Press Releases

United Therapeutics and Lee's Pharmaceutical Sign Remodulin Distribution Agreement for China

Thursday 1 Jul, 2010

United Therapeutics Corporation (Nasdaq: UTHR) and Lee's Pharmaceutical Holdings Ltd. (HKEx: 0950) announced today 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.

"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.

About Lee's Pharmaceutical Holdings Limited

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.  Currently, it markets nine pharmaceutical products in China.  The company focuses on many different areas such as cardiovascular diseases, dermatology, oncology, gynecology and others with more than 22 products under different development stages stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various U.S. and European companies.  

About United Therapeutics

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.

About Remodulin (treprostinil) Injection

Indication

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.

Important Safety Information

Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections, or BSI, and sepsis, which may be fatal.  Therefore, continuous subcutaneous infusion is the preferred mode of administration.  

Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH.  Remodulin is a potent pulmonary and systemic 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.  Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.  

Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care.  Therapy with Remodulin may be used for prolonged periods, and the patient's ability to administer Remodulin and care for an infusion system should be carefully considered.

Remodulin dosage should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic effects or for unacceptable infusion site symptoms.  

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 insufficiency.  

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, such as 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 intravenous 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, vasodilatation, and edema.

Forward-looking Statements

Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, among others, our expectations of future regulatory approvals, sales and use of Remodulin in China.  These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results.  Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K,  Quarterly Reports on Form 10-Q and current reports on Form 8-K.  We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements.  We are providing this information as of July 1, 2010, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.  [uthr-g]




Source: United Therapeutics Corporation