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news.GW Pharmaceuticals, a developer and marketer of cannabinoid prescription medicines, has received confirmation from its licensing partner, Laboratorios Almirall, a Spanish pharmaceutical company, that it will pay to GW a milestone payment of GBP8 million. GW will receive the payment within the next few weeks.
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Under the GW-Almirall contract, this milestone payment became due in the event that GW obtained positive results in its recent Sativex multiple sclerosis spasticity Phase III trial and, in addition, Almirall considered that the data was sufficiently positive to include a country within their licensed territory (Europe excluding UK) as part of the resultant Sativex regulatory submission.
Following review of the complete data from the positive Phase III trial, Almirall has now confirmed its positive opinion of the data and its wish to include Spain in the forthcoming regulatory submission.
GW expects to submit the regulatory submission in the second quarter of 2009 to the UK and Spain under the European decentralized procedure. Following approval in the UK and Spain, GW and Almirall intend to expand into other European countries under the mutual recognition procedure.
Justin Gover, GW’s managing director, said: “We are delighted that Almirall shares our positive view of the Phase III data and confidence in the prospects for regulatory approval. This milestone payment further underlines GW’s robust financial position.”