PAION AG / Research Update
16.03.2010 08:38
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Aachen (Germany), 16 March 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) reports
that its licensing partner H. Lundbeck A/S has initiated the first Japanese
clinical Phase II trial with Desmoteplase in the treatment of acute
ischaemic stroke (DIAS-J). This study is required for the approval of the
substance for the Japanese market. In 2009 Lundbeck successfully performed
a Phase I study in approximately 30 healthy Japanese volunteers with no
safety concern observed.
The primary objective of this randomised, double-blind, placebo-controlled,
dose-escalation Phase II study is to evaluate the safety and tolerability
of Desmoteplase in 48 Japanese patients with acute ischaemic stroke. Two
doses of Desmoteplase (70 and 90 µg/kg) will be tested versus placebo. The
efficacy of Desmoteplase will be assessed after 90 days. The DIAS-J study
is expected to take approximately 1½ years to conduct. Once DIAS-J is
completed, Lundbeck will determine the subsequent development strategy and
the clinical data package necessary for a Japanese NDA.
'We are impressed with the effort and commitment that our colleagues at
Lundbeck are investing to drive this project', said PAION CEO Dr Wolfgang
Söhngen. 'The development in Japan will expand the potential patient
population which may benefit from Desmoteplase upon market entry and thus
underscores the value of this licence for PAION.'
It is estimated that there are approximately 250,000 annual cases of acute
ischaemic stroke in Japan . In Japan, stroke is the third-leading cause of
death with mortality rate of 105 per 100,000 populations, and it remains
the most common cause of permanent disability in adults.
You will find further information in the Lundbeck press release published
today under www.lundbeck.com.
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About Desmoteplase
Desmoteplase, the most fibrin-specific plasminogen activator known today,
is a genetically engineered version of a clot-dissolving protein found in
the saliva of the vampire bat Desmodus rotundus. It is currently being
developed for the treatment of acute ischaemic stroke for which it has
received fast-track designation from the U.S. Food and Drug Administration.
The treatment is being carried out in a timeframe of 3 to 9 hours post
onset of stroke symptoms - a time window for which there currently is no
approved drug treatment.
So far Desmoteplase has been tested in two Phase II studies and one Phase
III study for the treatment of ischaemic stroke. In January 2008 H.
Lundbeck A/S obtained worldwide rights to Desmoteplase from PAION AG. A
clinical Phase III programme with Desmoteplase was initiated by Lundbeck in
December 2008, recruiting patients in Europe, North and South America,
Africa and Asia Pacific. In parallel Lundbeck also focuses on the
development of the compound for the Japanese market.
About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in indications for which there is a substantial unmet medical
need. PAION has a 'Search & Develop' business model, which is based on its
core expertise in drug development. Where appropriate, particularly during
the late stages of the clinical development, PAION seeks to collaborate
with experienced partners.
Contact
Ralf Penner
Director Investor Relations & Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen - Germany
Phone: +49 241 4453-152
E-mail: r.penner@paion.commailto:
www.paion.com
Disclaimer:
This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG's management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such
forward-looking statements. Considering the risks, uncertainties and other
factors involved, recipients should not rely unreasonably upon these
forward-looking statements. PAION AG has no obligation to periodically
update any such forward-looking statements to reflect future events or
developments.
16.03.2010 08:38 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv at |[![CDATA[|[a href="http://www.dgap-medientreff.de"|]www.dgap-medientreff.de|[/a|]]]|] and |[![CDATA[|[a href="http://www.dgap.de"|]www.dgap.de|[/a|]]]|]
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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Deutschland
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Hamburg, Stuttgart
End of News DGAP News-Service
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DGAP-News: PAION'S PARTNER LUNDBECK INITIATES JAPANESE CLINICAL PHASE II TRIAL WITH DESMOTEPLASE IN ISCHAEMIC STROKE
| Source: EQS Group AG