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 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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Merck closes in on a potential $40 billion buyout of Seagen, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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