Regeneron Pharmaceuticals

Tarrytown, NY, United States

Regeneron Pharmaceuticals

Tarrytown, NY, United States
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MAIN, GERMANY / ACCESSWIRE / July 24, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=REGN. The Company and Sanofi (NYSE: SNY) announced on July 21, 2017, that European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the marketing authorization of their drug Dupixent® (Dupilumab). The committee has recommended its license for use in adults who suffer from moderate-to-severe atopic dermatitis (AD) and are candidates for systemic therapy. Dupixent® is the first investigational targeted biologic in the EU to receive positive CHMP's opinion for atopic dermatitis. For immediate access to our complimentary reports, including today's coverage, register for free now at: At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on REGN and SNY. Go directly to your stock of interest and access today's free coverage at: AD, also known as atopic eczema is a form of eczema, a chronic inflammatory disease with symptoms such as a rash on the skin. In cases of moderate to severe AD, patients get rashes on most parts of their body, with extreme, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itchiness is the most troublesome symptom that can severely weaken patients. At times, people with moderate to severe AD also show symptoms of disrupted sleep, increased anxiety, and depression. In the United Kingdom, nearly 1.5 million (i.e. 3%) adults have AD. Within UK's population, it is assessed that there are about 14 adults per 100,000 with moderate AD and 6 adults per 100,000 with severe AD who may be eligible for treatment with Dupixent®. Dupixent® is an investigational fully human monoclonal antibody that has been specially designed to restrain overactive signaling of two key proteins IL-4 and IL-13. IL-4 and IL-13 are the main drivers of the inflammation in AD. Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi, are jointly developing Dupixent®. If this drug is approved, it will be available in a pre-filled syringe for self-administration by a patient. It is to be taken as a subcutaneous injection every other week after an initial loading dose. It can be used with or without topical corticosteroids. In the US, Dupixent® has been approved for the treatment of adults who have moderate to severe AD and whose disease is not properly controlled by topical prescription therapies, or in cases when those therapies are not advisable. Some views from the industry Dr. Mahreen Ameen, consultant dermatologist, Royal Free London NHS Foundation Trust stated that people suffering from AD live with a life-long condition that has intolerable symptoms impacting all aspects of their lives. He mentioned that doctors have had very few options to treat patients with this disease until now. He believes if Dupixent® is approved, it will be a greatly welcomed treatment option. Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme also had a similar opinion. He agreed that AD is a disease that can have a detrimental impact on a person's quality of life, causing physical discomfort and often emotional distress. He applauded CHMP's positive recommendation for Dupixent®. He said it is an important step for introducing an innovative treatment option for patients who are suffering from AD. Going by the common trend, the European Commission's (EC) final decision on the Marketing Authorization Application (MAA) for Dupixent® in the European Union is expected in the coming months. The CHMP's opinion is based on studies from the global LIBERTY AD clinical trial program, which includes SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS, and CAFÉ. These studies have included data from approximately 3,000 adult patients who had moderate to severe AD that was not properly controlled by topical prescription therapies or immunosuppressants such as cyclosporine, or in cases when those therapies were not advisable. In clinical trials, the common side effects noted were injection site reactions, viral infections such as herpes affecting the mouth, dry eye, and similar symptoms affecting the eye. On March 14, 2017, UK's Medicines and Healthcare Products Regulatory Agency (MHRA) had also granted Dupixent® a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). It is expected that Dupixent® will become a differentiator and an important growth driver for Regeneron Pharma and Sanofi in the coming times. Regeneron Pharma is a prominent biotechnology Company that invents life-transforming medicines for people with serious diseases. Physician-scientists founded it about 30 years ago. Its unique capability to unswervingly translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in their laboratories. The Company produces medicines to cure patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases as well as rare diseases. Sanofi is a leading healthcare Company that discovers, develops, and distributes therapeutic solutions focused on patients' varied needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular; General Medicines and Emerging Markets; Sanofi Genzyme; Sanofi Pasteur; and Consumer Healthcare. Of these, Sanofi Genzyme emphasizes on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. At the closing bell, on Friday, July 21, 2017, Regeneron Pharma's stock slipped 1.00%, ending the trading session at $515.92. A total volume of 617.66 thousand shares have exchanged hands. The Company's stock price skyrocketed 39.39% in the last three months, 42.30% in the past six months, and 32.45% in the previous twelve months. Moreover, the stock soared 40.54% since the start of the year. The stock is trading at a PE ratio of 62.07 and currently has a market cap of $54.85 billion.On Friday, July 21, 2017, the stock closed the trading session at $47.71, slightly down 0.73% from its previous closing price of $48.06. A total volume of 941.58 thousand shares have exchanged hands. Sanofi's stock price surged 8.21% in the last three months, 18.24% in the past six months, and 13.87% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have rallied 17.98%. The stock is trading at a PE ratio of 23.04 and has a dividend yield of 3.44%. At Friday's closing price, the stock's net capitalization stands at $121.23 billion. Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. PRO-TD, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. PRO-TD, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, PRO-TD, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither PRO-TD nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://protraderdaily.