Cesamet approved for use in U.S.

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Pharma gets high returns on 'pot pills'

The Montreal Gazette
PETER HADEKEL
Freelance


Friday, May 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.

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.

phadekel@videotron.ca

<center>© The Gazette (Montreal) 2006</center>

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Valeant Pharmaceuticals Announces Availability of Complimentary ``Managing Chemotherapy Side Effects For Dummies'' Cancer Chemotherapy Resource


Special Edition ``For Dummies'' Book Now Available for Cancer Chemotherapy Patients and Caregivers

COSTA MESA, Calif.--(BUSINESS WIRE)--Aug. 22, 2006--Valeant Pharmaceuticals International (NYSE:VRX) today announced that it will make available a new complimentary resource, "Managing Chemotherapy Side Effects For Dummies," for cancer chemotherapy patients and their caregivers. The special edition book from the popular "For Dummies" series was written by a medical oncologist, a supportive care physician and nurse and a professional writer, who is a cancer survivor, to help manage the disease and its treatment side effects, such as chemotherapy-induced nausea and vomiting (CINV), and is available at www.chemofordummies.com. The availability of the special edition book coincides with the recent announcement by Valeant for the availability of Cesamet (CII) (nabilone) Capsules, a synthetic cannabinoid approved for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.

"In addition to making Cesamet available for patients who continue to struggle with chemotherapy-induced nausea and vomiting despite their current treatment options, we are excited to provide an important, complimentary resource for the cancer community that supports them in managing common side effects associated with the condition," said Wes P. Wheeler, Valeant's president of North America and product development.

Nausea and vomiting are two of the most feared side effects of cancer chemotherapy treatment. Inadequately controlled nausea and vomiting can lead to poor patient compliance with treatment, up to and including complete cessation of potentially life-saving therapy. Despite the availability of several classes of anti-emetics, 40 to 60 percent of patients still report experiencing CINV.

"Patients are overwhelmed by the amount of information that physicians share with them about cancer, its treatments and potential side effects. 'Managing Chemotherapy Side Effects For Dummies' is a resource that can empower patients and their caregivers to feel more comfortable when talking about side effects of cancer chemotherapy such as CINV," said Neal Slatkin, M.D., DABPM and director, Department of Supportive Care, Pain and Palliative Medicine at City of Hope. "It's important that patients know there are new ways to manage these side effects so they do not refuse therapy that could save their life."

Valeant received approval for Cesamet from the Food and Drug Administration (FDA) on May 15, 2006 for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments. Cesamet is a synthetic cannabinoid, with a significantly different mechanism of action from conventional anti-emetics. Valeant currently sells Cesamet in Canada, where the product has an 87 percent share of the cannabinoid market, according to IMS Compuscript data from June 2006.

Important Safety Information

Cesamet, a synthetic cannabinoid similar to the active ingredient found in naturally occurring Cannabis sativa L. (Marijuana; delta-9-tetrahydrocannabainol (delta-9-THC)), is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid. Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet. During controlled clinical trials of Cesamet, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria (feeling "high"), ataxia, headache, and concentration difficulties. Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone. Since Cesamet can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly, and in patients with hypertension or heart disease. Cesamet should also be used with caution in patients with current or previous psychiatric disorders, (including manic depressive illness, depression, and schizophrenia) as the symptoms of these disease states may be unmasked by the use of cannabinoids. Cesamet should be used with caution in individuals receiving concomitant therapy with sedatives, hypnotics, or other psychoactive drugs because of the potential for additive or synergistic CNS effects. Cesamet should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet contains a similar active compound to marijuana. Cesamet should be used with caution in pregnant patients, nursing mothers, or pediatric patients because it has not been studied in these patient populations. For complete prescribing details, please see full prescribing information. For product-related questions, call Valeant Pharmaceuticals at 1-877-361-2719 or visit www.cesamet.com.

About "For Dummies"(R)

With near universal name recognition, more than 150 million books in print, and over 900 topics, "For Dummies" is the world's bestselling reference series. With loyal customers around the globe, "For Dummies" enriches people's lives by making knowledge accessible in a fun and easy way. Described by the N.Y. Times as "more than a publishing phenomenon, but a sign of the times," "For Dummies" span every section of the bookstore, covering everything from health to history, music to math, sports to self-help, technology to travel, and more. The "For Dummies" brand has expanded into new products and categories with an extensive licensed product line, including fitness and hobby DVDs, grilling kits, business software, cleaning products, automotive kits, craft kits, and apparel. For more information, visit www.dummies.com. "For Dummies" is a branded imprint of Wiley.

About Valeant

Valeant Pharmaceuticals International (NYSE:VRX) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.

Cesamet is a trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.

Contacts Valeant Pharmaceuticals International
Investor Contact:
Jeff Misakian, 714-545-0100 ext. 3309
jdmisakian@valeant.com
or
Media Contact:
Angie McCabe, 714-545-0100 ext. 3381
amccabe@valeant.com