Mer­ck snags pri­or­i­ty re­view for Pre­vnar 13 ri­val — just one month af­ter Pfiz­er sent its fol­low-on to the FDA

Al­most a decade af­ter Pre­vnar 13 was ap­proved — go­ing on to be­come Pfiz­er’s best-sell­ing prod­uct — Mer­ck is one step away from hav­ing a ri­val vac­cine to of­fer.

The FDA is tuck­ing V114, the 15-va­lent pneu­mo­coc­cal con­ju­gate vac­cine, in­to its pri­or­i­ty re­view line, mean­ing we’ll know by Ju­ly whether Mer­ck can fi­nal­ly com­plete the years-long jour­ney to de­throne Pre­vnar 13.

Mer­ck’s vac­cine con­ju­gates cap­su­lar poly­sac­cha­rides from 15 serotypes of Strep­to­coc­cus pneu­mo­nia to a car­ri­er pro­tein, two more than Pfiz­er’s.

Roy Baynes

“In­va­sive pneu­mo­coc­cal dis­ease in adults is on the rise in many coun­tries, dri­ven by high­ly-in­va­sive serotypes in­clud­ing serotype 3, which is in­clud­ed in the cur­rent­ly li­censed pneu­mo­coc­cal con­ju­gate vac­cine, as well as serotypes not in­clud­ed, such as serotypes 22F and 33F,” Roy Baynes, Mer­ck’s head of glob­al clin­i­cal de­vel­op­ment, said in a state­ment.

V114 proved non-in­fe­ri­or to Pre­vnar 13 in a piv­otal Phase III study in­volv­ing pa­tients over 50, with com­pa­ra­ble safe­ty pro­files. Ac­cord­ing to Mer­ck, it al­so beat Pre­vnar 13 on serotype 3.

The phar­ma gi­ant has the on­ly oth­er vac­cine that’s used in the US to pro­tect against pneu­mo­coc­cal dis­ease. But Pneu­movax 23, a poly­sac­cha­ride vac­cine cov­er­ing 23 serotypes, is most­ly rec­om­mend­ed for the el­der­ly and adults with med­ical con­di­tions, while Pre­vnar 13 is fre­quent­ly ad­min­is­tered to chil­dren younger than 2, tap­ping in­to an enor­mous mar­ket.

To take a snap­shot at Q3 of 2020, Pre­vnar 13 sales topped $1.5 bil­lion while Pneu­movax earned on­ly $375 mil­lion in the same three months.

None of this will mean a straight shot for Mer­ck at cre­at­ing a megablock­buster overnight, even if the FDA hands them an OK.

Pfiz­er, which has a $6 bil­lion fran­chise to guard, was grant­ed pri­or­i­ty re­view weeks ago for a fol­low-on vac­cine that cov­ers 20 serotypes — more than any cur­rent­ly li­censed or in late-stage de­vel­op­ment. A de­ci­sion is ex­pect­ed by June.

Then there are the up­start biotechs with plen­ty of VC cash bet­ting on a David ver­sus Go­liath tale. SutroVax and Affini­vax are each bring­ing on plat­form tech­nolo­gies that promise to kick up deep­er, more durable im­mune re­spons­es than tra­di­tion­al chem­i­cal con­ju­ga­tion.

For a while, though, Mer­ck sees it­self duk­ing it out with the oth­er be­he­moth.

Here’s chief mar­ket­ing of­fi­cer Michael Nal­ly from a re­cent in­vestor’s call:

When we look at the mar­ket, the first and fore­most area that we’re look­ing at, is mak­ing sure that we ac­tu­al­ly con­fer pro­tec­tion across the 13 shared serotypes of PCV13. And I think what we’ve been able to demon­strate in the Phase 2 re­sults that you’ve seen in the pe­di­atric pop­u­la­tion is that you see a ro­bust im­mune re­sponse across those 13 shared serotypes. And that’s af­ter dose three, which I think is al­so an im­por­tant fac­tor, be­cause the pri­ma­ry se­ries com­ple­tion is re­al­ly an im­por­tant time point. When you think about what’s next, then it’s about how do we add to those 13 shared serotypes.

And for our pro­gram, we’ve been able to show a ro­bust im­mune re­sponse on 22F and 33F, as well as a re­al­ly ro­bust re­sponse on serotype 3, which is a key con­tribut­ing fac­tor to resid­ual dis­ease. And so, I think when we look at the re­al ef­fort on V114, it’s al­ways been about mak­ing sure that we pro­vide the rel­e­vant lev­el of pro­tec­tion in the core serotypes, but then add all the serotypes to it. I think the ques­tion on the first year of life will be an im­por­tant one as well. And we’re look­ing for­ward to see­ing more da­ta from both our pro­gram as well as Pfiz­er’s pro­gram.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.