Sandoz, Novartis Philippines announce donation of hydroxychloroquine to DOH
Novartis has committed to making a global donation of up to 130 million doses of the anti-malarial drug hydroxychloroquine to support efforts to fight the COVID-19 pandemic.
Sandoz Philippines, the local subsidiary of the generics and biosimilars division of Novartis, today begins delivering the donated doses of hydroxychloroquine to the Department of Health (DOH), who are organizing its distribution to hospitals.
Manila, Philippines, April 30, 2020 – Today, the Novartis group in the Philippines announced the donation of a substantial amount of hydroxychloroquine to the Department of Health (DOH) to treat hospitalized COVID-19 patients in the country. The aim of the donation is to enable patients to access a potential treatment while also advancing clinical research in the fight against COVID-19. DOH is responsible for distributing the drug to hospitals.
The consignment of hydroxychloroquine donated by Novartis is expected to put the Philippine government in a position to roll out a national treatment protocol for all currently hospitalized COVID-19 patients, and collect respective clinical data. Sandoz, the generics and biosimilars division of Novartis, has started to deliver the hydroxychloroquine doses of the donation to DOH today.
The treatment protocol1 issued by the Philippine Society of Microbiology and Infectious Disease (PSMID), as endorsed by the DOH, includes hydroxychloroquine among the recommended treatments for hospitalized patients infected with COVID-19. Several clinical trials are underway to research the effect of hydroxychloroquine and chloroquine, a related substance, in treating COVID-19. This compound is used to treat malaria and auto-immune diseases such as lupus erythematosus and chronic polyarthritis. The product has not yet been approved in Europe for treating COVID-19 infections. The Philippine FDA responded quickly to the treatment recommendation by PSMID and DOH, fast-tracking the procedure to license Sandoz’s drug for use via donation by the Philippine DOH.
Eleanor Lopez, Country Head of Sandoz, the generics and biosimilars division of Novartis, in Philippines added: “At present, it is more important than ever that we fulfill our mission of providing primary healthcare in the Philippines. By donating this sizable quantity of hydroxychloroquine to the DOH, we are playing our part in this by enabling patients to access a potential treatment and supporting clinical research in the fight against COVID-19.”
This donation given to the DOH is part of the commitment made by Novartis to donate 130 million 200 mg doses of hydroxychloroquine globally by the end of May, subject to the condition that local regulatory authorities support the use of the drug for patients infected with COVID-19. In addition, Sandoz intends to work closely with other manufacturers to boost the production of hydroxychloroquine if required, and assist with supplying it to countries around the world.
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 www.novartis.com/coronavirus.
1. Philippine Society of Microbiology and Infectious Disease (PSMID) Treatment Guidelines for COVID-19 issued on 31 March 2020, which has been endorsed by the PH Government with the issuance of Department Memorandum No. 2020-0108.
Hydroxychloroquine Key Facts
Note: This HCQ infographics is being updated with new and important information.
What is Hydroxychloroquine or HCQ?
HCQ is a drug that has long been used for the treatment of malaria and certain autoimmune diseases such as systemic lupus erythematosis and rheumatoid arthritis in adults.1
Why is there so much interest in HCQ?
Based on preliminary medical evidence from researchers, there is interest in evaluating HCQ, and multi-drug combinations, as a potential treatment for COVID-19.2 HCQ has also demonstrated antiviral activity against the virus that causes COVID-19 (SARS-CoV-2) in laboratory tests.3,4 The medicine is currently under investigation in multiple large- and small-scale clinical trials to generate the necessary evidence for regulatory approval and generally accepted treatment guidelines.
Is HCQ safe and effective as a COVID-19 treatment?
The medical evidence at this point is preliminary and requires additional information to ensure that HCQ is effective and safe for this new indication. Several clinical trials assessing the safety and efficacy of HCQ in hospitalized COVID-19 patients are underway. Clinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease.5 The US Food and Drug Administration (US-FDA) authorized the temporary emergency use of HCQ during the pandemic for treatment of hospitalized COVID-19 patients when clinical trials are not available, or participation is not feasible.6
Is Novartis working with the FDA in conducting the HCQ clinical trials?
Yes, Novartis has reached an agreement with the US-FDA to proceed with a Phase III clinical trial in the US with approximately 440 patients to evaluate the use of HCQ for the treatment of hospitalized COVID-19 patients. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.7 We will report the results of the clinical trial as soon as these become available.
Is it true that Novartis is donating HCQ globally?
Yes, Novartis, through Sandoz, has made a global commitment to donate up to 130 million tablets of HCQ to supply global clinical research efforts. We donated HCQ to the Philippine Government in response to the request of the Department of Health (DOH). The donation aims to provide a potential treatment for hospitalized COVID-19 patients in the country, following the Philippine Society of Microbiology and Infectious Disease (PSMID) Treatment Guidelines for COVID-19,8 and to advance responsible clinical research on COVID-19.