2008-09-25

Recent Research Shows Significant Benefits in Acute Ischaemic Stroke With Actilyse(R) Beyond Currently Approved Three Hour Treatment Window


Ingelheim, Germany (ots/PRNewswire) -

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

- Favourable Safety and Efficacy Profile of Actilyse(R) Confirmedby ECASS 3 Study Investigating Treatment in an Extended Time Windowup to 4.5 Hours After Symptom Onset

First results from ECASS 3 (European Cooperative Acute StrokeStudy) were presented today at the 6th World Stroke Congress inVienna, Austria, showing that treatment with Actilyse(R) (alteplase)between 3 and 4.5 hours after stroke onset can improve clinicaloutcome. These results were also published today in the New EnglandJournal of Medicine.(1)

To view the Multimedia News Release, please click:http://www.prnewswire.com/mnr/boehringeringelheim/35105/

Importantly, data from the trial show that the safety profile ofActilyse(R), a recombinant tissue plasminogen activator (rt-PA), whenused in the 3 to 4.5 hour time window is consistent with the safetyprofile reported in previous clinical trials that investigatedActilyse(R) use in the currently approved time window of 0 to 3hours, including the incidence of haemorrhagic events.(2-6)

ECASS 3, which included 821 patients (418 treated with alteplasevs. 403 placebo-treated patients), was a randomised, double-blind,placebo-controlled trial designed to evaluate whether the efficacyand safety of alteplase were maintained up to 1.5 hours beyond thestandard 3-hour time window.

The study showed that patients treated with alteplase in thisextended time window had a 34 percent improvement in the odds ofhaving a favourable outcome versus placebo (absolute 7.2%improvement; p=0.04) as measured by the modified Rankin Scale (mRS0-1). This finding is important as it demonstrates that alteplase canincrease the likelihood of achieving only minimal or no disabilitypost-stroke, now shown for the first time beyond 3 hours and up to4.5 hours.

"Early treatment remains the cornerstone of acute stroke therapyand it is of paramount importance that patients arriving in strokeunits who are eligible for thrombolysis should be treated withoutdelay. However, the new ECASS 3 data show that stroke can beeffectively managed also in patients who are unable to reach a strokecentre within three hours," commented Professor Werner Hacke,Department of Neurology, Ruprecht-Karls-University of Heidelberg,Germany, lead study investigator. "The results of the trial show thata large group of patients currently excluded may benefit in thefuture from this therapy."

Furthermore, the ECASS 3 data are complemented by similarfindings from SITS-ISTR (Safe Implementation of Treatments in Stroke- International Stroke Thrombolysis Registry), an academic-drivenacute stroke registry of thrombolysis for ischaemic stroke, whichwere published last week in The Lancet(7). These data, collected in areal life clinical setting, suggest that patients who are treatedwith alteplase in accordance with the current European summary ofproduct characteristics, but in an extended time window of treatmentinitiation between 3 and 4.5 hours after stroke onset(*), canexperience a similar clinical outcome as compared with patients whoare treated earlier.

(*) Actilyse(R) is currently approved for use within the 3 hourtime window.

Please be advised

This release is from Boehringer Ingelheim Corporate Headquartersin Germany. Please be aware that there may be national differencesbetween countries regarding specific medical information, includinglicensed uses. Please take account of this when referring to theinformation provided in this document. This press release is notintended for distribution within the U.S.A.

Notes to Editor

Modified Rankin Scale

The Modified Rankin Scale is a numerical functional assessmentscale used to rank levels of disability after stroke. Patientsreceive a score between 0 and 6, where 0 represents no symptoms atall and higher scores represent increasingly severe disability.(8)

About ECASS 3

ECASS 3 was a randomised, double-blind, multicentre,placebo-controlled trial of Actilyse(R) in acute ischaemic strokewhere thrombolysis is initiated between 3 and 4.5 hours after strokeonset. The study, sponsored by Boehringer Ingelheim, was requested byEuropean authorities to support the licencing of Actilyse(R). ECASS 3started in July 2003 and was completed in February 2008. The patientsincluded in the study were in line with the Actilyse(R) indication inthe European Summary of Product Characteristics(6) with the exceptionof the time window. A total of 821 patients were recruited in 15European countries.

