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Regeneron Pharmaceuticals, Inc.

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George D. Yancopoulos, M.D., Ph.D., CSO, gave guidance for additional data from the Sarilumab program. He stated, "Turning now to Sarilumab, our IL-6 receptor antibody, which is in phase-III for rheumatoid arthritis or RA. We believe Sarilumab is positioned to provide an important new treatment option to the RA community, where patients often cycle through multiple medicines during the course of their disease. In the fourth quarter, we presented additional analyses from the SARIL-RA-MOBILITY study at the Annual Meeting of the American College of Rheumatology. This year, we expect results from three additional phase-III studies in the SARIL-RA program, which are evaluating Sarilumab in combination and as monotherapy."
Source: Q4 2014 earnings conference call, 2/10/15.

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George D. Yancopoulos, M.D., Ph.D., CSO, maintained guidance for data from the Sarilumab for RA program. He stated, "We will be reporting full data from the MOBILITY study in an upcoming medical conference. There are also four more phase-III studies of Sarilumab in RA that are ongoing with expected read outs beginning in 2015."
Source: Q4 2013 earnings conference call, 2/11/14.

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George D. Yancopoulos, M.D., Ph.D., CSO, commented on the start of the TARGET trial for Sarilumab. He stated, "In addition, we have now initiated another phase III study in the SARIL-RA program called the TARGET trial. TARGET is now recruiting and will evaluate Sarilumab in combination with non-biological disease modifying anti-rheumatic drugs, also known as DMARD, in adult patients with moderate-to-severe RA who have an inadequate response to for our intolerant drug or more TNF alpha inhibitors."
Source: Q3 2012 earnings conference call, 10/24/12.

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SARIL-RA-TARGET - A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-α Antagonists
Estimated Enrollment: 522
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01709578?term=Sarilumab&rank=3

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Sarilumab (REGN-88) (2) RARheumatologyRheumatoid Arthritis (RA)IL-6 inhibitorIL-6R alpha

Mechanism of action: Sarilumab (REGN88/ SAR153191) is the first fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex (IL-6R alpha). Sarilumab is a high affinity, sub-cutaneously delivered, specific inhibitor of IL-6 signaling. It blocks the binding of IL-6 to its receptor and interrupts the resultant cytokine-mediated inflammatory signaling cascade.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2015-01-01 - 2015-03-31

Results:

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November 8, 2015
Regeneron and Sanofi Present Results from Pivotal Phase 3 Study of Sarilumab at American College of Rheumatology Annual Meeting
Data Show Significant Improvement in Signs and Symptoms and Physical Function in Rheumatoid Arthritis Patients who were Inadequate Responders to or Intolerant of TNF-Alpha Inhibitors (TNF-IR)
Companies to host Investor Conference Call on sarilumab on Monday, Nov. 9 at 7:00 a.m. PT
TARRYTOWN, N.Y. and PARIS, Nov. 8, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced results from a pivotal Phase 3 study of sarilumab, an investigational, human antibody against the IL-6 receptor. The results of the study, SARIL-RA-TARGET, are being presented today at an oral session during the American College of Rheumatology (ACR) Annual Meeting in San Francisco, California. The study met both its co-primary endpoints of improvements in signs and symptoms of rheumatoid arthritis (RA) and improvements in physical function, as well as secondary efficacy endpoints.

"Rheumatoid arthritis can be a debilitating disease that has a significant impact on a patient, and despite the availability of a wide range of treatments, new agents are still needed to address unmet patient needs including failure to respond to therapy," said Dr. Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and lead study author. "These data suggest that sarilumab, if approved, may be a potential option for patients with moderate-to-severe RA."

The SARIL-RA-TARGET trial enrolled 546 RA patients who were inadequate responders or intolerant of TNF-alpha inhibitors (TNF-IR). Patients were randomized to one of three treatment groups self-administered subcutaneously (SC) every other week (Q2W): sarilumab 200 milligrams (mg), sarilumab 150 mg, or placebo, in addition to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy. Top-line results were previously announced in May 2015.

Both sarilumab groups showed clinically relevant and statistically significant improvements compared to placebo in both co-primary endpoints:

Improvement in physical function at week 12, as measured by mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). The HAQ-DI measures patients' abilities to perform a standard set of daily physical activities. The change from baseline to week 12 in HAQ-DI was -0.49, -0.50, and -0.29 in the sarilumab 200 mg (p=0.0004), sarilumab 150 mg (p=0.0007), and placebo groups, respectively.
Improvements in signs and symptoms of RA at week 24, as measured by the proportion of patients achieving an ACR20 response (ACR20) were 61 percent in the sarilumab 200 mg group; 56 percent in the sarilumab 150 mg group; and 34 percent in the placebo group, all in combination with DMARD therapy (p less than 0.0001).
Secondary efficacy endpoints that will be presented during the ACR oral session include the following:

