Polyphor par­lays a pathogen-spe­cif­ic an­tibi­ot­ic and I/O work in­to a $165M IPO for its PhI­II pro­gram

Polyphor has suc­cess­ful­ly com­plet­ed an IPO, rais­ing about $165 mil­lion to back its Phase III de­vel­op­ment of a new an­tibi­ot­ic specif­i­cal­ly de­signed to coun­ter­at­tack against Pseudomonas aerug­i­nosa along with an easy-stage shot at im­muno-on­col­o­gy.

The biotech priced an up­sized lot of shares at 38 Swiss Francs — or about $38 — for the of­fer­ing on the Swiss bourse. That makes for a fair­ly un­usu­al hit, with many Eu­ro­pean biotechs drawn to try their luck on the free­wheel­ing Nas­daq, where ear­ly-stage, high-risk biotechs have pulled off a string of suc­cess­ful rais­es.

Dubbed murepavadin (POL7080), their lead an­tibi­ot­ic had stirred some ex­cite­ment a few years ago when Roche stepped in with a deal to col­lab­o­rate with the com­pa­ny, then backed out in late 2015 say­ing that a stream­lined de­vel­op­ment path­way was no longer avail­able to the phar­ma gi­ant.

But Polyphor con­tin­ued to press for­ward, though, with help from the Well­come Trust and oth­ers. This is the first new class of an­tibi­otics to come along in 50 years, the biotech says, which they call Out­er Mem­brane Pro­tein Tar­get­ing An­tibi­otics. Its pitch to break from the usu­al brand of broad-spec­trum an­tibi­otics and de­vel­op a pathogen-spe­cif­ic rem­e­dy at a time of ris­ing drug re­sis­tance res­onat­ed in the com­mu­ni­ty. And Polyphor has been build­ing a pipeline of new prod­ucts in the process, with the Phase III fo­cused on ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia.

More re­cent­ly, Polyphor has al­so been at­tract­ing at­ten­tion in the boom­ing I/O field, where its drug, the an­ti-CX­CR4 drug bal­ix­afor­tide, com­bined with Halaven (eribu­lin) achieved a 38% over­all re­sponse rate.

Big Phar­ma has been a re­luc­tant play­er in an­tibi­ot­ic de­vel­op­ment for years now, put off by thin mar­gins and cheap gener­ics. De­spite the in­crease in drug re­sis­tance, the mar­ket it­self hasn’t been gen­er­ous and in­cen­tives by them­selves have not been enough to reawak­en their in­ter­est. That has left the bulk of the work to a start­up gen­er­a­tion of biotechs like Polyphor, which are ex­pect­ing to see the num­bers im­prove as the sit­u­a­tion wors­ens.

In this par­tic­u­lar case, murepavadin has the po­ten­tial to ad­dress hos­pi­tal cas­es, where the mor­tal­i­ty rate has been high and re­im­burse­ment can be as well.


Im­age: SIX Swiss Ex­change. SHUT­TER­STOCK

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.