Gilead Sciences Announces Measures to Expand Remdesivir Access Amid Surging COVID-19 Cases in India

April 28, 2021 /Bio ValleyBIOON/ --Currently, the COVID-19 epidemic abroad is still spreading rapidly. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport》, as of 00:00 on April 28, 2021, the global cumulative number of confirmed cases exceeded 140 million (148.6 million), and the number of deaths exceeded 3.13 million (3.136 million).

In particular, since April, the epidemic in India has developed in an "explosive" manner,The number of newly confirmed cases in the past week exceeded 2 million.. Currently, the epidemic situation in the country is extremely severe.

COVID-19 Outbreak in India (Click the image to view a larger version)

Recently, Gilead Sciences announced that, in response to the rapid surge in COVID-19 cases in India, the company is providing technical assistance to its voluntary licensing partners, supporting the expansion of new local manufacturing facilities and donating active pharmaceutical ingredients (APIs) to rapidly scale up the production of remdesivir.

In India, remdesivir has been approved for emergency use to treat hospitalized adult and pediatric patients with suspected or laboratory-confirmed severe COVID-19. In addition to supporting its license holder in expanding local production capacity, Gilead will donate at least 450,000 vials of Veklury (remdesivir) to help address the urgent needs of patients in India.

Johanna Mercier, Chief Commercial Officer of Gilead Sciences, stated: “The recent surge in COVID-19 cases in India has had a devastating impact on communities and placed unprecedented strain on healthcare systems. We are committed to doing our part to help address this crisis. Our current focus is on collaborating with governments, health authorities, and our voluntary licensees to help meet the needs of patients in India, enabling them to benefit from remdesivir treatment as quickly as possible.”

All seven of Gilead’s licensees in India have significantly accelerated the production of remdesivir by expanding batch sizes, adding new manufacturing facilities, and/or engaging local contract manufacturers across the country. Although these efforts are expected to increase the supply of remdesivir in the coming weeks, Gilead will donate at least 450,000 vials of Veklury to the Indian government to help address the urgent need for treatment.

To avoid disruptions in the supply of generic remdesivir to other low- and middle-income countries included in the voluntary licensing program, Gilead has also committed to providing support to voluntary license holders outside India to enhance their production capacity. Gilead’s planned support will include donating active pharmaceutical ingredients (APIs) to licensees to accelerate production.

Gilead’s voluntary licensing program for remdesivir, implemented in May 2020, has enabled more than 2.3 million people in over 60 low- and middle-income countries to access the medication. Building on Gilead’s pioneering voluntary licensing model for HIV and viral hepatitis therapies, the program grants long-term licenses to nine manufacturers, seven of which are headquartered in India, to facilitate access to remdesivir in 127 countries, including most low- and middle-income nations as well as India. These licenses remain royalty-free, reflecting Gilead’s commitment to ensuring broad patient access to remdesivir.

Veklury is an antiviral medication developed by Gilead Sciences, Inc. that inhibits the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19). In the United States, Veklury has been approved for the treatment of pediatric and adult patients aged 12 years and older, weighing at least 40 kg, who require hospitalization for COVID-19. The use of Veklury is restricted to hospitals or healthcare settings capable of providing acute care comparable to that provided in hospitalized patients.

Veklury (remdesivir) remains the standard of care for hospitalized adult patients with COVID-19. In the United States, more than half of hospitalized COVID-19 patients have received treatment with Veklury. Gilead Sciences continues to investigate the efficacy and safety of Veklury in hospitalized patient populations with persistent unmet medical needs, such as those with renal impairment, pediatric patients, and pregnant women, supported by several externally sponsored trials.

According to the annual report released in February this year, Veklury’s sales revenue reached $2.811 billion in 2020, with as much as $1.9 billion generated in the fourth quarter alone. (Bioon.com)

Original Source: Gilead Sciences Announces Steps to Expand Availability of Remdesivir in India