GW Wins US Okay for Pivotal Cannabis Drug Study

By Ben Hirschler
Reuters

Wednesday 04 January 2005

London - GW Pharmaceuticals has won approval from US regulators to conduct a pivotal Phase III study into its cannabis-based medicine Sativex as a treatment for cancer pain, the drug company said on Wednesday.

GW expects to start testing the product, which is sprayed into the mouth, in US patients with advanced cancer later this year and said it was raising $15 million (8.6 million pounds) in a discounted share placing to help fund the trial while it seeks a US partner.

The US randomised clinical trial will involve 250 people and is likely to last between 24 and 36 months, suggesting Sativex will not be ready for launch in the US marketplace until towards the end of the decade.

GW shares, which had risen 7.4 percent on Tuesday on rumours of positive news about Sativex, hit a 20-month high in early trade before retreating to stand 7.5 percent down on the day at 148 pence in late trade.

GW said it had agreed with Polygon Investment Partners of New York to raise 8.6 million pounds ($15 million), or 8.1 million after expenses, by placing 6.2 million new shares at 139.61p each, giving Polygon a 5.4 percent stake in the company.

Canada became the first country in the world to approve Sativex in April 2005 for the relief of neuropathic pain in patients with multiple sclerosis.

GW suffered a setback three weeks ago, however, when an inquest found the death of a patient taking Sativex in an earlier clinical study was probably linked to the medicine.

Sativex is GW's leading product and the source of most of the company's value.

The group grows thousands of marijuana plants at a secret location in the English countryside, having been granted a dispensation by the government to use the plant for medical research.

Stronger Hand in Talks

Geoffrey Guy, GW's executive chairman, said the acceptance of the Phase III study application by the Food and Drug Administration was a significant achievement for the company that would compress the overall length of time needed to win US approval by avoiding the need for earlier-stage trials.

Having the product in final tests should also strengthen GW's hand in negotiations with potential partners in the United States, where it has yet to sign up a marketing ally.

Germany's Bayer AG is GW's marketing partner in Canada and Britain, while Almirall of Spain recently agreed to market the drug in European countries excluding Britain.

Following the deal with Polygon, GW now has 30 million pounds in the bank, which industry analysts should remove the risk of further fundraising.

Cannabis has a long history of medicinal use dating back to ancient Chinese times. Queen Victoria, whose physician described it as "one of the most valuable medicines we possess", is said to have taken cannabis tincture for her menstrual pains.

It fell out of favour in the 20th century because of a lack of standardised preparations and the development of more potent synthetic painkillers.

GW says it has got round those standardisation problems with its spray-based product, which also avoids the damaging effects of smoking the drug.

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Rhode Island Legalizes Medical Marijuana
By M. L. Johnson
The Associated Press

Tuesday 03 January 2006

Providence, RI - Rhode Island on Tuesday became the 11th state to legalize medical marijuana and the first since the US Supreme Court ruled in June that patients who use the drug can still be prosecuted under federal law.

The House overrode a veto by Gov. Don Carcieri, 59-13, allowing people with illnesses such as cancer and AIDS to grow up to 12 marijuana plants or buy 2.5 ounces of marijuana to relieve their symptoms. Those who do are required to register with the state and get an identification card.

Federal law prohibits any use of marijuana, but Maine, Vermont, Alaska, California, Colorado, Hawaii, Montana, Nevada, Oregon and Washington allow it to be grown and used for medicinal purposes.

The US high court ruled June 6 that people who smoke marijuana because their doctors recommend it can still be prosecuted under federal drug laws, even if their states allow it.

Federal authorities, however, have conceded they are unlikely to prosecute many medicinal marijuana users.

"I'm sure everybody in this room knows at least one person who would have benefited from medical marijuana," Rep. Thomas Slater, who has cancer, told fellow lawmakers before the vote. Slater said he does not use marijuana now, but it could become part of his treatment in the future.

Carcieri, unhappy with the override, said the law fails to provide ways for users to buy marijuana legally and leaves Rhode Islanders open to federal prosecution.

"Users will be forced to purchase marijuana in the illegal street market, putting them at risk and complicating the difficult jobs that our law enforcement personnel must do every day," the governor said.

Tom Riley, a spokesman for the White House Office of National Drug Control Policy, said the vote showed "misguided and out-of-touch" views on the harms of marijuana.

"There's this notion from the '60s or the '70s that marijuana is a harmless drug," Riley said. "It's not."