United Therapeutics Corporation and Lee's Pharmaceutical Holdings Ltd. announced that they have entered into an exclusive agreement for the distribution of Remodulin (treprostinil) injection in China. Remodulin is a subcutaneously or intravenously administered prostacyclin analogue for the treatment of pulmonary arterial hypertension. Lee's Pharmaceutical is a leading Chinese pharmaceutical company with both a strong cardiovascular focus and extensive commercialization experience.
Remodulin is indicated for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted. In patients with PAH requiring transition from Flolan (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.
"We are delighted to work with Lee's Pharmaceutical as our exclusive partner to bring Remodulin to Chinese physicians and their patients," said Roger Jeffs, Ph.D., United Therapeutics' president and chief operating officer. "We believe that Remodulin will be an important addition to the currently available treatment options for PAH patients in China."
"We are excited to be United Therapeutics' partner in China for Remodulin," said Dr Benjamin Li, chief executive officer of Lee's Pharmaceutical. "We are proud to add this important product to our specialty pharmaceutical portfolio and are anxious to begin the cooperative work with United Therapeutics."
Under the terms of the distribution agreement, Lee's Pharmaceutical will be responsible for obtaining all necessary authorizations to market Remodulin in China, including conducting necessary bridging studies. Upon receipt of marketing authorization and pricing approval, Lee's Pharmaceutical will purchase Remodulin from United Therapeutics at a transfer price agreed to by the parties.
Lee's Pharmaceutical Holdings Limited, a biopharmaceutical company, was successfully listed on the Growth Enterprise Market (GEM) of the Stock Exchange of Hong Kong Limited in 2002 and was listed on the Main Board of Hong Kong Exchange Limited on May 14, 2010. The company has been in operation for over 15 years, and has fully integrated infrastructures in drug development, clinical development, regulatory, manufacturing and sales and marketing in China with global perspective.
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.