GlobeNewswire

Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19

Share
  • Phase III study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care)1
  • Detailed results will be submitted for publication to support scientific understanding of JAK inhibition in COVID-19 and inform ongoing research
  • Novartis commitment to address COVID-19 pandemic remains strong with multiple research collaboration initiatives ongoing

Basel, December 14, 2020 — Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint1. Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone1. The trial also did not show clinically relevant benefit among secondary and exploratory endpoints including mortality rate by Day 29, and time to recovery (no longer infected, or ambulatory with no or minimal limitations)1.

“While the RUXCOVID trial did not give us the results we hoped for, we will continue working with the medical community to analyze its findings to better understand COVID-19 and the role of JAK inhibition,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “We would like to thank the front-line clinical teams and staff at each of the trial sites and the hundreds of patients who volunteered to participate and their loved ones. We are deeply grateful to them and will continue our dedicated scientific research into the ongoing global pandemic.”

In the trial, the proportion of patients who died, or required mechanical ventilation due to respiratory failure or ICU care by Day 29, the primary endpoint, was 12.0% for ruxolitinib plus SoC vs. 11.8% for placebo plus SoC (OR: 0.91 [95% CI: 0.48-1.73]; p=0.769)1. Ruxolitinib was generally well-tolerated, and a comprehensive analysis including safety data is ongoing1. The results of RUXCOVID do not affect any ongoing trials for ruxolitinib in non-COVID-19 diseases.

About RUXCOVID
RUXCOVID (NCT04362137) is a Phase III multicenter, randomized, double-blind, placebo-controlled, 29-day study to evaluate the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy compared to placebo plus SoC therapy in patients aged ≥12 years hospitalized for COVID-19 and not intubated or receiving ICU care prior to randomization. The study has enrolled 432 patients globally2.

The composite primary endpoint is the proportion of patients who die, develop respiratory failure (require mechanical ventilation), or require admission to ICU by Day 29. Secondary endpoints include various efficacy assessments including evaluation of clinical status using a 9-point ordinal scale; in-hospital outcomes (mortality rate; proportion of patients requiring mechanical ventilation; duration of hospitalization, ICU stay, supplemental oxygen, invasive mechanical ventilation); change in the National Early Warning Score (NEWS2); change in SpO2/FiO2 ratio; proportion of patients with no oxygen therapy (oxygen saturation of ≥94% on room air); and safety. The exploratory endpoint of time to recovery (no longer infected, or ambulatory with no or minimal limitations) was also evaluated2.

Eligible patients were randomized 2:1 to receive oral ruxolitinib 5mg twice daily (BID) or oral-matching placebo for a total of 14 days. Study treatment is given in combination with SoC therapy according to the investigator’s clinical judgement. After 14 days of therapy, should clinical signs or symptoms not improve or worsen, and the potential benefit outweighs the potential risks, patients may receive an additional 14 days of study therapy. In total, patients are followed on study for 29 days post-randomization2.

RUXCOVID is sponsored by Novartis outside of the US and by Incyte in the US.

About ruxolitinib
Ruxolitinib is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. It is approved under the trade name Jakavi® in Europe and other regions and countries for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF), also known as chronic idiopathic MF, post-polycythemia vera MF or post-essential thrombocythemia MF. Approved indications vary by country3. The safety and efficacy profile of Jakavi has not yet been established outside of its approved indications.

Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the US. Ruxolitinib is marketed outside the US by Novartis as Jakavi®, and in the US by Incyte Corporation as Jakafi® for patients with PV who have had an inadequate response to or are intolerant of hydroxyurea, for patients with intermediate or high-risk MF, and steroid-refractory acute GvHD in adult and pediatric patients 12 years and older3. Jakavi is a registered trademark of Novartis AG in countries outside the US. Jakafi is a registered trademark of Incyte Corporation.

Novartis response to COVID-19 pandemic
Novartis is making multiple contributions to the global effort to combat the COVID-19 pandemic and support the stability of global healthcare systems. The company has committed to donating USD 40 million to support communities around the world impacted by the pandemic. In addition, Novartis is active in several key cross-industry research initiatives, the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard as well as a COVID-19 directed partnership supported by the Innovative Medicines Initiative (IMI)4. Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-195, and the company is separately supporting COVID-19-related clinical investigations of several Novartis medicines. Two medicines in early stage development are also being investigated focusing on stopping or slowing the body’s overactive immune response to COVID-196,7. In our labs, we have started a collaborative, longer-term drug discovery effort to develop an antiviral molecule to potentially treat all coronaviruses. To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines. We are making 15 drugs that treat key symptoms of COVID-19 available to low-and lower-middle income countries at zero profit until a vaccine or curative treatment is found. This includes dexamethasone, which is the only medicine shown to decrease mortality so far in severe hospitalized COVID pneumonia4. Furthermore, Novartis Gene Therapies entered into a manufacturing agreement with Massachusetts Eye and Ear and Massachusetts General Hospital to produce its novel genetic COVID-19 vaccine candidate called AAVCOVID8. More information about the Novartis response to COVID-19 is available at www.novartis.com/coronavirus.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com

