Gilead says it has prepared 1.5 million doses of Redcive for donations

On April 4, American time, Gilead Science Chairman and CEO Daniel O'Day (Daniel O'Day) published an open letter about Gilead's matters concerning the supply and donation of Ridsivir, Gilead Said: Every effort is being made to fulfil our major responsibilities with Red West.

"Including finished products available for distribution and drugs under study at the final production stage, our existing supply totals 1.5 million doses. This supply is calculated based on the optimal treatment time we are studying in clinical trials. The amount can meet the treatment of more than 140,000 patients. "

Daniel O’Day stated in an open letter that in the past week, Gilead has been in consultation with regulatory agencies to establish more expanded access options for the new treatment of redcive, a potential coronavirus pneumonia drug. Through this program, hospitals or doctors can apply for the emergency use of reduxil for multiple critically ill patients at the same time. These patients cannot participate in clinical trials, however, "emergency" is the truest description for them, their families, and the medical staff who provide them with treatment.

"We know the urgency of delivering medicines to these patients and believe that expanding the access plan will help speed up this process. In the plan, the new US hospital site has been launched and we continue to add new sites. We are in Europe Progress has also been made. Yesterday, the European Medicines Agency (EMA) announced that it has provided EU member states with recommendations on the implementation of the Radecivir expansion access plan in their countries. "

"In addition to expanding the access plan, we have continued to provide sympathetic medications of Randixvir for children and pregnant women on a case-by-case basis. Currently, more than 1,700 patients have been treated through these plans." Daniel O'Day In an open letter.

Redoxir is an experimental antiviral drug being developed by Gilead in the United States. It has not been approved for marketing. It has been used in clinical trials against Ebola virus infection in the past and has been serious in in vitro and animal studies. Acute respiratory syndrome (SARS) coronavirus and Middle East respiratory syndrome (MERS) coronavirus show good antiviral activity.

Since the outbreak of New Coronary Pneumonia, Radecivir is regarded as the most promising drug in research. Prior to the World Health Organization's investigation of the epidemic in China, it was stated that redoxivir may be the only effective drug for the treatment of new coronary pneumonia. In January of this year, based on the principle of "sympathetic medicine", American researchers used Radecivir on a person infected with a new coronavirus. The patient's symptoms improved significantly within a day or two, making the drug highly regarded.

Gilead emphasized that the company must take a responsible, ethical and ethical approach to determine whether redcive is indeed a safe and effective treatment plan. According to the plan previously disclosed by the company, they will disclose some clinical data in early April. At present, patients can obtain Radecivir through clinical trials, sympathetic medication and other channels.

Daniel O’Day stated in an open letter that one of Gilead ’s important responsibilities now is to ensure adequate supply of Redcive. To provide medicines for clinical trials, sympathetic medications, and expanded access programs, our increase in supply actually starts from scratch. So far, our progress in this area has benefited from our rapid expansion of production and increase in supply since January.

"We decided to invest and expand the scale, because if the patient needs Radecivir, we must be prepared." Daniel O'Day said, the production of Radecivir is a linear process that requires special chemical processes and more Some chemical reactions, some of which take several weeks to complete. It also requires scarce raw materials and a very limited global aseptic production capacity, which are necessary before providing finished pharmaceutical products for use by patients.

"Under these limiting factors, our team has found a variety of ways to speed up production. This includes improvements to the production process to shorten production time. Therefore, we reduced the overall production time from approximately one year to approximately six months . We have converted our equipment to produce Redcive, and we have expanded our network of external manufacturing partners around the world. "

According to reports, including the finished products available for distribution and the drugs under study in the final production stage, Gilead's existing supply of Ridesivir totals 1.5 million doses. Gilead is providing free medicines for the treatment of severe patients with new coronavirus pneumonia. "The 1.5 million doses of medicines can be used in clinical trials, sympathetic medicines, and expanded access programs, and donated to be widely used after possible regulatory approval in the future. These medicines can be administered by intravenous injection in hospitals every day for treatment Patients with severe symptoms. "Looking forward, Gilead will be able to further increase the supply of Ridesivir as raw materials with longer delivery periods arrive for production.

"We set an ambitious goal and strive to produce more than 500,000 courses of medicine by October, and the supply will exceed 1 million courses by the end of this year." Daniel O'Day introduced in an open letter To help achieve and surpass this goal, the company is building an alliance of pharmaceutical and chemical manufacturers, which are distributed around the world and can expand the global capabilities of raw material supply and production.