Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease





Trial is designed and implemented quickly to address the need for science-based investigation following early preclinical and clinical evidence 1,2,3 that hydroxychloroquine may help hospitalized patients with COVID-19 disease



that hydroxychloroquine may help hospitalized patients with COVID-19 disease Company will also make its hydroxychloroquine intellectual property available to support broad access if medicine is approved for COVID-19



Study complements Novartis commitment to donate up to 130 million doses of hydroxychloroquine globally to support the COVID-19 pandemic response



Novartis has a broad COVID-19 research and development commitment, including multiple large sponsored and investigator initiated clinical trials of its medicines

Basel,April 20, 2020 — Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.

The large trial sponsored by Novartis will be conducted at more than a dozen sites in the United States. Novartis plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible. To help achieve broad access to hydroxychloroquine as quickly as possible in these extraordinary circumstances, Novartis will make any intellectual property within our control that relates to the use of hydroxychloroquine to treat or prevent COVID-19 available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms.

“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

As the new virus continues to spread and claim lives around the globe, doctors and patients are eager for treatment options. In some cases, clinicians are evaluating drugs that have been approved for other diseases, hoping that these will also work against COVID-19.

Patients in the trial will be randomized into three groups. The first group or arm will receive hydroxychloroquine. The second group will receive hydroxychloroquine in combination with azithromycin, which is an antibiotic therapy. The third group will receive placebo. Patients in all treatment groups are receiving standard of care for COVID-19. Researchers at the company compressed months of work into a few weeks to design the large clinical trial in order to rapidly respond to the need for COVID-19 disease treatments.

The clinical trial complements a commitment by Novartis, through Sandoz, to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for treatment of COVID-19. Sandoz has already donated 30 million tablets to the US Department of Health and Human Services and is dispatching futher shipments to countries based on requests from governments around the world.

“We are donating hydroxychloroquine tablets for COVID-19 patients including for use in this and other clinical trials with the hope that researchers and healthcare workers can quickly and scientifically determine whether hydroxychloroquine can help patients around the world combat this disease,” said Richard Saynor, CEO of Sandoz. “We will continue to fulfill orders for existing customers to ensure the medicine remains available to US patients who rely on it for other indicated uses.”

As part of its research and development commitment, Novartis has formed a clinical investigation team to provide rapid access for approved clinical requests and support of clinical evaluation of its medicines to be repurposed and address the needs of patients with COVID-19 infections. In addition to hydroxychloroquine, Novartis plans to sponsor or co-sponsor clinical trials to study ruxolitinib and canakinumab for hospitalized patients with COVID-19 infections. Requests for investigator-initiated trials have been granted for COVID-19-related clinical studies of ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine and valsartan.

About hydroxychloroquine in COVID-19

The drug hydroxychloroquine has garnered interest in the medical community after showing preliminary promise in small clinical studies, including one with co-administration with the antibiotic azithromycin.1In addition, hydroxychloroquine has demonstrated antiviral activity against SARS-CoV-2 in laboratory tests.2,3 Hydroxychloroquine has long been used for the treatment of malaria and certain autoimmune diseases.4

Novartis commitment and response to COVID-19

Novartis is deeply dedicated to the global effort to combat COVID-19 and doing our part to support the stability of global healthcare systems. We announced a broad set of measures including the creation of a global fund of USD 20 million to support communities around the world impacted by the COVID-19 pandemic. Novartis also has committed 130 million doses of hydroxychloroquine to support pandemic response. In addition, Novartis joined two 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 organized by the Innovative Medicines Initiative (IMI). Novartis is separately supporting COVID-19 related clinical investigations of several Novartis medicines. To support 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. More information about the Novartis response to COVID-19 is available on 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 “to sponsor,” “to proceed,” “commitment,” “to support,” “to determine,” “continues,” “evaluating,” “to donate,” “to supply,” “ensure,” “to provide,” “potential,” “can,” “will,” “plans,” “may,” “could,” “committed,” “to commit,” 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, regarding potential future revenues from such products, or regarding drug discovery collaboration efforts and support of clinical trials for existing Novartis medicines, a USD 20 million Novartis COVID-19 response fund, a commitment to donate up to 130 million doses of hydroxychloroquine, and the Sandoz commitment to maintain stable prices on a basket of essential medicines that may help in the treatment of COVID-19. 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, or that the activities and efforts described in this release will be achieved or succeed in the expected time frame, or at all. In particular, our expectations regarding such products and activities and efforts described in this release 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 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at

https://www.novartis.com.

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References

Gautret et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: Results of an open-label, non-randomized clinical trial. International Journal of Antimicrobial Agents. In press 17 March 2020. DOI: 10.1016/j.ijantimicag.2020.105949 Wang, M. et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 30, 269–271 (2020). https://www.nature.com/articles/s41421-020-0156-0 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d22f0a8-170b-4c3e-8c2e-a5cf64b9958b

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