Sobi gains rights to distribute RAVICTI® on a named patient use basis in Middle East from Hyperion Therapeutics, Inc.
Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) and Hyperion Therapeutics, Inc.,
(NASDAQ: HPTX) announced today that Sobi has been granted the exclusive rights
by Hyperion to distribute RAVICTI (glycerol phenylbutyrate) Oral Liquid on a
named patient basis for the chronic treatment of Urea Cycle Disorders (UCD) in
the Middle East. Under the agreement, Sobi receives the rights to provide
RAVICTI in Saudi Arabia, Oman, United Arab Emirates, Jordan, Kuwait, Qatar and
Bahrain. Financial details were not disclosed.
"We are proud of this partnership with Hyperion and RAVICTI is a perfect fit
with our existing UCD business and the capabilities within our Genetics
Therapeutic Area," said Geoffrey McDonough, President and CEO at Sobi. "We
believe the recent FDA approval of RAVICTI can allow us to provide access for
this important therapy in the Middle East."
UCD patients lack enzymes or transporters necessary for the conversion of
ammonia to urea and experience heightened levels of ammonia in the bloodstream.
Left untreated, UCDs can result in neurological damage, coma, and/or death.
Approved by the Food and Drug Administration on February 1, 2013, RAVICTI is an
oral medication used for the long-term management of high blood levels of
- - -
In short term clinical studies involving more than 70 UCD patients ages two
years and older, RAVICTI was safe and efficacious based on 24-hour ammonia
profiles. In addition in long-term follow up studies, patients on RAVICTI
maintained average fasting ammonia levels below the upper limit of normal.
In the United States, RAVICTI is indicated for use as a nitrogen-binding agent
for chronic management of adult and pediatric patients >=2 years of age with
UCDs who cannot be managed by dietary protein restriction and/or amino acid
supplementation alone. RAVICTI must be used with dietary protein restriction
and, in some cases, dietary supplements (e.g., essential amino acids, arginine,
citrulline, protein-free calorie supplements). RAVICTI is not indicated for the
treatment of acute hyperammonemia in patients with UCDs because more rapidly
acting interventions are essential to reduce plasma ammonia levels. The safety
and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS)
deficiency has not been established. The use of RAVICTI in patients <2 months
of age is contraindicated.
For additional Important Safety Information, including Warnings and Precautions,
Adverse Events, Drug Interactions, and Special Populations, please see full
Prescribing Information (PDF) and Medication Guide (PDF) for RAVICTI at
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on inflammation and genetic diseases, with three late stage biological
development projects within haemophilia and neonatology. We also market a
portfolio of specialty and rare disease products for partner companies. Sobi is
a pioneer in biotechnology with world-class capabilities in protein biochemistry
and biologics manufacturing. In 2012, Sobi had total revenues of SEK 1.9 billion
(€ 215 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com.
About Hyperion Therapeutics, Inc.
Hyperion Therapeutics, Inc. is a commercial stage biopharmaceutical company
committed to developing and delivering life-changing treatments for orphan
diseases and hepatology. The company's first commercial product, RAVICTI®
(glycerol phenylbutyrate) Oral Liquid, was approved in February 2013 and is
currently being marketed in the United States. The company also owns and markets
BUPHENYL® (sodium phenylbutyrate) Tablets and Powder worldwide. For more
information, please visit www.hyperiontx.com.
Sobi Hyperion Therapeutics, Inc.
Media relations Sylvia Wheeler
Oskar Bosson Vice President, Investor Relations
Head of Communications T: (650) 745-7834
T: +46 70 410 71 80
Vice President, Head of Investor Relations
T: +46 8 697 20 00