PR Newswire
STOCKHOLM, Sweden, Dec 7, 2016
STOCKHOLM, Sweden, Dec 7, 2016 /PRNewswire/ --
Swedish Orphan Biovitrum AB (publ) (Sobi™) and Horizon Pharma plc (NASDAQ: HZNP) ("Horizon") today announced that the companies have entered into a five-year distribution agreement for Ravicti® (glycerol phenylbutyrate) in European countries, including United Kingdom, Germany, France, Italy and Spain and for Ammonaps® (sodium phenylbutryate) in the same European countries and certain Middle Eastern countries. Under the agreement, Sobi will have exclusive marketing, sales and distribution rights for the two medicines in the territory until 31 December 2021. Horizon has the ability to terminate the agreement after two years subject to certain pre-defined termination fees. Sobi currently distributes Ravicti in certain Middle Eastern countries and Ammonaps in certain European and Middle Eastern countries.
Ravicti and Ammonaps are authorised by the European Commission and are indicated for the treatment of Urea Cycle Disorders (UCD).
"We are happy to build on our successful relationship with Horizon Pharma to support providing treatment to people living with UCDs", says Alan Raffensperger, Chief Operating Officer of Sobi and continues: "This distribution agreement will allow us to leverage our existing expertise and extensive experience within the area of UCDs. Our main focus now will turn to implementing patient access activities with the objective to launch Ravicti in Europe during 2017."
"Sobi has been a trusted partner in Europe and the Middle East for the last three years," says Francoise de Craecker, group vice president and general manager, EMEA, orphan business unit, Horizon Pharma plc. "We believe that Sobi's current distribution of Ammonaps uniquely qualifies it to effectively provide Ravicti to people living with UCDs in European markets."
About Ravicti®
Ravicti is indicated for use in all 28 Member States of the European Union and 3 Member States of the European Economic Area as a nitrogen-binding agent for chronic management of adult and pediatric patients two months of age and older with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Important Safety Information
LIMITATIONS OF USE:
CONTRAINDICATIONS:
WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS:
DRUG INTERACTIONS:
About Ammonaps®
Ammonaps (sodium phenylbutyrate) is used to treat Urea Cycle Disorders (UCD). UCD is a group of serious conditions in which patients suffer from deficiencies in the enzymes required to remove ammonia from the blood stream.Ammonaps is used to reduce levels of ammonia and glutamine in the blood. Ammonaps is used with other treatments and a special diet for the long-term management of patients with urea cycle disorders where there is lack of one or more of the following enzymes: carbamyl phosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase. Ammonaps is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Important Safety Information
CONTRAINDICATIONS:
WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS:
DRUG INTERACTIONS:
About Sobi™
Sobi is an international specialty healthcare company dedicated to rare diseases. Sobi's mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion (USD 385 M) and about 700 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More information is available at www.sobi.com.
About Horizon Pharma plc
Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets 11 medicines through its orphan, rheumatology and primary care business units. For more information, please visit www.horizonpharma.com. Follow @HZNPplc on Twitter or view careers on our LinkedIn page.
Forward Looking Statements
This press release contains forward-looking statements, including statements regarding the potential benefits that may be derived from the distribution agreement between Horizon Pharma and Sobi, and plans and expected timing with respect to launching Ravicti in Europe. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include risks that the distribution agreement is terminated early, that either party does not comply with its obligations under the distribution agreement, that adequate pricing and reimbursement for Ravicti in Europe is not available, and those factors described in Horizon Pharma's filings with the United States Securities and Exchange Commission, including those discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law.
For more information please contact:
Media relations
Linda Holmström, Senior Communications Manager
T: + 46 708 73 40 95, + 46 8 697 31 74
linda.holmstrom@sobi.com
Investor relations
Jörgen Winroth, Vice President, Head of Investor Relations
T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
jorgen.winroth@sobi.com
Horizon Pharma contacts:
Media
Geoff Curtis
Senior Vice President, Corporate Communications
media@horizonpharma.com
Investor relations
Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizonpharma.com
CONTACT:
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SOURCE Swedish Orphan Biovitrum AB
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