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute. MAIN, GERMANY / ACCESSWIRE / July 24, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=REGN. The Company and Sanofi (NYSE: SNY) announced on July 21, 2017, that European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the marketing authorization of their drug Dupixent® (Dupilumab). The committee has recommended its license for use in adults who suffer from moderate-to-severe atopic dermatitis (AD) and are candidates for systemic therapy. Dupixent® is the first investigational targeted biologic in the EU to receive positive CHMP's opinion for atopic dermatitis. For immediate access to our complimentary reports, including today's coverage, register for free now at: At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on REGN and SNY. Go directly to your stock of interest and access today's free coverage at: AD, also known as atopic eczema is a form of eczema, a chronic inflammatory disease with symptoms such as a rash on the skin. In cases of moderate to severe AD, patients get rashes on most parts of their body, with extreme, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itchiness is the most troublesome symptom that can severely weaken patients. At times, people with moderate to severe AD also show symptoms of disrupted sleep, increased anxiety, and depression. In the United Kingdom, nearly 1.5 million (i.e. 3%) adults have AD. Within UK's population, it is assessed that there are about 14 adults per 100,000 with moderate AD and 6 adults per 100,000 with severe AD who may be eligible for treatment with Dupixent®. Dupixent® is an investigational fully human monoclonal antibody that has been specially designed to restrain overactive signaling of two key proteins IL-4 and IL-13. IL-4 and IL-13 are the main drivers of the inflammation in AD. Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi, are jointly developing Dupixent®. If this drug is approved, it will be available in a pre-filled syringe for self-administration by a patient. It is to be taken as a subcutaneous injection every other week after an initial loading dose. It can be used with or without topical corticosteroids. In the US, Dupixent® has been approved for the treatment of adults who have moderate to severe AD and whose disease is not properly controlled by topical prescription therapies, or in cases when those therapies are not advisable. Some views from the industry Dr. Mahreen Ameen, consultant dermatologist, Royal Free London NHS Foundation Trust stated that people suffering from AD live with a life-long condition that has intolerable symptoms impacting all aspects of their lives. He mentioned that doctors have had very few options to treat patients with this disease until now. He believes if Dupixent® is approved, it will be a greatly welcomed treatment option. Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme also had a similar opinion. He agreed that AD is a disease that can have a detrimental impact on a person's quality of life, causing physical discomfort and often emotional distress. He applauded CHMP's positive recommendation for Dupixent®. He said it is an important step for introducing an innovative treatment option for patients who are suffering from AD. Going by the common trend, the European Commission's (EC) final decision on the Marketing Authorization Application (MAA) for Dupixent® in the European Union is expected in the coming months. The CHMP's opinion is based on studies from the global LIBERTY AD clinical trial program, which includes SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS, and CAFÉ. These studies have included data from approximately 3,000 adult patients who had moderate to severe AD that was not properly controlled by topical prescription therapies or immunosuppressants such as cyclosporine, or in cases when those therapies were not advisable. In clinical trials, the common side effects noted were injection site reactions, viral infections such as herpes affecting the mouth, dry eye, and similar symptoms affecting the eye. On March 14, 2017, UK's Medicines and Healthcare Products Regulatory Agency (MHRA) had also granted Dupixent® a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). It is expected that Dupixent® will become a differentiator and an important growth driver for Regeneron Pharma and Sanofi in the coming times. Regeneron Pharma is a prominent biotechnology Company that invents life-transforming medicines for people with serious diseases. Physician-scientists founded it about 30 years ago. Its unique capability to unswervingly translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in their laboratories. The Company produces medicines to cure patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases as well as rare diseases. Sanofi is a leading healthcare Company that discovers, develops, and distributes therapeutic solutions focused on patients' varied needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular; General Medicines and Emerging Markets; Sanofi Genzyme; Sanofi Pasteur; and Consumer Healthcare. Of these, Sanofi Genzyme emphasizes on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. At the closing bell, on Friday, July 21, 2017, Regeneron Pharma's stock slipped 1.00%, ending the trading session at $515.92. A total volume of 617.66 thousand shares have exchanged hands. The Company's stock price skyrocketed 39.39% in the last three months, 42.30% in the past six months, and 32.45% in the previous twelve months. Moreover, the stock soared 40.54% since the start of the year. The stock is trading at a PE ratio of 62.07 and currently has a market cap of $54.85 billion.On Friday, July 21, 2017, the stock closed the trading session at $47.71, slightly down 0.73% from its previous closing price of $48.06. A total volume of 941.58 thousand shares have exchanged hands. Sanofi's stock price surged 8.21% in the last three months, 18.24% in the past six months, and 13.87% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have rallied 17.98%. The stock is trading at a PE ratio of 23.04 and has a dividend yield of 3.44%. At Friday's closing price, the stock's net capitalization stands at $121.23 billion. Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. PRO-TD, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. PRO-TD, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, PRO-TD, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither PRO-TD nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://protraderdaily.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.


