ECASS 3 Study Receives Recognition From the European Stroke Organisation and The Lancet

Ingelheim, Germany (ots/PRNewswire) -

- ESO Recommends Extended Time Window for Actilyse(R)

INGELHEIM, Germany, January 30 /PRNewswire/ --

- For Healthcare Media outside the U.S.A., Canada, and Japan

Based on key results from the European Cooperative Acute Stroke
Study (ECASS 3), the European Stroke Organisation (ESO) now
recommends that Actilyse(R) (alteplase) be given within 4.5 hours of
onset of ischaemic stroke, although treatment between 3 and 4.5 hours
is currently not included in the European labelling.(1) ECASS 3, a
randomised, double-blind, placebo-controlled trial, showed for the
first time that thrombolysis with Actilyse can increase the
likelihood of achieving good outcome with only minimal or no
disability after an acute ischaemic stroke when administered in an
extended time-window from 3 to 4.5 hours after symptom onset.(2) This
news comes shortly after The Lancet selected ECASS 3 as one of the
top three papers of 2008, and Lancet editors singled out the study as
their choice for paper of the year.(3)

Writing in the 24 January 2009 issue of The Lancet, Executive
Editor William Summerskill said that ECASS 3 and the other papers of
the year "embody the can-do spirit of visionary research. They extend
the horizon of our understanding and add to our tools for treating
important common health problems that were once believed
overwhelming."

The World Health Organization estimates that 5.7 million people
in the world die each year from stroke.(4) Among survivors, 40%
experience moderate to severe disability and 10% require
institutional care.(5) For patients with an acute ischaemic stroke
the only treatment currently available is Actilyse, which has to be
administered within 3 hours of symptom onset according to its
currently approved label. The ECASS 3 trial was set up to investigate
whether Actilyse can also safely extend the benefit of treatment in
the 3 to 4.5 hour time window. ECASS 3 included 821 patients in 15
European countries who were recruited by a team of investigators led
by Professor Werner Hacke of the University of Heidelberg. Results
were published in the New England Journal of Medicine in September
2008.(2)

Dr. Manfred Haehl, Corporate Senior Vice President Medicine,
Boehringer Ingelheim said: "We are proud of the success of ECASS 3
and would like to thank our lead investigator, all the investigators
throughout Europe, the trial team and most notably patients and their
relatives for their participation in this landmark study in acute
ischaemic stroke. Boehringer Ingelheim is committed to seeking an
update to the Actilyse label and will present the new clinical
evidence generated by ECASS 3 to regulatory authorities as soon as
possible."

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This release is from Boehringer Ingelheim Corporate Headquarters
in Germany. Please be aware that there may be national differences
between countries regarding specific medical information, including
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- ends -

Notes to Editor

About ECASS 3

ECASS 3 was a randomised, double-blind, multicentre,
placebo-controlled trial of Actilyse(R) in acute ischaemic stroke
where thrombolysis is initiated between 3 and 4.5 hours after stroke
onset. The study, sponsored by Boehringer Ingelheim, was requested by
European authorities to support the licencing of Actilyse(R). ECASS 3
started in July 2003 and was completed in February 2008. The patients
included in the study were in line with the Actilyse(R) indication in
the European Summary of Product Characteristics(6) with the exception
of the time window.

About Actilyse(R)

Stroke is a neurological emergency that can affect a specific
area, or sometimes all of the brain. It can be caused by a burst
blood vessel (haemorrhagic stroke) or occur when a vessel is
obstructed by a blood clot (ischaemic stroke). Actilyse(R) (active
ingredient: alteplase), a recombinant tissue plasminogen activator
(rt-PA), is a genetically engineered version of naturally occurring
tissue plasminogen activator, which has the biological function of
removing small clots that routinely form in the bloodstream.
Actilyse(R) is the only drug indicated for thrombolytic treatment of
acute ischaemic stroke within three hours of symptom onset, and is
recommended by international treatment guidelines.(7),(8) In line
with the current Actilyse(R) label, patients need to receive the
medication within three hours of the onset of their stroke
symptoms.(5) Alteplase was first approved in 1987 in major countries
across the globe in the indication acute myocardial infarction,
followed by subsequent approvals in the indications pulmonary
embolism and acute ischaemic stroke (registered indications can vary
across the globe).

Actilyse(R) is registered in over 85 countries across the world
and marketed outside North America and Japan by Boehringer Ingelheim.
Alteplase is marketed under the brand name Activase(R) in the U.S.A.
by Genentech, Inc. and in Canada by Roche Canada, where it has been
used extensively for the treatment of acute ischaemic stroke since
1996 and 1999, respectively.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 135 affiliates in 47 countries and 39,800
employees. Since it was founded in 1885, the family-owned company has
been committed to researching, developing, manufacturing and
marketing novel products of high therapeutic value for human and
veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion
euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.

For more information please visit
http://www.boehringer-ingelheim.com.

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http://www.boehringer-ingelheim.com/corporate/news/information_pa
cks/acut estroke.asp

References
(1) European Stroke Organisation. ESO GC Statement on revised guidelines
for intravenous thrombolysis. January 2009.
http://www.eso-stroke.org/pdf/ESO_Guideline_Update_Jan_2009.pdf
Accessed 28 January 2009.
(2) Hacke W, et al for the ECASS investigators. Thrombolysis with
alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med
2008; 359: 1317-1329
(3) Summerskill W. Paper of the year 2008: results. Lancet 2009; 373:
283-284
(4) Cardiovascular diseases. Fact sheet Ndegrees317. February 2007. WHO.
https://www.who.int/mediacentre/factsheets/fs317/en/
(5) National Institute of Neurological Disorders and Stroke. Stroke
Rehabilitation Information.
http://www.ninds.nih.gov/disorders/stroke/stroke_rehabilitation.htm
Accessed 27 January 2009
(6) Actilyse(R) Summary of Product Characteristics 2007. Available at:
http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=308
(7) European Stroke Organisation (ESO) Executive Committee; ESO Writing
Committee. Guidelines for management of ischaemic stroke and
Transient ischaemic attack 2008. Cerebrovasc Dis 2008; 25: 457-507
(8) Strokeupdate.org. Stockholm: Thrombolysis for acute ischaemic stroke.
Karolinska Stroke Update Consensus Statement 2002. Available from:
http://www.strokeupdate.org/ALLCURRENT/Consensus/Consensus_2002/Cons_thrombolysis_2002.htm
Accessed 27 January 2009

ots Originaltext: Boehringer Ingelheim
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Contact:
Contact: John Pugh, Corporate Division Communications, Boehringer
Ingelheim GmbH, 55216 Ingelheim/Germany, E-mail:
press@boehringer-ingelheim.com