BLAINVILLE, QC (Canada) – September 24th, 2014 – Medunik Canada, a Canadian pharmaceutical company specialized in orphan drugs, announces that PHEBURANE® (a tasteless oral formulation of sodium phenylbutyrate), indicated as adjunctive therapy in the chronic management of Urea Cycle Disorders (UCD), was granted a Priority Review Status by Health Canada. This treatment will provide Canadians living with a urea cycle disorder access to a lower-cost alternative solution for the treatment of this metabolic disease.
About PHEBURANE® and Urea Cycle Disorders (UCD)
Sodium phenylbutyrate is an ammonia scavenger used in the management of UCD. This molecule is particularly distasteful to patients resulting in serious difficulties in compliance with treatment. Methods to improve compliance to treatment may involve reformulation into sweetened suspensions to improve product acceptability, which has a limited effect, and the invasive administration via nasogastric or gastrostomy tubes. PHEBURANE®'s new formulation of sodium phenylbutyrate totally masks the unpleasant taste of the active substance.
"Medunik Canada wishes to better answer the needs of people living with a Urea Cycle Disorder and we are pleased to see that PHEBURANE® has passed this first stage with Health Canada." said Éric Gervais, Executive Vice-President of Medunik Canada. "We are proud to work with best in class Orphan Drug Companies like Lucane to make a difference for Canadians" concluded Mr. Gervais.
UCDs are caused by a deficiency of one of the enzymes in the urea cycle which is responsible for the removal of ammonia, a potent neurotoxin, from the body. The urea cycle involves a series of biochemical steps in which nitrogen, a waste product of protein metabolism, is removed from the blood and converted to urea which is excreted in the urine. In UCDs, the nitrogen removal is blocked and it accumulates in the form of ammonia. Left untreated, UCDs can cause dangerously increased levels of ammonia in the bloodstream (hyperammonemia) resulting in brain damage, coma and, if untreated, death.
PHEBURANE®, developed by Lucane Pharma is under an exclusive distribution deal in Canada with Medunik Canada. Lucane Pharma was granted a marketing authorisation valid throughout the European Union for PHEBURANE® in July 2013.
About Medunik Canada
Medunik Canada was created in December 2009 with the mission to make orphan drugs available to Canadians living with rare diseases through turn-key partnerships with international companies interested in making their products available to Canadian patients in need of otherwise unavailable treatments. Medunik Canada is a natural complement to its sister company Duchesnay Inc., a specialty pharmaceutical company providing safe and effective treatment options to pregnant women, who represent a small-size population with special pharmacological needs. Both Medunik Canada and Duchesnay Inc. are part of Le Groupe Pharmaceutique Boivin, a Canadian family-owned organization based in the greater Montreal area of Quebec since 1955. For more information, visit www.medunikcanada.com
About Lucane Pharma
Founded in Paris in late 2009 with private financing, Lucane Pharma develops, registers and sells drugs solely dedicated to the management of rare diseases. Over the last 4 years, Lucane Pharma has been successful in developing and registering with the European Union its first product in the area of metabolic diseases and has just received a positive opinion from the European Medicines Agency (EMA) for the registration of a drug for the treatment of multi-drug resistant tuberculosis. Several drugs are at the development stage, mostly in the area of metabolic diseases.