GW Pharmaceuticals plc
) recently announced that Sativex has been launched in Italy.
Sativex is approved for the treatment of moderate-to-severe
spasticity in multiple sclerosis (MS) patients who did not
respond adequately to other anti-spasticity medications.
In May this year, GW Pharma received full marketing authorization
for Sativex in Italy. GW Pharma has 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 becomes the only drug in Italy
containing cannabinoids, for the treatment of spasticity in MS.
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 Sativex in Mexico. However, GW Pharma holds the rights to
manufacture and supply Sativex to Almirall.
GW Pharma also has a licence agreement with
) to commercialise Sativex in Australia and 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
Sativex is approved in 21 countries for the treatment of MS
spasticity so far. The company is also looking for regulatory
submission for the drug in other countries. GW Pharma is
expecting several commercial launches of Sativex over the next
We remind investors that GW Pharma is also conducting two phase
III cancer pain studies on the drug in the US. 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
) currently look better positioned with a Zacks Rank #1 (Strong
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