Cannabis drug for MS goes on sale in UK

From the Wall Street Journal:

LONDON — A drug manufactured from cannabis went on sale in the U.K. June 21 as a treatment for symptoms of multiple sclerosis.

Sativex, which is made from cannabis plants grown at secret locations in England by developer GW Pharmaceuticals PLC, is the first prescription drug made from cannabis to officially go on sale anywhere in the world. It offers legal access to the beneficial effects of an illegal drug that thousands of multiple-sclerosis sufferers have smoked in an attempt to relieve their pain.

It is also a boon for small U.K. drug developers, which have struggled in recent years to win investor confidence—and funding—because of setbacks in clinical trials of their experimental medicines.

Sativex was approved Friday by the U.K. Medicines and Healthcare products Regulatory Agency, or MHRA, as a treatment for spasticity in multiple- sclerosis patients who aren't benefiting from other treatments. It had been in development for 11 years.

Sativex's approval follows successful clinical trials. The drug will be marketed in the U.K. by Germany's Bayer AG , which said Monday it will cost the country's state-run National Health Service roughly £11, or about $16, a day for each patient.

Sativex has been available previously on a limited basis to patients in Canada and the U.K. but hadn't yet been marketed.

The formal launch of Sativex represents a milestone in treating the disease, said Pam Macfarlane, chief executive of the MS Trust, a charity that has campaigned for a licensed medicine derived from cannabis to be made available to multiple-sclerosis sufferers.

The charity has long known cannabis helped patients' symptoms, Ms. Macfarlane said.

Roughly one-third of multiple-sclerosis patients are believed to have tried cannabis to get relief, with some surveys suggesting the proportion is as high as 43%, said GW Pharmaceuticals Managing Director Justin Gover.

Bayer said there are about 100,000 people in the U.K. who suffer from multiple sclerosis, and many experience spasms, cramps and similar symptoms known collectively as spasticity.

However, Sativex doesn't work for everyone. Bayer estimates about 11,500 people in the U.K. will be eligible for treatment with Sativex but only about half of them will get a good response.

Spain is expected to be the next country to approve Sativex for sale. Almirall SA holds the drug's marketing license in Spain and is GW's partner for the rest of Europe, excluding the U.K.

Mr. Gover said Almirall and GW will be seeking approval in Germany, Italy, France and other European countries later this year.

Analysts at brokers Nomura Code Securities and KBC Peel Hunt estimate that sales of Sativex as a multiple-sclerosis spasticity treatment will peak in Europe at about £50 million a year. Piper Jaffray forecasts peak annual sales of at least £100 million.

A bigger potential prize exists in the U.S., where Sativex is being developed as a painkiller for cancer patients. Mr. Gover said GW and U.S. partner Otsuka Pharmaceutical Co. of Japan are scheduled to meet with the Food and Drug Administration this summer to discuss Phase III trials.