Leading biopharmaceutical companies have been collaborating over the past seven months on researching and testing therapeutics that could lower mortality rates or lessen the severity of Covid-19.
While there is an urgent need for these therapeutics, the biopharmaceutical industry is committed to the rigorous standards needed for the approval of Covid-19 treatments and vaccines.
During the recent press conference of the International Federation of Pharmaceutical Manufacturers and Associations based in Geneva, it was reported that 22 leading IFPMA member companies are currently involved in the research and development of therapeutics and together, they have conducted 81 clinical trials that evaluated the therapeutics’ effectiveness.
The main Covid-19 treatments being looked at are anti-virals, antibodies and convalescent plasmas as well as anti-inflammatories. This is encouraging as the clinical response to help patients with Covid-19 requires multiple treatment options. Studies indicate that there is no one therapeutic that can treat or cure patients with the virus.
“We are continuing to see extraordinary collaboration across the biopharmaceutical industry, academe and biotech to accelerate research and development and develop new treatments and vaccines at record speed,” said David A. Ricks, Chairman and CEO of Eli Lilly and Company and President of IFPMA.
“Working together, we’ve made significant progress in the search for new treatments and vaccines to contain and ultimately extinguish Covid-19. And to ensure that no one is left behind in the face of this devastating disease, our industry remains committed to making sure they are available and affordable for all patients who need them.”
Update on therapeutics research
Present during the press conference were Daniel O’Day, Chairman of the Board and Chief Executive Officer of Gilead Sciences Inc.; Kenneth C. Frazier, Chairman of the Board and Chief Executive Officer of MSD; Dr. Albert Bourla, Chairman and CEO of Pfizer; Dr. Severin Schwan, CEO of the Roche Group and Vice President of IFPMA and Thomas Cueni, Director General of IFPMA.
The CEOs were given the opportunity to update attendees of their efforts in developing therapeutics and vaccines for Covid-19. One treatment that has been authorized for use so far against Covid-19 is Remdesivir, an anti-viral developed by Gilead.
O’Day explained that the development of Remdesivir did not happen over a short time frame. It is the result of “decades of investments in research and very importantly at Gilead, in anti-viral research.”
“The story of Remdesivir started 10 years ago due to our investments in emerging viruses. We say that Remdesivir had effects on other viruses in this family of coronaviruses like MERS and SARS in the laboratory and that level of investment and preparedness allowed us to move quickly,” O’Day said.
“The way that Remdesivir works is that it is an anti-viral. It is one of the mechanisms that we believe will have an impart in this devastating disease and what Remesivir has is that it inhibits the ability of the virus to replicate,” O’Day added.
Clinical trials
When the nature of Covid-19 was first announced in January, O’Day said Gilead moved rapidly to conduct a suite of clinical trials “that were designed to answer different questions and the results of three very robust randomized trials had consistent results.”
“The results showed that for severe, hospitalized patients, Remdesivir is an IV medicine that is administered in an acute setting and this resulted in improvement in clinical symptoms, in a significant reduction in hospital stay and an improvement in mortality,” he said.
Now that Remdesivir has had such an impact on hospitalized patients as a stand alone agent, O’Day said Gilead is also collaborating with other companies “to see if we can have a combination approach to get an even stronger effect, a more durable effect on patients.”
“This is characteristic of viral diseases like HIV and Hepatitis C. We have seen at times that when combining an anti-rival medicine with other anti-virals with other mechanisms, we can even have a greater impact on patients and society,” he said.
Available in the Philippines
Remdesivir will be made available in the Philippines through a Compassionate Special Permit (CSP) under Camber Pharmaceuticals, a subsidiary of Hetero. Camber Pharma’s Remdesivir is the first authorized and licensed Remdesivir by Gilead Sciences to be supplied and distributed in the Philippines.
“It is a significant milestone for all of us and we are very thankful to our parent company Hetero. With Remdesivir, we hope to reduce the treatment time of patients in hospitals thereby reducing the burden on medical facililites in Covid -19 cases,” said Camber Pharma’s Country Manager Manoj Singh.
As for their future plans for Remdesivir, O’Day said they are looking into delivering the therapeutic in an inhaled mechanism. He explained that Remdesivir’s formulation is not suitable for a pill because “the way it is metabolized in the body is that it metabolizes very quickly to the liver.”
“However, an inhaled mechanism will directly go to the lungs which is the greatest of viral replication for the disease. Early results have been interesting and we actually just started clinical trials on an inhaled version of this so earlier in the treatment course is almost always better in anti-virals and in combination can improve the benefits,” O’Day added.
Vaccine
For his part, Dr. Bourla said that in addition to developing an antiviral therapeutic for Covid-19, Pfizer started to develop in partnership with a German company a vaccine for Covid-19. According to Dr. Bourla, the vaccine is already “at a very advanced stage.”
“We started developing the vaccine at the end of July. We will have one big pivotal trial that will tell us if we have an effective vaccine or not,” Dr. Bourla said. “This is a trial that will need us to enroll 30,000 participants to be able to be able to come to a conclusion. So far, we have enrolled 23,000 patients and a significant number of them have already started to get the second dose of the vaccine.”
He said by the end of October, Pfizer would be able to have “enough events to say if the product works or not” and that it would be submitted for approval by then.
“If we have enough events, we may be able to say that the product is safe and efficacious in that October time frame and submit it immediately for approval,” he said.