Novartis donates 20,000 doses of hydroxychloroquine for COVID-19 PEP clinical trial

• Trial being conducted at University of Washington International Clinical Research Center with funding from the Bill & Melinda Gates Foundation

• Donation to cover approximately 2,000 patients in post-exposure prophylaxis study of effectiveness of hydroxychloroquine to prevent severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) infection and its symptoms

• Earlier this month, Novartis announced commitment to donate up to 130 million doses of generic hydroxychloroquine to support global COVID-19 pandemic response

• Sandoz, the Novartis generics and biosimilars division, facilitates the donations. Sandoz was first company to commit to keep stable prices for basket of essential medicines including chloroquine, which may help to treat COVID-19

East Hanover, NJ, March 30, 2020 – Novartis announced today that it is donating 20,000 doses of hydroxychloroquine to the University of Washington for a COVID-19 PEP clinical trial. Sandoz, the company’s generics and biosimilars division, is facilitating the donation. 

A large post-exposure prophylaxis study is being conducted by the University of Washington International Clinical Research Center with funding from the Bill & Melinda Gates Foundation as part of the COVID-19 Therapeutics Accelerator. The donation is expected to provide approximately 2,000 patients with a 14-day post-exposure regimen.

“Sandoz, and the generics industry as a whole, play a vital role through support across all sectors of the healthcare system to do all we can to discover an effective and safe treatment regimen for COVID-19,” said Carol Lynch, President of Sandoz Inc. “As part of our efforts to establish clear and generally accepted treatment protocols, we are providing the required allocation to the University of Washington to support this crucial clinical trial.”

Earlier this month, Novartis announced its commitment to donate up to 130 million doses (200mg tablets) of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine is currently under evaluation in several clinical trials for the treatment of COVID-19, including this one by the University of Washington.

The commitment came just weeks after Sandoz was the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of coronavirus cases, in an initial contribution to the global effort to combat COVID-19 and ensure the stability of global healthcare systems.

Hydroxychloroquine sulfate has long been used for the treatment of uncomplicated malaria, as well as for some autoimmune diseases including systemic lupus erythematosis and rheumatoid arthritis in adults. 

Chloroquine (CQ) phosphate demonstrated effective repression of the SARS-CoV-2 infection in vitro¹, and has been described as the apparent “drug of choice” among several potential candidates for large-scale use – pending appropriate clinical evidence -- due to its availability, proven safety record, and relatively low cost².

Recently, CQ was added to the list of trial drugs in the Guidelines for the Diagnosis and Treatment of COVID-19 (sixth edition) published by National Health Commission of the People’s Republic of China.

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Bill & Melinda Gates Foundation

University of Washington International Clinical Research Center

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 support,” “commitment,” “commit,” “facilitates,” “can,” “will,” “plan,” “may,” “could,” “would,” “expected,” “under evaluation,” 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 discussions regarding Novartis 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 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 efforts 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; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; 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

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Located in East Hanover, NJ Novartis Pharmaceuticals Corporation – an affiliate of 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 employs about 15,000 people in the United States. For more information, please visit http://www.novartis.us.

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References

1. Wang, M. et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 30, 269–271 (2020).
2. https://www.nature.com/articles/s41421-020-0156-0

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