




Healthcare Industry News: PAH
News Release - March 27, 2007
United Therapeutics and Mochida Pharmaceutical Sign Remodulin Distribution Agreement for Japan
SILVER SPRING, Md., March 27 (HSMN NewsFeed) -- United Therapeutics Corporation (Nasdaq: UTHR ) and Mochida Pharmaceutical Co., Ltd. announced today that the companies have signed an agreement for the exclusive distribution in Japan of Remodulin® (treprostinil sodium) Injection administered subcutaneously or intravenously for the treatment of patients with pulmonary arterial hypertension. Mochida Pharmaceutical is a leading Japanese pharmaceutical company with both a strong cardiovascular focus and extensive orphan-drug commercialization experience."Japan is one of the largest and most important pulmonary arterial hypertension markets in the world," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "We are delighted to work with Mochida as our exclusive partner to bring our lead product Remodulin to Japanese physicians and their patients."
"Remodulin is expected to provide many advantages over currently approved treatments in Japan for pulmonary arterial hypertension patients," said Mr. Naoyuki Mochida, President of Mochida 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, Mochida Pharmaceutical will be responsible for obtaining marketing authorization for Remodulin with United Therapeutics' assistance, including conducting necessary bridging studies. Upon receipt of marketing authorization and pricing approval, Mochida will purchase Remodulin from United Therapeutics for distribution in Japan at a transfer price agreed to by the parties.
About Mochida Pharmaceutical
Since its foundation, Mochida Pharmaceutical has concentrated its efforts on the research and development of original pharmaceuticals and is now focused on four important areas: cardiovascular, obstetrics and gynecology, dermatology and emergency care. As a comprehensive healthcare company focused on the three primary fields of pharmaceuticals, medical electronics and equipment, and healthcare products, the Mochida Pharmaceutical group has aimed to make significant contributions to the improvement of human health and welfare since its formation in 1913. The company's major products include Atelec, a long-acting calcium channel blocker and Epadel, a treatment for hyperlipidemia. For the fiscal year ended March 2006, the company's net income reached 4.9 billion yen on net sales of 70.6 billion yen. The company employs approximately 1,800 people. For more information, please visit http://www.mochida.co.jp/.
About United Therapeutics
United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life- threatening cardiovascular, cancer and infectious diseases.
About Remodulin
Remodulin® is approved in the United States as a continuous subcutaneous infusion or IV infusion (for those not able to tolerate a subcutaneous infusion) for the treatment of PAH in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.
Remodulin is indicated to diminish the rate of clinical deterioration in patients requiring transition from Flolan®; the risks and benefits of each drug should be carefully considered prior to transition.
Important Safety Information:
Remodulin is contraindicated in patients with hypersensitivity to Remodulin, its ingredients, or similar drugs. Remodulin is a potent vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. Remodulin inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants. Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided. Caution should be used in patients with hepatic or renal problems. The most common side effects of Remodulin included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of Remodulin. For IV infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilation, and edema.
Source: United Therapeutics
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