Janssen Receives Positive CHMP Opinion for SYMTUZA™ The First Darunavir-Based Single-Tablet Regimen for the Treatment of HIV
Janssen-Cilag International NV (Janssen) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for SYMTUZA™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single tablet regimen (STR).
If approved, it will be the only darunavir-based STR indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg, with genotypic testing guiding use. This STR combines the proven efficacy and durability of darunavir with the improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (tenofovir disoproxil fumarate), and will be the only treatment that could deliver the adherence advantages of a STR coupled with the high genetic barrier to resistance that darunavir offers.
“Darunavir is one of the most widely used HIV treatments in the European Union due to its ability to control the HIV virus while offering a high barrier to resistance. We will now be able to combine a complete darunavir-based HIV treatment regimen into a once daily tablet. We are extremely excited to be one step closer to getting this therapy to people living with HIV and in doing so hope to reduce the treatment burden faced by many living with the virus,” said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Janssen Infectious Diseases Therapeutics.
“A darunavir-based STR represents a significant evolution in treatment options for HIV patients,” said Jean-Michel Molina, Professor of Infectious Diseases at the University of Paris Diderot. “With around two million people in Europe currently managing their HIV, this is a true advancement in helping patients achieve an undetectable viral load and improving quality of life. Reducing the pill burden allows people greater freedom and flexibility, and through this we may also improve treatment adherence.”
The Positive Opinion is based on a bioequivalence study comparing the once-daily STR with the combined administration of the separate agents darunavir [D] 800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200 mg/10 mg fixed-dose combination. A Phase 3 clinical trial programme investigating the efficacy and safety of the darunavir-based combination is underway. Data on the bioequivalence study, as well as interim data from the Phase 3 Pivotal EMERALD trial in virologically suppressed antiretroviral therapy (ART) experienced patients, who were switched to the STR, will be presented at the upcoming International AIDS Society (IAS) conference in Paris, France. Further EMERALD 48-week data, and 48-week data from the Phase 3 AMBER trial in ART naïve patients, will be released in due course. Please visit www.jnj.com/HIV for further details on the breadth of science being presented by Johnson & Johnson companies and its partners.
The CHMP's Positive Opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorisation for medicines in the European Economic Area. The European Commission’s final decision is anticipated in the coming months.
Janssen have brought medicines to market across a range of patient populations that have helped to transform the efficacy and tolerability of treatment. Treatment regimens that combine D/C (REZOLSTA®, Janssen-Cilag International NV, U.S name PREZCOBIX®) and F/TAF (DESCOVY®, Gilead Sciences International Ltd) are currently approved1,2 for the treatment of HIV. SYMTUZA™ is a significant evolution of this approach, combining both treatments in a single, convenient tablet, and is part of Janssen’s broader commitment to develop effective and innovative therapies which address the issues of adherence and resistance.
Notes to editors
On 23 December 2014, Janssen and Gilead Sciences International Ltd amended a licensing agreement for the development and commercialisation of a once-daily STR combination of darunavir and Gilead's TAF, emtricitabine and cobicistat. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialisation of this STR worldwide.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea/ and follow us at @JanssenEMEA.
About PREZISTA ® (darunavir)
PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.
PREZISTA, co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
In deciding to initiate treatment with PREZISTA co-administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
About REZOLSTA ® (darunavir/cobicistat)
REZOLSTA is an antiviral medicine used, in combination with other medicines, to treat adults with human immunodeficiency virus type 1 (HIV-1). REZOLSTA contains the active substances darunavir and cobicistat. The medicine is for use only in patients who have not received HIV treatment before or previously treated patients whose disease is not expected to be resistant to darunavir and who are healthy enough and have HIV virus levels below a certain threshold.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new indications and therapeutic combinations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the year ended January 1, 2017, including under “Item 1A Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1. European Medicines Agency:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002819/human_med_001817.jsp&mid=WC0b01ac058001d124 Last accessed June 2017.
2. European Medicines Agency:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004094/human_med_001978.jsp&mid=WC0b01ac058001d124 Last accessed June 2017.
+ 33 6 88 09 33 35
Phone: +1 732-524-3922
Joseph J. Wolk
Phone: +1 732-524-1142
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 22:40 | Tiedote
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will
Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 17:00 | Tiedote
Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a
Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 16:13 | Tiedote
Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform
Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 15:00 | Tiedote
Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-
JPMorgan Chase Bank launches offering of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 15:00 | Tiedote
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the launch of an offering of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of up to approximately USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Issuer is rated A+ (Stable outlook) by Standard & Poor’s, Aa3 (Stable outlook) by Moody’s and AA (Stable outlook) by Fitch. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest.
Greene Tweed Achieves Nadcap Accreditation for Non-Metallic Materials Testing17.7.2018 14:01 | Tiedote
Greene Tweed’s Central Engineering (CE) Materials Test Lab recently completed its final Nadcap accreditation audit for Non-Metallic Materials Testing (NMMT) of composite materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180717005200/en/ Greene Tweed Achieves Nadcap Accreditation (Photo: Greene Tweed) In support of Aerospace’s strategic initiative, this positions Greene Tweed as one of a select few aerospace companies who have attained this accreditation as validation of our materials testing capabilities and our position as a composite solutions provider. To achieve this standard, Greene Tweed’s CE lab completed a comprehensive audit against the highest standards for special process controls, test completion, and validation. This in-house accreditation adds to Greene Tweed’s responsiveness to new product development requests while expanding production material and customer product certification capabilities. It also
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme