Marco Taglietti, Scynexis CEO

Scynex­is will pit a new class of an­ti­fun­gals against yeast in­fec­tions — and it won't come cheap

The FDA ush­ered in a new class of triter­penoid an­ti­fun­gals this week, giv­ing Scynex­is the OK for its oral ibrex­a­fungerp — a non-azole treat­ment the com­pa­ny de­signed to de­throne Pfiz­er’s flu­cona­zole in vagi­nal yeast in­fec­tion.

The de­ci­sion came right on time for Scynex­is’ June 1 PDU­FA date, and was based on two Phase III tri­als in which about 50% and 63% of pa­tients giv­en the drug, re­spec­tive­ly, saw all signs and symp­toms of their yeast in­fec­tions dis­ap­pear by day 10.

Just about 29% and 44% of pa­tients on the place­bo saw a clin­i­cal cure by Day 10, ac­cord­ing to da­ta pre­sent­ed at the Amer­i­can Col­lege of Ob­ste­tri­cians and Gy­ne­col­o­gists in April. By Day 25, symp­tom res­o­lu­tion in the treat­ment arms in­creased to 60% and near­ly 74%, Scynex­is re­port­ed.

“This first ap­proval in the U.S. is a ma­jor step to­wards build­ing the ibrex­a­fungerp an­ti­fun­gal fran­chise as we in­tend to lever­age an ex­tend­ed 10-year pe­ri­od of reg­u­la­to­ry ex­clu­siv­i­ty and 14 years of patent pro­tec­tion,” CEO Mar­co Tagli­et­ti said in a state­ment.

Though vagi­nal yeast in­fec­tions — al­so known as vul­vo­vagi­nal can­didi­a­sis (VVC)— af­fect three out of four women across their life­times, the con­di­tion has lim­it­ed treat­ment op­tions. Flu­cona­zole was ap­proved by the FDA as Di­flu­can in 1990, and now has many equiv­a­lents on the mar­ket.

David An­gu­lo

Ibrex­a­fungerp — now mar­ket­ed as Brex­afemme — was ap­proved as a first-line treat­ment, but Tagli­et­ti told End­points News last year that the drug can al­so be used on pa­tients who don’t re­spond to flu­cona­zole, adding that the drug will be priced at a pre­mi­um. At the time, he es­ti­mat­ed the drug would come at a list price of $300 to $400, which would work out to a co­pay of $25 to $30.

CMO David An­gu­lo told the New York Times on Wednes­day that Brex­afemme’s list price will range from $250 to $450. Ac­cord­ing to GoodRx, the av­er­age re­tail price of flu­cona­zole is $29.81.

The drug is al­so be­ing eval­u­at­ed in pa­tients with re­cur­rent VVC in a Phase II study dubbed CAN­DLE. An­gu­lo said on Wednes­day that Scynex­is is “work­ing on com­plet­ing” that tri­al, and ex­pects to sub­mit a sup­ple­men­tal NDA in the first half of 2022.

My­covia could beat it to the punch though, an­nounc­ing on Tues­day that it sub­mit­ted an NDA for its oral an­ti­fun­gal otesec­ona­zole in RVVC. Com­bined Phase III da­ta showed that the drug pro­tect­ed more than 90% of par­tic­i­pants from hav­ing a re­cur­rence for near­ly a year, ac­cord­ing to My­covia.

Back in March, Scynex­is un­veiled in­ter­im re­sults from two open-la­bel Phase III tri­als test­ing oral ibrex­a­fungerp in a range of in­fec­tions. In the first, called FU­RI, the drug was giv­en to pa­tients with dif­fi­cult-to-treat mu­co­cu­ta­neous and in­va­sive fun­gal in­fec­tions that are re­sis­tant to or in­tol­er­ant of cur­rent stan­dards of care, or who re­quire a non-azole oral step-down ther­a­py for the treat­ment of azole-re­sis­tant species. Clin­i­cal ben­e­fit was shown in 86.5% of 74 pa­tients treat­ed, with 46 pa­tients achiev­ing a com­plete or par­tial re­sponse and 18 pa­tients achiev­ing a sta­ble dis­ease re­sponse, ac­cord­ing to the com­pa­ny.

The sec­ond analy­sis, dubbed CARES, in­clud­ed 10 pa­tients who were hos­pi­tal­ized with can­didi­a­sis and can­didemia due to the fun­gus Can­di­da au­ris. The or­gan­ism is of­ten mul­ti-drug re­sis­tant, and re­cent­ly made the CDC’s list of Ur­gent Threats to pub­lic health. Eight of the pa­tients achieved a com­plete re­sponse, ac­cord­ing to Scynex­is.

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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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

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.”

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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Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

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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Todd Zavodnick, Dermavant CEO

With top­i­cal ap­proval, Der­ma­vant looks to bring new stan­dard-of-care to plaque pso­ri­a­sis pa­tients

Dermavant CEO Todd Zavodnick has been plotting to upend the plaque psoriasis market for years now. And with the company’s first approval on Tuesday, he’s pulling the trigger.

The FDA on Tuesday approved Dermavant’s “cosmetically elegant” vanishing cream tapinarof, the first steroid-free topical medication in its class, now marketed as Vtama. And unlike other launches, which could take months, Zavodnick is ready to roll it out as early as next week.