regeneron pharmaceuticals (REGN) Key Developments
Regeneron Pharmaceuticals Inc. Announces Updates on Phase 3 Study of Sarilumab
May 21 15
Regeneron Pharmaceuticals Inc. announced 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): Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20% improvement (ACR20), were as follows: 61% in the sarilumab 200 mg group; 56% in the sarilumab 150 mg group; and 34% in the placebo group, all in combination with DMARD therapy.
Regeneron and Sanofi Announce Positive Pivotal Phase 2b Dupilumab Data in Asthma Presented at the American Thoracic Society 2015 International Conference
May 18 15
Regeneron Pharmaceuticals, Inc. and Sanofi shared positive results from an interim analysis of a pivotal Phase 2b study of dupilumab in adult patients with moderate-to-severe asthma, who are uncontrolled despite treatment with inhaled corticosteroids and long-acting beta agonists (ICS/LABA). As previously reported, the study met its primary endpoint of improving lung function in asthma patients with high blood eosinophil counts (HEos, greater than or equal to 300 eosinophilic cells/microliter). Such high counts are thought to be a marker for patients more likely to have "atopic" or "allergic" asthma. New data presented on secondary endpoints at the American Thoracic Society 2015 International Conference included positive results in study patients with low blood eosinophil counts (LEos, less than 300 eosinophilic cells/microliter), who are thought to be less likely to suffer from "allergic" asthma and thus less likely to respond to TH2 targeted therapies. Dupilumab is an investigational therapy that inhibits signaling of IL-4 and IL-13, two cytokines required for the TH2 (or Type 2) immune response. Based on discussions with the U.S. Food and Drug Administration (FDA), this Phase 2b study may be considered one of two pivotal efficacy studies required for a potential dupilumab biologics license application (BLA) in asthma. The companies also announced the initiation of a Phase 3 clinical trial of dupilumab in patients with uncontrolled persistent asthma, known as LIBERTY ASTHMA QUEST, which will serve as the second required pivotal efficacy study. The global, placebo-controlled Phase 3 study will enroll more than 1,600 patients with uncontrolled persistent asthma and will evaluate two doses of dupilumab, 200 milligrams (mg) and 300 mg, subcutaneously administered every other week (Q2W). The new results focused on LEos asthma patients. In this population, patients treated with either 200 mg or 300 mg Q2W doses of dupilumab showed a greater than 8% improvement in forced expiratory volume over one second (FEV1, a standard measure of lung function) at Week 12 (p less than 0.001), in comparison to placebo, both in combination with ICS/LABA. Additionally, the 200 mg and 300 mg Q2W doses of dupilumab in combination with ICS/LABA showed 68% and 62% reductions, respectively, in adjusted annualized rate of severe exacerbations in the LEos population (p less than 0.01 and p less than 0.05), in comparison to placebo in combination with ICS/LABA. These results are consistent with previously reported positive results in HEos asthma patients and the overall patient population, in which the two Q2W doses (200 mg and 300 mg) of dupilumab in combination with ICS/LABA demonstrated a statistically significant 12 to 15% improvement in FEV1 over placebo at Week 12 and a 64 to 75% improvement in annualized rate of severe exacerbations over placebo. Dupilumab also significantly reduced mean fractional exhaled nitric oxide (FeNO) across both Q2W doses tested (200 and 300 mg) and the three patient populations (overall, LEos and HEos), in a roughly dose-dependent manner. FeNO is recommended by the American Thoracic Society clinical practice guidelines to assess airway inflammation, since higher than normal levels of nitric oxide may be released when a patient has a chronic airway disease, such as asthma. The most common adverse event was injection site reaction, which was more frequent in the dupilumab dose groups (13 to 25%) compared to placebo (12%). Other common adverse events in the study included upper respiratory tract infection (10 to 13% dupilumab; 13% placebo), headache (5 to 10% dupilumab; 8% placebo), nasopharyngitis (3 to 10% dupilumab; 6% placebo) and bronchitis (5 to 8% dupilumab; 8% placebo). The incidence of infections was balanced across treatment groups (42 to 45% dupilumab; 46% placebo), as was the incidence of serious adverse events (3 to 7% dupilumab; 5% placebo).
Regeneron Pharmaceuticals, Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Updates Financial Guidance for the Full Year 2015
May 7 15
Regeneron Pharmaceuticals, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company announced net product sales were $545 million compared to $362 million in the first quarter of 2014. Total revenues increased by 39% to $870 million compared to $626 million in the first quarter of 2014. The Company reported non-GAAP net income of $336 million, or $3.28 per basic share and $2.88 per diluted share compared to non-GAAP net income of $263 million, or $2.66 per basic share and $2.26 per diluted share, in the first quarter of 2014. The Company reported GAAP net income of $76 million, or $0.74 per basic share and $0.66 per diluted share, compared to GAAP net income of $68 million, or $0.69 per basic share and $0.61 per diluted share, in the first quarter of 2014. Income from operations was $283,553,000 compared to $191,562,000 in the first quarter of 2014. Income before income taxes was $276,523,000 compared to $180,886,000 in the first quarter of 2014. Total collaboration revenue was $297,202,000 compared to $255,820,000 in the first quarter of 2014. Collaboration revenues in the first quarter of 2015 increased primarily due to higher reimbursement of the Company's development expenses under its antibody collaboration with Sanofi and an increase in the Company's net profit from commercialization of EYLEA outside the United States, partly offset by the Company's share of antibody collaboration commercialization costs primarily related to Praluent. In addition, collaboration revenues in the first quarter of 2015 and 2014 included $15 million and $30 million, respectively, of sales milestones earned from Bayer HealthCare. Capital expenditures for the quarter were $114 million.
The company updated full year 2015 financial guidance. The company reaffirmed cash tax non-GAAP pre-tax income of 10% - 20%. Capital expenditures will be in the range of $650 million - $750 million compared to previous guidance of $650 million - $800 million. The company raising its guidance for the U.S. EYLEA net sales growth for the full year 2015 to 30% to 35% from the previously provided range of 25% to 30%.
Regeneron Pharmaceuticals, Inc. Presents at NewYork BIO 25th Anniversary Conference 2015, May-04-2015 through May-05-2015
May 4 15
Regeneron Pharmaceuticals, Inc. Presents at NewYork BIO 25th Anniversary Conference 2015, May-04-2015 through May-05-2015. Venue: Time Warner Center, New York, United States. Presentation Date & Speakers: May-05-2015, Alan Shuldiner, Vice President of Translational Genetics, Aris Baras, Co-Head, Regeneron Genetics Center, Larry Coury, Director, Dispute Resolution.
Regeneron Pharmaceuticals, Inc. Presents at Bank of America Merrill Lynch 2015 Health Care Conference, May-12-2015 11:20 AM
Apr 29 15
Regeneron Pharmaceuticals, Inc. Presents at Bank of America Merrill Lynch 2015 Health Care Conference, May-12-2015 11:20 AM. Venue: Encore at the Wynn, 3131 S Las Vegas Blvd, Las Vegas, Nevada, United States. Speakers: Leonard S. Schleifer, Co-Founder, Chief Executive Officer, President, Executive Director and Ex-Officio Member of Technology Committee.