Actelion obtains option to acquire privately-held Trophos
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Actelion Pharmaceuticals Ltd / Actelion obtains option to acquire privately-held Trophos processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Late-stage Phase III compound in Amyotrophic Lateral Sclerosis to report data in
late 2011 - Novel therapeutic approach to be further explored in drug discovery
collaboration
ALLSCHWIL, SWITZERLAND and MARSEILLE, FRANCE - 20 July 2010 - Actelion Ltd (SIX:
ATLN) and privately-held Trophos SA announced today that they have entered into
a binding agreement whereby Actelion has, for EUR 10 million, obtained an
exclusive option to acquire privately-held Trophos SA, a clinical stage
pharmaceutical company.
Trophos' lead compound olesoxime has completed enrollment into a Phase III study
in Amyotrophic Lateral Sclerosis (ALS), an orphan disease also known as Lou
Gehrig's disease. This study is expected to report data by the end of 2011; at
this time Actelion may exercise the option for an acquisition price between EUR
125 and 195 million in cash, contingent on different regulatory approvals and
other clinical progress of Trophos' pipeline.
Simon Buckingham, President, Global Corporate and Business Development: "Trophos
has done an excellent job to enroll more than 500 ALS patients into a
well-designed pivotal study. Once study results are available, Actelion is
ideally positioned to leverage these achievements with our proven global
regulatory and marketing expertise in the area of orphan drugs."
Trophos is a clinical stage company with a pipeline of new molecular entities in
development for the motor neuron diseases ALS and spinal muscular atrophy (SMA)
as well as a novel compound for cardiac ischemia-reperfusion injury.
Damian Marron, Chief Executive Officer at Trophos commented: "Since its
inception, Trophos has made significant progress in turning its key expertise in
neurodegenerative disorders and orphan diseases into achievements that include
advancing our lead compound olesoxime into late stage clinical development. The
development of olesoxime has benefited from significant support from patient
communities, clinical investigators and the European Union (EU), including
Trophos spearheading an EU-funded consortium dedicated to improving the
treatment of ALS."
Damian Marron continued: "We are delighted with the option agreement with
Actelion, which will bring additional expertise and competencies to enable
Trophos' compound to rapidly reach patients following a successful study
outcome."
Damian Marron concluded: "I am also pleased with the option agreement as it
provides the Trophos' investors an opportunity to realize the value of their
investments."
The two companies also agreed on a research collaboration to allow Actelion
access to Trophos' proprietary CNS assay technology and compound library. The
technology mimics neuronal degeneration processes in the test tube and is used
to screen chemical compounds for their ability to block these processes.
Martine Clozel, MD and Chief Scientific Officer at Actelion commented: "Trophos
has a pioneering approach and proprietary expertise that has enabled the
development of high throughput screens using primary neurons as well as the
ability to broadly profile more advanced compounds. This is of great value to
Actelion as we have developed a large in-house compound library and significant
expertise in the field of neurological disorders."
###
Notes to Editor:
About the agreement
On July 19, 2010, Actelion signed an acquisition agreement to purchase Trophos
SA, a French clinical stage pharmaceutical company developing drugs for patients
with neurodegenerative diseases. The acquisition is contingent on the exercise
of an option, whereas Actelion has the right to terminate the agreement at any
time during the option period. The option will become effective upon payment of
EUR 10 million by Actelion and end two months after Actelion's receipt of the
results of an ongoing Phase III study with olesoxime but not later than December
31, 2012. The purchase consideration will be paid in cash and is partially
contingent on market approval of olesoxime by the US Food and Drug
Administration (FDA) as well as overall pipeline progression of other compounds.
Consequently, the purchase price might vary between EUR 125 million and 195
million.
About Olesoxime
Olesoxime is Trophos' lead compound of a proprietary mitochondrial pore
modulator series. Preclinical studies have demonstrated that olesoxime promotes
the function and survival of neurons and other cell types under disease-relevant
stress conditions, through interactions with the mitochondrial permeability
transition pore (mPTP). Olesoxime has been shown to be active in the SOD1 model
of ALS (Bordet et al., JPET 322:709-720, 2007).
