Tolmar Establishes Tolmar Canada to Sell, Market and Distribute ELIGARD® in Canada
Tolmar will resume the rights to ELIGARD® in the Canadian Market from Sanofi Canada
BUFFALO GROVE, Ill., Oct. 8, 2021 /PRNewswire/ -- Tolmar, a specialty pharmaceutical company, today announced that, effective January 1, 2022, the company will hold exclusive distribution rights to ELIGARD® (leuprolide acetate for injectable suspension) in Canada. ELIGARD® is a prescription medication for the palliative treatment of advanced prostate cancer.
With the establishment of Tolmar Pharmaceuticals Canada, Tolmar will resume the rights to ELIGARD® in the Canadian market. Sanofi Canada has ceased marketing and promotional activities of ELIGARD® in the Canadian market as of Sept. 30, 2021 and will cease selling and distribution after Dec. 31, 2021. Tolmar will exclusively market, sell, and distribute ELIGARD® in Canada after those respective dates.
"We are excited to regain the sales and marketing rights for ELIGARD® in Canada," said Anil D'souza, CEO of Tolmar Pharmaceuticals. "Tolmar is dedicated to supporting healthcare providers and their patients with advanced prostate cancer. The establishment of Tolmar Pharmaceuticals Canada will allow Tolmar to continue to advance ELIGARD® into the future."
Throughout the transition, Sanofi Canada and Tolmar are collaborating fully to help ensure smooth transfer of the product and services for patients and healthcare providers, including the ELIGARD® Home Injection Program in place in Canada. Tolmar has established operations in Canada and is fully committed to serving the uro-oncology community in Canada, with reliable supply of ELIGARD® and a dedicated Canadian team to support healthcare providers and their patients, with no disruption.
ELIGARD® is a gonadotropin releasing hormone (GnRH) agonist, designed to reduce the amount of testosterone in the body by reducing its production. It is not a cure for advanced prostate cancer. Testosterone is known to stimulate prostate cancer cells to grow. ELIGARD® received marketing clearance from the U.S. Food and Drug Administration (FDA) and launched in the U.S. in 2002.
Tolmar, the original developer of the drug, will continue to manufacture ELIGARD® for worldwide distribution, maintaining the highest levels of quality standards.
For complete ELIGARD® prescribing information, please go to Prescribing Information for the U.S.
This press release is intended for a United States audience.
About Tolmar and ELIGARD®
Tolmar is a fully integrated pharmaceutical company focused on the development, approval, and commercialization of specialty pharmaceutical products. Tolmar Pharmaceuticals is based in Lincolnshire, IL, with Tolmar global headquarters, product development and manufacturing facilities based in Fort Collins, Colorado.
Tolmar Pharmaceuticals has the exclusive distribution rights for ELIGARD® in the U.S. and Puerto Rico. ELIGARD® is a gonadotropin releasing hormone (GnRH) agonist prescribed for the treatment of advanced prostate cancer, developed and manufactured by Tolmar Inc. " Tolmar " refers to Tolmar Holding Inc. and its wholly owned operating subsidiaries, Tolmar Inc., (product development and manufacturing), Tolmar Therapeutics, Inc. (licensing) and Tolmar Pharmaceuticals, Inc. (sales and marketing). For more information about the company, please visit tolmar.com Information about ELIGARD® is available at eligardhcp.com.
IMPORTANT SAFETY INFORMATION
ELIGARD® is indicated for the palliative treatment of advanced prostate cancer. ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression.
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits. May cause fetal harm. Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to current clinical practice.
ELIGARD may impair fertility in males of reproductive potential.
The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. See package insert for full Prescribing and Safety Information.
MEDIA CONTACT:
Julie Ferguson
JFPRMEDIAGROUP
(312) 385-0098
[email protected]
SOURCE Tolmar
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