Proportion of patients achieving an ACR50 response at week 24 were 41 percent in the sarilumab 200 mg group, 37 percent in the sarilumab 150 mg group, and 18 percent in the placebo group (p less than 0.0001).
Proportion of patients achieving an ACR70 response at week 24 were 16 percent in the sarilumab 200 mg group (p=0.0056), 20 percent in the sarilumab 150 mg group (p=0.0002), and 7 percent in the placebo group.
The mean change from baseline to week 24 in disease activity score in 28 joints using C-reactive protein (DAS28-CRP), which evaluates the disease activity of RA, were as follows: -2.82, -2.35 and -1.38 in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively.
The proportion of patients achieving DAS28-CRP less than 2.6 at week 24 were as follows: 29 percent, 25 percent, and 7 percent in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively.
The change from baseline to week 24 in clinical disease activity index (CDAI), which also evaluates the disease activity of RA, were as follows: -30.43, -27.14, and -23.9 in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively.
The change from baseline to week 24 in HAQ-DI were as follows: -0.58, -0.52 and -0.34 in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively.
Treatment-emergent adverse events (TEAEs) were more frequent in the sarilumab groups (65 percent and 66 percent in sarilumab 200 mg and 150 mg vs 50 percent in placebo respectively). The incidence of serious adverse events (SAEs) was higher than placebo in the sarilumab 200 mg group (5 percent vs. 3 percent) and was similar to placebo in the 150 mg group (3 percent). Infection was the most frequently reported adverse event (30, 22 and 27 percent in the 200 mg, 150 mg and placebo groups respectively). Serious infections occurred in 2 patients in the sarilumab 200 mg group, 1 patient in the sarilumab 150 mg group and 2 patients on placebo. The most frequent events leading to treatment discontinuation were infection and neutropenia. Adverse events and laboratory changes were consistent with observations from the MOBILITY study and with the mechanism of action of sarilumab.

During the same oral session at ACR, data from the SARIL-RA-ASCERTAIN/1309 studies will also be presented. In total, 14 abstracts were accepted for presentation at the meeting. This includes additional abstracts detailing data from the sarilumab clinical trial program: SARIL-RA-MOBILITY and SARIL-RA-EXTEND.

Sanofi and Regeneron recently submitted a Biologics License Application (BLA) for sarilumab to the U.S. Food and Drug Administration (FDA).

Sanofi and Regeneron will host an IR Thematic Conference Call for the financial community focusing on sarilumab on Monday, November 9 at 7:00 a.m. PDT. The conference call will include a presentation followed by a Q&A session. It will be accessible through an audio webcast at www.sanofi.com and www.regeneron.com and also via the following telephone numbers: France, +33 (0) 1 70 77 09 40; UK, +44 (0) 207 107 1613; and USA, +1 855 402 7761.

The investigational agent described above is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.
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Source: press release, 11/08/15. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=941387

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Regeneron and Sanofi Announce Positive Topline Results from Phase 3 Studies with Sarilumab in Patients with Rheumatoid Arthritis
Includes study in patients who were inadequate responders to or intolerant of TNF-alpha inhibitors
U.S. regulatory submission planned for Q4 2015
TARRYTOWN, N.Y. and PARIS, May 21, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced today that a Phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks, compared to placebo. The study, called SARIL-RA-TARGET, evaluated the efficacy and safety of two subcutaneous sarilumab doses versus placebo, added to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy in RA patients who were inadequate responders to or intolerant of TNF-alpha inhibitors (TNF-IR).

The SARIL-RA-TARGET trial enrolled 546 TNF-IR patients who were randomized to one of three treatment groups self-administered subcutaneously (SC) every other week (Q2W): sarilumab 200 milligrams (mg), sarilumab 150 mg, or placebo, in addition to DMARD therapy. Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in both co-primary endpoints (p greater than 0.001):

(1) Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20 percent improvement (ACR20), were as follows: 61 percent in the sarilumab 200 mg group; 56 percent in the sarilumab 150 mg group; and 34 percent in the placebo group, all in combination with DMARD therapy.

(2) Improvement in physical function, as measured by change from baseline in the Health Assessment Question-Disability Index (HAQ-DI) at week 12.

The most frequently reported adverse events included infections (30, 22 and 27 percent in the 200 mg, 150 mg and placebo groups respectively) and injection site reactions (8, 7, 1 percent in the 200 mg, 150 mg and placebo groups respectively). Serious infections were uncommon (1, 0.6 and 1 percent in the 200 mg, 150 mg and placebo groups respectively). Reduction in neutrophil count was the most common lab abnormality. No unexpected safety findings were observed.

Two additional trials from the Phase 3 program, SARIL-RA-EASY and SARIL-RA-ASCERTAIN, also met their primary endpoints:

SARIL-RA-EASY enrolled 217 patients and was designed to evaluate the technical performance and usability of the sarilumab autoinjector device. There were no product technical failures with the autoinjector, the primary endpoint of the study.
SARIL-RA-ASCERTAIN was a 202 patient safety calibrator study, designed to assess the safety of two subcutaneous doses of sarilumab and tocilizumab infusion in combination with DMARDs in patients with RA who were TNF-IR. There were no clinically meaningful differences between the treatment groups in serious adverse events and serious infections.
Detailed results from all three SARIL-RA trials will be presented at future medical congresses.
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Source: press release, 5/21/15. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=914294

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