Covid-19 roundup: J&J charts swift path to 1B vaccine doses; Embassy cable spotlights possible Wuhan lab connection to coronavirus
J&J, the first large pharmaceutical company to unveil its performance in the first quarter, acknowledged the coronavirus pandemic has had a sharp impact across its full-year guidance and offered some fresh details on its Covid-19 vaccine in development.
J&J, like its peers, is attempting to do in six to 12 months what usually takes 5 to 7 years, CEO Alex Gorsky reminded analysts on a conference call on Monday.
The plan is to initiate human testing of its candidate by September, have safety and data by the end of the year, and have the vaccine ready on a not-for-profit basis for emergency pandemic use in early 2021, executives said, adding that they expect to have the capacity to generate 600 to 900 million doses at the start of 2021 and ramp up to a billion doses over the course of the year.
The Band-Aid makers’ cuts across its 2020 guidance were driven exclusively due to the uncertainty surrounding its medical device business linked to deferred procedures, executives stressed.
“Our estimates of the Covid-19 impact assume the relative shape of the Covid-19 curve as being more of an acute shorter-term impact, rather than a prolonged impact,” said CFO Joe Wolk, explaining the basis of the company’s revised 2020 projections.
The assumptions at play here are a mid-to-late April peak; that the virus does return with the “same intensity” in the fall, in that the world will be better prepared to test, identify and isolate it, and therapeutic options may be available; that elective procedures and doctor visits will largely be permissible in the second half of 2020 — with recovery for procedures beginning in the third quarter and improving further in the last quarter; and economic disruptions that have a knock-on effect on employment and insurance coverage could begin to improve in the second half of the year, he said.
In the first quarter, global sales of the company’s medical devices also fell nearly 5% year-over-year as the coronavirus crisis deferred medical procedures in areas such as orthopedics and ophthalmology. The appetite for medical devices will be uncertain over the course of the year, the company said.
“We believe hospital systems will have the capacity to make up different procedures from earlier in the year, but we suspect it could take time for patients to get comfortable scheduling an elective procedure, hospitals and surgeons may still be recovering from peak Covid-19 impact,” Wolk said. “And there will be economic challenges we discussed earlier, namely a potential impact on the number of insured patients, and a changing prioritization of income in the near term. Those factors lead us to assume a recovery in a range of zero percent to 15%.”
Conversely, J&J’s over-the-counter and consumer products business saw some growth, as hoarding and stocking up behavior saw an uptick in the quarter. However, these gains are expected to correct over the year, although demand for the company’s sunscreen products will understandably slow.
Even the pharmaceutical business saw a marginal benefit as providers stocked up on 90-day supplies versus the previous 30-day paradigm in the quarter, apart from gains in market share that were marginally offset by biosimilar and generic competition. J&J expects a “small level of disruption” associated with delayed diagnoses and new patient starts in the coming months. Still, the status of its 2020 projected regulatory filings remain intact, the company said, underscoring that it has not received notifications from regulatory authorities on any potential delays.
As expected, the company stuck by its dividend, indeed lifting it for the 58th consecutive year, but disclosed that it was not planning to engage in any stock repurchase program for the foreseeable future. Meanwhile, while it is planning to hold off on divestitures given the financial environment, the company did indicate that it is still shopping for deals.
“The current crisis does not reduce our desire to do these transactions. In fact, given our financial strength, we may be in a better position to find opportunities that will augment sustainable long term growth,” Wolk said.
— Natalie Grover
Theories that the coronavirus originated in a Wuhan lab are revived by warnings from US embassy — report
The notion that the coronavirus originated in a lab in Wuhan took root early in the brewing pandemic, spread online and never completely died out — despite repeated assurances that the virus is of animal origin and was not engineered in a lab.
Now reports are circulating that US Embassy officials in China sent back a pair of official warnings about a lack of biosafety measures at one of the suspected research facilities where researchers carried out work on bat coronaviruses. And that raises the possibility — I’ll emphasize possibility — that the virus may have escaped the lab.
The lab is the Wuhan Institute of Virology, which Washington Post columnist Josh Rogin notes received the highest biosecurity level rating 5 years ago — a first in China. Researchers at the center led by Shi Zhengli were studying bat coronaviruses linked to SARS. The other lab that has attracted attention is the Wuhan Center for Disease Control and Prevention.
