PRESS RELEASE
Alirocumab (Praluent®▼) Injection Significantly Reduced the
Need for Invasive Cholesterol-Removing Procedure in Patients
with Inherited High Cholesterol
– Phase 3 ODYSSEY ESCAPE data to be featured in Hot Line session at European Society of
Cardiology (ESC) Congress 2016 and concurrently published in the European Heart Journal –
Guildford, United Kingdom – August 29, 2016 - Sanofi today announced detailed positive results
from ODYSSEY ESCAPE, a Phase 3 trial which evaluated Praluent®▼ (alirocumab) Injection in
patients with an inherited form of high cholesterol known as heterozygous familial
hypercholesterolemia (HeFH) who require regular weekly or bi-weekly apheresis treatment. The trial
demonstrated that adding alirocumab to existing therapy reduced ‘bad’ cholesterol (low-density
lipoprotein cholesterol), or LDL-C, by approximately 50 percent from baseline compared to a two
percent increase for placebo. Praluent significantly reduced the need for apheresis treatment by 75
percent compared to placebo (p<0.0001), the primary endpoint of the study.1 The product was
developed jointly by Sanofi and Regeneron.
“Apheresis therapy is an invasive, time-consuming and expensive treatment therefore it is promising
to see that alirocumab has the potential to reduce the frequency of this burdensome treatment in
patients with inherited high cholesterol,” said Dr Handrean Soran, Consultant Physician &
Endocrinologist at Central Manchester University Hospitals. “These data are particularly exciting as
93 percent of patients treated with alirocumab experience at least a 50 percent reduction in their
apheresis therapy sessions.”
Despite being treated with apheresis and entering ODYSSEY ESCAPE with very high ‘bad’
cholesterol levels (mean of 4.7 mmol/L or 181 mg/dL across all treatment arms), 63 percent of
patients treated with alirocumab no longer required apheresis therapy after six weeks of receiving
alirocumab.1 At this same time point, the average ‘bad’ cholesterol level among the alirocumabtreated group was 2.3 mmol/L (90 mg/dL), compared to 4.8 mmol/L (185 mg/dL) in the placebo
group.1 The recommended target cholesterol level is less than 3 mmol/L for ‘bad’ cholesterol,
depending on cardiovascular risk.2
Apheresis is a procedure similar to kidney dialysis where ‘bad’ cholesterol is removed from the blood,
and is usually reserved for high-risk patients with very high cholesterol levels who are unable to
achieve their cholesterol-lowering goals on any other therapy. Treatment can cost between £17,000
to £31,000 for each patient per year in the UK.3 Approximately, 200 people in the UK are eligible for
the treatment however only 30-40 patients receive the treatment each year. Furthermore, there are
only eight apheresis centres in the UK and many patients have to travel for the procedure.3
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“At Sanofi we are committed to improving the quality of life for people with inherited high cholesterol.
We’re therefore extremely encouraged by the results from the ODYSSEY ESCAPE trial, which
provide an important insight into the effect of alirocumab when added to existing therapies,” said Dr
Tunde Falode, Director of the Cardiovascular Division at Sanofi. “This is the first clinical trial to
demonstrate that alirocumab reduced the frequency of apheresis therapy and these data reinforce the
value of alirocumab for patients with high cholesterol.”
Alirocumab received approval from the National Institute for Health and Care Excellence (NICE) in
June 2016 and from the Scottish Medicines Consortium (SMC) in August 2016 as a treatment option
for people who have raised levels of ‘bad’ cholesterol and who are at a high risk of a heart attack or
stroke.4,5
About ODYSSEY ESCAPE1
The completed Phase 3 placebo-controlled ODYSSEY ESCAPE trial involved 62 patients from 14
treatment centres in the U.S. and Germany. These patients were receiving regular baseline apheresis
therapy at fixed intervals of every week or every two weeks prior to randomisation. Average LDL
cholesterol at baseline was 4.7 mmol/L (181 mg/dL) and 86 percent (placebo group) and 90 percent
(alirocumab group) of patients had a history of coronary heart disease (CHD).
Patients were randomised to receive alirocumab 150 mg (n=41) subcutaneously every two weeks or
placebo (n=21), in addition to their existing treatment regimen. The double-blind treatment period
comprised two intervals: for the first 6 weeks, patients remained on their established apheresis
schedule at baseline, and for the following 12 weeks, apheresis frequency was adjusted based on the
patient’s LDL cholesterol response to treatment. ODYSSEY ESCAPE is part of the overarching Phase
3 ODYSSEY program, which includes more than 25,000 patients.
Other key results from ODYSSEY ESCAPE, which will be concurrently published in the European
Heart Journal, include:
 93 percent of patients treated with alirocumab experienced at least a 50 percent reduction in
their apheresis procedures (p>0.0001).
 Throughout the trial, patients treated with alirocumab experienced significant reductions in
their LDL cholesterol compared to placebo, starting at week six (55 percent greater reduction),
and lasting until the trial ended, at week 18 (46 percent greater reduction) (p<0.0001).