References

  1. Novartis Data on File
  2. “A Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID).” ClinicalTrials.gov. 2020. https://clinicaltrials.gov/ct2/show/NCT04362137.
  3. Jakavi® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; May 2020.
  4. Novartis.com. COVID-19 Novartis response. Available from: https://www.novartis.com/coronavirus/response [Last accessed: December 2020].
  5. Novartis Media Release. Novartis announces collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. October 28, 2020. Available from: https://www.novartis.com/news/media-releases/novartis-announces-collaboration-molecular-partners-develop-two-darpin-therapies-designed-potential-use-against-covid-19 [Last accessed: December 2020].
  6. Clinical trials.gov. Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia. NCT04382053. Available from: https://clinicaltrials.gov/ct2/show/NCT04382053 [Last accessed: December 2020].
  7. Clinical trials.gov. Study of Efficacy and Safety of MAS825 in Patients With COVID-19 (MAS-COVID). NCT04382651. Available from: https://clinicaltrials.gov/ct2/show/NCT04382651 [Last accessed: December 2020].
  8. Novartis Media Release. AveXis joins AAVCOVID vaccine program from Massachusetts Eye and Ear and Massachusetts General Hospital. May, 28 2020. Available from: https://masseyeandear.org/news/press-releases/2020/05/aavcovid-vaccine-program-enters-manufacturing-agreement-with-avexis [Last accessed: November 2020]. 

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com

Anja von Treskow
Novartis Global Media Relations
+41 61 324 2279 (direct)
+41 79 392 8697 (mobile)
anja.von_treskow@novartis.com



Eric Althoff
Novartis US External Communications
+1 646 438 4335
eric.althoff@novartis.com
Michael Billings
Novartis Oncology Communications
+1 862 778 8656 (direct)
+1 201 400 1854 (mobile)
michael.billings@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

CentralNorth America
Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052
Thomas Hungerbuehler        
Isabella Zinck
+41 61 324 8425
+41 61 324 7188

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

AS PRFoods unaudited preliminary consolidated turnover of the 2nd quarter and 6 months of the 2020/2021 financial year17.1.2021 20:58:59 CETPress release

PRFoods unaudited preliminary consolidated turnover in the 2nd quarter of the financial year 2020/2021 amounted to 17.07 million euros. Compared to the previous quarter i.e. the 1st quarter, the sales increased by 33.9%, (1Q 2020/2021: 12.74 million euros), with retail sector increased by 30.7%, wholesale by 43.6% and HoReCa sector by 14.2%. Compared to last year same period, sales decreased by 32.9% (2Q 2019/2020: 25.43 million euros), decrease in HoReCa by 52.7% and in wholesale by 60.9%. Sales increased in retail sector by 3.2% Indrek Kasela, CEO, PRFoods: „The impact of COVID-19 continues in fish sector and as we noted in last sales announcement, HoReCa sector which gives ca 1/3 of salmon- and troutbusiness both globally and regionally, will not recover to previous levels in next 12 months. End of the year brought Christmas lockdowns around Europe, for example UK was in full lockdown. In December, price of fresh salmon and trout was at historic 12 year low, which is total anomaly,

Announcement | MCH Group | Board of Directors and Executive Board16.1.2021 19:00:00 CETPress release

MCH Group: Appointments to the Board of Directors and Executive Board Andrea Zappia proposed as new chairman of the Board of Directors, Marco Gadola foreseen as Vice Chairman Beat Zwahlen appointed as interim CEO and Michael Hüsler as new CFO Bernd Stadlwieser leaving the company by mutual agreement Following completion of the capital increases, the partial renewal of the Board of Directors of MCH Group Ltd., which was approved by the General Meeting on 27 November 2020, took effect on 21 December 2020: James Murdoch, Jeffrey Palker and Eleni Lionaki have taken up their mandates as successors to Karin Lenzlinger Diedenhofen, André Odermatt and Tanja Soland respectively. Today, the Board of Directors announces further intended personnel renewals: The Board of Directors will propose Andrea Zappia and Marco Gadola for election as new members of the Board of Directors at the General Meeting on 28 April 2021. Andrea Zappia will also be proposed for election as Chairman and successor to Ulri

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK TREASURY BILLS15.1.2021 16:20:00 CETPress release

