United
Therapeutics Corporation (Nasdaq: UTHR) today announced new guidance from
pulmonary arterial hypertension opinion leaders relating to intravenous
therapies. The new guidance was issued by the Scientific Leadership
Committee (SLC) of the Pulmonary Hypertension Association in response to
the release of a slide presentation prepared by CDC researchers entitled
"Bloodstream infections among patients treated with intravenous
epoprostenol and intravenous treprostinil for pulmonary arterial
hypertension, United States 2004 - 2006". The slides accompanied a
presentation to the SLC on February 23, 2007, and may be published as a
report in the CDC's Morbidity and Mortality Weekly Report. The new guidance
from pulmonary hypertension opinion leaders is for physicians to be mindful
of the range of possible gram negative and gram positive infectious
organisms in patients with long-term central catheters and initiate
appropriately broad spectrum antibiotics in patients with suspected
bloodstream infections until culture results and antibiotic sensitivity are
known.
"We welcome the new guidance from pulmonary hypertension opinion
leaders," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and
Chief Executive Officer. "We believe that if a patient is predisposed to
sepsis, then subcutaneous Remodulin, which has never been associated with
septicemia, is the safest catheter-based treatment option; other patients
have a very small chance of developing sepsis. For a disease in which mean
survival is counted in single digit years, everyone wants to go the extra
mile to provide patients needing prostacyclin therapy with the most options
-- this is why we developed the micro-pump, ice-free and rapid-switch
characteristics of intravenous Remodulin."
Scientific Leadership Committee Guidance
The Pulmonary Hypertension Association Scientific Leadership Committee
(SLC) is composed of more than 20 leaders in the field of pulmonary
hypertension. The members of the SLC are clinicians, research scientists,
and nurses who come from medical centers recognized for performing
outstanding research and providing excellent care for patients with
pulmonary hypertension. The mission of the SLC is to provide medical and
scientific leadership and guidance for the mission of the Pulmonary
Hypertension Association by proactively facilitating the development of new
knowledge about pulmonary hypertension, actively disseminating knowledge
about pulmonary hypertension to medical and public audiences, and
advocating and raising awareness about pulmonary hypertension.
Following the CDC researcher's presentation, the SLC posted the
following guidance statement on the Pulmonary Hypertension Association
website, phassociation:
"The SLC notes the observation that patients on long-term intravenous
therapy are susceptible to bloodstream infections caused by a broad range
of organisms. The Centers for Disease Control and Prevention (CDC) report
suggests a hypothesis that different patient profiles may be subject to
higher risk of various types of infections. The SLC considers the CDC
document to be a hypothesis generating report which does not permit
definitive or specific conclusions at this time. Therefore, the SLC
supports the following:
1. Further appropriately designed studies are required to determine the validity of the hypothesis raised by the current document.
2. Pending rigorous studies, physicians should be mindful of the range of possible gram negative and gram positive infectious organisms in patients with long-term central catheters and initiate appropriately broad spectrum antibiotics in patients with suspected bloodstream infections until culture results and antibiotic sensitivity are known.
3. Choice of specific parenteral prostacyclin agents, as well as all pulmonary vascular targeted therapy should continue to be based on a global assessment of efficacy, risk, expense and feasibility of each agent in each individual patient's clinical context."
United Therapeutics' Response
"We will work closely with the Pulmonary Hypertension Association and
prescribers to improve patient care. We are confident that central line
filters and heightened emphasis on sterility best practices will go a long
way to address the issues raised in the CDC presentation," said Roger
Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer.
"As with any therapy for a life-threatening condition, prescribers will
balance the risk/benefit profile of IV Remodulin against their patients'
needs in light of the experiences they have had with the drug."
United Therapeutics plans to take the following actions in response to
the Scientific Leadership Committee guidance:
-- United Therapeutics will commence a multi-center, multi-national,
multi-year and multi-agent prospective study to scientifically test the
hypothesis of whether there are differences in the risk of sepsis and
sepsis sub-types among parenterally-delivered prostacyclin mimetics and
analogs. The company anticipates this study to enroll several hundred
patients and is expected to commence later this year. "We are excited
about taking the lead in testing some of the hypotheses suggested by
the CDC's observations," said David Zaccardelli, PharmD, United
Therapeutics' Senior Vice President for Pharmaceutical Development. "No
doubt there is much new information to be learned from prospective
study of a large number of patients receiving chronic intravenous
therapy for pulmonary hypertension."
-- United Therapeutics also plans to coordinate a working group with the
Pulmonary Hypertension Association and physicians and nurses, along
with its network of specialty distributors and home health care
providers, to develop unified best practice recommendations related to
the chronic administration of IV prostanoids via central venous
catheters.
-- United Therapeutics will revise Remodulin package labeling to more
fully describe the known infection risk and appropriate technique that
should be practiced when preparing and administering intravenous
treprostinil.
About Remodulin
Remodulin(R) is indicated 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(R); 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.
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.
Forward-Looking Statements
In addition to historical information, this press release contains
forward-looking statements about the publication of a report in the CDC's
Morbidity and Mortality Weekly Report, United Therapeutics' plans to
commence a study of sepsis in parenterally-delivered prostanoids, and the
design of such study and its enrollment commencement date, United
Therapeutics' plans to coordinate a working group to develop unified best
practice recommendations for IV prostanoids, its plans to revise Remodulin
package labeling, and expectations with respect to the impact of central
line filters and best practices on the issues raised in the presentation
that are based on United Therapeutics' current beliefs and expectations as
to future outcomes. These expectations are subject to risks and
uncertainties such as those described in United Therapeutics' periodic
reports filed with the Securities and Exchange Commission which may 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 United Therapeutics'
periodic reports and documents filed with the Securities and Exchange
Commission, including the company's most recent Form 10-K and Form 10-Q.
United Therapeutics is providing this information as of February 26, 2007
and undertakes no obligation to publicly update or revise the information
contained in this press release whether as a result of new information,
future events or any other reason.
United Therapeutics Corporation
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