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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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