Gw Pharmaceuticals (LON:GWP) announced today their update on their submission of Sativex for the treatment of symptoms of spasticity caused by Multiple Sclerosis.
GW Pharmaceuticals was founded in 1998 and listed on AIM in June 2001. The Group's lead programme is the development of a product portfolio of cannabinoid prescription medicines, including Sativex Oromucosal Spray, to meet patient needs in a wide range of therapeutic indications.
Today the company revealed that it has submitted Sativex Oromucosal Spray, which has been filed in the UK and Spain under the European decentralised procedure in May 2009, with the UK reportedly acting as the Reference Member State.
Following the regulatory period of 150 days, both UK and Spanish regulators have confirmed that they have found no quality, efficacy and safety issues with this product.
The next steps require the regulators to complete the wording on the patient leaflets, after which the decentralised procedure can close the process and begin the final stage, known as the national phase. This will take place in both the UK and Spain with the goal of finalising local working on product packaging and related documents. The Director of GW, Dr Stephen Wright, commented:
"This is a major milestone in the regulatory process for Sativex, and for GW's future prospects. We look forward to working with the regulators towards a successful completion of this process and to supporting our marketing partners as they prepare for product launch. This progress with Sativex also provides further validation of GW's cannabinoid platform and the significant long term promise of GW's portfolio of cannabinoid medicines."
The also report confirmed that Schering Pharma will we the UK marketing arm of operations, whilst Almirall S.A will do the rest of the European Union. The company expects all regulatory approval to be signed off Q2 2010, from which they anticipate receiving a GBP10m milestone payment from Bayer and a further GBP2.5m milestone payment from Admirall.
Following UK and Spanish approvals, submissions will also be made in other European countries during 2010, the report said.