Thurston G.,Regeneron Pharmaceuticals | Daly C.,Regeneron Pharmaceuticals
Cold Spring Harbor Perspectives in Medicine | Year: 2012

The angiopoietin-Tie signaling system is a vascular-specific receptor tyrosine kinase pathway that is essential for normal vascular development. Although the basic functioning of the pathway is understood, many uncertainties remain about the role of certain members of the pathway, particularly angiopoietin-2 (Ang2), in pathological vascular remodeling and angiogenesis. We summarize the components of the angiopoietin-Tie pathway and then focus on studies that highlight the role of Ang2 in disease settings, including cancer and inflammation. The expression of Ang2 is elevated in many cancers and types of inflammation, which prompted the development of specific reagents to block its interaction with the Tie2 receptor. The application of these reagents in preclinical models of inflammation and cancer has begun to elucidate the role of Ang2 in vascular remodeling and disease pathogenesis and has led to emerging clinical tests of Ang2 inhibitors. © 2012 Cold Spring Harbor Laboratory Press.


Patent
Regeneron Pharmaceuticals, Institute For Research In Biomedicine Irb and Yale University | Date: 2013-11-05

Genetically modified non-human animals are provided that may be used to model human hematopoietic cell development, function, or disease. The genetically modified non-human animals comprise a nucleic acid encoding human IL-6 operably linked to an IL-6 promoter. In some instances, the genetically modified non-human animal expressing human IL-6 also expresses at least one of human M-CSF, human IL-3, human GM-CSF, human SIRPa or human TPO. In some instances, the genetically modified non-human animal is immunodeficient. In some such instances, the genetically modified non-human animal is engrafted with healthy or diseased human hematopoietic cells. Also provided are methods for using the subject genetically modified non-human animals in modeling human hematopoietic cell development, function, and/or disease, as well as reagents and kits thereof that find use in making the subject genetically modified non-human animals and/or practicing the subject methods.


Patent
Regeneron Pharmaceuticals, Institute For Research In Biomedicine Irb and Yale University | Date: 2013-10-14

A mouse with a humanization of the mIL-3 gene and the mGM-CSF gene, a knockout of a mRAG gene, and a knockout of a mIl2rg subunit gene; and optionally a humanization of the TPO gene is described. A RAG/Il2rg KO/hTPO knock-in mouse is described. A mouse engrafted with human hematopoietic stem cells (HSCs) that maintains a human immune cell (HIC) population derived from the HSCs and that is infectable by a human pathogen, e.g., S. typhi or M. tuberculosis is described. A mouse that models a human pathogen infection that is poorly modeled in mice is described, e.g., a mouse that models a human mycobacterial infection, wherein the mouse develops one or more granulomas comprising human immune cells. A mouse that comprises a human hematopoietic malignancy that originates from an early human hematopoietic cells is described, e.g., a myeloid leukemia or a myeloproliferative neoplasia.


TARRYTOWN, N.Y. and CAMBRIDGE, Mass., Feb. 27, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that detailed results from the Phase 3 CHRONOS study will be presented as a late-breaking abstract at this year's Annual Meeting of the American...


