Actelion announces acquisition of a new formulation of intravenous epoprostenol with improved thermal stability for the treatment of Pulmonary Arterial Hypertension

Monday, 23. February 2009 07:00
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ALLSCHWIL/BASEL, SWITZERLAND - 23 February 2009 - Actelion Ltd (SIX:
ATLN) announced today it has entered into a definitive agreement to
acquire an improved, thermostable formulation of epoprostenol sodium
for the intravenous treatment of pulmonary arterial hypertension
(PAH) from privately-held GeneraMedix Inc. (GXI). GeneraMedix
specializes in injectable products for U.S. hospital and specialty
markets and is located in Liberty Corner, New Jersey/United States.

On 27 June 2008, the United States Food and Drug Administration (FDA)
approved this improved formulation of Epoprostenol for Injection (1.5
mg/ml vial) for the long-term intravenous treatment of primary
pulmonary hypertension and pulmonary hypertension associated with the
scleroderma spectrum of disease in NYHA Class III and Class IV
patients who do not respond adequately to conventional therapy.

The formulation is protected by patent applications. Actelion will be
responsible for worldwide development, registration and
commercialization of the product. Financial details of the agreement
are not disclosed.

This improved formulation of i.v. epoprostenol uses non-proprietary
diluents, and once reconstituted prior to use, it may be stored for
up to 48 hours at 25º C or for 5 days in the refrigerator at 2º to 8º
C.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion
commented: "We are very pleased to acquire this innovative product as
it builds on our commitment to PAH therapy. Actelion has always led
the drive for improving the lives of PAH patients and we believe this
new improved formulation could potentially play a significant role in
the management of PAH."

Unlike other epoprostenol formulations approved for PAH, this unique
formulation is stable at room temperature for up to 24 hours when
diluted and filled into the pump for administration and so can be
used without frozen gel packs.

Jean-Paul Clozel continued: "This feature may provide clear benefits
with respect to its administration. It may allow PAH patients greater
freedom and convenience. There could also be less drug wastage. We
will work with patients and PAH specialists to further optimize the
use of this new formulation."

Otto Schwarz, President Business Operations, commented: "Actelion has
grown Tracleer® into a cornerstone therapy in PAH. We are also
committed to making further investments in developing innovative
therapies for patients and their treating physicians. This
thermostable formulation of epoprostenol addresses several
limitations of conventional epoprostenol. We will work closely with
PAH specialists to generate strong clinical experience with this
product and to have a best-in-class product available for all PAH
patients, first in the United States, followed later by other
territories worldwide."

###

Notes to the editor:
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening
disorder characterized by abnormally high blood pressure in the
arteries between the heart and lungs of an affected individual. The
function of the heart and lungs is severely compromised, manifested
by a limited exercise capacity, and, ultimately, a reduced life
expectancy. Approximately 100,000 people in Europe and the United
States are afflicted with either primary or secondary forms of the
disease related to conditions or tissue disorders that affect the
lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart
disease.

PAH is associated with structural changes in both the pulmonary
vasculature and the right ventricle. Recent advances [1] in the
understanding of the pathogenic factors leading to the pulmonary
vascular disease have led to the development of new therapies
targeting specific pathways (the prostacyclin pathway; the endothelin
pathway; and the nitric oxide pathway) [2]. The available therapies
have positive effects in PAH, but they do not provide a cure, and in
many patients the disease will progress. PAH remains a serious
life-threatening condition [2,3]. Early recognition and an
understanding of the selection and timing of therapeutic options
remain critical elements in the optimal management of patients with
this disorder.

About Tracleer® in Pulmonary Arterial Hypertension (PAH)
Tracleer® (bosentan), the first oral dual endothelin receptor
antagonist, is approved for the treatment of pulmonary arterial
hypertension (PAH) and made available by Actelion subsidiaries in the
United States, the European Union, Japan, Australia, Canada,
Switzerland and other markets worldwide.

Requires attention to two significant safety concerns: Potential for
serious liver injury (including rare cases of liver failure and
unexplained hepatic cirrhosis in a setting of close monitoring) -
Liver monitoring of all patients is essential prior to initiation of
treatment and monthly thereafter. Tracleer® treatment must not be
initiated in women of childbearing potential unless they practice
reliable contraception and participate in monthly pregnancy testing.
Due to these risks, Tracleer® is only supplied through a controlled
distribution.


References
1. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary
arterial hypertension. N. Eng. J. Med. 2004; 351: 1655-65.
2. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary
arterial hypertension. N. Eng. J. Med. 2004; 351: 1425-36.
3. Humbert M; Morrell NW; Archer SL; et al. Cellular and
molecular pathobiology of pulmonary arterial hypertension. J. Am.
Coll. Cardiol. 2004; 43: Suppl. 12: 13S-24S.
4. Tracleer® SPC.

Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate
headquarters in Allschwil/Basel, Switzerland. Actelion's first drug
Tracleer®, an orally available dual endothelin receptor antagonist,
has been approved as a therapy for pulmonary arterial hypertension.
Actelion markets Tracleer® through its own subsidiaries in key
markets worldwide, including the United States (based in South San
Francisco), the European Union, Japan, Canada, Australia and
Switzerland. Actelion, founded in late 1997, is a leading player in
innovative science related to the endothelium - the single layer of
cells separating every blood vessel from the blood stream. Actelion's
over 1900 employees focus on the discovery, development and marketing
of innovative drugs for significant unmet medical needs. Actelion
shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as
part of the Swiss blue-chip index SMI (Swiss Market Index SMI® )

GeneraMedix, Inc.
GeneraMedix Inc. is a privately held pharmaceutical company
specializing in difficult to develop and/or manufacture injectable
products for the U.S. hospital and specialty markets. In addition to
its marketed products, GeneraMedix has a significant number of
injectable products under development, as well as a number of
products currently under FDA review. Headquartered in Liberty Corner,
New Jersey, the company was founded in July of 2004, with equity
partners GTCR Golder Rauner, LLC, and Ferrer Freeman & Company, LLC.
Additional information is available on the company's website at
www.generamedix.com


Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil

Roland Haefeli
Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com



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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil
Switzerland

WKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP,
SMIM, SPI, SPIEX;
Listed: Main Market in SIX Swiss Exchange;

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