Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Es­pe­ri­on’s ex­ec­u­tive team spent years in­sist­ing that they had found the sweet spot in the mar­ket for their cho­les­terol drug. But that strat­e­gy has soured bad­ly, and af­ter strug­gling to sell its heart dis­ease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The lay­offs will take place across the board, from sales and mar­ket­ing to R&D, CEO Shel­don Koenig told End­points News on Mon­day. While the chief ex­ec­u­tive de­clined to elab­o­rate on how many em­ploy­ees will be af­fect­ed, an SEC fil­ing stat­ed that ap­prox­i­mate­ly 170 staffers are on the chop­ping block.

The re­duc­tions, which will be com­plete by the end of the month, are ex­pect­ed to save the com­pa­ny up to $80 mil­lion go­ing in­to 2022, Koenig said. Es­pe­ri­on’s stock $ES­PR dipped about 4.7% up­on the news, with shares pric­ing at $8.71 apiece. Shares have fall­en more than 74% over the last year.

Nexle­tol, Es­pe­ri­on’s “goldilocks” cho­les­terol ther­a­py al­so known as be­mpe­doic acid, was ap­proved back in ear­ly 2020 as an oral op­tion that’s bet­ter than decades-old statins, but not as ef­fec­tive — or as ex­pen­sive — as in­jectable PC­SK9 ther­a­pies. A week lat­er, the FDA ap­proved Nexl­izet, a com­bi­na­tion of be­mpe­doic acid and eze­tim­ibe (an­oth­er cho­les­terol-low­er­ing med­i­cine).

Es­pe­ri­on thought that with a smart pric­ing strat­e­gy — Nexle­tol costs just over $11 per day — it could beat out the pricey PC­SK9s Repatha and Pralu­ent.

But launch­ing a heart drug amid the pan­dem­ic proved to be a chal­lenge. Pa­tients were see­ing their doc­tors less of­ten, sales forces couldn’t trav­el, and even if they could, physi­cians’ of­fices weren’t nec­es­sar­i­ly open to reps. Es­pe­ri­on pock­et­ed just $12.1 mil­lion last year on a drug they al­ways be­lieved would be a block­buster.

In April, Es­pe­ri­on turned to Dai­ichi Sankyo, the Japan­ese phar­ma that was al­ready com­mer­cial­iz­ing Nexle­tol in Eu­rope and Japan. Es­pe­ri­on struck a deal with Dai­ichi to mar­ket the drug in oth­er re­gions in ex­change for $30 mil­lion cash, tiered roy­al­ties and $175 mil­lion in mile­stones.

“It def­i­nite­ly was prob­a­bly the hard­est time to ever launch prod­ucts, right in the mid­dle of Covid, which was March of 2020,” Koenig said.

Koenig took the helm in May, short­ly af­ter long­time for­mer CEO Tim Mayleben aban­doned his post. At the time, the com­pa­ny’s stock had been trad­ing for less than half of what it was when Nexle­tol was ap­proved in Feb­ru­ary.

The chief ex­ec­u­tive says the com­pa­ny has seen a bit of a boost in the last cou­ple quar­ters, with de­mand ris­ing 30% be­tween first and sec­ond quar­ter this year, and 10% be­tween sec­ond and third.

The com­pa­ny’s cur­rent­ly work­ing on a Phase III tri­al dubbed CLEAR Out­comes in car­dio­vas­cu­lar pa­tients who have statin in­tol­er­ance and el­e­vat­ed LDL-C, or “bad” cho­les­terol lev­els. Topline re­sults from that study are com­ing in ear­ly 2023, Koenig said.

“We still be­lieve that we can con­tin­ue to have con­sis­tent growth be­tween now and when the CLEAR Out­comes study re­ports out,” he added.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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