GW Pharmaceuticals plc (GWPH) recently announced that Sativex has been launched in Italy. Sativex is approved for the treatment of moderate-to-severe spasticity in multiple sclerosis (MS) patients who did not respond adequately to other anti-spasticity medications.
In May this year, GW Pharma received full marketing authorization for Sativex in Italy. GW Pharma has also successfully reimbursed Sativex in Italy as a Class H (hospital dispensed) medicine. The price reimbursed in Italy is comparable to the price in Spain. Following the launch, Sativex becomes the only drug in Italy containing cannabinoids, for the treatment of spasticity in MS.
We note that GW Pharma has a licencing agreement with Almirall S.A. for Sativex. As per the agreement, Almirall has the exclusive rights to market the drug in the European Union (excluding the UK), EU accession countries as well as Switzerland, Norway and Turkey. Almirall also has the rights to market Sativex in Mexico. However, GW Pharma holds the rights to manufacture and supply Sativex to Almirall.
GW Pharma also has a licence agreement with Novartis (NVS) to commercialise Sativex in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), the Middle East (excluding Israel/Palestine) and Africa. As per the agreement, Novartis holds exclusive commercialization rights to Sativex and will also act as marketing authorization holder of the drug while GW Pharma will be responsible for the manufacture and supply of Sativex.
Sativex is approved in 21 countries for the treatment of MS spasticity so far. The company is also looking for regulatory submission for the drug in other countries. GW Pharma is expecting several commercial launches of Sativex over the next one year.
We remind investors that GW Pharma is also conducting two phase III cancer pain studies on the drug in the US. The company expects top-line results from these studies by next year, after which it will file a New Drug Application (:NDA) for the drug in the US.
GW Pharma presently carries a Zacks Rank #3 (Hold). However, other pharma stocks such as Jazz Pharmaceuticals (JAZZ), and Targacept, Inc. (TRGT) currently look better positioned with a Zacks Rank #1 (Strong Buy).
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