An early 2018 cable from the embassy reported:
“During interactions with scientists at the WIV laboratory, they noted the new lab has a serious shortage of appropriately trained technicians and investigators needed to safely operate this high-containment laboratory.”
The Chinese scientists reported on their work in a paper titled: “Discovery of a rich gene pool of bat SARS-related coronaviruses provides new insights into the origin of SARS coronavirus.”
And that has US officials buzzing about a possible connection to Covid-19, Rogin reports.
The Chinese government has reported its theory that the outbreak began at a Wuhan fish market. But since then the Post columnist says that the Chinese have locked down any info on the source of the virus.
The WIV, meanwhile, insists it had no connection to the outbreak and weeks ago their scientists said that the 2019-nCoV virus was a bat-derived coronavirus.
Just another conspiracy theory? Perhaps. But Rogin thinks it’s a lead that ought to be followed in determining exactly where the virus originated, with an eye to preventing any re-occurrence, whether man-made or nature-made. — John Carroll
GSK, Sanofi enter pact to co-develop vaccine
British drugmaker GSK, whose vaccine adjuvant technology is already being used by two Chinese companies and an Australian university as the groups develop Covid-19 vaccines, is now joining forces with its French peer Sanofi to work on a vaccine.
The Europe-based drugmakers will join a cadre of others — including Moderna, Pfizer and a platoon of academic groups — feverishly working on a weapon that could relegate the often life-threatening illness to the annals of the past.
Sanofi’s recombinant DNA technology, which is the basis of the company’s licensed influenza product in the United States, is set to make the Covid-19 vaccine more potent and easier to manufacture at scale with the addition of GSK’s adjuvant. The candidate is expected to enter human trials in the second half of this year and, if successful, the companies aim to complete the development required for deployment by the second half of 2021.
Definitive terms of the pact, which joins two of the world’s largest vaccine companies, will be ironed out over the coming weeks.
Sanofi also has two other Covid-19 projects in its repertoire. In February, the company said it was developing a Covid-19 vaccine candidate in partnership with BARDA, using its egg-free, recombinant DNA platform and work from a previous SARS vaccine. The following month, Sanofi unveiled it was partnering with Translate Bio to create an mRNA vaccine candidate for Covid-19. — Natalie Grover
AstraZeneca kicks off Calquence trial against Covid-19
Months after scoring expanded approval for its BTK inhibitor Calquence, AstraZeneca has announced it will be testing the therapy in a trial designed to evaluate the agent’s effect on mortality and diminishing the need for assisted ventilation in patients with life-threatening Covid-19 symptoms.
AstraZeneca’s Calquence belongs to a family of drugs that thwart Bruton’s tyrosine kinase, an enzyme that plays a role in oncogenic signaling and the rise of some leukemic cells. It is a second-generation BTK inhibitor, designed to be a safer and more tolerable option for certain blood cancer patients, versus J&J and AbbVie’s first iteration — Imbruvica — which has generated billions in sales, but carries significant side-effects.
Early clinical data suggest Calquence induces diminished inflammation and reduces the severity of Covid-19-related respiratory distress, the company said, adding that the impact of the drug will be measured in hospitalized patients both inside and outside ICUs. — Natalie Grover
China greenlights two more vaccine trials
In mid-March, China’s CanSino Biologics became one of the frontrunners in the race to develop a Covid-19 vaccine. Now, two other Chinese drugmakers have secured approval to kick off human testing for their respective vaccine candidates.
The experimental vaccines were developed by Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm), and Beijing-based company Sinovac Research and Development. Trials have begun, news agency Xinhua reported on Tuesday.
Unlike CanSino’s recombinant adenovirus vector vaccine, these two companies are developing inactivated vaccines in which dead pathogens, in this case SARS-CoV-2, are used to enhance immunogenicity. Such vaccines already exist to protect against diseases such as hepatitis A and influenza.
Sinopharm, which is also working on another inactivated vaccine and a genetically engineered vaccine for Covid-19, has set aside $142 million for its vaccine research. Sinovac, which has experience developing a SARS vaccine, has shown promising cross-neutralization reaction to different Covid-19 strains, the report said. — Natalie Grover
For a look at all Endpoints News coronavirus stories, check out our special news channel.