Sandoz donates 100.000 units hydroxychloroquine to Romania

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Sandoz, a division of Novartis Group in Romania (Novartis Pharma, Novartis Oncology and Sandoz), has announced today the donation of 100.000 dozes of generic hydroxychloroquine produced by Sandoz to cover the treatment for more than 4.000 hospitalized COVID-19 patients, in Romania. The aim of the donation is to enable patients access a potential effective treatment in the fight against COVID-19. The Romanian healthcare authorities will allocate the drug from C.N. UNIFARM S.A. to the hospitals in need. Hydroxychloroquine – a medicine included in the national standard treatment protocol against COVID-19 established by the Romanian Ministry of Health.

Hydroxychloroquine, an old antimalarial drug also indicated for lupus and rheumatoid arthritis, is currently under clinical investigation in patients with COVID-19. While there is a lot of hope world community places on this medicine and combinations including it to treat COVID-19 patients, the scientific evidence at this point is preliminary and requires additional evaluation. At a global level, Novartis is supporting ongoing clinical trial efforts and will evaluate the needs for additional clinical trials.

The treatment protocol established by the Romanian Ministry of Health includes hydroxychloroquine among the recommended treatments for hospitalized patients infected with COVID-19.

“I value the social involvement and the outstanding support from the company to support our efforts to overcome the crisis. The Ministry of Health team is working 24 hours a day to find the resources that are needed and to take measures adapted to the situation and any support is welcome and in the benefit of our patients”, stated Nelu Tătaru, Ministry of Health in Romania.

Thodoris Dimopoulos, Country Head of Sandoz Romania, added: “At present, it is more important than ever that we fulfill our mission of providing primary healthcare in Romania. We are happy that in collaboration with regulatory authorities in Romania we were able to respond fast to the request coming from the Ministry of Health, to support supplying part of the hydroxychloroquine quantity needed as part of the national treatment protocol. By donating this sizable quantity of hydroxychloroquine to the Romanian authorities, on top of the previous contribution from Novartis Group in Romania of approximately 480.000 USD, including Azithromycin produced by Sandoz in Romania, we are playing our part in this by enabling hospitalized patients access the medicines prescribed in the national treatment protocol for COVID-19. In such times social solidarity is essential. We need to support our authorities and to treasure our healthcare professionals”.

Hydroxychloroquine is approved in the US by the FDA and has long been used for the treatment of malaria, as well as for some autoimmune diseases including systemic lupus erythematosis and rheumatoid arthritis in adults.

Although there is no approved treatment for COVID-19 today, hydroxychloroquine (HCQ) has shown promise in early studies in vitro1 and it is currently used in the treatment against COVID19, including in Romania in accordance with the national treatment protocol. Novartis Group in Romania is supporting its use only according to the national protocol elaborated by the Ministry of Health, for the hospitalized patients, under strict medical monitoring.

The 100.000 doses of generic hydroxychloroquine produced by Sandoz donation builds on the contribution to the Romanian Healthcare system that Novartis Group in Romania announced on April 6th. That support consisted of around 480.000 USD to the Romanian healthcare system to fight against COVID-19 pandemic. The company supported with approximately 380.000 USD the National Society of Red Cross Romania, to build an emergency fund for protection materials, medical supplies and equipment, and with a total amount of 50.000 USD to cover the urgent COVID-19 related needs expressed by five frontline hospitals in Bucharest, Cluj Napoca, Iasi, Ploiesti, and Targu Mures, to acquire protection equipment, materials, goods, and other medical equipment. Also, Novartis Group in Romania donated 100.000 dozes of azithromycin 250 mg produced by Sandoz to the National Institute of Infectious Diseases – Prof. Dr. Matei Balş and to the national network of hospitals designated as frontline fight against COVID-19. This quantity can cover the treatment of approximately 5.000 patients. Azithromycin is a medicine recommended by the World Health Organization and is part of some therapeutic combinations, including with hydroxychloroquine, in hospitalized patients with chronic diseases associated with COVID-19. Azithromycin donation was possible thanks to the Sandoz Targu Mures production unit, where this medicine is manufactured for 60 countries in Europe, North America and other countries where all the efforts to increase the production of Azithromycin were intensified.

The 100.000 doses of hydroxychloroquine donation in Romania 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, at a global level, 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.

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