SOURCE: Horizon Pharma

Horizon Pharma

November 11, 2013 07:30 ET

Horizon Pharma and Mundipharma Sign Exclusive Agreement to Commercialize LODOTRA® in the Middle East and Africa

Under the Amended Exclusive Distribution and Supply Agreements, Mundipharma Will Have Rights to Commercialize LODOTRA in 55 Additional Countries; LODOTRA Is Approved in the U.S. and Over Thirty Other Countries to Treat Rheumatoid Arthritis and Associated Morning Stiffness

DEERFIELD, IL--(Marketwired - Nov 11, 2013) - Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that its Swiss subsidiary has signed an exclusive agreement with Mundipharma for the commercialization and distribution of LODOTRA® in the Middle East and African Region. LODOTRA, an innovative delayed-release formulation of prednisone specifically designed to deliver the active drug at the most physiologically efficient time, is approved in the U.S. under the trade name RAYOS® and in over thirty other countries to treat moderate to severe active Rheumatoid Arthritis (RA) when accompanied by morning stiffness.

LODOTRA brings an important potential innovation in RA treatment to the Middle East and African regions. It helps control a wide number of disease states characterised by excessive inflammation, including inflammation of the joints in arthritis. LODOTRA also helps to reduce the early morning joint pain and stiffness associated with RA, which can greatly improve a patient's quality of life.

"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, executive vice president, chief commercial officer, Horizon Pharma, Inc.

Under the agreement, Mundipharma will have rights to commercialize LODOTRA in fifty-five additional countries. Mundipharma will utilize a combination of company resources and partnerships to support LODOTRA commercialization in the licensed regions.

"We are excited to expand our collaboration with Horizon to new territories and offer a new therapeutic option for Rheumatoid Arthritis patients in the Middle East and Africa. Mundipharma has always focused on alleviating the burden of patients suffering from chronic pain. We are pleased to add LODOTRA to our product portfolio in these additional territories as it represents an important advancement in improving the quality of life and outcomes for those afflicted with RA," said Raman Singh, Managing Director of Mundipharma Asia Pacific, Latin America, Middle East and Africa.

About LODOTRA®
LODOTRA is a proprietary delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of LODOTRA is different with an approximately four-hour lag time from that of immediate-release prednisone formulations. In clinical trials studying use of LODOTRA in RA, patients were administered LODOTRA at 10 p.m. with food. The delayed-release profile of LODOTRA helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night. While the pharmacokinetic profile of LODOTRA differs in terms of lag time from immediate-release prednisone, its absorption, distribution and elimination processes are comparable.

LODOTRA is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in over 30 countries. Horizon has granted commercialization rights for LODOTRA in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited. LODOTRA utilizes SkyePharma's proprietary Geoclock™ technology.

LODOTRA, known as RAYOS® in the United States, is commercialized by Horizon Pharma in the U.S. market. For more information, please visit www.RAYOSrx.com.

About Horizon Pharma
Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing DUEXIS and RAYOS/LODOTRA, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. The Company's strategy is to develop, acquire and/or in-license additional innovative medicines where it can execute a targeted commercial strategy in specific therapeutic areas while taking advantage of its commercial strengths and the infrastructure the Company has put in place. For more information, please visit www.horizonpharma.com.

About Mundipharma
Mundipharma and its independent associated companies are privately owned entities covering the world's pharmaceutical markets. Mundipharma is a prime example of a company that consistently delivers high quality products while standing by the values that represent the company. Our mission is to alleviate the suffering of patients with cancer and non-cancer pain and to substantially improve their quality of life. Mundipharma is 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.

Forward-Looking Statements
This press release contains forward-looking statements regarding the distribution and supply arrangement with Mundipharma for LODOTRA® in selected countries in the Middle East and Africa the potential commercialization of LODTORA in these countries, and the potential for LODOTRA to be an important potential innovation in RA treatment and to help in controlling a wide number of disease states characterized by excessive inflammation, including inflammation of the joints in arthritis and its potential to improve patients' quality of life. 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.

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