Unimed Pharmaceuticals, Inc. to Be Sole Marketer of Marinol®
Co-marketing Arrangement with Roxane Laboratories ends December 31, 2000
Deerfield, Ill. (Jan. 2, 2001) – Unimed Pharmaceuticals, Inc. announced today that effective January 1, 2001, it has become solely responsible for the marketing of Marinol® CIII (dronabinol) capsules. Marinol® is the only FDA approved synthetic form of tetrahydrocannabinol (THC). Marinol® was first brought onto the market for the treatment of cancer chemotherapy induced nausea and vomiting that is unresponsive to conventional medications. In 1992, the FDA approved Unimed’s supplemental new drug application for Marinol® for the treatment of appetite loss or anorexia associated with weight loss in AIDS patients.
Roxane Laboratories launched Marinol in 1987. In 1992, Unimed and Roxane Laboratories started co-promoting Marinol® in the United States. Now, as sole marketer of Marinol®, Unimed Pharmaceuticals assumes responsibility for all manufacturing, distribution, and marketing responsibilities for the product.
"Marinol® has provided HIV and cancer patients nationwide a safe and effective treatment for anorexia and nausea," said Robert Dudley, Ph.D., President and CEO, Unimed Pharmaceuticals, Inc. "Unimed looks forward to fully supporting the continuing education of health care providers and patients on the medical role of Marinol®, including support of an indigent patient assistance program. Moreover, Unimed is currently exploring Marinol's use in additional therapeutic areas."
In 1999, the Drug Enforcement Agency (DEA) reclassified Marinol® from a Schedule II to a Schedule III medication, indicating lower abuse and addiction potential and facilitating the prescription refill process. To date, 41 of 50 states have rescheduled Marinol“ in accordance with DEA actions, and efforts are underway to ensure the reclassification in all 50 states.
Marinol® is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid or sesame oil. Patients receiving treatment with Marinol® should be specifically warned not to drive, operate machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and perform such tasks safely. Marinol® should be used with caution in patients with cardiac disorders, a history of substance abuse, mania, depression, schizophrenia, or concomitant therapy with sedatives, hypnotics and other psychoactive drugs.
For additional information, physicians and patients may visit www.marinol.com.
Unimed Pharmaceuticals, Inc., a wholly owned, independently operated subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of cardiology, men’s health (urology and endocrinology), and certain infectious diseases.
Solvay Pharmaceuticals, Inc. of Marietta, Ga., is a research-based pharmaceutical company active in therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies headquartered in Brussels, Belgium.
Roxane Laboratories, Inc. is a leading manufacturer of prescription medicines. The Company is a wholly owned subsidiary of Boehringer Ingelheim Corporation, located in Ridgefield, Connecticut, and is part of the Boehringer Ingelheim worldwide group of companies. Boehringer Ingelheim, headquartered in Ingelheim (Germany) ranks among the top 20 pharmaceutical companies in the world with reported revenues exceeding U.S. $4.78 billion in 1999.
Boehringer Ingelheim has world-wide some 140 affiliated companies. The focus is on the human pharmaceutical as well as on the animal health business. The human pharmaceutical business, which is responsible for 92% of sales, includes mainly ethical pharmaceuticals and self-medication but also products for industrial customers (chemicals and biopharmaceuticals).
