Ef­fi­ca­cy of Pfiz­er's Covid pill holds up in fi­nal analy­sis, re­duc­ing risk of hos­pi­tal­iza­tion or death by al­most 90%

The dras­tic dif­fer­ence in ef­fi­ca­cy for Mer­ck’s Covid-19 pill be­tween in­ter­im and fi­nal analy­ses — from a 50% rel­a­tive re­duc­tion in hos­pi­tal­iza­tions and deaths at the in­ter­im to just 30% in the fi­nal re­sults — had some wor­ry­ing that the Pfiz­er pill’s ear­ly suc­cess for adults at high risk of hos­pi­tal­iza­tion might al­so be more mut­ed in the fi­nal re­sults.

But that wasn’t the case ear­ly Tues­day as Pfiz­er said that fi­nal da­ta avail­able from the more than 2,200 high-risk pa­tients en­rolled in its tri­al con­firmed pri­or re­sults show­ing Paxlovid re­duced the risk of hos­pi­tal­iza­tion or death by 89% (with­in three days of symp­tom on­set) and 88% (with­in five days of symp­tom on­set) com­pared to place­bo. The com­pa­ny added:

0.7% of pa­tients who re­ceived PAXLOVID were hos­pi­tal­ized through Day 28 fol­low­ing ran­dom­iza­tion (5/697 hos­pi­tal­ized with no deaths), com­pared to 6.5% of pa­tients who re­ceived place­bo and were hos­pi­tal­ized or died (44/682 hos­pi­tal­ized with 9 sub­se­quent deaths). The sta­tis­ti­cal sig­nif­i­cance of these re­sults was high (p<0.0001).

The da­ta have al­ready been shared with the FDA as part of an on­go­ing rolling EUA sub­mis­sion, Pfiz­er said.

And the FDA may act soon on Pfiz­er and Mer­ck’s pills, both of which need to be tak­en over five days, and both of which seem to hold up against the Omi­cron vari­ant.

But there may be cer­tain re­stric­tions on who should ac­cess the pills, and some lin­ger­ing con­cerns on the Mer­ck pill’s mech­a­nism of ac­tion. For in­stance, the FDA is un­like­ly to au­tho­rize Mer­ck’s pill in preg­nant women, due to the po­ten­tial for fe­tal tox­i­c­i­ties, or those who have been vac­ci­nat­ed be­cause they were not in­clud­ed in the piv­otal tri­al.

And the Mer­ck pill’s MOA, which dri­ves the mu­ta­ge­n­e­sis of the SARS-COV-2 virus to kill it off, could the­o­ret­i­cal­ly in­crease the like­li­hood of vari­ants as a re­sult of wide­spread treat­ment. But so far those fears are the­o­ret­i­cal, and Mer­ck nar­row­ly won the back­ing of an ad­comm for its EUA about two weeks ago.

Once the pills are au­tho­rized by the FDA, sup­plies should be dis­trib­uted short­ly there­after. The US last month paid $5.29 bil­lion for 10 mil­lion cours­es of the Pfiz­er pill, and for Mer­ck’s pill, the US has now pur­chased more than 3 mil­lion cours­es for about $2.2 bil­lion so far.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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