BioWorld International Correspondent

LONDON - GW Pharmaceuticals plc got the FDA's go-ahead to move Sativex, a cannabis-based painkiller, directly into Phase III, and raised $15 million to fund the trial.

Justin Gover, managing director, told BioWorld International: "We are delighted to have raised the money and got the go-ahead to start Phase III. That was the strategy and has been for many years. We had a meeting with the FDA last year on that footing, and that was the basis of the [investigational new drug application]."

The funding allows Salisbury, UK-based GW to begin working on the U.S. Phase III trials for pain in advanced cancer that is not adequately relieved by opioids. Gover expects the first patients to be treated in the second half of 2006.

Supplies of Sativex for the trial will be imported from the UK, where the company grows and processes the plant in secret locations, under a special license. Gover said there is a clear regulatory pathway for registering the drug in the U.S. if the Phase III trial is positive. "We expect it to be dealt with in the same way as registering any controlled substance. There are precedents, and there is a route to approval," he said.

He added, "You don't permit a Phase III in a patient population from an ethical perspective if you can't justify it from a regulatory perspective."

GW placed 6.2 million shares at £1.40 (US$2.47) per share with a U.S.-based institutional investor. The new shares represent 5.4 percent of the share capital and were placed at a 5 percent discount to the average price of Jan. 3. In addition, GW issued to the same investor warrants for 924,897 shares at £1.61 per share and 924,897 at £1.745 per share. The warrants can be exercised at any time over the next five years.

GW, which is listed on London's Alternative Investment Market, fell by 12 pence to £1.48 when the placing was announced.

Gover said: "While we did this fund raising specifically to allow us to begin the U.S. development plan, it is not intended that we will fund the entire development ourselves. We still expect to have a marketing partner in place."

Sativex is an orally administered spray comprising primarily tetrahydrocannabinol and cannabidiol. The Phase III U.S. trial will recruit 250 patients in a double-blind, randomized, placebo-controlled study that will evaluate Sativex in relieving average daily pain, reducing the use of opioids, improving the quality of sleep and other quality-of-life measures.

A UK Phase III study showed a significant improvement in pain relief in terminal cancer patients. Although opioids are effective, GW said as many as one-third of patients do not obtain adequate relief.

Gover said the company chose the cancer pain indication in the U.S. on the basis of the overall data package. "This is an area of high patient need, where there aren't many alternatives on offer, and it is a significant commercial opportunity."

Sativex is registered in Canada for treating neuropathic pain associated with multiple sclerosis. UK regulators refused to allow it on the market for the treatment of spasticity in multiple sclerosis in June, despite an appeal. The regulators did agree that Sativex could be approved if a second Phase III in that indication, which is due to complete soon, is positive.

"Once we have the results of this trial, we will re-engage formally with UK regulators and take forward our strategy elsewhere in Europe," Gover said.