Last updated on April 17, 2014 at 9:23 EDT

Medunik Canada and Orphan Europe sign a new distribution agreement to help Canadians with rare diseases

July 5, 2012

BLAINVILLE, QC, July 5, 2012 /PRNewswire/ – Medunik Canada, is an orphan drug company dedicated to helping Canadians with rare
diseases access therapies currently unavailable in Canada. Medunik
Canada is proud to announce that it has signed an exclusive
distribution agreement with Orphan Europe Recordati Group. Under this
agreement, Medunik Canada receives the exclusive Canadian rights to
market and distribute four important therapies in the following medical
conditions: (1) acute hepatic porphyria, (2) hyperammonaema due to
N-acetylglutamate synthase (NAGS) deficiency or one of three organic
acidurias (isovaleric, methylmalonic or propionic), (3) patent ductus
arteriosus and (4) vitamin E deficiency in chronic cholestasis.

“We are thrilled to enter into a new partnership with Orphan Europe
Recordati Group” stated Éric Gervais, Executive Vice-President of
Medunik Canada. “This new strategic collaboration complements our
existing alliances and represents an important milestone in our
endeavor to help patients with a rare disease in Canada to benefit from
the best treatments available”.

Marco Liguori, General Manager & Recordati Vice-President, Special care
and Orphan Drugs went on to say that “Orphan Europe Recordati Group is
delighted to extend its products and services to rare disease patients
in Canada. We are particularly happy to work with a company like
Medunik Canada which is committed to building awareness and promoting
better diagnosis and care of rare disease patients in Canada.”

About the Medical Conditions

Acute hepatic porphyrias: The porphyrias are a group of disorders of the heme biosynthesis pathway
that present with acute neurovisceral symptoms, skin lesions or both.
Acute porphyria is a term that includes three similar inherited
diseases: acute intermittent porphyria (AIP), variegate porphyria (VP)
and hereditary coproporphyria (HCP). They are characterised by episodic
acute neurovisceral attacks which may be life threatening. These
attacks are uncommon and are often difficult to diagnose. In AIP only
acute attacks occur and the skin is never affected, whilst in VP or HCP
skin may also be affected.

Hyperammonaema due to N-acetylglutamate synthase (NAGS) deficiency or one of three organic acidurias (isovaleric, methylmalonic
or propionic): NAGS deficiency is one of the urea cycle disorders
(UCD). UCDs are caused by a deficiency of one of the enzymes in the
urea cycle which is responsible for removing ammonia from the blood
stream and organic acidurias disrupt normal amino acid metabolism
causing a buildup of acidsm. Both groups of disorders can cause
hyperammonemia. Accumulation of ammonia in the body causes irreversible
brain damage, coma, and can be fatal.

Patent Ductus Arteriosus (PDA): In the developing fetus, the ductus arteriosus (DA) is a shunt
connecting the pulmonary artery to the aortic arch. It allows the blood
from the right ventricle to bypass the lungs. In normal newborns, the
DA is closed within a few hours after birth. However, in preterm
babies, this blood vessel sometimes remains open and because of the
pressure gradient blood flows back from the aorta to the pulmonary
artery. This condition is called patent ductus arteriosus (PDA) and
affects the perfusion of the lungs and other organs (brain, kidney,

Vitamin E deficiency in chronic cholestasis:  Chronic cholestasis represents a symptom of various conditions where
the flow or the formation of bile is impaired. Patients with chronic
cholestasis cannot absorb fat soluble vitamins. Vitamin E deficiency is
therefore a complication often observed in patients presenting with
this condition and can lead to neurological abnormalities.

About Medunik Canada

Medunik Canada was created in December 2009 with the mission to bring to
Canada currently unavailable orphan drugs for women, men and children
with rare diseases. 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 health 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 morem information, visit www.medunikcanada.com.

About Orphan Europe

Orphan Europe is a pharmaceutical company aiming at providing treatment
for patients with unmet medical needs suffering from rare diseases.
Being part of Recordati Group since December 2007, it continues to be
one of the most active players in the field of rare diseases. In 2011,
Orphan Europe received the Corporate Award from the National
Organization for Rare Disorders (NORD) for the development of a
therapeutic agent for the treatment of NAGS deficiency in the United
States. For morem information, visit www.orphan-europe.com

SOURCE Médunik Canada

Image with caption: “Logo of Orphan Europe Recordati Group (CNW Group/Médunik Canada)”. Image available at: http://photos.newswire.ca/images/download/20120705_C6293_PHOTO_EN_15975.jpg

Source: PR Newswire