Several pharmaceutical firms announced today their commitment to support the COVID-19 pandemic response by either donating or accelerating production of hydroxychloroquine and chloroquine.
Both drugs currently are under evaluation in clinical trials for the treatment of COVID-19.
Hydroxychloroquine sulfate is in a class of medications historically used to treat and prevent malaria, but is not approved for the treatment of COVID-19. It has been identified as a possible treatment for COVID-19, and the U.S. government has requested its immediate availability.
Novartis said it is supporting ongoing clinical trial efforts and will evaluate needs for additional clinical trials.
When supported for use in COVID-19 infected patients by regulatory authorities, Novartis intends to donate up to 130 million 200 mg doses of generic hydroxychloroquine by the end of May, including its current stock of 50 million 200 mg doses. The company also is exploring further scaling of capacity to increase supply and is committed to working with manufacturers around the world to meet global demand.
Novartis' Sandoz division, which currently only holds a registration for hydroxychloroquine in the United States, will pursue appropriate regulatory authorizations from the FDA and the European Medicines Agency. Novartis will work with such stakeholders as the World Health Organization to determine the best distribution of the medicine to ensure broad access to patients most in need of it globally. The company aims to ensure that patients currently depending on this medicine are not impacted by the donation.
The commitment announced today builds on the previously announced commitments of a $20 million Novartis COVID-19 Response Fund, drug discovery collaboration efforts, support of clinical trials for existing Novartis medicines, and Sandoz's commitment to maintain stable prices on a basket of essential medicines that may help in the treatment of COVID-19.
Novartis, which intends to work closely with other manufacturers to scale up production of hydroxychloroquine as necessary to support global supply, encourages industry, governments and international institutions to ensure adequate global supply of medications to treat COVID-19 patients.
Mylan announced that it has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility in the United States to meet the expected increased demand resulting from potential effectiveness of the product in treating COVID-19. The company also is taking steps to initiate production of this product outside the United States in the coming weeks, as well as be in a position to begin supplying the product by mid-April and ramp up manufacturing to provide 50 million tablets to potentially treat a total of more than 1.5 million patients.
Although the product currently is not approved for the treatment of COVID-19, it is listed by the World Health Organization as a drug under investigation for efficacy against the coronavirus.
Teva also announced the immediate donation of more than 6 million doses of hydroxychloroquine sulfate tablets through wholesalers to hospitals across the United States.
Amneal is ramping up production of hydroxychloroquine sulfate at several of its manufacturing sites and expects to produce approximately 20 million tablets between now and mid-April. Those tablets will be made available nationwide through Amneal’s existing retail and wholesale customers, as well as through direct sales to larger institutions in need.
“This is a critical time in the fight against COVID-19,” said Chirag and Chintu Patel, Amneal's co-CEOs. “With our existing supply of hydroxychloroquine sulfate, and the ability to fast-track production, Amneal is well positioned to help meet the potential demand for patients in need. We are grateful to our employees for working to accelerate production and will continue to do everything we can to support the healthcare needs of our communities.”
Amneal already has begun shipping product. As a socially responsible company, Amneal will work to ensure its available inventory allocation is widely and evenly distributed to benefit the most patients possible, the company said.
Two Indian pharmaceutical firms, Ipca Laboratories and Zydus Cadila, have received orders to produce chloroquine for the U.S. market, according to a report in The Print.
“Yes, we have received inquiries for the supply of hydroxychloroquine," according to an official spokesperson at Zydus Cadila. "Our priority at this moment is to ensure consistent supplies, if need arises, and are ramping up our production.”
The spokesperson also said that the company can “even quadruple our capacities if need be as we are fully integrated to produce both API and finished dose formulation. We believe that we will be able to cater to the requirements as we are among the few companies in the world who have capabilities to manufacture the drug in large quantities.”