Blog Coverage EMA’s Committee for Medicinal Products for Human Use Provides Positive Opinion for the Marketing Authorization of Amgen’s ABP 501

Upcoming AWS Coverage on Alexion Pharmaceuticals Post-Earnings Results

LONDON, UK / ACCESSWIRE / January 30, 2017 / Active Wall St. blog coverage looks at the headline from Amgen Inc. (NYSE: AMGN) as the Company announced on January 27, 2017, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 501. Register with us now for your free membership and blog access at:

http://www.activewallst.com/register/

One of Amgen’s competitors within the Biotechnology space, Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN), announced on January 26, 2017, that it will report its financial results for Q4 and full year ended December 31, 2016 on Thursday, February 16, 2017 before the US financial markets open. Following the release of the financial results, Alexion’s management will hold a conference call and audio webcast on Thursday, February 16, 2017, at 10:00 a.m. ET. AWS will be initiating a research report on Alexion Pharma in the coming days.

Today, AWS is promoting its blog coverage on AMGN; touching on ALXN. Get all of our free blog coverage and more by clicking on the links below:

http://www.activewallst.com/registration-3/?symbol=AMGN

http://www.activewallst.com/registration-3/?symbol=ALXN

Approval for Available Indications

Amgen stated that CHMP has recommended ABP 501 for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. The CHMP opinion also recommends approval for the treatment of certain paediatric inflammatory diseases, including moderate-to-severe Crohn’s disease, severe chronic plaque psoriasis, enthesitis-related arthritis and polyarticular juvenile idiopathic arthritis.

“The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU,” said Sean E. Harper, M.D., Executive Vice President of Research and Development at Amgen, “This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”

Backed By Trial

The Marketing Authorization Application (MAA) submission for ABP 501 was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, pharmacokinetic and clinical data, including results from two Phase-3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. Amgen in the press release noted that the Phase-3 studies each met their primary endpoint showing no clinically meaningful differences to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.

Way Forward

CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland, and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC. ABP 501 was approved in the United States by the US Food and Drug Administration (FDA) on September 23, 2016, and is known by the brand name AMJEVITA™ (adalimumab-atto).

About ABP 501

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. AMJEVITA will be delivered in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.

Stock Performance

At the closing bell, on Friday, January 27, 2017, Amgen’s stock rose 2.73%, ending the trading session at $157.16. A total volume of 4.88 million shares were traded at the end of the day, which was higher than the 3-month average volume of 4.21 million shares. In the last month and previous twelve months, shares of the Company have advanced 5.93% and 8.73%, respectively. Moreover, the stock gained 7.49% since the start of the year. The stock is trading at a PE ratio of 15.70 and has a dividend yield of 2.93%.

Earnings Alerts: Amgen will hold a conference call on February 02, 2017 at 2:00 PM PT to discuss its Q4 2016 financial results.

Active Wall Street:

Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS 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.

AWS has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

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 info@activewallst.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 AWS. AWS 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.

NO WARRANTY

AWS, 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. AWS, 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, AWS, 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.

NOT AN OFFERING

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 AWS 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://www.activewallst.com/disclaimer/

CONTACT

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:

Email: info@activewallst.com

Phone number: 1-858-257-3144

Office Address: 3rd floor, 207 Regent Street, London, W1B 3HH, United Kingdom

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Active Wall Street

ReleaseID: 453793