore, this partnership is fully aligned with our neurology franchise strategy focused on helping patients suffering from debilitating neurologic diseases, in particular spasticity.”
Sativex® is already licensed to Otsuka Pharmaceutical Co., Ltd in the United States; to Almirall S.A. in Europe (excluding the UK) and Mexico; to Bayer in the UK and Canada; to Novartis in Australasia, Asia (excluding China and Japan), the Middle East (excluding Israel) and Africa; and to Neopharm in Israel.
Financial terms:
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