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Biopharmaceuticals Neurology

 News Release - September 25, 2008

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

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

Favourable Safety and Efficacy Profile of Actilyse(R) Confirmed by ECASS 3 Study Investigating Treatment in an Extended Time Window up to 4.5 Hours After Symptom Onset


INGELHEIM, Germany, September 25 (HSMN NewsFeed) -- First results from ECASS 3 (European Cooperative Acute Stroke Study) were presented today at the 6th World Stroke Congress in Vienna, Austria, showing that treatment with ActilyseŽ (alteplase) between 3 and 4.5 hours after stroke onset can improve clinical outcome. These results were also published today in the New England Journal of Medicine.(1)

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

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

The study showed that patients treated with alteplase in this extended time window had a 34 percent improvement in the odds of having a favourable outcome versus placebo (absolute 7.2% improvement; p=0.04) as measured by the modified Rankin Scale (mRS 0-1). This finding is important as it demonstrates that alteplase can increase the likelihood of achieving only minimal or no disability post-stroke, now shown for the first time beyond 3 hours and up to 4.5 hours.

"Early treatment remains the cornerstone of acute stroke therapy and it is of paramount importance that patients arriving in stroke units who are eligible for thrombolysis should be treated without delay. However, the new ECASS 3 data show that stroke can be effectively managed also in patients who are unable to reach a stroke centre 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 that a large group of patients currently excluded may benefit in the future from this therapy."

Furthermore, the ECASS 3 data are complemented by similar findings from SITS-ISTR (Safe Implementation of Treatments in Stroke - International Stroke Thrombolysis Registry), an academic-driven acute stroke registry of thrombolysis for ischaemic stroke, which were published last week in The Lancet(7). These data, collected in a real life clinical setting, suggest that patients who are treated with alteplase in accordance with the current European summary of product characteristics, but in an extended time window of treatment initiation between 3 and 4.5 hours after stroke onset(*), can experience a similar clinical outcome as compared with patients who are treated earlier.

(*) ActilyseŽ is currently approved for use within the 3 hour time window.

Please be advised

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 licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

Notes to Editor

Modified Rankin Scale

The Modified Rankin Scale is a numerical functional assessment scale used to rank levels of disability after stroke. Patients receive a score between 0 and 6, where 0 represents no symptoms at all and higher scores represent increasingly severe disability.(8)

About ECASS 3

ECASS 3 was a randomised, double-blind, multicentre, placebo-controlled trial of ActilyseŽ 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 ActilyseŽ. ECASS 3 started in July 2003 and was completed in February 2008. The patients included in the study were in line with the ActilyseŽ indication in the European Summary of Product Characteristics(6) with the exception of the time window. A total of 821 patients were recruited in 15 European countries.

About ActilyseŽ

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). ActilyseŽ (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. ActilyseŽ 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.(9,10) In line with the current ActilyseŽ label, patients need to receive the medication within three hours of the onset of their stroke symptoms.(6) 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).

ActilyseŽ 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 ActivaseŽ 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.

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

References

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

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

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

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

5. Wahlgren N, et al. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet 2007; 369: 275-82

6. ActilyseŽ Summary of Product Characteristics 2007. Available at: http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=308

7. Wahlgren N, Ahmed N, Dávalos A, et al, for the SITS investigators. Thrombolysis with alteplase 3-4-5 h after acute ischaemic 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 at http://www.strokecenter.org/trials/scales/rankin.html Accessed 4 May 2008

9. 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

10. 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 4 September 2008


Source: Boehringer Ingelheim

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