News Article | March 1, 2017
Site: www.prnewswire.com

NEW YORK, Feb. 28, 2017 /PRNewswire/ -- Summary This report provides all the information you require to better understand Regeneron Pharmaceuticals and its partnering interests and activities since 2010.Read the full report:...


CAMBRIDGE, Mass. and TARRYTOWN, N.Y., Feb. 27, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced that detailed results from the Phase 3 CHRONOS study will be presented as a late-breaking abstract at this year's Annual Meeting of the American Academy of...


News Article | February 21, 2017
Site: globenewswire.com

MENLO PARK, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq:ADVM) a gene therapy company committed to discovering and developing novel medicines for patients suffering from diseases with few or burdensome treatment options, announced today that Amber Salzman, Ph.D., president and chief executive officer of Adverum, will present at two upcoming investor conferences: The audio portions of the corporate presentations will be accessible live through the investors’ section of the Company’s website at www.adverum.com. A replay will be available for 14 days following the presentations. About Adverum Biotechnologies, Inc. Adverum is a gene therapy company committed to discovering and developing novel medicines that can offer life-changing benefits to patients living with rare diseases or diseases of the eye who currently have limited or burdensome treatment options. Adverum has a robust pipeline that includes product candidates to treat wet age-related macular degeneration (wAMD), alpha-1 antitrypsin (A1AT) deficiency, and hereditary angioedema (HAE).  Leveraging a next-generation adeno-associated virus (AAV)-based directed evolution platform, the Company generates product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum has collaboration agreements with Regeneron Pharmaceuticals to research, develop, and commercialize gene therapy products for ophthalmic diseases and Editas Medicine to explore the delivery of genome editing medicines for the treatment of inherited retinal diseases. Adverum has clinical development expertise and core capabilities in vector optimization, process development, manufacturing, and assay development. For more information please visit www.adverum.com.


Sanofi and Regeneron Announce Praluent® (alirocumab) Cardiovascular Outcomes Trial will Continue as Planned Following Interim Analysis - ODYSSEY OUTCOMES trial1 is designed to prospectively assess the effect of Praluent on cardiovascular events in high-risk patients - Paris, France and Tarrytown, New York - November 17, 2016 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the ongoing Praluent® (alirocumab) ODYSSEY OUTCOMES trial will continue as planned, based on the recommendation of an independent Data Monitoring Committee (DMC) after it completed a second pre-specified interim analysis. The DMC will continue to monitor the ongoing safety and efficacy of Praluent as planned. The Phase 3, multi-center, randomized, double-blind, placebo-controlled ODYSSEY OUTCOMES trial involves more than 18,000 patients from 57 countries. All patients who entered the trial had experienced a heart attack or unstable angina requiring hospitalization within a year of entering the trial, and were unable to control their LDL cholesterol despite receiving maximally-tolerated statins and potentially other lipid-lowering therapies. Patients receiving maximally-tolerated statin therapy were randomized to receive either Praluent 75 milligrams (mg) every two weeks or placebo. Patients on Praluent had their dose increased to 150 mg every two weeks at week 8 if their LDL cholesterol remained above 50 milligrams/deciliter (mg/dL).1 About Praluent Praluent is a human monoclonal antibody that inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL cholesterol levels in the blood. Praluent is the only PCSK9 inhibitor available in two dosages with two levels of efficacy (75 mg and 150 mg), allowing physicians to select the dose based on a patient's LDL cholesterol lowering needs. Praluent is currently approved in approximately 40 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). In the U.S., Praluent is approved for use as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol. In the E.U., Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on CV morbidity and mortality has not yet been determined. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. About Sanofi Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized 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 that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer 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 regarding the marketing and other potential of Praluent, or regarding potential future revenues from Praluent. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of Praluent; the absence of guarantee that Praluent will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to Praluent, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation, volatile economic conditions, and the impact of cost containment initiatives and subsequent changes thereto, as well as those risks 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. Regeneron Forward-Looking Statements and Use of Digital Media This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation Praluent® (alirocumab) Injection; unforeseen safety issues and possible liability resulting from the administration of products (including without limitation Praluent) and product candidates in patients; serious complications or side effects in connection with the use of Regeneron's products and product candidates in clinical trials, such as the ODYSSEY OUTCOMES trial discussed in this news release, which is prospectively assessing the potential of Praluent to demonstrate cardiovascular benefit; the timing of completion of the ODYSSEY OUTCOMES trial; coverage and reimbursement determinations by third-party payers, including Medicare, Medicaid, and pharmacy benefit management companies; ongoing regulatory obligations and oversight impacting Regeneron's marketed products (such as Praluent), research and clinical programs, and business, including those relating to the enrollment, completion, and meeting of the relevant endpoints of post-approval studies (such as the ODYSSEY OUTCOMES trial); determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates; risks associated with intellectual property of other parties and pending or future litigation relating thereto; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; and the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare LLC (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2015 and its Form 10-Q for the quarterly period ended September 30, 2016. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).


