Encysive Pharmaceuticals Launches Thelin (sitaxentan sodium) in Italy
First Selective, Once-Daily Oral Endothelin A Receptor Antagonist Now
Available to Patients in All Big Five EU Countries
HOUSTON, Nov. 26, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals
Inc. (Nasdaq:ENCY) today announced the commercial availability of
THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets in Italy for the
treatment of pulmonary arterial hypertension (PAH). 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).
"Italy joins the countries in which two different endothelin
receptors antagonists are marketed for the PAH indication," said
Nazzareno Galie, M.D., Director of the Pulmonary Hypertension Centre
of the University of Bologna. "The possibility of alternative drugs
of the same class can be utilized by clinicians to identify the
optimal benefit-to-risk ratio in the individual patient."
The European Commission's centralized licensing procedure permits
Encysive to market THELIN in all 27 member states of the EU. THELIN
has already been launched in the United Kingdom, Germany, Ireland,
Spain, France and the Netherlands and will be launched in additional
EU member states as local government approval for reimbursement is
obtained.
"The launch of Thelin in Italy marks an important achievement for
Encysive Pharmaceuticals," commented George Cole, President and CEO
of Encysive. "Thelin is now being commercialized in the five largest
markets in the EU, positioning us for substantial sales growth in
2008."
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://media.primezone.com/prs/single/?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 Italy and the EU; our ability to quickly
and successfully commercialize THELIN in Italy and other countries of
the EU; market acceptance of THELIN in Italy 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 Italy; 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 Italy and the EU; our
estimate of the sufficiency of our existing capital resources; our
ability to attract and retain qualified personnel; 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 Italy and other countries of the EU; and our ability to
earn a profit from sales of THELIN in Italy 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
Marcy Strickler
(646) 378-2927