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Horizon Pharma Enters into Exclusive Agreement with Mundipharma for Commercialization of LODOTRA® (Modified-Release Prednisone) in Asia
Horizon Pharma Enters into Exclusive Agreement with Mundipharma for Commercialization of LODOTRA® (Modified-Release Prednisone) in Asia
Horizon Pharma Enters into Exclusive Agreement with Mundipharma for Commercialization of LODOTRA® (Modified-Release Prednisone) in Asia
10/05/10
Horizon Pharma Enters into Exclusive Agreement with Mundipharma for Commercialization of LODOTRA® (Modified-Release Prednisone) in AsiaNORTHBROOK, Ill. – November 5, 2010 – Horizon Pharma, Inc., a biopharmaceutical company developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases, today announced its Swiss subsidiary has entered into exclusive distribution and supply agreements with Mundipharma International Corporation Limited for commercialization of LODOTRA®, programmed release formulation of low-dose prednisone, in Australia, China, Hong Kong, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand and Vietnam.
"With the signature of this agreement, patients suffering from morning stiffness associated with rheumatoid arthritis will potentially have a new therapeutic option," said Timothy P. Walbert, chairman, president and chief executive, Horizon Pharma. "Mundipharma has strong expertise in supportive care of chronic illnesses and has a highly respected reputation through its current product portfolio, which will now include LODOTRA® in these territories.”
Henrik Glarbo, Regional Managing Director for Mundipharma Asia Pacific said, "LODOTRA® represents a potential important advancement in the improvement of outcomes and the quality of life for rheumatoid arthritis patients in Asia Pacific. We are therefore excited about the addition of LODOTRA® to our existing product portfolio."
About LODOTRA®
LODOTRA® is a proprietary programmed-release formulation of low-dose prednisone and has received regulatory approval in Europe for reduction in morning stiffness associated with rheumatoid arthritis (RA). Merck Serono holds marketing rights to LODOTRA® in Germany and Austria and Mundipharma International Corporation Limited holds marketing rights to LODOTRA® for the rest of Europe.
The company has completed a Phase 3 trial for LODOTRA® in the United States for the treatment of the signs and symptoms of RA. The company anticipates submitting a New Drug Application (NDA) for LODOTRA® for the treatment of the signs and symptoms of RA to the U.S. Food and Drug Administration in the fourth quarter of 2010.
LODOTRA® is also being investigated for the treatment of severe nocturnal asthma and polymyalgia rheumatica (PMR).
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, antiseptics and laxatives. For more information please visit: www.mundipharma.asia
Forward Looking Statements
This press release contains forward-looking statements regarding the distribution and supply arrangement with Mundipharma for LODOTRA® in selected countries in Asia, Australia, New Zealand and South Africa, the potential payments that the company may receive from Mundipharma, 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® in 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 the company, please see the risk factors described in the company’s Registration Statement on Form S-1 that was originally filed with the United States Securities and Exchange Commission on August 3, 2010, and the amendments thereto, 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 the company undertakes no obligation to update or revise these statements, except as may be required by law.
"With the signature of this agreement, patients suffering from morning stiffness associated with rheumatoid arthritis will potentially have a new therapeutic option," said Timothy P. Walbert, chairman, president and chief executive, Horizon Pharma. "Mundipharma has strong expertise in supportive care of chronic illnesses and has a highly respected reputation through its current product portfolio, which will now include LODOTRA® in these territories.”
Henrik Glarbo, Regional Managing Director for Mundipharma Asia Pacific said, "LODOTRA® represents a potential important advancement in the improvement of outcomes and the quality of life for rheumatoid arthritis patients in Asia Pacific. We are therefore excited about the addition of LODOTRA® to our existing product portfolio."
About LODOTRA®
LODOTRA® is a proprietary programmed-release formulation of low-dose prednisone and has received regulatory approval in Europe for reduction in morning stiffness associated with rheumatoid arthritis (RA). Merck Serono holds marketing rights to LODOTRA® in Germany and Austria and Mundipharma International Corporation Limited holds marketing rights to LODOTRA® for the rest of Europe.
The company has completed a Phase 3 trial for LODOTRA® in the United States for the treatment of the signs and symptoms of RA. The company anticipates submitting a New Drug Application (NDA) for LODOTRA® for the treatment of the signs and symptoms of RA to the U.S. Food and Drug Administration in the fourth quarter of 2010.
LODOTRA® is also being investigated for the treatment of severe nocturnal asthma and polymyalgia rheumatica (PMR).
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, antiseptics and laxatives. For more information please visit: www.mundipharma.asia
Forward Looking Statements
This press release contains forward-looking statements regarding the distribution and supply arrangement with Mundipharma for LODOTRA® in selected countries in Asia, Australia, New Zealand and South Africa, the potential payments that the company may receive from Mundipharma, 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® in 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 the company, please see the risk factors described in the company’s Registration Statement on Form S-1 that was originally filed with the United States Securities and Exchange Commission on August 3, 2010, and the amendments thereto, 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 the company undertakes no obligation to update or revise these statements, except as may be required by law.
Contacts:
Horizon
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
investor-relations@horizonpharma.com
Geoff Curtis
WCG
312-646-6298
gcurtis@wcgworld.com