News Article | February 15, 2017
Site: www.businesswire.com

NEW YORK--(BUSINESS WIRE)--In its latest Cardiology Report, BioPharm Insight (BPI) reported that Amgen’s Repatha Phase III FOURIER trial will be deemed successful by experts if it shows a 35% reduction in major cardiovascular events (MACE). The report from BPI, the most comprehensive life science news and analytical solution, highlights recent editorial coverage of cardiology therapies in development that have potentially market-moving clinical events expected in the next few months. It also provides analysis of sales forecasts and licensing deals. “Amgen’s announcement at the start of February that it met its primary and key secondary composite endpoints was a hugely anticipated event for a drug predicted to have peak sales in excess of $7 billion,” said Peter Murphy, BPI senior editorial analyst. Amgen management has reiterated the cardiovascular outcomes trial (CVOT) trial is powered to show a 15% risk reduction but did not provide further details on FOURIER outcomes, which the market widely expects could be a game-changer for the lipid-lowering treatment space. While equity analysts think a 20% reduction has been hit, experts BPI spoke to said that anything lower than a 35% MACE reduction may mean that the cost outweighs the treatment benefit. “Although Amgen’s news has significant implications for the entire PCSK9-inhibitor class, experts expect to see similar results between Repatha and its competitor Praluent,” said BPI reporter Alexandra Thompson. Amgen’s (NASDAQ:AMGN) Repatha and Praluent, from Sanofi (EPA:SAN) and Regeneron Pharmaceuticals (NASDAQ:REGN), were approved within one month of each other in 2015 and are currently the only two anti-PCSK9s on the market. BPI reports, though, that so far physicians and payers alike are not satisfied that PCSK9 inhibitors successfully lower LDL-c (bad cholesterol) levels. The market is looking for evidence that the reduction in LDL also drives a reduction in the likelihood of patients suffering potentially catastrophic cardiovascular events. Praluent’s Phase III CVOT is due in late 2017, and Alnylam Therapeutics (NASDAQ:ALNY)/The Medicines Company’s (NASDAQ:MDCO)/inclisiran is due to start its own Phase III trials soon. BPI’s Cardiology Report also highlights articles covering experts’ dubious expectations for Merck’s (NYSE:MRK) hypercholesterolemia drug anacetrapib’s Phase III CV trial following termination of three drugs of the same CETP inhibitor class. Pfizer’s (NYSE:PFE) torcetrapib, Roche’s (VTX:ROG) dalcetrapib and Eli Lilly’s (NYSE:LLY) evacetrapib all suffered high-profile clinical trial failures over the past decade. Additionally, the report offers insights on several ongoing therapies under development to prevent heart failure (HF), including Novartis’ (VTX:NOVN) Entresto (sacubitril/valsartan) and Mesoblast’s (ASX:MSB) MPC-150-IM. The perforation risk of MPC-150-IM’s transendocardial delivery could possibly limit its administration to specialized cardiology cell injection centers or warrant cardiologist training, but the significant positive outcomes of the earlier Phase II trial have analysts optimistic, forecasting peak sales of the HF therapy to be $5.2 billion if successful. Learn more about expected market catalyst events in Cardiology Indications with BioPharm Insight’s full report: BioPharm Insight is the most comprehensive life science market intelligence and analytics solution, featuring a team of investigative journalists writing exclusive news and thousands of healthcare data points, aggregated into one centralized source. In addition to the proprietary articles, BioPharm Insight is currently tracking 250,000 management and R&D contacts, 7,500 biopharma companies with full pipeline data, 120,000 investigational and approved drug profiles, 28,000 M&A and licensing deals, 10,000 extended sales forecasts and epidemiology profiles for hundreds of indications.

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