Covid-19 roundup: Mer­ck sub­mits mol­nupi­ravir for EUA; In­dia re­sumes vac­cine ex­ports af­ter Delta surge

Mer­ck’s oral an­tivi­ral drug for Covid-19 has been sub­mit­ted to the FDA for emer­gency use au­tho­riza­tion, the com­pa­ny an­nounced Mon­day morn­ing.

The com­pa­ny, which col­lab­o­rat­ed with Ridge­back Bio­ther­a­peu­tics, an­nounced last week that mol­nupi­ravir re­duced death and hos­pi­tal­iza­tions by 50%. The sub­mis­sion for EUA is based on pos­i­tive re­sults from the Phase III tri­al. Of 385 pa­tients in the tri­al, just 28 were hos­pi­tal­ized af­ter re­ceiv­ing mol­nupi­ravir, com­pared to 53 out of 337 pa­tients on the place­bo. No pa­tients who re­ceived mol­nupi­ravir died, com­pared with eight who were on the place­bo.

If au­tho­rized, it will be the first pill giv­en the go-ahead to treat Covid-19 and pro­vide doc­tors an eas­i­ly ad­min­is­tered tool to pre­vent new­ly di­ag­nosed pa­tients from pro­gress­ing in­to more se­ri­ous cas­es. Right now, the on­ly treat­ment au­tho­rized to keep pa­tients from be­ing hos­pi­tal­ized is mon­o­clon­al an­ti­bod­ies.

Sev­er­al coun­tries have al­ready inked sup­ply deals for the drug, in­clud­ing Thai­land, South Ko­rea, Malaysia and the US, with which Mer­ck agreed to sup­ply 1.7 mil­lion dos­es ear­li­er this year.

Be­fore it was li­censed out to Mer­ck and Ridge­back, a non-prof­it biotech at Emory Uni­ver­si­ty de­vel­oped the drug for the flu pan­dem­ic, but shift­ed when the coro­n­avirus broke out.

“The ex­tra­or­di­nary im­pact of this pan­dem­ic de­mands that we move with un­prece­dent­ed ur­gency, and that is what our teams have done by sub­mit­ting this ap­pli­ca­tion for mol­nupi­ravir to the FDA with­in 10 days of re­ceiv­ing the da­ta,” Robert Davis, Mer­ck’s CEO, said in a state­ment. “We are grate­ful to the pa­tients and in­ves­ti­ga­tors in our study, and of course to our own col­leagues who have ex­em­pli­fied Mer­ck’s high stan­dards of sci­en­tif­ic ex­cel­lence and our un­wa­ver­ing com­mit­ment to pa­tients.

In­dia re­sumes vac­cine ex­ports af­ter Delta surge

Af­ter a near­ly eight-month de­lay, the Serum In­sti­tute of In­dia has shipped an­oth­er batch of vac­cines. On Sat­ur­day, those vac­cines ar­rived in Bangladesh.

The Bangladesh gov­ern­ment, dis­trib­u­tor Bex­im­co Phar­ma­ceu­ti­cals and the Serum In­stitue have a deal for 30 mil­lion dos­es of the As­traZeneca jab. In­dia had stopped ex­ports while it ex­pe­ri­enced a bru­tal wave of the pan­dem­ic ear­li­er this year.

Dai­ly case num­bers sky­rock­et­ed from around 25,000 in mid-March to more than 400,000 a day by May. Since then, how­ev­er, the vac­cine out­put has more than dou­bled, and min­is­ter Man­sukh Man­daviya said that it was set to quadru­ple to more than 300 mil­lion dos­es in Oc­to­ber. The time­line has held strong. Al­most 50% of peo­ple in In­dia have re­ceived at least one shot of the vac­cine.

Com­pa­nies in In­dia have the ca­pac­i­ty to pro­duce al­most 3 bil­lion Covid-19 vac­cines a year, the Arab News re­port­ed. The coun­try sold or do­nat­ed near­ly 66 mil­lion dos­es be­fore the ex­port halt in April.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Aaron Siri, Siri & Glimstad

FDA shuts down an­ti-vax lawyer's pe­ti­tion to end Mod­er­na and J&J EUAs

Despite the efforts of a law firm leading the charge on the anti-vaccination movement, the emergency use authorization for Moderna and J&J’s Covid-19 vaccines will not be revoked, the agency said in a response letter Monday.

The FDA said so in a letter to an anti-vax lawyer based in New York City. Aaron Siri, from Siri & Glimstad, requested in a formal petition that the EUAs granted to Moderna and J&J be revoked after weeks of back-and-forth email correspondence with Peter Marks, Lorrie McNeill and others at the FDA.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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