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Regeneron Pharmaceuticals, Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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George D. Yancopoulos, M.D., Ph.D., CSO, gave guidance for the data from the Fasinumab (REGN475) phase-II/III trial for osteoarthritis. He stated, "Blocking NGF has already shown the ability to improve pain compared to placebo or an active comparator such as nonsteroidal anti-inflammatory drugs or NSAIDs in phase-II and phase-III trials. We now have a clear path forward from the FDA and will be starting a 10,000-pateint long-term treatment phase-III clinical study of Fasinumab in the first half of the year. We anticipate reporting data from a 16-week study in osteoarthritis pain in the first half of the year."
Source: Q4 2015 earnings conference call, 2/09/16.

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A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Enrollment: 421
Study Start Date: May 2015
Estimated Study Completion Date: November 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02447276?term=regn475&rank=5

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Fasinumab (REGN475)RheumatologyPain management (OA)NGF inhibitorNerve growth factor (NGF)

Mechanism of action: Fasinumab (REGN475) is an antibody against nerve growth factor (NGF), a novel target for the treatment of pain. Recently, studies have shown that nerve growth factor (NGF) is a major mediator of inflammatory and neuropathic pain. Although originally discovered as a trophic factor for sympathetic and sensory neurons during development, it now appears that in adults, levels of NGF are elevated in many acute and chronic pain conditions. The molecular mechanisms involved are being elucidated.

Phase of Development: II/III

Event Type: Data: Phase II/III trial results

Dates: 2016-03-01 - 2016-06-30

Results:

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Regeneron and Teva Provide Update on Fasinumab Clinical Development Programs
TARRYTOWN, N.Y. and JERUSALEM, Oct. 17, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today provided an update on fasinumab, triggered by a recent development in a Phase 2b fasinumab study in patients with chronic low back pain. Fasinumab is an investigational Nerve Growth Factor (NGF) antibody in clinical development for osteoarthritis pain and chronic low back pain.

Chronic Low Back Pain Program Update
The U.S. Food and Drug Administration (FDA) has placed the Phase 2b study in chronic low back pain on clinical hold and requested an amendment of the study protocol after observing a case of adjudicated arthropathy in a patient receiving high dose fasinumab who had advanced osteoarthritis at study entry. As a result of the FDA decision, Regeneron completed an unplanned interim review of results and has stopped dosing in the study. The unplanned analysis showed clear evidence of efficacy with improvement in pain scores in all fasinumab groups compared to placebo at the 8- and 12-week time points (nominal p less than 0.01). Preliminary safety results are generally consistent with what has been previously reported with the class. The Phase 2b chronic low back pain study enrolled approximately 70 percent of the targeted 800 patients in four dose groups: placebo, 6mg subcutaneously monthly, 9mg subcutaneously monthly and 9mg intravenously every two months. Regeneron has notified health authorities and study investigators about the decision. Patients will continue to be followed for up to 36 weeks.

Based on these results, Regeneron and Teva plan to design a pivotal Phase 3 study in chronic low back pain that excludes patients with advanced osteoarthritis. The companies plan to submit a pivotal program plan for review with the FDA and other health authorities.

Osteoarthritis Pain Program Update
Sixteen week positive results from the fasinumab Phase 2/3 osteoarthritis pain study in 421 patients were previously reported. Patients received their last dose at 12 weeks and a follow-up analysis occurred at 36 weeks. The study incorporated extensive imaging and analyses at baseline and during the study of index and non-index joints, with particular focus on arthropathies including subchondral insufficiency fractures (SIF), osteonecrosis (ON) and rapidly progressive osteoarthritis (RPOA). At the 36-week analysis, the incidence of adjudicated arthropathies was found to be potentially dose-dependent, with a higher rate of patients experiencing arthropathies in the higher dose groups [12 percent (9mg), 7 percent (6mg), 5 percent (3mg), 2 percent (1mg) and 1 percent (placebo)]. Based on these data, the companies are planning to advance only lower doses in the ongoing fasinumab osteoarthritis pivotal Phase 3 program, subject to discussion with the FDA and other health authorities.

Updated data from the osteoarthritis pain Phase 2/3 study and the chronic low back pain Phase 2b study will be presented at upcoming medical congresses.

