Encysive Pharmaceuticals Launches THELIN (Sitaxentan Sodium) in
Sweden
First Selective, Once-Daily Oral Endothelin A Receptor Antagonist Now
Available to Patients in Sweden
HOUSTON, Jan. 31, 2008 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals
Inc. (Nasdaq:ENCY) today announced the commercial availability of
THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets in Sweden. THELIN
is approved for the treatment of pulmonary arterial hypertension
(PAH) and has received reimbursement approval for use in Sweden.
Encysive received European Union (EU) marketing authorization for
THELIN from the European Commission in August 2006. THELIN is the
first selective endothelin A receptor antagonist, and the first
once-daily oral treatment available for patients with PAH.
THELIN is indicated for improving exercise capacity in PAH patients
classified as World Health Organization (WHO) functional class III.
Efficacy has been shown in primary pulmonary hypertension(3) and
pulmonary hypertension associated with connective tissue disease
(CTD).
"A number of evidence-based treatment options for PAH have been
developed in recent years. Sitaxentan provides us with another
therapy to tailor and optimize treatment for the individual patient,"
stated Bjorn Ekmehag, MD, Director of the Pulmonary Hypertension
Centre, Lund Sweden.
The EU's centralized licensing procedure permits Encysive to market
THELIN in all 27 member states of the EU. THELIN has been launched in
the United Kingdom, Germany, Ireland, Spain, France, Italy, Belgium,
Luxembourg and the Netherlands and will be launched in additional EU
member states as local governmental approval for reimbursement is
obtained.
THELIN(r) (Sitaxentan Sodium) Overview
THELIN is an endothelin A receptor antagonist, a small molecule that
blocks the action of endothelin, a potent mediator of blood vessel
constriction and growth of smooth muscle in vascular walls.
Endothelin receptor antagonists may prove to be effective in the
treatment of a variety of diseases where the regulation of vascular
constriction is important. THELIN is 6,500-fold selective in the
targeting of the endothelin A receptor versus the endothelin B
receptor. Highly selective endothelin A receptor antagonism has been
shown to increase blood flow and reverse vasoconstriction in human
clinical pharmacology studies. For more information, please visit
www.encysive.com.
Important Safety Information
In placebo-controlled clinical trials, the most frequent adverse
events that occurred in patients receiving THELIN, which were
considered to possibly be related to THELIN treatment, were headache,
peripheral edema and nasal congestion. Other adverse events that
occurred in at least 2% of THELIN patients, at a rate greater than
placebo and considered to possibly be related to THELIN treatment,
included dizziness, constipation, epistaxis, flushing, international
normalized ratio (INR) increase, insomnia, nausea, upper abdominal
pain, vomiting, dyspepsia, diarrhea, fatigue, muscle cramp, and
prothrombin time (PT) prolongation. THELIN is also associated with
liver function abnormalities. Because THELIN inhibits the metabolism
of warfarin and other vitamin K antagonists, a dose adjustment for
these drugs is needed when co-administered with THELIN. THELIN and
other endothelin receptor antagonists have potential for liver
toxicity and are teratogenic. Testing of liver enzymes is required
prior to the initiation of THELIN and monthly thereafter. THELIN
should not be used during pregnancy unless clearly necessary. THELIN
is contraindicated in patients receiving cyclosporine A, patients
with mild to severe hepatic impairment (Child-Pugh Class A-C),
patients with elevated liver aminotransferases prior to starting
treatment (elevation in liver enzymes to levels greater than 3 times
the upper limit of normal), lactating patients, or patients with
hypersensitivity to the active substance or any excipients.
About PAH
It is estimated that PAH afflicts approximately 100,000 to 200,000
people in North America and Europe. The disease is characterized by
high blood pressure and structural changes in the walls of the
pulmonary arteries, the blood vessels that connect the right side of
the heart to the lungs. As these arteries become increasingly
constricted, blood flow and oxygenation may be inadequate to meet the
body's demands. Since the heart must then pump harder to overcome the
resistance, patients are susceptible to heart failure.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a global biopharmaceutical company
engaged in the discovery, development and commercialization of novel,
synthetic, small molecule compounds to address unmet medical needs.
Our research and development programs are predominantly focused on
the treatment and prevention of interrelated diseases of the vascular
endothelium and exploit our expertise in the area of the
intravascular inflammatory process, referred to as the inflammatory
cascade, and vascular diseases. To learn more about Encysive
Pharmaceuticals please visit our web site: www.encysive.com.
The Encysive Pharmaceuticals Inc. logo is available at
http://www.primenewswire.com/newsroom/prs/?pkgid=843
(1) THELIN is an EU registered trademark of Encysive Pharmaceuticals
Inc.
(2) "Sitaxentan" sodium is the spelling recognized by the World
Health Organization for Encysive Pharmaceuticals' sitaxsentan sodium.
(3) Primary pulmonary hypertension is also known as idiopathic
pulmonary arterial hypertension.
This press release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements are subject to certain risks, trends and
uncertainties that could cause actual results to differ materially
from those projected. Among those risks, trends and uncertainties are
reduced estimates concerning the size of the PAH patient population
and PAH diagnosis rates in Sweden and the EU; our ability to quickly
and successfully commercialize THELIN in Sweden and other countries
of the EU; market acceptance of THELIN in Sweden and the actual rate
of acceptance; the speed with which pricing and reimbursement
approvals and product launches for THELIN may be achieved in other
countries of the EU; difficulties or delays in manufacturing,
packaging or distributing THELIN in Sweden and other countries of the
EU; legislation or regulations within the EU affecting THELIN's
pricing, reimbursement or access; the scope of our patents for THELIN
and our ability to protect our patents and other intellectual
property for THELIN in Sweden and the EU; our estimate of the
sufficiency of our existing capital resources; our ability to attract
and retain qualified personnel in the EU; our ability to raise
additional capital to fund cash requirements for our EU commercial
requirements; our inability to predict revenues from sales of THELIN
in Sweden and other countries of the EU; and our ability to earn a
profit from sales of THELIN in Sweden and other countries in the EU
as well as other risks, trends and uncertainties facing Encysive such
as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed
with the U.S. Securities and Exchange Commission. Given these risks,
trends and uncertainties, any or all of these forward-looking
statements may prove to be incorrect. Therefore you should not rely
on any such forward-looking statements. Furthermore, Encysive
undertakes no duty to update or revise these forward-looking
statements. The Private Securities Litigation Reform Act of 1995
permits this discussion.
CONTACT: Encysive Pharmaceuticals
Investors:
Ann Tanabe, VP, Investor Relations and Corporate Communications
(713) 796-8822
BMC Communications
Media:
Dan Budwick
(212) 477-9007 ext. 14
The Trout Group
Investors:
Marcy Strickler
(646) 378-2927