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Dose-finding Phase IIb study started in patients with multiple sclerosis - Actelion/Roche S1P1 alliance achieves clinical milestone
Oct 09, 2009 (Hugin via COMTEX) --
Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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ALLSCHWIL, SWITZERLAND - 09 October 2009 - Actelion Ltd (SIX: ATLN)
announced today that the selective S1P1 receptor agonist ACT-128800/
RG3477 has achieved an important clinical milestone. Actelion's
first-in-class selective S1P1 (Sphingosine-1-phosphate) receptor
agonist has entered into a Phase IIb dose-finding study in patients
suffering from multiple sclerosis. This triggers a milestone payment
by Roche to Actelion of USD 20 million.
Guy Braunstein, M.D., Ph.D. and Head of Clinical Development at
Actelion, commented: "Together with our partner Roche, we are
committed to the rapid development of our selective S1P1 receptor
agonist for patients suffering from autoimmune disorders. With the
start of this dose-finding study in patients with multiple sclerosis,
we have made an important step forward."
About the Actelion / Roche alliance
Actelion and Roche entered into an exclusive worldwide collaboration
in July 2006 to jointly develop and commercialize Actelion's
selective S1P1 receptor agonist, an immunomodulator with the
potential for once-a-day oral dosing. The two companies plan to
jointly develop and commercialize this novel compound for multiple
autoimmune disorders. For the current selective S1P1 receptor
agonist, Actelion will fully fund all development activities up to
the end of Phase II for the first two indications. All subsequent
development and commercialization costs will be shared equally
between Roche and Actelion. Both companies will co-promote any
product resulting from this collaboration and will equally share
profit.
This S1P1 collaboration covers both the current selective S1P1
receptor agonist in clinical development, as well as any other
selective S1P1 receptor agonists resulting from Actelion's research
efforts in the field. Actelion received an upfront payment of USD 75
million in July 2006. In the case of future development and approval
milestones being achieved, Actelion will be eligible to receive
further payments of up to USD 535 million for the first compound for
all targeted indications. Further development and approval milestone
payments are due for additional compounds. Roche will pay Actelion
undisclosed royalties on all product sales.
Selective S1P1 receptor agonists
Sphingosine-1-phosphate (S1P) is a phospholipid released by
platelets, mast cells and other cells. It is currently established
[1,2] that S1P stimulates at least five different G-protein coupled
receptors (GPCRs): S1P1,2,3,4, and 5. Activation of these GPCRs
mediates a complex variety of biological responses, such as
lymphocyte migration, endothelial cell proliferation, blood vessel
constriction and heart rate modulation.
Actelion's efforts in the field of selective S1P1 receptor agonists
started in 1999 by focusing on GPCRs found on the endothelium, the
inner lining of blood vessels. The result of these research efforts
is Actelion's orally active selective S1P1 receptor agonist.
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Notes to the editor
About autoimmune disorders
Autoimmune disorders are diseases caused by the body producing an
immune response against its own tissues. The cause of autoimmune
disorders is unknown. Some of the most common types of autoimmune
disorders include psoriasis, rheumatoid arthritis, multiple
sclerosis, inflammatory bowel disease and rejection of transplanted
organs. These disorders affect millions of people worldwide.
About multiple sclerosis
Multiple sclerosis (MS) is an inflammatory autoimmune disorder of the
central nervous system (CNS) and is the most common cause of
progressive neurological disability in young adults [3,4]. This
chronic demyelinating disease is characterized by heterogeneous
clinical expression, an unpredictable course and a variable
prognosis. MS results from a cascade of events involving an
activation of the immune system, acute focal inflammatory
demyelination, and axonal loss with limited remyelination,
culminating in chronic multifocal sclerotic plaques in brain and
spinal cord. The large variety of symptoms and signs of MS result
from axonal demyelination which leads to the slowing or blockade of
axonal conduction at diverse affected sites of the brain and spinal
cord. Repeated episodes of disease activity may lead to progressive
loss of neurological function.
The incidence of MS is about 7 cases per 100,000 persons per year and
although the etiology of MS is still unknown, the prevalence rate
varies between races and geographical latitudes, ranging from 50-120
per 100,000 [3]. It is widely accepted that it is an immune-mediated,
demyelinating disease precipitated by unknown environmental factors
in genetically susceptible people.
References
1. Huwiler A, Pfeilschifter J. Biochem Pharmacol. 2008 May
15;75(10):1893-900. Review.
2. Rivera J, Proia RL, Olivera A.Nat Rev Immunol. 2008
Oct;8(10):753-63. Review.
3. Compston A, Coles A. Multiple sclerosis. Lancet
2002;359:1221-31.
4. Compston A, Coles A. Multiple sclerosis. Lancet
2008;372:1502-18.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate
headquarters in Allschwil/Basel, Switzerland. Actelion's first drug
Tracleer(R), an orally available dual endothelin receptor antagonist,
has been approved as a therapy for pulmonary arterial hypertension.
Actelion markets Tracleer(R) 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 2000 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).
For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com
--- End of Message ---
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;
SOURCE: Actelion Pharmaceuticals Ltd
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