Mer­ck out­flanks Pfiz­er's 20-va­lent shot with pneu­mo­coc­cal vac­cine ap­proval for kids

Back in April, the FDA asked for more analy­sis from Mer­ck on its 15-va­lent pneu­mo­coc­cal vac­cine for chil­dren and pushed back its ap­proval dead­line by three months. As the three-month mark ap­proach­es, the FDA ap­pears to be sat­is­fied.

Mer­ck an­nounced to­day that the FDA ap­proved its vac­cine for chil­dren ages 6 weeks and up, mak­ing it the third pneu­mo­coc­cal shot ap­proved for chil­dren. The vac­cine, which is mar­ket­ed as Vaxneu­vance, was al­ready OK’d for adults back in Ju­ly 2021.

The FDA ap­proved Vaxneu­vance for chil­dren and in­fants based on re­sults from sev­en tri­als that com­pared Vaxneu­vance to Pfiz­er’s Pre­vnar 13, which, as the name sug­gests, is a 13-va­lent pneu­mo­coc­cal vac­cine. Mer­ck’s shot cov­ers the 13 strains of pneu­mo­coc­cal bac­te­ria in Pre­vnar, along with two ad­di­tion­al strains — 22F and 33F.

“De­spite de­creas­es in in­ci­dence of in­va­sive pneu­mo­coc­cal dis­ease in chil­dren, cer­tain key serotypes con­tin­ue to cause se­ri­ous ill­ness that can lead to death in chil­dren un­der the age of 5, with serotypes 3, 22F and 33F re­spon­si­ble for more than a quar­ter of all in­va­sive pneu­mo­coc­cal dis­ease cas­es in this pop­u­la­tion,” Steven Shapiro, the lead in­ves­ti­ga­tor for Mer­ck’s pe­di­atric Vaxneu­vance tri­al, said in a state­ment.

Pneu­mo­coc­cal bac­te­ria can cause an ar­ray of se­ri­ous dis­eases, in­clud­ing pneu­mo­nia, bac­teremia and menin­gi­tis, which can cause long-term neu­ro­log­i­cal dam­age.

Mer­ck’s ear­ly pneu­mo­coc­cal vac­cine, known as pneu­mo­coc­cal poly­sac­cha­ride vac­cine 23, or PPSV23 for short, was ap­proved in the ear­ly 1980s. How­ev­er, it was not ef­fec­tive in kids un­der 2 since they didn’t re­spond much to the poly­sac­cha­rides. As a re­sult, vac­cine man­u­fac­tur­ers turned to con­ju­gate vac­cines, which at­tach poly­sac­cha­rides to a pro­tein and elic­it a stronger im­mune re­sponse.

Ac­cord­ing to Ul­rike Buch­wald, Mer­ck’s sec­tion head for pneu­mo­coc­cal vac­cines, link­ing the poly­sac­cha­ride from the bac­te­ria to a pro­tein can help re­cruit T cells, in what is known as “T cell help.”

Pfiz­er is al­so work­ing to get its new­er 20-va­lent pneu­mo­coc­cal vac­cine ap­proved in kids. Pre­vnar 20 was ap­proved in adults a month be­fore Vaxneu­vance but is still in clin­i­cal tri­als for kids. Mer­ck al­so has a 21-va­lent vac­cine for adults in the works, set to en­ter Phase III clin­i­cal tri­als lat­er this year.

Buch­wald not­ed that the 21-va­lent vac­cine, dubbed V116, is meant to ad­dress the “resid­ual bur­den of dis­ease” in adults. V116 in­cludes 8 serotypes that aren’t in any cur­rent vac­cines, but it does not con­tain cer­tain serotypes that are im­por­tant for in­fants, she said. Buch­wald called it a “pop­u­la­tion-spe­cif­ic ap­proach” for adults, adding that the vac­cine isn’t be­ing de­vel­oped as a pri­ma­ry shot for chil­dren.

Pfiz­er and Mer­ck were al­so tan­gled in a patent dis­pute over the pneu­mo­coc­cal con­ju­gate vac­cine de­signs that end­ed with Mer­ck agree­ing to pay Pfiz­er a small per­cent of its net sales on all of its pneu­mo­coc­cal con­ju­gate shots through 2035.

Mean­while, Vax­cyte — pre­vi­ous­ly known as SutroVax — has a 24-va­lent vac­cine in Phase I/II tri­als, with an ex­pect­ed Phase I read­out by the end of this year. And In­vent­prise, a Seat­tle-based biotech backed by the Bill and Melin­da Gates Foun­da­tion, is try­ing to cre­ate a shot that cov­ers 25 strains.

Ed­i­tor’s note: This sto­ry was up­dat­ed to in­clude com­ment from Ul­rike Buch­wald.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Susan Galbraith, AstraZeneca EVP, oncology R&D

Catch­ing up with Bris­tol My­ers and Mer­ck, As­traZeneca de­clares neoad­ju­vant win for PD-L1/chemo com­bo

When AstraZeneca started the Phase III AEGEAN trial for Imfinzi in 2018, it was, alongside several Big Pharma brethren, hoping to push the use of PD-(L)1 therapies into earlier lines of treatment. Three and a half years later, the British drugmaker has nabbed promising data in a type of lung cancer.

Topline results from an interim analysis showed that adding Imfinzi to chemotherapy before surgery spurred a “statistically significant and meaningful” improvement in pathologic complete response for patients with resectable non-small cell lung cancer compared to chemotherapy alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Nassim Usman, Catalyst Biosciences CEO

Fac­ing set­backs for months and an ac­tivist at­tack, Cat­a­lyst Bio­sciences pre­pares to call it quits

After downsizing for several months, Catalyst Biosciences is getting ready to tap out.

The San Francisco biotech announced Wednesday that it would be liquidating and distributing cash back to shareholders, with total proceeds expected to reach $65 million. Catalyst intends to return the money “as soon as practicable,” the company said, as it has ceased all R&D activities, CEO Nassim Usman said in a statement.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.