GW Pharmaceuticals 8m Milestone Payment from Almirall

 

TIDMWP 
 
RNS Number : 8710P 
GW Pharmaceuticals PLC 
01 April 2009 
 

 
 
GW ANNOUNCES GBP8M MILESTONE PAYMENT FROM ALMIRALL 
 
 
Porton Down, UK, 1 April 2009: GW Pharmaceuticals plc (GWP:AIM) today announces 
that it has received confirmation from its licensing partner, Laboratorios 
Almirall S.A., that it will pay to GW a milestone payment of GBP8 million. GW 
will receive the payment within the next few weeks. 
 
 
Under the GW-Almirall contract, this milestone payment became due in the event 
that GW obtained positive results in its recent Sativex  Multiple Sclerosis 
Spasticity Phase III trial and, in addition, Almirall considered that the data 
was sufficiently positive to include a country within their licensed territory 
(Europe excluding UK) as part of the resultant Sativex regulatory submission. 
Following their review of the complete data from the positive Phase III trial 
announced on 11th March, Almirall have now confirmed their positive opinion of 
the data and that they wish to include Spain in the forthcoming regulatory 
submission. 
 
 
GW expects to submit the regulatory submission in Q2 09 to the UK and Spain 
under the European decentralized procedure. Following approval in the UK and 
Spain, GW and Almirall intend to expand into other European countries under the 
mutual recognition procedure. 
 
 
Justin Gover, GW's Managing Director, said, "We are delighted that Almirall 
share our positive view of the Phase III data and confidence in the prospects 
for regulatory approval. This milestone payment further underlines GW's robust 
financial position." 
Enquiries: 
 
 
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| GW Pharmaceuticals plc                     |    (Today) + 44 20 7831 3113 | 
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|  Justin Gover, Managing Director           |       (Thereafter) + 44 1980 | 
|                                            |                       557000 | 
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|                                            |                              | 
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| Financial Dynamics                         |            + 44 20 7831 3113 | 
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| Ben Atwell / John Dineen                   |                              | 
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|                                            |                              | 
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| Investec Bank plc                          |            + 44 20 7597 4000 | 
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| Patrick Robb                               |                              | 
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Notes to Editors 
 
 
Sativex Phase III Trial 
On 11 March 2009, GW announced positive preliminary results from a pivotal Phase 
III double-blind randomised placebo-controlled study of Sativex  in patients 
with spasticity due to Multiple Sclerosis (MS), who have achieved inadequate 
spasticity relief with existing therapies. This study was requested by the UK 
regulator in order to gain approval in this indication. 
 
 
The prospectively defined primary efficacy endpoint of the study - the 
difference between the mean change in spasticity severity of Sativex vs Placebo 
- was highly statistically significantly in favour of Sativex (p=0.0002). The 
difference between Sativex and placebo was also highly significant for a number 
of secondary endpoints, including the 30% responder analysis (p=0.0003), spasm 
frequency (p=0.005), sleep disturbance (p<0.0001), patient global impression of 
change (p=0.023), and physician global impression of change (p=0.005). 
 
 
Regulatory Strategy 
Following these positive results, GW will submit a regulatory application in Q2 
09 in the UK and Spain. The UK will act as Reference Member State. Following 
approval in these two countries, GW will seek to expand the approval into other 
European countries via the mutual recognition procedure. 
 
 
Upon approval, Sativex will be marketed exclusively in the UK by Bayer 
HealthCare and in the rest of Europe by Almirall. 
 
 
MS Spasticity 
Spasticity (spasms and stiffness) is one of the most common symptoms of MS 
occurring in as many as three-quarters of people with MS. Spasticity can affect 
many aspects of daily life, such as walking and sitting. Sativex aims to treat 
high need patients who have previously failed to gain adequate benefit from 
currently available anti-spasticity treatments 
 
 
Sativex Prescription Use 
Sativex is approved and marketed in Canada for the treatment of cancer pain and 
MS neuropathic pain. In addition, Sativex is available on prescription in the UK 
on a "named patient" basis and has to date been exported to 22 countries around 
the world. 
 
 
About GW 
GW was founded in 1998 and listed on the AIM, a market of the London Stock 
Exchange, in June 2001. Operating under license from the UK Home Office, the 
company researches and develops cannabinoid pharmaceutical products for patients 
who suffer from a range of serious ailments, in particular multiple sclerosis 
and cancer pain. GW has assembled a large in-house scientific team with 
expertise in cannabinoid science as well as experience in the development of 
both plant-based prescription pharmaceutical products and medicines containing 
controlled substances. GW occupies a world leading position in cannabinoids and 
has developed an extensive international network of the most prominent 
scientists in the field. 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
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