Covid-19 roundup: Pfizer hustling up millions of doses of vaccine — details $748M BioNTech deal; CDC tweaks stance on controversial malaria drugs
Pfizer and BioNTech are ready to outline the details of their ambitious alliance on a Covid-19 mRNA vaccine for the world.
Their plan now is to start human trials in a matter of days, while ramping up manufacturing for a global market well ahead of the first readout. And the German mRNA company — largely owned by the billionaire Struengmann brothers — is getting a big upfront to go with the collaboration.
The pharma giant is providing the biotech $185 million in cash, including an equity investment of $113 million. Then there’s $563 million in milestones. They plan to jointly commercialize the vaccine around the planet, with Fosun taking China per their separate pact with BioNTech.
The clinical trial supplies of the vaccine will be provided by BioNTech’s existing manufacturing facility, leaving the partners to start immediately building out enough manufacturing capacity to provide “millions” of doses before the end of this year and “hundreds of millions” by next year. All of that investment is “at risk” — a bet that their jab can end the outbreak.
Pfizer, meanwhile, is also beginning testing soon on a new Covid-19 drug for mild to moderate cases. The company tells the Wall Street Journal that the therapy has the potential to stop the virus from replicating. And they also plan to study their rheumatoid arthritis drug Xeljanz against the virus, part of a multi-prong effort to combat Covid-19.
First up, though, is mRNA.
A group of mRNA companies are taking a shot at producing new vaccines in record time. That group includes BioNTech, CureVac and Moderna in the US. Their technology, while yet to produce an approved product, holds the promise of swift identification of the antigens needed to come up with an effective way to spur immune resistance to the coronavirus.
If it works, it will revolutionize pandemic preparedness efforts. The whole world is watching what happens next. — John Carroll
CDC tweaks guidance on controversial coronavirus meds — report
The European Medicines Agency has cautioned against using the pair of malaria drugs — chloroquine and hydroxychloroquine — outside of clinical trials or national emergency use programs for coronavirus patients, citing the potential for serious side-effects at high doses or when used in combination with other drugs.
Meanwhile, in the middle of March, President Trump reportedly personally pressed federal health officials to make the malaria drugs available to treat the new coronavirus. Soon after, the FDA cited limited in-vitro and anecdotal clinical data to endorse the emergency use of the two therapies to treat malaria and lupus among other disorders for Covid-19 when clinical trials are not available, or participation is not feasible.
Now, the CDC has walked into the controversy. According to a report by Reuters, the agency hastily removed from its website atypical guidance informing doctors on how to prescribe hydroxychloroquine and chloroquine. Initially, the CDC webpage, titled Information for Clinicians on Therapeutic Options for Patients with COVID-19, said: “Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally” several ways to prescribe the drugs to treat Covid-19.
A few tiny trials out of France and China have so far yielded inconclusive evidence on the use of the drugs in patients with Covid-19. The studies and the data that emanated from them is not peer-reviewed.
“Why would CDC be publishing anecdotes?” asked Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, in conversation with the wire agency.
On Wednesday, the CDC website read: “There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19.” The truncated guidance also said “hydroxychloroquine and chloroquine are under investigation in clinical trials” for use in coronavirus patients.
Trump has been touting the pair of drugs as Covid-19 treatments for weeks now, despite caution from his own scientific advisors, including infectious disease expert and NIAID chief Anthony Fauci who has insisted that there is no strong scientific proof backing their efficacy against Covid-19.
Cowen analyst Yaron Werber, in a note on Wednesday, suggested that given the existing (limited) data on hydroxychloroquine (HCQ), the potential for its use will likely be as a prophylactic agent.
“(B)ased on all available data, HCQ is unlikely to significantly improve clinical outcomes for hospitalized patients with COVID-19…we would likely already be aware if HCQ was having a robust effect given its wide use throughout China, Italy and the U.S. thus far,” he wrote. “The role for HCQ in post-exposure prophylaxis appears more promising with many clinical trials currently investigating this concept. The drug has shown effectiveness in viral clearance in vitro and may provide benefit if viral replication is impaired in the very early stages of illness, before the systemic inflammatory cascade takes hold.” — Natalie Grover
Boston hospitals assemble a small Covid-19 study in the front lines of the Covid-19 war
A flu antiviral from Japan that was rushed into use in China to help fight the first outbreak of Covid-19 will now be featured in a small US study — right in one of the central fronts of the outbreak.
Brigham and Women’s Hospital, Massachusetts General Hospital and the University of Massachusetts Medical School have begun collaborating on a Phase II study of favipiravir that will recruit 50 patients suffering from coronavirus, according to its manufacturer, Fujifilm.
This small trial comes a little more than a week after Fujifilm launched a more ambitious Phase III in Japan.
Favipiravir — sold as Avigan in Japan since its initial approval in 2014 — attracted a lot of attention in China during the peak of its fight against the new virus. The Chinese adopted it after a pair of small studies. And it’s helped shed some additional luster on Gilead’s remdesivir, which many believe will work better using the same mechanism of action.
As far as the data we’ve seen so far, though, it’s all still a crapshoot.
The drug inhibits RNA polymerase necessary for influenza virus replication, which could be useful in the Covid-19 war. The jury, though, is still very much out over how effective it may be or whether it can be more than a marginal treatment against a fast-spreading virus. — John Carroll
Biotechs broaden the spectrum of anti-inflammatory drugs thrown against Covid-19
With the FDA signalling a willingness to wave a broad spectrum of Covid-19 therapies into the clinic, two biotechs are pitching in their pipeline stars to tame the inflammation often responsible for devastating patients.
Biohaven has the green light to begin testing intranasal vazegepant — its CGRP receptor antagonist designed for acute migraines — in pulmonary complications of the viral infection. “This pandemic is a call to action for our entire industry,” CEO Vlad Coric said, and Biohaven with researchers at Thomas Jefferson University to develop the protocol.
Similarly, San Diego-based CalciMedica has permission to study whether its small molecule drug — which inhibits calcium release-activated calcium (CRAC) channels — can keep patients with severe pneumonia from going on ventilators.
Once they provided data from their Phase II pancreatitis trial involving patients with systemic inflammation and hypoxia, as well as animal data suggesting CM4620-IE has protective effects on lung injury, the FDA approved their IND in less than 10 days, CMO Sudarshan Hebbar told Endpoints News.
The trial will start small with plans to recruit 60 patients between Regions Hospital in St. Paul, Minnesota and Henry Ford Hospital in Detroit. Patients will be randomized to receive drug or placebo in a 2:1 ratio. — Amber Tong
Ramaswamy’s Datavant kicks off effort to create a data repository for US coronavirus patients
Forget Zoom, health care and software companies are reportedly looking to collate data from coronavirus-infected patients to study disease transmission, identify the most vulnerable groups of the population and evaluate how effective investigational drugs are.
Vivek Ramaswamy’s Datavant — which aggregates and analyzes real-world medical data from a suite of sources to assist biopharma companies, providers and payers — began to spearhead one such effort in March, according to the Wall Street Journal, which cited a person familiar with the matter.
Health care tech companies — Allscripts Healthcare Solutions and Change Healthcare — have committed to donating data for the effort, while health insurance company Anthem has been approached to contribute medical claims data, the report said.
Datavant, which calls the big CRO Parexel a partner, aims to include data about every Covid-19 positive patient (excluding names or identifying details) drawing on information that emanates from hospitals, pharmacies and health insurers. The registry is being positioned as a free resource for government and academic researchers, the WSJ reported.
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