BLAINVILLE, Quebec (Canada) – August 18, 2020 – Médunik Canada, a pharmaceutical company dedicated to improving the health and quality of life of Canadians with rare diseases, is extremely pleased to announce that our orphan disease portfolio just expanded further with the recent addition of a new drug. Health Canada has issued a Notice of Compliance (NOC) for Ruzurgi® (amifampridine), a drug indicated for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in patients 6 years of age or older.
Ruzurgi® is an oral potassium channel inhibitor designed to prolong signals released from nerves to allow greater stimulation of muscle. Developed by Jacobus Pharmaceutical Co., the drug received FDA (Food and Drug Administration) market authorization in the United States in May 2019 for the treatment of LEMS in patients 6 to less than 17 years of age and is since commercialized under the brand name Ruzurgi® (also known as 3,4-DAP). To bring the drug to Canadian patients, Jacobus established a strategic partnership with Médunik Canada, which submitted a marketing application for Ruzurgi® to Health Canada in December 2019.
“Considering that many patients are already under treatment due to the Special Access Program (SAP), Médunik Canada has plans in place to ensure a smooth transition towards a dedicated Patient Support Program (PSP) to avoid any treatment interruptions,” affirmed Dany Hallé, Vice-President, Commercial Affairs of Médunik Canada.
“We are proud to have reached an exclusive distribution agreement to ensure Canadian patients can benefit from this life-changing medication,” said Éric Gervais, Executive Vice-President of Médunik Canada. “Thus fulfilling, furthermore, Médunik Canada’s mission with the addition of a third product to our orphan disease treatment product offering.”
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ABOUT LAMBERT-EATON MYASTHENIC SYNDROME (LEMS)
LEMS, a debilitating neuromuscular syndrome, is a rare autoimmune disorder in which the immune system attacks the neuromuscular junction, interfering with the ability of nerve cells to send signals to muscle cells. LEMS generally affects the extremities, causing muscle weakness, especially in the legs and hips, which can ultimately lead to difficulty walking. Weakness in the eye muscles and those involved in talking, swallowing and chewing may also occur. LEMS may be associated with small-cell lung cancer, where its onset precedes or coincides with the cancer diagnosis. While the prevalence of LEMS in children is not known, the disease is estimated to affect 3-4 of every 1 million individuals worldwide and can occur at any age.
ABOUT MÉDUNIK CANADA
Médunik Canada’s vision is to improve the health and quality of life of Canadians living with rare diseases. Founded in December 2009, the company’s mission is to make orphan drugs available to Canadians by partnering with international companies interested in making their products available to Canadian patients. For more information, please visit www.medunikcanada.com.
ABOUT JACOBUS PHARMACEUTICAL Co.
Jacobus Pharmaceutical Co. is a privately owned, family-run pharmaceutical company based in Princeton, New Jersey, United States. Since its founding in 1977, Jacobus’ mission has been to improve the lives of patients by providing affordable treatments for unmet medical needs. Jacobus has supported the worldwide LEMS community for more than 20 years by providing Ruzurgi® through compassionate distribution programs. In that time, the company has committed considerable resources to ensure that patients with LEMS had access to Ruzurgi® to treat this ultra-rare disease. In May 2019, Ruzurgi® received regulatory approval in the United States for the treatment of LEMS in patients 6 to less than 17 years of age. Jacobus is dedicated to helping as many patients living with LEMS as possible.