SPRING VALLEY, N.Y., Nov. 3 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that it has entered into an agreement with Valeant Pharmaceuticals North America to promote the antiemetic drug Cesamet(TM) (nabilone) capsules following approval by the U.S. Food and Drug Administration (FDA). Cesamet is a cannabinoid agonist for the treatment of chemotherapy-induced emesis (CIE). Valeant has received an approvable letter from the FDA for Cesamet and is awaiting final approval.
“The Par sales force is excited to add a second product to its portfolio this soon,” said Scott Tarriff, president and chief executive officer of Par. “Cesamet’s unique profile will benefit many of the patients suffering with CIE who have not responded to other therapies. The product also represents an ideal complement to Par’s Megace(R) ES and will permit us to utilize our sales force more efficiently.”
“We look forward to a very successful collaboration with Par,” said Wesley P. Wheeler, president of Valeant Pharmaceuticals North America. “Cesamet is a drug that will address an important and unmet medical need for many patients. Its rapid adoption in Canada clearly demonstrates the product’s utility. We expect Cesamet’s U.S. introduction to benefit greatly from the efforts of Par’s team of highly experienced sales professionals.”
Under the terms of the agreement, Par will promote Cesamet to physicians in the U.S. Valeant will record sales of Cesamet and fund all marketing expenses associated with the product.
Valeant acquired Cesamet from Eli Lilly & Company in 2004 and currently markets the product in Canada. Cesamet now holds approximately 85 percent share of total prescriptions in the Canadian cannabinoid market.
Cesamet is intended to be marketed for use in the treatment of nausea and vomiting associated with cancer chemotherapy in patients who do not respond to conventional antiemetic treatments. Compared to similar cannabinoid treatment options, Cesamet has a longer duration of action, which allows for less frequent dosing. For patients using Cesamet, the absence of tetrahydrocannabinol (THC) detection in urine testing avoids any issues with drug testing for employment or associated stigmas.
Important Safety Information
Cesamet is contraindicated in patients whose nausea and vomiting arises from any cause other than cancer chemotherapy and in any patient known to be hypersensitive to the drug. The most frequent adverse reactions to Cesamet are vertigo, drowsiness, dry mouth, ataxia, euphoria, visual disturbance, concentration difficulties, and sleep disturbance. Patients should not drive, operate complex machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and perform such tasks safely.
About Valeant
Valeant Pharmaceuticals North America is a subsidiary of Valeant Pharmaceuticals International , a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at http://www.valeant.com.
About Par
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace(R) ES, for specialty markets. Par currently manufactures, markets or licenses more than 90 prescription drugs. For press release and other company information, visit http://www.parpharm.com.
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission, such as the Company’s Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.
CONTACT: Stephen J. Mock or Cecelia C. Heer of Par PharmaceuticalCompanies, Inc., +1-201-802-4000