Bid procedure, 2021-01-18BillsSWEDISH T-BILL: SE0014555991. 2021-06-16 SWEDISH T-BILL: SE0014808747, 2021-09-15 Bid date2021-01-18Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SE0014555991: 500 mln SEK +/-250 mln SEK SE0014808747: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)SE0014555991: 500 mln SEK per bid SE0014808747: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2021-01-20Delivery of billsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-01-15 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK MUNICIPAL BONDS15.1.2021 16:20:00 CETPress release

Anbudsförfarande kommuner och regioner, 2021-01-19BondsFloating-rate Notes(FRN) issued in SEK by Municipalities or Regions with maturity in: 2023 The following issuers are accepted for delivery: Borås Stad Göteborgs Stad Helsingborgs Stad Huddinge Kommun Lunds Kommun Malmö Stad Norrköpings Kommun Region Skåne Stockholms Stad Region Stockholm Sundsvalls Kommun Södertälje Kommun Täby Kommun Uppsala Kommun Västerås Stad Örebro Kommun Östersunds Kommun Delivery may not be made in Bonds purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Specific terms, i.e. the purchase may not have been made after: 2021-01-08BidsBids are made to tel 08-696 69 70 and confirmed in writing by a filled-in Bid form by e-mail to EOL@riksbank.se Bid date2021-01-19Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 1000 +/- 1000 millionHighest permitted bid volume (corresponding nominal amount)The total bid volume from

CONDITIONS FOR PURCHASES OF CORPORATE BONDS15.1.2021 16:20:00 CETPress release

Bid procedure, 2021-01-20BondsBonds issued in SEK by Swedish non-financial undertakings. The following bonds are eligible for delivery: AKELIUS RESIDENTIAL AB: XS1692931980, 2021-10-04 AKELIUS RESIDENTIAL AB: XS1889043359, 2023-10-03 FASTIGHETS AB BALDER: SE0013359726, 2022-07-01 FASTIGHETS AB BALDER: SE0012675940, 2022-01-28 WILLHEM AB: SE0012193985, 2025-02-22 WILLHEM AB: SE0011088921, 2022-01-11 LUNDBERGFORETAGEN AB: SE0012676666, 2024-12-06 LUNDBERGFORETAGEN AB: SE0012676609, 2025-11-13 TELE2 AB: XS2187707463, 2025-06-10 TELE2 AB: XS1571151627, 2023-02-24 Delivery of a Bond may not occur if the Counterparty has purchased the Bond from the issuer more recently than one month prior to the date of announcement of the Special terms, that is, the purchase may not have taken place after: 2020-12-20Bid date2021-01-20Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)XS1692931980: 30 mln SEK +/-30 mln SEK XS1889043359: 30 mln SEK +/-30 mln SEK SE0

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK COVERED BONDS15.1.2021 16:20:00 CETPress release

Bid procedure, 2021-01-21BondsSTADSHYPOTEK AB: 1590. SE0012676690. 2025-09-03 NORDEA HYPOTEK AB: 5534, SE0012230415, 2024-09-18 SKANDINAVISKA ENSKILDA: 576, SE0010049841, 2023-12-20 DANSKE HYPOTEK AB: 2312, SE0011116474, 2023-12-20 LANSFORSAKRINGAR HYPOTEK: 518, SE0011309244, 2025-09-17 SWEDISH COVERED BOND: 146, SE0013381571, 2025-06-11 SWEDBANK HYPOTEK AB: 194, SE0012142206, 2024-09-18 Bid date2021-01-21Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)1590: 1500 mln SEK +/-500 mln SEK 5534: 1300 mln SEK +/-500 mln SEK 576: 900 mln SEK +/-450 mln SEK 2312: 400 mln SEK +/-200 mln SEK 518: 800 mln SEK +/-400 mln SEK 146: 800 mln SEK +/-400 mln SEK 194: 1300 mln SEK +/-500 mln SEK Highest permitted bid volume (corresponding nominal amount)1590: 1500 mln SEK per bid 5534: 1300 mln SEK per bid 576: 900 mln SEK per bid 2312: 400 mln SEK per bid 518: 800 mln SEK per bid 146: 800 mln SEK per bid 194: 1300 mln SEK per bid Lowest permitted bid volume

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS15.1.2021 16:20:00 CETPress release

Bid procedure, 2021-01-22BondsSWEDEN I/L BOND: 3112. SE0008014062. 2026-06-01 SWEDEN I/L BOND: 3111, SE0007045745, 2032-06-01 Bid date2021-01-22Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)3112: 500 mln SEK +/-250 mln SEK 3111: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)3112: 500 mln SEK per bid 3111: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNo later than 10.10 (CET/CEST) on the Bid dateDelivery and payment date2021-01-26Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-01-15 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions can be r