|
Cannabis drug begins last phase of U.S. testing |
LONDON: GW Pharmaceuticals and its Japanese partner, Otsuka Pharmaceutical, began the final phase of U.S. testing of the cannabis-based Sativex pain-relief medicine for some cancer patients.
| The five-week trial of 336 patients will test whether the drug helps advanced cancer sufferers who no longer respond to opium-based pain relievers, the companies said in a statement Monday. GW Pharma, based in Salisbury, England, plans to report findings from the study next year and expects to receive U.S. regulatory approval in 2011.
|  | Otsuka, which is closely held, has exclusive rights to develop and market Sativex in the United States.
|
There are more than six million cancer patients and GW Pharma estimates as much as 40 percent of them have severe enough pain to warrant an opium-based treatment. Sativex, a mist sprayed in the mouth, is already approved in Canada for pain relief from advanced cancer and multiple sclerosis.
"Sativex has the potential to be a lucrative niche drug," Stefan Hamill, a Clear Capital analyst, said in London. "Data in the beginning of 2008 will convince the market that this is actually a real drug."
Hamill, who has a buy rating on GW Pharma, estimates peak sales for U.S. cancer pain at $200 million a year and worldwide annual revenue of $350 million.
GW Pharma shares plunged 29 percent, the most ever, on July 20 after the drug maker withdrew an application to European regulators for Sativex as treatment for MS muscle spasms. GW Pharma said it plans to resubmit the application after conducting a new trial that regulators requested. The shares rose 1 percent, to 50 pence, or $1.03, in early trading Monday. The stock is down about 43 percent this year.
"We think the pessimism has peaked and the positive clinical data is going to turn things around," Hamill said. He has a target price of 102 pence.
Under the February agreement, Otsuka agreed to pay GW Pharma as much as $273 million plus a royalty, as well as bear all the costs for the U.S. development of the drug.
Otsuka, the discoverer of the antipsychotic medicine Abilify, and GW Pharma in July also agreed to collaborate on researching and developing cannabis-based treatments related to the central nervous system and cancer.
GW Pharma is already screening molecules from marijuana plants for Otsuka, and the first potential products may enter very early clinical testing next year, said Justin David Gover, the managing director at GW Pharma.
The agreement gives GW Pharma "a pipeline that is fully funded," he said Nov. 15. "We were wondering how we were going to fund the U.S. bit" before the deal.
GW Pharma also has Sativex licensing agreements with Bayer for Britain and Canada and Laboratorios Almirall for the rest of Europe. Gover said the company will seek partners next year to develop cannabis-based treatments for inflammatory conditions, obesity, diabetes, Alzheimer's, and osteoporosis.
| http://www.iht.com
| |
Trackback(0)
 |
Medical Marijuana 
TrackBack URI for this entry
Subscribe to this comment's feed
Show/Hide comments
Show/Hide comment form