"We are making data-driven decisions on Phase 3 fasinumab dosing that we believe will maximize potential benefit for patients in need, while minimizing the likelihood of side effects," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. "We look forward to working with global health authorities to advance this important investigational therapy for patients with often difficult-to-treat osteoarthritis pain and chronic low back pain."

"We believe fasinumab represents an important potential innovation for patients with osteoarthritis pain and chronic low back pain who currently have clear unmet need and limited treatment options," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. "We look forward to advancing clinical development for this promising novel therapy."

Regeneron and Teva are collaborating on the global development and commercialization of fasinumab. Under a separate agreement with Regeneron, Mitsubishi Tanabe Pharma has exclusive development and commercial rights to fasinumab in Japan, Korea and nine other Asian countries.
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Source: press release, 10/17/16. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=993787

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Regeneron Announces Positive Topline Results from Phase 2/3 Fasinumab Study in Patients with Osteoarthritis Pain
TARRYTOWN, N.Y., May 2, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a placebo-controlled Phase 2/3 study evaluating fasinumab in patients with moderate-to-severe osteoarthritis pain of the hip or knee who have a history of inadequate pain relief or intolerance to current analgesic therapies. At 16 weeks, patients treated with all four doses of fasinumab, an investigational Nerve Growth Factor (NGF) antibody, demonstrated a statistically significant improvement in pain relief, the primary endpoint of the study, as well as improvements in the secondary measure evaluating physical function.

"Chronic osteoarthritis is a common cause of pain, disability, and productivity loss for older adults," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "There is a real need for new, non-opioid pain therapies that can provide relief to patients without the toxicity and potential for abuse of currently available opioid treatments. We had previously evaluated an intravenous formulation of fasinumab in osteoarthritis patients, and this is our first trial of a convenient subcutaneous monthly regimen. We look forward to continuing to study the safety and efficacy of fasinumab in our Phase 3 program."

The U.S. study enrolled 421 adult patients with moderate-to-severe osteoarthritis of the hip or knee who had a history of inadequate pain relief or intolerance to acetaminophen, and at least one oral nonsteroidal anti-inflammatory drug (NSAID) and an opioid. Patients in the study were experiencing significant pain at baseline with an average pain score of 6.3 on a 10-point scale. Patients were evaluated for pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in addition to other measures. Patients were randomized to one of five treatment groups in a 1:1:1:1:1 fashion: fasinumab 1mg, 3mg, 6mg, 9mg, or placebo, all delivered subcutaneously every 4 weeks through week 12, with the primary efficacy measured at week 16. Following week 16, patients are being studied for an additional 20 weeks off treatment.

On the primary endpoint, fasinumab-treated patients reported less pain at 16 weeks when compared to placebo on the 10-point WOMAC subscale for pain. Results for each of the dose groups are noted below.

Table: http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=968327

The safety analysis includes all results at the time of the primary efficacy analysis; complete data will be reported when all patients complete the full 36 weeks. Overall incidence of adverse events, including serious and severe events, was similar across the fasinumab groups and placebo. As expected with antibodies to NGF, there was an increase in certain neuro-musculoskeletal adverse events in the fasinumab treatment groups (17 percent combined fasinumab; 6 percent placebo) including arthralgia, paraesthesia, hypoaesthesia, and peripheral edema.

Because of prior concerns with other anti-NGF therapies regarding the possible risk of joint damage, the study incorporated extensive imaging and analyses at baseline and during the study, of index and non-index joints, with particular focus on subchondral insufficiency fractures (SIF), osteonecrosis (ON) and rapidly progressive osteoarthritis (RPOA). Approximately 2 percent of screened subjects were excluded from participation based on findings of SIF or ON on baseline imaging exams. During the study period there were no cases of ON, there was 1 case of SIF in placebo, 0, 2, 0 and 4 cases of SIF in the 1mg, 3mg, 6mg, and 9mg fasinumab dose groups respectively, and 1 case of RPOA in each of the 3mg, 6mg, and 9mg fasinumab dose groups. A modest increase in the lab value for bone-specific alkaline phosphatase, a marker of osteoblast activity, was noted in fasinumab-treated patients; there was no increase in liver ALT and AST enzymes.

The company plans to present detailed results at an upcoming medical congress.
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Source: press release, 5/02/16. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=968327

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