) 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
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.
) with a Zacks Rank #1 (Strong Buy), and
) with a Zacks Rank #2 (Buy).
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