EXCLAIM Study Publication in Annals of Internal Medicine Shows that Extended Anticoagulant Prophylaxis with Enoxaparin is Beneficial in Acutely Ill Medical Patients

Patients With Restricted Mobility, Elderly and Women Subgroups Drive the Patients' Benefit

NEW YORK, July 6, 2010 - The Steering Committee of the EXCLAIM study that explored the
benefit of extended prophylaxis of venous thrombo embolism (VTE) with
enoxaparin in acutely ill medical patients, announced today the publication
of the comprehensive study results in the peer-reviewed journal Annals of
Internal Medicine.

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The study showed that in recently immobilized patients, who
received usual short-term prophylaxis of 10 days (+/- 4) with the standard of
care enoxaparin (Lovenox/Clexane), an additional 28 days (+/- 4) prophylaxis
with enoxaparin further reduced the risk of VTE events (2.5% for enoxaparin
arm vs. 4% for placebo comparator [absolute risk reduction 1.5%; 95.8% CI
-2.54% to -0.52%]);

The populations who benefited most from the extended
anticoagulation prophylaxis with enoxaparin included patients with restricted
mobility (Level 1 immobilisation, confined to bed), elderly patients (older
than 75 years) and women. This reduction in VTE risk was largely attributable
to the reduction of some of the most serious forms of deep vein thrombosis,
the symptomatic manifestations.

The EXCLAIM randomized trial enrolled 6085 acutely ill medical
patients, with recently reduced mobility, in 370 sites in 20 countries across
North America, South America, Europe and Asia. Patients where classified
according to immobility criteria: Level 1 (bed rest or sedentary without
bathroom privilege), Level 2 (as previously with bathroom privilege). After
an interim analysis, eligibility criteria for patients with Level 2
immobility were amended to include only those who had at least one of three
additional risk factors (i.e., age > 75 years, history of VTE, cancer)

In the extended prophylaxis phase, the bleeding risk was
generally manageable with a major bleeding rate of 0.8% in the enoxaparin arm
and 0.3% in the placebo arm. This difference was similar to what was
generally observed in placebo-controlled trials of standard-duration VTE
anticoagulant prophylaxis.

" EXCLAIM study gathered momentous information that will help
improve the understanding of VTE risk in acutely ill populations, and is
opening a new path for the individualised anticoagulation management of
recently immobilised patients according to their individual risk profile"
said Pr Russell Hull from the Calgary University, Canada, lead author of the
publication and chair of the Steering Committee.

"EXCLAIM landmark trial is the largest study that established
that the heterogeneous group of acutely ill patients continue to be exposed
to VTE risk after the usual short term anticoagulant prophylaxis, similarly
to the patients undergoing high risk major orthopedic surgery " said Pr
Turpie, from McMaster University, Canada, and member of the study Steering
Committee.

"A decade after MEDENOX study that established the benefit of
enoxaparin based short term prophylaxis in acutely ill medical patients,
EXCLAIM is building in this paradigm and highlighting even further the
necessity to optimising enoxaparin thromboprophylaxis according to patients'
venothrombotic risks" added Pr Samama, from Hotel-Dieu Hospital Paris, member
of the EXCLAIM study Steering Committee

EXCALAIM study was sponsored by sanofi-aventis, the company
that discovered and developed enoxaparin, the worldwide standard low
molecular weight heparin that is available under the brand name Lovenox
/Clexane.

About the EXCLAIM Study Steering Committee:

Russell D. Hull, MBBS; Sebastian M. Schellong, MD; Victor F. Tapson, MD;
Manuel Monreal, MD; Meyer-Michel Samama, MD PharmD; Philippe Nicol, PhD; Eric
Vicaut, MD, PhD; Alexander G.G. Turpie, MD; Roger D. Yusen, MD, MPH

Author Affiliations:

University of Calgary, Foothills Hospital, Calgary, Alberta, Canada (Dr
Hull); Hospital Carl Gustav Carus, Dresden, Germany (Dr Schellong); Duke
University Medical Center, Durham, NC, USA (Dr Tapson); Hospital Germans
Trias i Pujol, Barcelona, Spain (Dr Monreal); Service d'Hematologie
Biologique Hotel-Dieu, Paris, France (Dr Samama); sanofi-aventis, Paris,
France (Dr Nicol); McMaster University; HHSC McMaster Clinic, Hamilton,
Ontario, Canada (Dr Turpie); and Washington University School of Medicine,
St. Louis, MO, USA (Dr Yusen).

About Venous Thromboembolism (VTE)

Venous thromboembolism is a general term describing the
formation of a blood clot (thrombus) that blocks a vessel. The thrombus may
occur in any part of the venous system, but the most common manifestations
are deep-vein thrombosis (DVT), usually in the leg, and pulmonary embolism
(PE, occurs when all or part of the blood clot dislodges from the vessel wall
and travels through the venous system to the lungs).

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Media Contact: Salah Mahyaoui, salah.mahyaoui at sanofi-aventis.com,
Telephone: +33-6-73-68-78-88