Sanofi and Regeneron Report Positive Top-line Results with Alirocumab from First Phase 3 Study of a PCSK9 Inhibitor for LDL

PR Newswire/Les Echos/ 

    Sanofi and Regeneron Report Positive Top-line Results with Alirocumab from 
     First Phase 3 Study of a PCSK9 Inhibitor for LDL Cholesterol Reduction
    - alirocumab monotherapy reduced "bad" cholesterol three times more than
                                   ezetimibe -

Paris, France, and Tarrytown, NY, October 16, 2013 -- Sanofi (EURONEXT: SAN and
NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the Phase 3 ODYSSEY MONO trial with alirocumab, an investigational
monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin 
type 9), met its primary efficacy endpoint. The mean lowdensity
lipoprotein-cholesterol (LDL-C, or "bad" cholesterol) reduction from baseline 
to week 24, the primary efficacy endpoint of the study, was significantly 
greater in patients randomized to alirocumab, as compared to patients 
randomized to ezetimibe (47.2% vs. 15.6%, p<0.0001). In the trial, which 
employed a dose increase (up-titration) for patients who did not achieve an 
LDL-C level of 70 milligrams/deciliter (mg/dL), the majority of patients 
remained on the initial low dose of alirocumab of 75 milligrams (mg).

"We are excited with the findings from the first Phase 3 trial with alirocumab.
While the majority of our clinical program is investigating alirocumab in
combination with lipid-lowering therapies, these monotherapy results are
encouraging," said Jay Edelberg M.D., Ph.D., Head of the PCSK9 Development and
Launch Unit, Sanofi Group. "As in this trial, several of our Phase 3 studies
will utilize an up-titration approach, the aim of which is to bring patients to
goal with the lowest effective dose of anti-PCSK9 antibody. We look forward to
results from the remaining Phase 3 trials, which are investigating alirocumab 
in a variety of patient populations, combinations with different background
therapies, and dosing regimens."

The percentage of patients who reported treatment emergent adverse events was
78.4% in the ezetimibe group and 69.2% in the alirocumab group. The most common
class of adverse events was infections (39.2% with ezetimibe vs. 42.3% with
alirocumab), which included nasopharyngitis, influenza, and upper respiratory
tract infection. Injection-site reactions occurred in less than 2% of patients
in both groups. Muscle-related adverse events occurred in 3.9% of patients
treated with ezetimibe and 3.8% of patients treated with alirocumab.

ODYSSEY MONO is the first study to report data from the 12 Phase 3 trials that
have been initiated so far as part of the more than 23,000 patient ODYSSEY
clinical trial program.

"There are still millions of people around the globe who have poorly controlled
LDL-C," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of
Regeneron and President of Regeneron Laboratories. "Three years ago, our Phase
1 trials generated the first clinical evidence that blocking PCSK9 could 
markedly lower cholesterol levels in humans. Today, it is very gratifying to 
be able to report the first Phase 3 data for this promising potential new 
class of lipid-lowering agents. It is important to point out that these are 
just the first of a large amount of data yet to come from our extensive 
ODYSSEY Phase 3 program."

ODYSSEY MONO (N=103) was a randomized, double-blind, active-controlled,
parallel-group study to evaluate the efficacy and safety of alirocumab over 24
weeks in patients with primary hypercholesterolemia and moderate cardiovascular
risk. Patients in the trial were randomized to receive monotherapy with either
ezetimibe 10 mg, an alternative to statin therapy, or alirocumab. Alirocumab 
was self-administered initially at its low dose of 75 mg every two weeks, and 
was uptitrated at week 12 to 150 mg if the LDL-C measurement at week 8 was 
above 70 mg/dL. The majority of alirocumab patients in the trial remained on 
the initial low dose of alirocumab because they achieved LDL-C below 70 mg/dL 
at week 8. Alirocumab was self-administered subcutaneously using a single-use 
1 milliliter (mL) auto-injector.

Detailed results from the ODYSSEY MONO study will be presented at an upcoming
medical conference in 2014.

The global Phase 3 ODYSSEY program is expected to enroll more than 23,000
patients and currently includes 12 clinical trials of alirocumab both in
combination with other lipid-lowering agents and as monotherapy. The primary
Phase 3 study endpoint is the percent mean reduction in LDL-C at 24 weeks,
giving a robust measure of efficacy and safety. In addition, several other 
lipid markers will also be assessed.

Phase 3 trials are designed to create different options to help meet the needs
of individual patients. In addition to the up-titration option explored in this
study in which patients received a 75 mg Q2W (once every two weeks) dose of
alirocumab, and were only be up-titrated to 150 mg Q2W if they were unable to
reach prespecified target LDL-C levels, the other ODYSSEY trials are also
exploring initiating patients with a 150 mg every two week regimen (intended 
for patients needing a larger reduction in LDL-C), as well as regimens 
evaluating alirocumab dosed once every four weeks.

All of the ODYSSEY trials, with the exception of ODYSSEY CHOICE I and ODYSSEY
OUTCOMES, are fully enrolled. For more information on the ODYSSEY clinical
trials, please visit

About PCSK9
PCSK9 is known to be a determinant of circulating LDL levels, as it binds to 
LDL receptors resulting in their degradation so that fewer are available on 
liver cells to remove excess LDL-cholesterol from the blood. Moreover, 
traditional LDL-lowering therapies such as statins actually stimulate the 
production of PCSK9, which limits their own ability to lower LDL-cholesterol. 
Blocking the PCSK9 pathway is therefore a potentially novel mechanism for 
lowering LDL-cholesterol.

About alirocumab
Alirocumab is an investigational, fully-human monoclonal antibody that targets
and blocks PCSK9. It is administered via subcutaneous injection. By inhibiting
PCSK9, a determinant of circulating LDL-C levels in the blood, alirocumab has
been shown in pre-clinical studies to increase the number of LDL receptors on
hepatocytes, thereby lowering LDL-C.

The investigational agent described above is currently under clinical
development and its safety and efficacy have not been fully evaluated by any
regulatory authority.

About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in Paris 
(EURONEXT: SAN) and in New York (NYSE: SNY).

About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading science-based biopharmaceutical company based in
Tarrytown, New York that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical conditions.
Regeneron markets medicines for eye diseases, colorectal cancer, and a rare
inflammatory condition and has product candidates in development in other areas
of high unmet medical need, including hypercholesterolemia, oncology, 
rheumatoid arthritis, asthma, and atopic dermatitis. For additional 
information about the company, please visit

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-0- Oct/16/2013 06:50 GMT
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