GlobeNewswire by notified

Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above

Share
  • Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adults
  • Xofluza is the first influenza antiviral with a new mechanism of action in almost 20 years, stopping viral replication faster than oseltamivir
  • Single-dose Xofluza helps reduce the societal burden of influenza by helping patients recover quickly and by preventing infection in individuals following contact with someone with the virus

Basel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The Commission’s Decision is based on the results of the phase III miniSTONE-2 and BLOCKSTONE studies.1,2 This approval marks the first single-dose, oral influenza medicine approved in Europe for children, and now means that Xofluza can be used to treat and prevent uncomplicated influenza in children aged one year and above, and in adolescents and adults.3

“We are delighted that the European Commission has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are hopeful that Xofluza’s convenient single-dose oral regimen will help children recover quickly, as well as reduce the societal burden of influenza.”

Influenza is a serious infectious disease and represents a significant threat to public health.4-6 Rates of influenza in Europe are rising and it is expected that the virus will infect around one in four children each year.6,7 In addition to being at higher risk of infection, children also play a significant role in the spread of influenza from one person to another.6,8 In studies of influenza transmission in households, the risk of infection from others in the household was as high as 38%.9 Prophylactic treatment with Xofluza, which stops viral replication faster than oseltamivir, may help to limit the spread of influenza and therefore reduce the impact and burden of influenza on society.2,10,11

The approval is based on the results of the phase III miniSTONE-2 and BLOCKSTONE studies.1,2 The miniSTONE-2 study met its primary endpoint of safety and showed that Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir (viral replication; median time of 24.2 hours versus 75.8 hours, respectively). Xofluza was well tolerated with no new safety signals identified.1

In the BLOCKSTONE study Xofluza showed a statistically significant prophylactic effect after a single oral dose, by reducing the risk of people developing influenza after exposure to an infected household member by 86% versus placebo (1.9% in participants treated with Xofluza and 13.6% in the placebo group).2

Xofluza was first approved for use in Europe in 2021 for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in adults and adolescents aged 12 years and above.12 Xofluza is now approved in more than 70 countries for the treatment of influenza types A and B.13 Roche is continuing to investigate Xofluza in phase III trials in children under the age of one (NCT03653364), as well as to assess its potential to reduce transmission of influenza from an infected person to household members (NCT03969212).14,15

About miniSTONE-21
miniSTONE-2 was a phase III, multicentre, randomised, double-blind study that evaluated the safety, pharmacokinetics and efficacy of a single-dose of Xofluza® (baloxavir marboxil) compared with oseltamivir in otherwise healthy children aged one to less than 12 years with influenza infection and displaying influenza symptoms for no more than 48 hours (temperature of 38°C or over, and one or more respiratory symptoms).

Participants enrolled in the study were recruited in parallel into two cohorts: children aged five to less than 12 years and children aged one to less than five years. Participants were randomly assigned to receive a single-dose of Xofluza or oseltamivir twice a day over five days (dosing according to body weight).

Time to alleviation of influenza signs and symptoms were comparable between Xofluza and oseltamivir. The median time to alleviation of signs and symptoms in influenza-infected participants was 138 hours (95% CI: 117, 163) and 150 hours (95% CI: 115, 166) for those who received Xofluza or oseltamivir, respectively. Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir (viral replication; median time of 24.2 hours versus 75.8 hours, respectively). Xofluza was well tolerated with no new safety signals identified.

About BLOCKSTONE2
BLOCKSTONE was a phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that evaluated single-dose Xofluza® (baloxavir marboxil) compared with placebo in household members (adults and children), who were living with someone with influenza, confirmed by a rapid influenza diagnostic test (the ‘index patient’).

Participants enrolled in the study were household members of someone who had been diagnosed with influenza. The participants were randomised to receive a single-dose of Xofluza (dose according to body weight) or placebo as a preventive measure against developing influenza.

Xofluza showed a statistically significant prophylactic effect after a single oral dose, by reducing the risk of people developing influenza after exposure to an infected household member by 86% versus placebo. The proportion of households, who developed laboratory-confirmed clinical influenza was 1.9% in participants treated with Xofluza and 13.6% in the placebo-treated group.

Xofluza was well tolerated in this study and no new safety signals were identified. The study was conducted in Japan by Shionogi & Co., Ltd.

