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Content :

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 alirocumab-treated 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

“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

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 500,9however 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 forward-looking 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 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

emily.lord@sanofi.com

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-high-cholesterol/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-facts-figures [Last accessed August 2016].

10. HEART UK. Saving lives, saving families: the health, social and economic advantages of detecting and treating familial hypercholesterolemia. 2012.

Date of preparation: August 2016 - Job bag number: SAGB.ALI.16.08.0781

Updated: August 29, 2016

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