Horizon Pharma, Inc.'s 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 US under the trade name Rayosand 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 RA 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.

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 Rayosin the United States, is commercialized by Horizon Pharma in the US market.

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.

Mundipharma and its independent associated companies are privately owned entities covering the world's pharmaceutical markets and 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.