) sole marketed drug Sativex is currently approved in 23
countries across the globe for the treatment of spasticity due to
multiple sclerosis (MS). The 23
country where drug received approval is Switzerland.
GW Pharma gained Swiss approval for Sativex for the treatment
of moderate-to-severe spasticity in MS patients non-responsive to
other anti-spasticity therapies.
The drug will be launched in Switzerland by GW Pharma's
commercial partner Almirall S.A. We note that GW Pharma has a
licensing agreement with Almirall S.A. for Sativex. As per the
agreement, Almirall has exclusive rights to market the drug 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.
GW Pharma also 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. The
company expects to start phase III study in 2014
Meanwhile, 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 one of these studies to
come out by the end of next year. Results from another study will
be out shortly thereafter following which approval will be sought
for Sativex in the U.S.
As per World Health Organization (WHO), 1.3 million people
suffer from MS globally, of whom 80% suffer from spasticity.
GW Pharma, a biopharmaceutical company, carries a Zacks Rank
#4 (Sell). Investors interested in the biopharmaceutical industry
), which carries a Zacks Rank #1 (Strong Buy). Other
better-ranked stocks include
Jazz Pharmaceuticals plc
), carrying a Zacks Rank #1 and Zacks Rank #2 (Buy)
AFFYMETRIX INC (AFFX): Free Stock Analysis
ACTELION LTD (ALIOF): Get Free Report
GW PHARMA-ADR (GWPH): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
To read this article on Zacks.com click here.