Medunik Canada obtains new Notice of Compliance from Health Canada for Ruzurgi® (amifampridine) following a favourable Canadian Federal Court of Appeal ruling

BLAINVILLE, Quebec, Jan. 17, 2023 (GLOBE NEWSWIRE) -- Medunik Canada Inc. ("Medunik"), a company dedicated to improving the health and quality of life of Canadians with rare diseases by bringing orphan drugs to Canada, is pleased to announce that on January 9, 2023, the Federal Court of Appeal of Canada set aside an earlier decision of its Trial Division which had removed a Notice of Compliance on Medunik's Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome ("LEMS") patients and sent the matter back to Health Canada.

The Notice of Compliance which had been previously granted by Health Canada is now restored.

The Federal Court of Appeal set aside the earlier decision of the trial division revoking the Notice of Compliance while the matter was sent back to Health Canada. The Court of Appeal confirmed the reasonableness of Health Canada's review and the grant of a Notice of Compliance for Ruzurgi®.

"We are very pleased by the Court of Appeal's decision confirming that the Notice of Compliance for Ruzurgi® had been rightly granted by Health Canada," said Alain M. Leclerc, Vice-President, Legal Affairs, for Medunik.

Medunik, a division of Duchesnay Pharmaceutical Group led by President Éric Gervais, will now work on re-establishing availability of Ruzurgi® for the benefit of eligible LEMS patients who rely on this important medicine. "Our position has always been that we were not at fault in these unique proceedings and have always been confident that the facts would result in a positive outcome," said Mr. Gervais.

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 RUZURGI

Ruzurgi® (amifampridine), indicated for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in patients 6 years of age or older, is an oral potassium channel inhibitor designed to prolong signals released from nerves to allow greater stimulation of muscle. Developed by Jacobus Pharmaceutical Co. and made available to Canadian patients in partnership with Medunik Canada, the drug originally received market authorization from Health Canada under the brand name Ruzurgi ® in August 2020. Following the initial court action, this approval was later suspended in June of 2021 and reinstated in the same month, to be suspended once more in March of 2022 and now reinstated again in January of 2023.

ABOUT MEDUNIK CANADA

Medunik 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.medunik.com.

For further information:

Mariia Savchuk
Duchesnay Pharmaceutical Group
[email protected]
450 433-7734 | 1 877 833-7734 poste 149

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5c736dcf-4b49-4346-9c43-43af4b1879f0