DEERFIELD, IL--(Marketwire - March 07, 2012) - 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 commercialize 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."
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.
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
This press release contains forward-looking statements regarding the distribution and supply arrangement with Mundipharma for LODOTRA in selected countries in Latin America and the potential commercialization of LODTORA in these countries, and the potential for LODOTRA to treat patients suffering from rheumatoid arthritis. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, risks regarding reliance on Mundipharma to obtain regulatory approval for and commercialize LODOTRA the relevant markets, including risks that Mundipharma may not devote sufficient efforts to those activities, whether due to lack adequate financial or other resources, a strategic decision to focus on other initiatives or otherwise, and risks that the agreements with Mundipharma may be terminated, requiring Horizon to pursue other arrangements in order to recognize revenues from commercialization of LODOTRA in the relevant markets, as well as risks regarding regulatory review and approval of LODOTRA in the relevant territories, market adoption of LODOTRA in any territories where it is approved for marketing, and competition in the markets for LODOTRA. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release, and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.