Encysive Pharmaceuticals Announces Launch of Thelin in Germany
First Selective, Once-Daily Oral Endothelin A Receptor Antagonist Now
Commercially Available for Pulmonary Arterial Hypertension Patients
HOUSTON, Dec. 18, 2006 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals
(Nasdaq:ENCY) today announced that THELIN(r)(1) (sitaxentan
sodium(2)) 100 mg tablets are now commercially available in Germany
for the treatment of pulmonary arterial hypertension (PAH). The
Company received European Union 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.
"As a newly available treatment option, THELIN offers further hope to
PAH patients in Germany," commented Leo Kwakkenbos, President of the
Pulmonary Hypertension Association of Europe. "With more therapies in
existence to help patients manage their symptoms, individuals are
able to make bigger strides in improving their quality of life."
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).
"THELIN's ease of use in a once-daily oral tablet, combined with its
safe and efficacious profile, makes it a unique new option for
treating PAH," said Christian Opitz, M.D., Assistant Professor,
Department of Cardiology, DRK Hospital-Westend, Berlin, Germany.
"Clinical studies have demonstrated that THELIN can benefit PAH
patients with CTD-related disease, which is a significant advancement
to the treatment landscape for this patient group," stated Ardeschir
Ghofrani, M.D., Associate Professor of Internal Medicine and Head of
the Pulmonary Hypertension Division, University Hospital Giessen,
Giessen, Germany.
The European Commission's centralized licensing procedure permits
Encysive to market THELIN in all 25 member states of the EU. THELIN
will be launched in successive EU member states as local government
approval for reimbursement is obtained.
"We are pleased that Germany is the second EU country where THELIN is
now available for patients. Physicians have already begun to
prescribe THELIN for patients in Germany in anticipation of its
commercial availability," said Bruce D. Given, M.D., President and
Chief Executive Officer of Encysive Pharmaceuticals. "Our recent
United Kingdom launch was well received, and we look forward to
continued success in introducing THELIN to additional EU countries in
the coming year."
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 be possibly 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 be possibly 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; female
patients are required to undergo a pregnancy test prior to receiving
THELIN. 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 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
our estimates concerning the size of the PAH patient population; our
ability to quickly and successfully commercialize THELIN in Germany
and other countries of the EU; market acceptance of THELIN in Germany
and the actual rate of acceptance; the speed with which pricing and
reimbursement approvals and product launches for THELIN may be
achieved in Germany and other countries of the EU; difficulties or
delays in manufacturing, packaging or distributing THELIN in Germany;
legislation or regulations within the EU affecting THELIN's pricing,
reimbursement or access; our ability to protect our patents and other
intellectual property for THELIN; and our ability to earn a profit
from sales of THELIN 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) 378-2900 ext. 27
