Study discontinued due to feasibility of recruitment; no safety issues have been reported or efficacy conclusions made
Novartis remains committed to ongoing research and development for COVID-19
Supply of hydroxychloroquine (HCQ) from Novartis will continue for clinical trials and upon government requests worldwide
Basel, June 19, 2020 — Novartis has made the decision to stop and discontinue its sponsored HCQ clinical trial for COVID-19 due to acute enrollment challenges that have made trial completion infeasible. The recruitment challenge facing our HCQ trial has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of HCQ in treating patients with COVID-19. No safety issues have been reported, and there are no conclusions on efficacy from the study.
Novartis will continue to provide supply of HCQ for ongoing investigator-initiated trials (IITs) and upon government requests, as appropriate, where certain conditions are met and the medicine is used in accordance with a nationally endorsed treatment protocol. Researchers at Novartis continue to monitor ongoing guidance from health authorities on the further study of HCQ for COVID-19, as well as the decision by the US Food and Drug Administration to stop the emergency use authorization of HCQ for COVID-19 treatment. In addition, ongoing studies involving other Novartis treatments continue, as well as the newly announced support of a potential vaccine. Novartis also continues to collaborate to find answers for COVID-19 through various partnerships with multi-stakeholder external consortia.
Novartis wishes to thank all of the patients, their families, investigators and healthcare professionals who played a vital part in our HCQ clinical trial (CJWT629A12301, NCT04358081) for COVID-19.
This media update 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 media update, or regarding potential future revenues from such products, or regarding our activities and commitments to respond to the COVID-19 pandemic. 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 media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that such products will be commercially successful in the future. Nor can there be any guarantee that our activities and commitments to respond to the COVID-19 pandemic will achieve any or all of their intended goals in the expected time frame, or at all. In particular, our expectations regarding such products, activities and commitments 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
Sandoz, a division of Novartis, is a world leader in generic and biosimilar pharmaceuticals. Our purpose is to pioneer patient access by developing and commercializing innovative and affordable approaches to address unmet medical needs. Our broad portfolio of high-quality drugs, covering all major therapeutic areas, represented sales of $9.7 billion in 2019. Sandoz is headquartered in Holzkirchen, in the Greater Munich area of Germany.