About Actilyse(R)

Stroke is a neurological emergency that can affect a specificarea, or sometimes all of the brain. It can be caused by a burstblood vessel (haemorrhagic stroke) or occur when a vessel isobstructed by a blood clot (ischaemic stroke). Actilyse(R) (activeingredient: alteplase), a recombinant tissue plasminogen activator(rt-PA), is a genetically engineered version of naturally occurringtissue plasminogen activator, which has the biological function ofremoving small clots that routinely form in the bloodstream.Actilyse(R) is the only drug indicated for thrombolytic treatment ofacute ischaemic stroke within three hours of symptom onset, and isrecommended by international treatment guidelines.(9,10) In line withthe current Actilyse(R) label, patients need to receive themedication within three hours of the onset of their strokesymptoms.(6) Alteplase was first approved in 1987 in major countriesacross the globe in the indication acute myocardial infarction,followed by subsequent approvals in the indications pulmonaryembolism and acute ischaemic stroke (registered indications can varyacross the globe).

Actilyse(R) is registered in over 85 countries across the worldand 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 beenused extensively for the treatment of acute ischaemic stroke since1996 and 1999, respectively.

About Boehringer Ingelheim

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

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

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

For related media information please click here: http://www.boehringer-ingelheim.com/corporate/news/information_packs/acutestroke.asp

References

1. Hacke W, et al for the ECASS investigators. Thrombolysis withalteplase 3 to 4.5 h after acute ischemic stroke. N Engl J MedSeptember 2008

2. The National Institute of Neurological Disorders and Strokert-PA Stroke Study Group. N Engl J Med 1995; 333: 1581-7

3. Albers GW, et al. ATLANTIS trial: results for patients treatedwithin 3 hours of stroke onset. Alteplase Thrombolysis for AcuteNoninterventional Therapy in Ischemic Stroke. Stroke 2002; 33: 493-5

4. Hacke W et al. Association of outcome with early stroketreatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroketrials. Lancet 2004; 363: 768-74

5. Wahlgren N, et al. Thrombolysis with alteplase for acuteischaemic stroke in the Safe Implementation of Thrombolysis inStroke-Monitoring Study (SITS-MOST): an observational study. Lancet2007; 369: 275-82

6. Actilyse(R) Summary of Product Characteristics 2007. Availableat: http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=308

7. Wahlgren N, Ahmed N, Dávalos A, et al, for the SITSinvestigators. Thrombolysis with alteplase 3-4-5 h after acuteischaemic stroke (SITS-ISTR): an observational study. Lancet 2008;published online Sept 15. DOI:10.1016/S0140-6736(08)61339-2

8. Modified Rankin Scale. Internet Stroke Center. Available athttp://www.strokecenter.org/trials/scales/rankin.html Accessed 4 May2008

9. European Stroke Organisation (ESO) Executive Committee; ESOWriting Committee. Guidelines for management of ischaemic stroke andtransient ischaemic attack 2008. Cerebrovasc Dis 2008; 25: 457-507

10. Strokeupdate.org. Stockholm: Thrombolysis for acute ischaemicstroke. Karolinska Stroke Update Consensus Statement 2002. Availablefrom: http://www.strokeupdate.org/ALLCURRENT/Consensus/Consensus_2002/Cons_thrombolysis_2002.htm Accessed 4 September 2008

Contact: Ursula Bardon Corporate Division Communications Boehringer Ingelheim GmbH 55216 Ingelheim/Germany Phone +49-61-32-77-2622 E-mail: press@boehringer-ingelheim.com

ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de

Contact:Contact: Ursula Bardon, Corporate Division Communications, BoehringerIngelheim GmbH, 55216 Ingelheim/Germany, Phone +49-61-32-77-2622

Boehringer Ingelheim

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Recent Research Shows Significant Benefits in Acute Ischaemic Stroke With Actilyse(R) Beyond Currently Approved Three Hour Treatment Window

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