Isao Teshirogi, Shionogi CEO (Kiyoshi Ota/Bloomberg via Getty Images)

Sh­iono­gi backs F2G in de­vel­op­ing rare-dis­ease an­ti­fun­gal in Eu­rope and Asia

Sh­iono­gi, an ac­tive play­er in the arid field of an­timi­cro­bials, has now set its eye on the ad­ja­cent sphere of an­ti­fun­gals.

The Japan-based phar­ma is part­ner­ing with F2G, which de­scribes it­self as a “rare fun­gal dis­ease com­pa­ny,” to push F2G’s olo­rofim through clin­i­cal tri­als and reg­u­la­to­ry ac­tion in Eu­rope and Asia, the two com­pa­nies an­nounced to­day. Olo­rofim is be­ing test­ed to treat in­va­sive as­pergillo­sis, a rare mold in­fec­tion that can im­pact im­muno­sup­pressed peo­ple, specif­i­cal­ly those that have re­ceived cer­tain can­cer ther­a­pies.

The dol­lars of the deal: Sh­iono­gi will pay F2G $100 mil­lion up­front, fol­lowed by up to $380 mil­lion in down­stream mile­stones and dou­ble-dig­it roy­al­ties on po­ten­tial sales.

“We are pleased to part­ner with F2G, which is bold­ly tack­ling fun­gal in­fec­tions where new drug de­vel­op­ment is dif­fi­cult,” Sh­iono­gi CEO Isao Teshi­ro­gi said in a state­ment. “We will con­tin­ue to ad­dress un­met med­ical needs in in­fec­tious dis­eases, and to work to­wards to­tal care for this area. As part of this mis­sion and through our part­ner­ship with F2G, we hope to be able to pro­vide new an­ti­fun­gal drugs to pa­tients to pro­tect peo­ple’s health from life-threat­en­ing, in­va­sive fun­gal in­fec­tions.”

Olo­rofim, pre­vi­ous­ly dubbed F901318, rep­re­sents a new class of an­ti­fun­gals — the oro­to­mides — that in­hibits the pro­duc­tion of pyrim­idines, a key DNA base, de­signed to kill the fun­gi. How­ev­er, un­like an­timi­cro­bials, re­sis­tance is not the on­ly is­sue for an­ti­fun­gals, F2G CEO Francesco Lavi­no said.

Azoles, which are the ma­jor an­ti­fun­gal class cur­rent­ly used to treat in­va­sive as­pergillo­sis among oth­er in­fec­tions, in­ter­act with oth­er drugs, and there­fore can­not be giv­en along­side “some of the back­bone treat­ments for leukemias and lym­phomas,” Lavi­no said. But olo­rofim, with its dif­fer­ent mech­a­nism, doesn’t share those same prob­lems.

The an­ti­fun­gal, cur­rent­ly in a Phase II study, re­ceived break­through ther­a­py des­ig­na­tion from the FDA last year.

Lavi­no al­so not­ed that while olo­rofim is an an­ti­fun­gal, they are treat­ing it more as a rare dis­ease ther­a­py.

Ac­cord­ing to the CDC, the ex­act num­ber of as­pergillo­sis cas­es in the US is hard to es­ti­mate, but a 2014 study count­ed 15,000 as­pergillo­sis-as­so­ci­at­ed hos­pi­tal­iza­tions state­side. As such, EU au­thor­i­ties and the FDA both gave olo­rofim or­phan drug sta­tus for in­va­sive as­pergillo­sis. “With a very well-de­fined pa­tient pop­u­la­tion, the rel­a­tive­ly small num­ber of pa­tients, and lim­it­ed treat­ment op­tions, [that] re­al­ly makes olo­rofim more a rare dis­ease prod­uct,” Lavi­no said.

F2G isn’t the on­ly com­pa­ny tak­ing an­ti­fun­gals the rare dis­ease route. Last year, UK-based Pul­mo­cide en­tered Phase III tri­als for its azole an­ti­fun­gal for in­va­sive pul­monary as­pergillo­sis.

F2G is al­so look­ing for oth­er part­ners to de­vel­op olo­rofim in Latin Amer­i­ca, but it plans on launch­ing on its own in the US, where it has been ex­pand­ing since Lavi­no joined as CEO around a year ago.

In the US, F2G plans on go­ing af­ter one oth­er rare in­di­ca­tion — val­ley fever. Al­so known as coc­cid­ioidomy­co­sis, val­ley fever on­ly im­pacts some 15,000 peo­ple each year, like as­pergillo­sis, most­ly in Ari­zona and Cal­i­for­nia ac­cord­ing to the CDC. F2G plans on fil­ing through the FDA’s LPAD path­way, meant specif­i­cal­ly for an­tibac­te­ri­als and an­ti­fun­gals in ar­eas of un­met need, Lavi­no not­ed.

“If every­thing goes well, we should be on the mar­ket this time next year,” Lavi­no said.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Atomwise CEO and co-founder Abraham Heifets (left) and co-founder Izhar Wallach

A cou­ple bil­lion for Ex­sci­en­tia was on­ly part of Sanofi's AI am­bi­tions, as the Big Phar­ma adds Atom­wise to the ta­ble

Sanofi made clear its AI ambitions were real at the beginning of this year when the Big Pharma took its drug discovery collaboration with Exscientia to the next level, inking a pact that could birth 15 drugs and deliver $5.3 billion to the UK partner.

Seven months later, the AI blueprint is far from over at the French Big Pharma, as another of the much-hyped drug discovery startups is coming to the table in a five-drug deal. Sanofi will pay Atomwise $20 million to kick off the hunt for up to five targets, which are aimed at leading to the creation of new small molecules. Another $1 billion is on the line — as are royalties — and the companies kept mum on the specific diseases or broader therapeutic areas of interest.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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