) 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
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
) 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
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
GW Pharma presently carries a Zacks Rank #3 (Hold). However,
other pharma stocks such as
Sarepta Therapeutics, Inc.
) currently look better positioned with a Zacks Rank #1 (Strong
GW PHARMA-ADR (GWPH): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
SAREPTA THERAP (SRPT): Free Stock Analysis
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