Press Release : Phase II/III trial shows -2-

In February 2021, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) initiated a rolling review of our partner Regeneron's Ronapreve(TM) (casirivimab and imdevimab). In parallel, the CHMP issued a scientific opinion (under Article 5(3) of Regulation 726/2004) supporting the use of the 2,400 mg dose of Ronapreve as a treatment option for non-hospitalised patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk for progressing to severe COVID-19, which can be used by European Union member states to support national decision making before a formal authorisation is issued. Ronapreve has been approved for use in Japan and conditionally in the United Kingdom, and is authorised for emergency or temporary pandemic use in additional territories such as the United States (US), India, Canada and several European countries. In addition, the World Health Organization issued guidance regarding the use of Ronapreve for the treatment of certain patients with COVID-19. The antibody combination has been studied in two phase I-III adaptive clinical trials for the treatment of COVID-19 and in a phase III trial for the prevention of the disease. As part of the global partnership with Regeneron, we are committing a significant amount of manufacturing capacity and are working to expand supply of this antibody combination beyond the US to as many people as possible.

In October 2020, Roche announced a partnership with Atea Pharmaceuticals to jointly develop the investigational compound AT-527. If approved, Atea will distribute AT-527 in the US and Roche will be responsible for global manufacturing and distribution outside the US. Atea's compound has the potential to be the first oral antiviral to treat COVID-19 patients outside the hospital setting as well as in the hospital. Its anticipated formulation (pill) may help to facilitate access to a broad patient population.

In addition, we have explored the potential of our existing medicine Actemra/RoActemra in three global phase III clinical trials investigating its safety and efficacy in COVID-19 associated pneumonia (COVACTA, EMPACTA and REMDACTA). In June 2021, Actemra/RoActemra received an EUA from the U.S. FDA for the intravenous treatment of COVID-19 in hospitalised adults and paediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. ACTEMRA is not FDA-approved for this use. In addition, the World Health Organization issued guidance regarding the use of Actemra/RoActemra for the treatment of patients with COVID-19.

For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page https://www.globenewswire.com/Tracker?data=r0wAaF5V-mO-xHKrp-oRLJOz3JQTIxiPhmYQo488UCtUy_L-Thd8lA4Xt58sSvN6FQXRTjuBGI7GMSDchKfvBAARBGLmCBooS6WF-8V2L6mBYuZ_6RvXx_oJe27Zna4TwmDwnrPRs5R0ybVIejZVc1jygFaHzldQT81WmQCGkwtJg7Vey2De5pisb7UdJavqSNskQBGKJUxKvEmsiEcej9laQu5v8FFMCDN06Kxw0cZ2mzmyFCHCV0qwA_gleib0DOywCcKrzJ3nxn0bzO8CD1hdvGK00dEXXageMvMWgoqHyZr3GGeY7KCyBeK1DQC75b9KFsPat-0Tv14gIPmSkw== .

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. 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] World Health Organisation: Coronavirus (COVID-19) Dashboard. [Internet cited; September 2021] Available from: https://covid19.who.int/

Roche Group Media Relations

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(END) Dow Jones Newswires

September 30, 2021 01:00 ET (05:00 GMT)