Princeton - Novartis announced today that Sandoz, its generics and biosimilars division, has started to ship a consignment of 30 million doses of hydroxychloroquine tablets to the US Department of Health and Human Services (HHS) for immediate use in controlled clinical studies. The study will evaluate the medicine’s effectiveness in people who have tested positive for COVID-19. The shipment is part of the previously announced global Novartis donation of 130 million tablets in total to be distributed across a variety of clinical trials and stakeholders internationally.
Sandoz is providing the 30 million doses of hydroxychloroquine to HHS through the Assistant Secretary for Preparedness and Response (ASPR) with additional shipments to be agreed upon at a future date. “Our company, and the healthcare industry as a whole, play a vital role in offering medicine and support to address the SARS-CoV-2 pandemic,” said Carol Lynch, President of Sandoz Inc. “With this donation to HHS, we are helping to scientifically answer the question of whether HCQ may play a role in treating COVID-19.”
Hydroxychloroquine sulfate is currently approved by the US Food and Drug Administration (FDA) for – and 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.
Although there have been no clinical trials to date of hydroxychloroquine in patients who tested positive for COVID-19, there is in vitro evidence that the medicine may be effective against the virus that causes COVID-191. In support of HHS’s response to the COVID-19 public health emergency, Sandoz and HHS plan to evaluate hydroxychloroquine in the US to determine whether it could provide a potential treatment option for COVID-19 patients.
Novartis and its Sandoz generics and biosimilars divison are deeply dedicated to the global effort to combat COVID-19 and ensure the stability of global healthcare systems. The commitment of 130 million doses of hydroxychloroquine includes donations to several important clinical trials from public and private sector and governments around the world. The donation was announced a few weeks after Sandoz became the first company to commit to keeping prices stable for a basket of essential medicines that may help in the treatment of COVID-19.
These materials contain 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 “commitment,” “commit,” “can,” “will,” “plan,” “may,” “could,” “would,” “expected,” “evaluate,” “ensure,” “to ship,” “to be distributed,” “to be agreed,” 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 these materials, or discussions regarding the 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 these materials 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 these materials as of this date and does not undertake any obligation to update any forward-looking statements contained in these materials as a result of new information, future events or otherwise.