Horizon Pharma Inks Deal with Mundipharma
The deal involves commercialization of LODOTRA in Australia, China, Hong Kong, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand and Vietnam.
According to Horizo, 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 holds marketing rights to LODOTRA for the rest of Europe.
The company has completed a phase 3 trial for LODOTRA in the US for the treatment of the signs and symptoms of RA. The company anticipates submitting a new drug applications for LODOTRA for the treatment of the signs and symptoms of RA to the FDA in the fourth quarter of 2010.
LODOTRA is also being investigated for the treatment of severe nocturnal asthma and polymyalgia rheumatica.
Timothy Walbert, chairman, president and CEO of Horizon Pharma, said: “With the signature of this agreement, patients suffering from morning stiffness associated with rheumatoid arthritis will potentially have a new therapeutic option.
“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.”
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