COVID-19 Pandemic Turns Big Pharma Rivals Into Bedfellows
Executive Summary
Industry leaders at a PhRMA briefing talked about the unprecedented level of partnership going into developing COVID-19 vaccines and treatments – not to mention making enough of them.
Drug companies are collaborating at an unprecedented level to help solve the global health crisis caused by COVID-19. Industry leaders talked during a media briefing hosted by the Pharmaceutical Researchers & Manufacturers of America (PhRMA) on 16 June about the collaboration going into the development of new treatments and vaccines and what will need to be an industry-wide commitment to help supply enough of the winning products to meet the global demand.
Cooperation among drug manufacturers amid the pandemic points to the severity of the global health crisis, and partnerships are forming along the spectrum from research to production. But the industry seems to have a collective understanding that the current crisis could be a chance to turnaround its tarnished reputation in the eyes of the public after years of drug pricing backlash. The level of cooperation going on may say something about the amount of goodwill – rather than profit – the industry hopes to reap from the effort.
"There isn't a week that goes by that I don't speak to maybe a dozen other CEOs," Eli Lilly & Co. CEO David Ricks said. He made similar statements in a fireside chat during the BIO Digital meeting, stressing that industry should draw from the fast-moving, collaborative pandemic response to find better ways to work in the future. (Also see "BIO 2020 Notebook: Conversations On Rebates, Racism And Remote Working" - Scrip, 12 Jun, 2020.)
AstraZeneca PLC CEO Pascal Soriot told the PhRMA briefing he was recently in a meeting with drug manufacturers including Merck & Co. Inc., Pfizer Inc., and Johnson & Johnson to discuss supply chain and distribution issues.
"The companies that are developing vaccines have agreed that if their vaccine doesn't work they will immediately surrender the capacity to another vaccine that could use the capacity," Soriot said. The vow is one Pfizer agreed to in the early months of the pandemic, when the company announced a multi-pronged commitment to helping solve the crisis.
Better Supply Strategies
Meeting the global demand for a vaccine, preventative antibody or treatment remains a big concern after one is successfully developed. The US government has already allocated 98% of the supply Gilead Sciences Inc. donated of remdesivir. (Also see "Coronavirus Notebook: Remdesivir Supply Dwindles; US FDA Signs Another RWE Deal; Corning Gets BARDA Contract For Glass Vials" - Pink Sheet, 9 Jun, 2020.) Drug makers are already ramping up manufacturing, well ahead of any potential approvals, so that they can be ready if they are successful.
Ricks suggested that like vaccine production, building a sufficient supply of antibody products requires a collaborative effort as well. “I think the best chance is to assemble a consortium around the best antibody solutions and encourage companies to join on to that,” he told the briefing. “If all of them are equal, then it won’t matter. We can just all make our own. But if there are some that are better than others we’ll need to be able to adjust capacities between companies in a network.”
Lilly is testing its antibody candidate LY-CoV555 for the treatment and prevention of COVID-19. (Also see "Coronavirus Update: Lilly Begins Clinical Trial Of Antibody Therapy" - Scrip, 2 Jun, 2020.)Ricks said the company is ramping up manufacturing production of the drug at sites now so that commercial product will be available in October. That could be "the best-case scenario," he said, for a potential approval under some kind of emergency use authorization.
Soriot said AstraZeneca has scaled up manufacturing for a vaccine in development under a partnership with Oxford University. The company received $1bn in funding from the US government for the production and delivery of the product now called AZD1222. SC142268 A Phase I/II trial is already under way in over 1,000 healthy volunteers and the company said it has plans to run a Phase III trial with 30,000 volunteers in the US. Soriot said AstraZeneca has scaled up manufacturing of about 2 billion doses of the vaccine, partly through partnerships.
"We have actually been developing the vaccine and manufacturing it in parallel," he said. "The risk we take is a financial risk because if the vaccine doesn't work than the investment in manufacturing would be lost."
He also said the company is committed to providing the vaccine at no profit during the pandemic phase of the health crisis, as some other drug makers have also vowed.
Genentech CEO Alexander Hardy also said Roche is putting millions of dollars at risk by increasing the production of Actemra (tocilizumab) as a potential treatment for COVID-19 before clinical trial data has read out successfully.
Roche is studying the IL-6 inhibitor in a Phase III trial for hospitalized COVID-19 patients with pneumonia and also more recently started a Phase III trial in combination with Gilead's remdesivir. Hardy said the company has gone from producing hundreds of thousands of doses of Actemra to millions of doses.
"We want to make sure we aren't in a situation where there is going to be difficult trade-off decisions because demand will far exceed supply. That is why we are all doing this," he said.
Global supply issues remain a concern, Hardy added. Genentech moved end-to-end product supply for Actemra to the US because that is where the company has the largest manufacturing plants and the ability to produce millions of treatments.
"Now we are in a situation where we are really dependent on ...[supplying] the world out of the US," he said. He said he spends a lot of time talking to legislators and policymakers about the importance of keeping the international supply chains working and open.
In Search Of Glass Vials And Rubber Stoppers
Scarce production inputs are adding to the supply chain problems. Ricks said that coronavirus monoclonal antibody candidates will need many of the same items existing products use, such as resins and filters, to manufacture the medicine.
Ricks added that glass vials and rubber are the “tightest part right now.”
“I think we’ll need to just balance that between companies and contract manufacturers,” he said.
Amid the push to approve vaccines and therapeutics, concerns are rising that supplies of essential items like glass vials will be in short supply. The Health and Human Services Department, as part of Operation Warp Speed, recently awarded a grant to Corning Glass to expand production of the vials needed for vaccine packaging. (Also see "Coronavirus Notebook: Remdesivir Supply Dwindles; US FDA Signs Another RWE Deal; Corning Gets BARDA Contract For Glass Vials" - Pink Sheet, 9 Jun, 2020.)Early in the outbreak, the supply chain for vials and other products was stretched thin, which limited supplies of essential medicines. (Also see "Hospitals Struggle To Supply COVID-19 Teams With The Medicines They Need" - Pink Sheet, 16 Apr, 2020.)
Additional reporting by Derrick Gingery ([email protected])