Mar 07 2012
DEERFIELD, Illinois – Horizon Pharma, Inc., (NASDAQ: HZNP) a biopharmaceutical company developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases, today announced that its Swiss subsidiary and Mundipharma International Corporation Limited and Mundipharma Medical Company have amended their exclusive distribution and supply agreements for commercialization of LODOTRA, a proprietary, programmed-release formulation of low-dose prednisone, in Asia to also include Mexico, Brazil, Argentina, Colombia, Venezuela, Peru, Chile, Ecuador, Dominican Republic, Guatemala, Costa Rica, Uruguay, Bolivia, Panama, Nicaragua, El Salvador and Honduras.
“Mundipharma has a highly respected reputation through its product portfolio across multiple geographies, including LODOTRA in Europe, and we are pleased to expand our existing agreement with them to pursue commercialize of LODOTRA in these additional territories,” said Todd N. Smith, senior vice president, sales, marketing and business development, Horizon Pharma, Inc.
“LODOTRA represents an important advance in the improvement of outcomes and the quality of life for rheumatoid arthritis patients,” said Raman Singh, Regional Managing Director, Mundipharma Asia Pacific & Latin America. “We are excited about the addition of LODOTRA to our existing product portfolio in Latin America.”
About LODOTRA
LODOTRA is a proprietary programmed-release formulation of low-dose prednisone and has received regulatory approval for the treatment of moderate to severe active rheumatoid arthritis (RA) when accompanied by morning stiffness in Europe where it is promoted by Mundipharma. LODOTRA utilizes SkyePharma’s proprietary Geoclock™ technology
Horizon has completed a Phase 3 trial for LODOTRA in the United States for the treatment of the signs and symptoms of RA. In November 2011, the United States Food and Drug Administration (FDA) accepted for filing and review, Horizon’s New Drug Application for LODOTRA and set a PDUFA action date of July 26, 2012, based on a standard 10 month review.
About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit www.horizonpharma.com
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About Mundipharma International Corporation Limited Mundipharma and its independent associated companies are privately owned companies and joint ventures covering the world’s pharmaceutical markets. The companies are dedicated to bringing to patients with severe and debilitating diseases the benefit of novel treatment options in fields such as severe pain, oncology, respiratory disease rheumatoid arthritis, antiseptics and laxatives. For more information please visit: www.mundipharma.asia
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