Marco Taglietti, Scynexis CEO

‘Say no more’ to yeast in­fec­tions: Scynex­is rolls out new Brex­afemme mar­ket­ing — and ral­ly­ing cry

Scynex­is is rolling out a new cam­paign for its Brex­afemme yeast in­fec­tion treat­ment, but the ef­fort is more than just ad­ver­tis­ing.

As CEO Mar­co Tagli­et­ti said in wrap­ping his pre­pared com­ments dur­ing an earn­ings call on Thurs­day, “Let me fin­ish with our new ral­ly­ing cry — yeast in­fec­tion, say no more.”

Chris­tine Coyne

That head­line — writ­ten as “Yeast in­fec­tion? Say no more” — ap­pears on Scynex­is’ re­cent­ly launched ad cam­paign to health­care providers and will be­gin rolling out to con­sumers lat­er this month.

Chief com­mer­cial of­fi­cer Chris­tine Coyne ex­plained the ral­ly­ing cry is meant for pa­tients “who have been suf­fer­ing from yeast in­fec­tions and try­ing the same thing.” The same things mean over-the-counter treat­ments and long-ap­proved oral Pfiz­er’s flu­cona­zole.

The dig­i­tal and so­cial me­dia cam­paign in­cludes changes to Scynex­is’ ini­tial Brex­afemme pro­mo­tion­al ma­te­r­i­al lan­guage “to be more pow­er­ful and more ro­bust,” Coyne said. “Our new pa­tient ma­te­ri­als are much more about em­pow­er­ment which res­onates with our tar­get au­di­ences.”

Nkechi Azie

The “Say No More” de­but cam­paign with health­care providers in April us­es “re­lat­able and icon­ic im­agery paired with new da­ta and mes­sag­ing” to dri­ve home that same mes­sage to doc­tors. The cam­paign in­clud­ed a me­dia tour and cov­er­age on 25 ra­dio and TV sta­tions last week with two Brex­afemme spokes­peo­ple, Scynex­is’ clin­i­cal de­vel­op­ment leader Nkechi Azie and women’s health ad­vo­cate Bar­bara Dehn, a nurse prac­ti­tion­er bet­ter known as Nurse Barb. The me­dia tour drove view­ers and lis­ten­ers to www.YourVHealth.com which redi­rects to Brex­afemme’s home page.

Scynex­is is part­ner­ing with Am­pli­ty Health con­tract com­mer­cial or­ga­ni­za­tion for a ded­i­cat­ed Brex­afemme sales team of 70 reps.

The new cam­paign comes on the heels of Brex­afemme’s fall launch — af­ter FDA ap­proval in June — and first full quar­ter sales of less than $1 mil­lion re­port­ed on Thurs­day. To­tal rev­enue was $687,000 with Scynex­is re­port­ing about 4,000 pre­scrip­tions for the three-month pe­ri­od.

But Scynex­is re­mains con­fi­dent in Brex­afemme and ex­pand­ing in­di­ca­tions for the drug al­so known by its gener­ic ibrex­a­fungerp. An FDA sub­mis­sion to treat re­cur­rent vul­vo­vagi­nal can­didi­a­sis is planned for the sec­ond half with ap­proval ex­pect­ed lat­er by the end of 2022. Tagli­et­ti said it ex­pects a first hos­pi­tal in­di­ca­tion nod as an oral step-down ther­a­py for in­va­sive can­didi­a­sis by the end of 2024.

“With ex­clu­siv­i­ty pro­tec­tion un­til 2035, ibrex­a­fungerp is ex­pect­ed to be­come a sig­nif­i­cant, long-last­ing an­ti­fun­gal fran­chise with po­ten­tial com­bined peak sales of $700M to $800M,” ac­cord­ing to a Scynex­is pre­sen­ta­tion slide, with that to­tal in­clud­ing both com­mu­ni­ty and hos­pi­tal in­di­ca­tions.

Over­all, Scynex­is re­port­ed a $5.5 mil­lion loss for the quar­ter. It re­mains pos­i­tive on its cash flows as well, re­port­ing a cash bal­ance of $95.2 mil­lion at the end of March, boost­ed by an ad­di­tion­al $45 mil­lion pub­lic of­fer­ing in May, and pre­dict­ing a cash run­way in­to the first quar­ter of 2024.

Brex­afemme is the first and on­ly oral and non-azole treat­ment for vagi­nal yeast in­fec­tions — al­so known as vul­vo­vagi­nal can­didi­a­sis — and is priced at a pre­mi­um to old­er treat­ment op­tions. Pfiz­er’s oral Di­flu­can, ap­proved in 1990, is now gener­ic flu­cona­zole with many equiv­a­lents now on the mar­ket. The gener­ic is priced around $10 ac­cord­ing to GoodRx, while a four-tablet treat­ment of Brex­afemme is $475.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.