United Therapeutics and Lee's Pharmaceutical Sign Remodulin Distribution Agreement for China
July 1, 2010
Silver Spring, MD : 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. For more information, please visit
http://www.leespharm.com/en/.
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 - or PAH- 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.
For full prescribing information, visit
http://www.remodulin.com/images/pdf/PI.pdf, or call 1-866-458-6479.
Forward-looking Statements
Statements included in this press release that are not historical in
nature are "forwardlooking 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 forwardlooking 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 June 30, 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] Remodulin is a registered trademark of
United Therapeutics Corporation.
For Further Information Contact:
Andrew Fisher at (202) 483-7000
Email: Afisher @unither.com