Spanish pharma company Almirall has started a second wave of regulatory filings in Europe for Sativex, a drug for the treatment of spasticity in patients with multiple sclerosis (MS) originally developed by GW Pharmaceuticals.
Almirall has already launched Sativex (delta-9-tetrahydrocannabinol and cannabidiol) in its first markets - Spain, Germany and Denmark - in 2011, and is awaiting approval in Austria, Sweden, Italy and Czech Republic.
The latest round of filings have taken place in in Belgium, Finland, Iceland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.
Sativex is an oromucosal spray containing active ingredients from the cannabis sativa plant which is used to provide an additional line of therapy for MS patients who have already failed other treatments for spasticity symptoms.
It is manufactured by GW Pharma under Home Office licence at an undisclosed location in the UK, and represents the first new therapeutic class to treat spasticity in over 10 years. Around 700,000 people in Europe have MS - 80 per cent of whom exhibit spasticity symptoms.
Less than a third of MS patients with spasticity currently receive treatment for the symptom, according to Almirall.
The drug is already sold by Bayer in the UK, which is acting as the reference member state for EU-wide approval, as well as Canada.
Meanwhile, Novartis has launched the drug in New Zealand and also has rights in Australia, Asia (excluding Japan, China and Hong Kong), the Middle East (excluding Israel/Palestine) and Africa.
Otsuka licenses the product in the US and is scheduled to see approval there in 2013.
For Almirall, Sativex is one of six new products coming through development that are lending renewed growth to the business, and the company expects it to be in its top 15 products in 2012.
Sativex and its recently-launched peers - Tesavel (sitagliptin) and Efficib (sitagliptin and metformin) for diabetes, Actikerall (5-FU and salicylic acid) for actinic keratosis, Silodyx (silodosin) for benign prostatic hyperplasia and dermatological treatment Toctino (alitretinoin) - contributed €34m to Almirall's €591m total sales in the first nine months of 2011.
Sativex is also in phase III testing for cancer, with results expected in 2013. Analysts have predicted that the additional indication could drive global sales towards the $400m-$500m range at peak.
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