Phase I studies in healthy volunteers and Phase Ib studies in ALS patients
demonstrated that olesoxime is well-tolerated. These studies also helped to
determine the dose regimen used in the pivotal Phase III study.
About the Phase III study in ALS
The study is an 18-month randomized, parallel group, double-blind,
placebo-controlled trial evaluating the efficacy and safety of olesoxime against
placebo and has benefited from protocol advice obtained from the European
Medical Agency EMA. The study completed enrollment in the first quarter of 2010
with 512 patients diagnosed with ALS between 6 and 36 months before enrollment
and receiving standard of care. Olesoxime is dosed at 330 mg once-a-day oral
capsules. The study is being undertaken in 15 centers in France, Germany, UK,
Belgium and Spain and is part of a 3-year collaborative project named MitoTarget
(Grant Agreement No: HEALTH-F2-2008-223388) for which the European Commission
has awarded a grant of nearly EUR 6 million.
The primary endpoint of the study is the overall 18-month survival rate.
Secondary endpoints include the ALS Functional Rating Scale, time to assisted
ventilation, vital capacity (a measure of respiratory function), Manual Muscular
Testing and quality of life.
About Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), often referred to as "Lou Gehrig's
Disease", is the most common motor neuron disease with a prevalence of 2-3 per
100,000 (30,000 patients in US; 45,000 in Europe at any given time).
Most people who develop ALS are between the ages of 40 and 70 (average age of
55) and over 80% die three to five years after diagnosis. The most common form
of ALS is sporadic, but 5-10% of cases are inherited in a dominant manner
(familial ALS).
Early symptoms of ALS include muscle weakness in arms and legs; later
difficulties in breathing and swallowing are generally the cause of death. There
is no treatment today that halts disease progression in ALS patients.
About Trophos' discovery strategy
The Trophos discovery strategy involves recreating neuronal degeneration
processes in the test tube and screening chemical compounds for their ability to
block these processes. Disease-relevant assays are developed using the specific
neurons affected in each disease, for example: motor neurons for amyotrophic
lateral sclerosis (ALS) and spinal muscular atrophy (SMA), striatal neurons for
Huntington's disease and cortical neurons for Alzheimer's Disease. In essence,
Trophos considers the neuron as a cellular test tube filled with the diverse
products of the 30,000 genes expressed by the cell under the conditions that are
as close to the physiological environment as possible.
About Trophos SA
Trophos SA is a clinical stage pharmaceutical company developing innovative
therapeutics for indications with under-served needs in neurology and
cardiology. The company has a novel and proprietary cholesterol-oxime based
chemistry platform generating a pipeline of drug candidates with the lead
product, olesoxime, fully enrolled in a Phase III study in ALS patients and a
second product in the cardiovascular field entering Phase I clinical
development. Trophos' mitochondrial pore modulator compounds enhance the
function and survival of stressed cells via modulation of dysfunctional
mitochondria through interactions at the permeability transition pore (mPTP).
Recently published clinical studies support the therapeutic rationale for
mitochondria-targeted drugs in neurology (Alzheimer's disease) and cardiology
(ischemia-reperfusion injury), which Trophos is uniquely placed to exploit.
Trophos was founded in 1999 by Antoine Beret and Michel Delaage, former CEO and
CSO respectively of Immunotech, and has been financed by funds represented by
Amundi PEF (formerly SGAM AI), Turenne Capital Partenaires, Viveris Management,
OTC Asset Management, Sofimac, Sofipaca, CM-CIC Capital Privé, Blue Medical
Investment and the Association Française contre les Myopathies (AFM). Trophos
has also received non-equity financing from the European Commission, the AFM,
the Agence Nationale de Recherche and Oseo Innovation.
About 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 2,300 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(®)).
For further information please contact:
For Actelion Ltd:
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
For Trophos SA:
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100
allo(at)ala.com / neil(at)ala.com
http://www.trophos.com
[HUG#1432469]
--- End of Message ---
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
Media Release PDF: http://hugin.info/131801/R/1432469/378583.pdf
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Datum: 20.07.2010 - 07:05 Uhr
Sprache: Deutsch
News-ID 24138
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