Stock Monitor: SteadyMed Post Earnings Reporting
LONDON, UK / ACCESSWIRE / April 13, 2018 / Active-Investors.com has just released a free research report on Mylan N.V. (NASDAQ: MYL). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/'symbol=MYL as the Company's latest news hit the wire. On April 11, 2018, the Company announced that it will collaborate with Fujifilm Kyowa Kirin Biologics Co., Ltd to commercialize FKB327, a biosimilar to Humira® (adalimumab) developed by Fujifilm Kyowa Kirin Biologics. As per the agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe. Register today and get access to over 1,000 Free Research Reports by joining our site below:
www.active-investors.com/registration-sg
Active-Investors.com is currently working on the research report for SteadyMed Ltd (NASDAQ: STDY), which also belongs to the Healthcare sector as the Company Mylan. Do not miss out and become a member today for free to access this upcoming report at:
www.active-investors.com/registration-sg/'symbol=STDY
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Mylan most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
www.active-investors.com/registration-sg/'symbol=MYL
Terms of the Agreement
- Fujifilm Kyowa Kirin Biologics will grant Mylan an exclusive license to commercialize FKB327 in Europe.
- In addition to the up-front fee, Fujifilm Kyowa Kirin Biologics will receive a subsequent commercialization milestone payment and sales royalties. Other financial terms of the deal remain undisclosed.
- Mylan will be responsible for the sales activity of the product in European countries. The two companies continue to negotiate for commercializing the product in additional territories
Mylan's Expertise in Regulatory Commercialization with Fujifilm Kyowa Kirin Biologics' Scientific Expertise Will Benefit Patients across Europe
Dr. Yoshifumi Torii, President and CEO of Fujifilm Kyowa Kirin Biologics, stated that the Company is delighted that it has entered into partnership with Mylan for an adalimumab biosimilar, FKB327 in Europe. Dr. Yoshifumi added that the establishment of this agreement with Mylan attests to the value of Fujifilm Kyowa Kirin Biologics' proprietary technology in biosimilars space and Mylan's significant experience and expertise in regulatory commercialization with Fujifilm Kyowa Kirin Biologics' scientific expertise will ensure patients across Europe benefit from the treatment option.
EMA Accepted for Review the Marketing Authorization Application for FKB327
The European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for FKB327 on May 18, 2017. The companies expect to receive a decision from the EMA in the second half of 2018. In December 2014, Fujifilm Kyowa Kirin Biologics began a Phase-3 global clinical study of FKB327 at sites in the US, Europe, and other countries to compare the efficacy and safety profile of FKB327 with Humira® in patients with moderate to severe rheumatoid arthritis. In this study, FKB327 met the primary endpoint and prespecified criteria for equivalence, and there were no significant differences in the rate of adverse events between FKB327 and Humira®. Based on the top-line results, announced in October 2016, Fujifilm Kyowa Kirin Biologics decided to file the MAA for FKB327 to the EMA in April 2017.
About Fujifilm Kyowa Kirin Biologics
Established by FUJIFILM Corporation and Kyowa Hakko Kirin Co., Ltd in March 2012, Fujifilm Kyowa Kirin Biologics develops, manufactures, and markets biosimilars. Its pipeline includes an adalimumab biosimilar and a biosimilar of the anti-VEGF humanized monoclonal antibody bevacizumab, a drug used to treat a range of cancers including colorectal and non-small cell lung cancer. Fujifilm Kyowa Kirin Biologics established Centus Biotherapeutics Ltd, a joint venture for the development and commercialization of FKB238 with AstraZeneca PLC.
About Humira®
Humira® (adalimumab) is a TNF-inhibitor1 aimed at treating multiple chronic inflammatory conditions. The product is indicated in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Humira® is the world's best-selling biologic medication and had brand sales of approximately $4.1 billion in Europe for the 12 months ending December 31, 2017, according to IQVIA.
About Mylan N.V.
Founded in 1961 and headquartered in Canonsburg, Pennsylvania, Mylan is a global healthcare company focused on making high quality medicines available to everyone who needs them. The Company has one of the broadest and most diverse portfolios, with more than 7,500 marketed products that include prescription generic and brand-name medicines, and consumer healthcare products.
Stock Performance Snapshot
April 12, 2018 - At Thursday's closing bell, Mylan's stock climbed 2.15%, ending the trading session at $41.26.
Volume traded for the day: 4.44 million shares.
Stock performance in the previous six-month period - up 7.31%; and past twelve-month period - up 7.31%
After yesterday's close, Mylan's market cap was at $21.74 billion.
Price to Earnings (P/E) ratio was at 26.84.
The stock is part of the Healthcare sector, categorized under the Drugs - Generic industry. This sector was up 0.8% at the end of the session.
Active-Investors:
Active-Investors (A-I) 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. A-I 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.
A-I 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@active-investors.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 A-I. A-I 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
A-I, 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. A-I, 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, A-I, 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 A-I 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://active-investors.com/legal-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@active-investors.com
Phone number: 73 29 92 6381
Office Address: 6, Jalan Kia Peng, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.
SOURCE: Active-Investors