 A similar proportion of patients experienced adverse events (AEs) in both the alirocumab and
placebo groups (76 percent both groups). The most common AEs (occurring in at least five
percent of the alirocumab group) were: fatigue (15 percent alirocumab; 10 percent placebo),
nasopharyngitis (10 percent alirocumab; 10 percent placebo), diarrhoea (10 percent
alirocumab; 0 percent placebo), myalgia (10 percent alirocumab; 5 percent placebo), upper
respiratory infection (seven percent alirocumab; 19 percent placebo), headache (seven
percent alirocumab; five percent placebo), arthralgia (7 percent alirocumab; 10 percent
placebo), and back pain (five percent alirocumab; 10 percent placebo).
About Praluent (alirocumab)
Despite the widespread use of statins and other lipid-lowering therapies to reduce raised cholesterol
levels, some people in the UK remain at significant risk of having a cardiovascular event and are
unable to lower their cholesterol to levels indicated within national guidelines.6
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Alirocumab belongs to the most recent cholesterol-lowering class of treatments called PCSK9
inhibitors. PCSK9 is a protein that plays an important role in managing ‘bad’ cholesterol by regulating
the number of receptors for ‘bad’ cholesterol on the liver’s surface. By reducing PCSK9, the treatment
increases the availability of receptors for ‘bad’ cholesterol and therefore lowers the levels of ‘bad’
cholesterol in the blood.7
Alirocumab is available in two starting strengths (75 mg and 150 mg) to be used once every two
weeks as a single 1-millilitre (ml) injection.7
The effect of alirocumab on cardiovascular (CV) morbidity and mortality has not yet been determined.
ODYSSEY OUTCOMES is prospectively evaluating the effect of alirocumab on the occurrence of CV
events in approximately 18,000 patients who have experienced an acute coronary syndrome.8
About FH
Familial Hypercholesterolemia (FH) is an inherited disorder, which causes people to have cholesterol
levels which are higher than normal from birth. The prevalence of FH in the UK population is
estimated to be 1 in 500,9 however an estimated 85% of people living with FH remain undiagnosed.10
Without treatment, people with FH can die prematurely of heart disease in their 20s, 30s and 40s.9
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organised into five global business units: Diabetes and Cardiovascular,
General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is
listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ:REGN) is a leading science-based biopharmaceutical company based in
Tarrytown, New York that discovers, invents, develops, manufactures, and commercialises medicines
for the treatment of serious medical conditions. Regeneron commercialises medicines for high LDL
cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in
development in other areas of high unmet medical need, including oncology, rheumatoid arthritis,
asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the
company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These
statements include projections and estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future financial results, events, operations, services,
product development and potential, and statements regarding future performance. Forward-looking statements
are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the expectations reflected in such forwardlooking statements are reasonable, investors are cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control
of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether
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SAGB.ALI.16.08.0781
and when to approve any drug, device or biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other matters that could affect the availability or
commercial potential of such product candidates, the absence of guarantee that the product candidates if
approved will be commercially successful, the future approval and commercial success of therapeutic
alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances
risks associated with intellectual property and any related pending or future litigation and the ultimate outcome
of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact
of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as
well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year ended December 31, 2015. Other than as required by
applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or
statements.
Contact:
Media Relations
Emily Lord
Cardiovascular Communications Lead
Tel.: +44 (0)7740 410 878
[email protected]
References
1. Moriarty, P. ESCAPE - Effect of alirocumab on the frequency of lipoprotein apheresis: a
randomised Phase III trial. Presented at European Society of Cardiology (ESC) Congress
2016, Rome, Italy. Hot Line prevention and lipids.
2. HEART UK. Know your numbers. Available at : https://heartuk.org.uk/health-and-highcholesterol/cholesterol-tests---know-your-number [Last accessed August 2016]
3. British Journal of Cardiology. Low-density lipoprotein-apheresis: an update. 2008. Available at:
https://bjcardio.co.uk/2008/03/low-density-lipoprotein-apheresis-an-update/ [Last accessed
August 2016]
4. National Institute for Health and Care Excellence. Technology appraisal guidance 393.
Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. June 2016
5. Scottish Medicines Consortium. Detailed Advice on Alirocumab. SMC No. 1147/16. August
2016.
6. Steinberg D, Witztum JL. Inhibition of PCSK9: A powerful weapon for achieving ideal LDL
cholesterol levels. PNAS 2009; 106:9546–7.
7. Sanofi. Summary of Product Characteristics (Praluent). 2016
8. ClinicalTrials.gov. ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an
Acute Coronary Syndrome During Treatment With Alirocumab. Available at:
https://clinicaltrials.gov/ct2/show/NCT01663402 [Last accessed August 2016]
9. HEART UK. Key facts and figures. Available at: http://heartuk.org.uk/press/press-kit/key-factsfigures [Last accessed August 2016].
10. HEART UK. Saving lives, saving families: the health, social and economic advantages of
detecting and treating familial hypercholesterolemia. 2012.
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