GW Pharmaceuticals (GWPH - Snapshot Report) announced a new pricing agreement for Sativex in Germany. As per the agreement, a mutually-acceptable reimbursement price has been agreed upon between GW Pharma’s commercial partner in Germany, Almirall S.A., and the German National Association of Statutory Health Insurance Funds (GKV-SV).
Sativex is approved in 22 countries for the treatment of spasticity due to multiple sclerosis (MS).
Alimirall had objected to the reduced price of Sativex enforced by the German authorities in Mar 2013. The newly announced agreement resolves this issue as it has resulted in a price increase.
Under a licensing agreement with GW Pharma, Almirall has exclusive rights to market Sativex in the EU (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 has filed a phase III Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in Aug 2013 to evaluate Sativex for MS spasticity.
GW Pharma is also conducting two phase III studies on Sativex in the U.S. 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) in the U.S.
GW Pharma carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Gilead Sciences Inc. (GILD - Analyst Report) and Actelion Ltd. (ALIOF - Snapshot Report) with a Zacks Rank #1 (Strong Buy), and Jazz Pharmaceuticals (JAZZ - Analyst Report) with a Zacks Rank #2 (Buy).