Buzzby

Pharma Gets High Returns On 'Pot Pills'
Peter Hadekel | The Gazette | 05/26/2006

Pot in a pill? Not quite. But cancer patients desperate for relief from the nausea and vomiting associated with chemotherapy are increasingly turning toward synthetic cannabinoids.

And that's good news for the Montreal facility that manufactures Cesamet, a drug that replicates the active ingredient in marijuana.

In a decision last week by the Food and Drug Administration, Cesamet was approved for sale in the U.S., about 25 years after it was first authorized in Canada.

The drug is made almost exclusively in Ville St. Laurent by Valeant Pharmaceuticals International of Costa Mesa, Calif. (although it's also produced by a different company in Britain).

Thomas Schlader, Valeant's general manager in Montreal, says FDA approval means the plant can gear up to serve the large potential market in the United States.

Valeant purchased Cesamet from pharmaceutical giant Eli Lilly in 2001 and has watched Canadian sales more than double each year. The drug is expected to generate revenues of $18 million to $20 million this year, he says.

The FDA decision could solidify the company's future in Montreal, where 145 are employed.

Valeant - a mid-size pharmaceutical company with annual revenue of about $800 million U.S. - has been closing and rationalizing facilities around the world. The Montreal plant now has a brighter future with what amounts to a world mandate to produce a drug with significant growth potential. That could lead to more investment and new products at the facility, Schlader says.

Aside from Cesamet, the Montreal plant produces about three dozen branded and generic pharmaceutical products, largely for the Canadian market.

In Canada, where Cesamet has been sold since 1981, it has an 88-per-cent market share, according to the company. Two competing cannabinoids are Marinol, made by Solvay Pharmaceuticals, and Savitex, a mouth spray approved for treating pain associated with multiple sclerosis.

The U.S. approval of Cesamet - the second such cannabinoid now allowed in that country - is somewhat ironic. The FDA said last month there's no scientific basis to approve the medical use of marijuana. Yet soon after that decision, the agency authorized Cesamet, which essentially mimics the marijuana ingredient THC, but without the same kind of "high" that would come from smoking cannabis.

"There's been a lot of research on cannabinoids on a worldwide basis and people have found they can be very useful in (treating) pain and in other areas like post-traumatic stress," Schlader notes.

"The physician community, especially those working in the area of pain, are always looking for products that will respond when nothing else is working."

Yvon Beauchamp, a physician in palliative care and pain management at Sacre Coeur Hospital, says that doctors are becoming more widely aware of the medication's benefits.

While Cesamet is primarily indicated for nausea and vomiting in cancer treatment, it's also effective in treating acute pain, he said. "We have noticed that when taken in combination with morphine, it can reduce anxiety and muscle spasms and facilitate sleep."

A pill has the additional advantage that patients can avoid the toxic effects that come with smoking marijuana.

(BuzzNote: It has the disadvantages that it's expensive, takes an hour to provide relief, and the patient can't closely control the dosage. Smoked marijuana doesn't cause lung cancer. It's also not the best way of using whole marijuana to alleviate medical problems. [Think vaporizers!])

Ottawa has authorized the medical use of marijuana, but there are still questions surrounding the suitability and consistency of the product.

In comparison, Cesamet is "a standardized product, so that's it's always the same quality, it's always the same pharmo-kinetic profile within the body. Physicians have confidence in this approach," Schlader said.

While it's difficult to gauge the market potential for Cesamet in the U.S., he points out that the cannabinoid Marinol, already approved south of the border, has reached sales of $160 million U.S.

It's estimated that half a million Americans each year receive chemotherapy treatment and that 70 per cent experience nausea and vomiting.

Elsewhere, the drug has been approved in Argentina, and is in the regulatory process in several other Latin American countries.

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