About Xofluza® (baloxavirmarboxil)
Xofluza is a first-in-class, single-dose oral medicine with an innovative mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.10,16,17 Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.10

Xofluza is approved in more than 70 countries for the treatment of influenza types A and B. In Europe, Xofluza is now approved for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adults. Xofluza is the first innovation in mechanism of action for an influenza antiviral approved by the European Commission in almost 20 years.18

Robust clinical evidence has demonstrated the benefit of Xofluza in several populations (otherwise-healthy, high-risk, children and post-exposure prophylaxis in individuals aged one year and above).1,2,10,19 Xofluza is being further studied in a phase III development programme, including in children under the age of one (NCT03653364) as well as to assess its potential to reduce transmission of influenza from an infected person to healthy people (NCT03969212).14,15

Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialised globally in collaboration with the Roche Group (which includes Genentech in the US) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. 

About Roche in influenza
Influenza is a serious infectious disease and represents a significant threat to public health. Seasonal epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths globally every year.4 Roche has a long heritage in developing medicines that contribute to public health. We are committed to bringing innovation in the field of infectious diseases, including influenza. Tamiflu® (oseltamivir) has made a significant difference both to the treatment of seasonal influenza as well as in the management of recent pandemics, and we are proud to have brought this innovative medicine to patients. Although vaccines are an important first line of defence in preventing influenza, there is a need for new medical options for prevention (prophylaxis) and treatment. Roche is committed to addressing the unmet need in this area through its agreement with Shionogi & Co., Ltd. to develop and commercialise Xofluza® (baloxavir marboxil).

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Baker J, et al. Pediatr Infect Dis J. 2020;39(8):700-705.
[2] Ikematsu H, et al. N Engl J Med. 2020;383:309-320.
[3] European Medicines Agency. Xofluza. [Internet; cited December 2022]. Available from: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/xofluza-0.
[4] World Health Organization. Influenza (seasonal). [Internet; cited December 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).
[5] Centers for Disease Control and Prevention. Disease burden of influenza. [Internet; cited December 2022]. Available from: https://www.cdc.gov/flu/about/burden/index.html.
[6] World Health Organization. Influenza. [Internet; cited December 2022]. Available from: https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/influenza.
[7] World Health Organization. Joint statement - Influenza season epidemic kicks off early in Europe as concerns over RSV rise and COVID-19 is still a threat. [Internet; cited December 2022]. Available from: https://www.who.int/europe/news/item/01-12-2022-joint-statement---influenza-season-epidemic-kicks-off-early-in-europe-as-concerns-over-rsv-rise-and-covid-19-is-still-a-threat.
[8] Influenza in children. Paediatr Child Health. 2005;10(8):485-487. doi:10.1093/pch/10.8.485.
[9] Tsang T, et al. Trends Microbiol. 2016;24(2):123-133.
[10] Hayden F, et al. N Engl J Med 2018;379:913–923.
[11] Zhanwei D, et al. Nat Commun. 2020;11:2750.
[12] European Medicines Agency. Xofluza: EPAR – Medicine overview. [Internet; cited December 2022]. Available from: https://www.ema.europa.eu/en/documents/overview/xofluza-epar-medicine-overview_en.pdf.
[13] Roche. Data on File.
[14] Clinicaltrials.gov. Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms. [Internet; cited December 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT03653364.
[15] Clinicaltrials.gov. Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households. [Internet; cited December 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT03969212.
[16] Noshi T, et al. Antiviral Res. 2018;160:109-117.
[17] Taniguchi K, et al. Sci Rep. 2019;9:3466.
[18] Roche.com. Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years. [Internet; cited December 2022]. Available from: https://www.roche.com/media/releases/med-cor-2021-01-11.
[19] Ison, et al. Lancet Infect Dis 2020;20(10):1204–14.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 79 407 72 58
Nathalie Altermatt
Phone: +41 79 771 05 25

KarstenKleine
Phone: +41 79 461 86 83
Nina Mählitz
Phone: +41 79 327 54 74

Dr. Barbara von Schnurbein
Phone: +41 79 699 97 44
SileiaUrech
Phone: +41 79 935 81 48

Roche Investor Relations

Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

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

https://notified.com

GlobeNewswire by notified 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 by notified

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

Latest releases from GlobeNewswire by notified

Nikkiso Clean Energy & Industrial Gases Group Announces Expansion of Service for Middle East and Northern Africa30.1.2023 23:49:26 CET | Press release

TEMECULA, Calif., Jan. 30, 2023 (GLOBE NEWSWIRE) -- Nikkiso Clean Energy & Industrial Gases Group (“Group”), a part of the Nikkiso Co., Ltd (Japan) group of companies, is proud to announce yet another expansion of their manufacturing and service capabilities for the Middle East and Northern Africa markets. With this expansion, they will be providing pump and turboexpander aftermarket repairs of their full line, including J.C. Carter pumps. Their new state-of-the-art service center will allow repairs to be made locally rather than the need to ship elsewhere. The new facility, based in the Sharjah Free Zone, was established to provide expanded support for the Middle East and Northern Africa markets. They have added field service support, and shop technicians specifically trained to support Marine, J.C. Carter, Nikkiso Cryogenic Pumps (ACD and Nikkiso Cryo) and Turboexpanders. In addition to in-shop and on-site repairs, they will provide aftermarket service. “With this facility, we will b

