GW Pharmaceuticals (GWPH - Analyst Report) recently submitted a marketing authorization application for Sativex in France as per the European Mutual Recognition Procedure (MRP). GW Pharma is looking to get Sativex approved for the treatment of spasticity due to multiple sclerosis (MS).
Earlier this month, Sativex was launched in Italy. In May 2013, GW Pharma received full marketing authorization for Sativex in Italy. GW Pharma 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 became the only drug in Italy containing cannabinoids, for the treatment of spasticity in MS.
Sativex is approved in 21 countries for the treatment of MS spasticity so far. The company is also seeking regulatory submission for the drug in other countries. GW Pharma is also looking to launch the drug in 8 European countries, and also in Australia and New Zealand.
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 the drug in Mexico. However, GW Pharma holds the rights to manufacture and supply Sativex to Almirall.
GW Pharma also has an agreement with Novartis (NVS - Analyst Report) to commercialize Sativex in Australia, 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 the drug.
GW Pharma is also conducting two phase III studies on the drug in the US for treating pain in cancer patients. 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 - Analyst Report) and Sarepta Therapeutics, Inc. (SRPT - Analyst Report) currently look better positioned with a Zacks Rank #1 (Strong Buy).