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Cesamet™ (nabilone) Marketing Approval B-Roll
May 10, 2006
B-roll Rundown:
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Title Slate
About Cesamet™ (CII) (nabilone)
About Chemotherapy-induced nausea and vomiting (CINV)
Statistics
Fair balance
About Valeant Pharmaceuticals International
Soundbites
Product still shots
B-roll footage
Slate #1: Title Slate
FDA Approves Cesamet to Treat
Nausea and Vomiting Associated with Cancer Chemotherapy
VIDEO PROVIDED BY: Valeant Pharmaceuticals International
Slate #2: About Cesamet
Valeant Pharmaceuticals International announced that the U.S. Food and Drug Administration (FDA) has
given marketing approval for Cesamet™ (CII) (nabilone) oral capsules. Cesamet is used to treat 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 that is thought to act as an omnineuromodulator – interacting with the
cannabinoid receptor, CB1, which is present throughout the nervous system. This receptor is involved in
regulating nausea and vomiting. Because of this omnineuromodulation, the mechanism of action for
Cesamet is significantly different from conventional anti-emetics. Cesamet has a long duration of action,
which allows for less frequent dosing, typically twice daily.
Slate #3: About Chemotherapy-induced nausea and vomiting (CINV)
The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006. For
patients on chemotherapy, stomach upset may occur and trigger a strong urge to vomit. Approximately 70
to 80 percent of all patients receiving chemotherapy experience chemotherapy-induced nausea and
vomiting (CINV). Although the use of anti-emetic agents decreases the incidence and severity of CINV,
symptoms continue to occur in 40 to 60 percent of patients.
Slate #4: Statistics
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In 2006, there will be approximately 1.4 million new cancer cases
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70 to 80 percent of all patients receiving chemotherapy experience nausea and vomiting
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Despite current treatments, nausea and vomiting still occurs in 40 to 60 percent of patients on
chemotherapy
Slate #5 Fair balance
Cesamet, a synthetic cannabinoid similar to the active ingredient found in naturally occurring Cannabis
sativa L (marijuana; 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 taking 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, 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. Caution must be used when administering Cesamet in combination
with any CNS depressant.
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 found in 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 more information about Cesamet, please call toll free 1-877-361-2719.
Slate #6: About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a global, publicly traded, research-based specialty
pharmaceutical company that develops, manufactures and markets products primarily in the areas of
neurology, infectious disease and dermatology. More information about Valeant can be found at
www.valeant.com.
Slate #7: Soundbites
Neal Slatkin
Director of Supportive Care of Pain and Palliative Medicine, City of Hope National Medical Center
Soundbite #1: “Many of the chemotherapy-induced sided effects are distressing and disabling to patients,
but none more so than the chemotherapy-induced nausea and vomiting. Very often it causes patients to
curtail their activities, to limit work, family, leisure and social activities, and sometimes even causes them to
prematurely abandon treatment.”
Soundbite #2: “We have many good medications available to treat chemotherapy-induced nausea and
vomiting, but none of them are perfect, and still, between 30 and 50 percent of patients continue to
experience these very distressing symptoms, even on best available treatment.”
Soundbite #3: “Cesamet is a new medication to control chemotherapy induced nausea and vomiting. It’s a
member of a class of compounds call the cannabinoids, which are medications that resemble cannabis, or
marijuana. The medication works the same way, but this is an FDA approved medication that can be easily
taken in capsule form to control problems related to chemotherapy nausea and vomiting.”
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Paul Daeninck
Oncologist and Palliative Care Physician, Saint Boniface Hospital and Cancer Care Manitoba, Winnipeg
Manitoba, Canada
Soundbite #1: “Cesamet works in a unique way on the area of the brain that controls nausea and
vomiting.”
Soundbite #2: “Cesamet has been very effective for my patients. They’ve been able to go about their
activities of daily living as they normally do.”
Soundbite #3: “Chemotherapy causes a variety of side effects, and chemotherapy induced nausea and
vomiting is one of the worst ones that patients tell us about. Certainly it’s one that has a variety of
treatments, but treatments to date have not been as effective as we would like.”
Slate #8: Product still shots
Cesamet product shots
Slate #9: B-roll Footage
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Shot of Dr. Neal Slatkin and Michelle Rhiner, NP in hallway
Shot of Dr. Neal Slatkin and Michelle Rhiner, NP reviewing materials
Shot of Dr. Neal Slatkin at desk
Shot of Dr. Neal Slatkin writing prescription
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