Constellation Brands Prices Offering of Senior Notes30.1.2023 22:40:18 CET | Press release

VICTOR, N.Y., Jan. 30, 2023 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE: STZ), a leading beverage alcohol company, announced today that it priced the public offering of $500.0 million aggregate principal amount of 5.000% Senior Notes due 2026 (the “notes”) for a public offering price of 99.829% of the principal amount of the notes. The notes will be senior obligations that rank equally with all of Constellation’s other senior unsecured indebtedness. Closing of the offering is expected to occur on February 2, 2023. Constellation intends to use the net proceeds from the offering for general corporate purposes, including the repayment of a portion of its indebtedness outstanding under the delayed draw three-year term loan facility of its term loan credit agreement, dated as of August 9, 2022, as amended on October 18, 2022. BofA Securities, Inc., Goldman Sachs & Co. LLC, and J.P. Morgan Securities LLC are acting as the joint book-running managers of the offering. The notes are be

Nokia Corporation: Repurchase of own shares on 30.01.202330.1.2023 20:00:00 CET | Press release

Nokia Corporation Stock Exchange Release 30 January 2023 at 21:00 EET Nokia Corporation: Repurchase of own shares on 30.01.2023 Espoo, Finland – On 30 January 2023 Nokia Corporation (LEI: 549300A0JPRWG1KI7U06) has acquired its own shares (ISIN FI0009000681) as follows: Trading venue (MIC Code)Number of sharesWeighted average price / share, EUR*XHEL279,9364.37CEUX20,9634.38AQEU7,9574.36TQEX6,3444.39Total315,2004.37 * Rounded to two decimals On 3 February 2022, Nokia announced that its Board of Directors is initiating a share buyback program under the authorization granted by Nokia’s Annual General Meeting on 8 April 2021 to return up to EUR 600 million of cash to shareholders in tranches over a period of two years. The second phase of the share buyback program in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR), the Commission Delegated Regulation (EU) 2016/1052 and under the authorization granted by Nokia’s Annual General Meeting on 5 April 2022 started on 2 January 2023

Mendus AB: Mendus announces request for conversion of convertible bonds by Negma Group30.1.2023 18:00:00 CET | Press release

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced that Negma Group (“Negma”) has by notice to Mendus requested the conversion of convertible bonds that have been issued to Negma in accordance with the financing agreement announced by Mendus through press releases on 26 August and 26 October 2022. Negma has requested conversion of two (2) convertible bonds issued on 3 January 2023, corresponding to SEK 50,000 of the convertible loan amounting to a total of SEK 13,700,000, into 20,325 shares. Upon registration at the Swedish Companies Registration Office, Mendus’ total share capital will amount to SEK 9,971,046.20 and the total number of shares and votes will amount to 199,420,924. The conversion price per share is SEK 2.46, equivalent to 92% of the second lowest closing volume weighted average share price (VWAP) of the 10 consecutive trading days preceding the issuance of conversion request by Negma. F

Mendus AB: Mendus tillkännager begäran från Negma Group om konvertering av konvertibla skuldebrev30.1.2023 18:00:00 CET | Pressemelding

Mendus AB (“Mendus” publ; IMMU.ST), ett bioläkemedelsföretag fokuserat på immunterapier mot tumöråterfall, tillkännager idag att Negma Group (”Negma”) genom meddelande till Mendus har begärt konvertering av konvertibla skuldebrev som utfärdats till Negma i enlighet med det finansieringsavtal som Mendus tillkännagivit genom pressmeddelanden den 26 augusti och 26 oktober 2022. Negma har begärt konvertering av två (2) konvertibla skuldebrev som emitterades den 3 januari 2023, motsvarande 50 000 kronor av det konvertibla lånet som uppgår till totalt 13 700 000 kronor, till 20 325 aktier. Efter registrering hos Bolagsverket kommer Mendus totala aktiekapital att uppgå till 9 971 046,20 kronor och det totala antalet aktier och röster kommer att uppgå till 199 420 924. Konverteringspriset per aktie är 2,46 kronor, motsvarande 92% av det näst lägsta dagliga volymvägda genomsnittliga aktiekursen (VWAP) under de 10 på varandra följande handelsdagarna före konverteringsbegäran från Negma. För ytte