Agios CEO Jackie Fouse

Agios CSO to de­part amid lay­offs as biotech looks for new drugs to li­cense or ac­quire

A year and a half af­ter end­ing work in on­col­o­gy and three months af­ter se­cur­ing the first nod for its new “an­chor prod­uct,” Agios is once again shak­ing things up.

As many as 50 ex­plorato­ry re­search em­ploy­ees will be let go and chief sci­en­tif­ic of­fi­cer Bruce Car will de­part the com­pa­ny at the end of Ju­ly, the biotech said af­ter the clos­ing bell Mon­day. That rep­re­sents near­ly 13% of the work­force that Agios em­ployed at the end of 2021, with 390 full-time work­ers as of De­cem­ber 31.

Bruce Car

Agios’ re­main­ing re­search team will em­ploy about 50 peo­ple, a spokesper­son told End­points News in an emailed state­ment.

Med­ical chief Sarah Gheuens will add head of R&D to her check­list of du­ties, the biotech al­so said, fill­ing the void left by Car’s ex­it. Pri­or to Agios, she led MS late-stage clin­i­cal de­vel­op­ment at Bio­gen, play­ing a crit­i­cal role in the biotech’s spinal mus­cu­lar at­ro­phy drug Spin­raza.

SVB Se­cu­ri­ties an­a­lysts called the lay­offs a sur­prise.

“Con­cep­tu­al­ly the re­struc­tur­ing is like­ly to be de­bat­ed, giv­en that it was large­ly un­ex­pect­ed, es­pe­cial­ly giv­en the re­cent share buy­backs, which sug­gest it was not nec­es­sary for cost sav­ings. Ad­di­tion­al­ly, giv­en the com­pa­ny’s lega­cy of biotech drug dis­cov­ery, this is a sig­nif­i­cant shift, per­haps on­ly ex­ceed­ed by the pri­or di­vesti­ture of the on­col­o­gy di­vi­sion to Servi­er,” the an­a­lysts wrote in a note Tues­day morn­ing.

Sarah Gheuens

The lay­offs and re-shift­ed re­search work will save Agios $40 mil­lion to $50 mil­lion per year, start­ing next year and through 2026, the com­pa­ny said. Those sav­ings could go to­ward beef­ing up Agios’ pipeline with new ther­a­pies from in-li­cens­ing deals or ac­qui­si­tions, the Cam­bridge, MA biotech an­nounced, char­ac­ter­iz­ing its shop­ping list as “well-char­ac­ter­ized as­sets.”

“We con­tin­ue to pri­or­i­tize in­vest­ment in ad­vanc­ing pro­grams that we be­lieve have the high­est like­li­hood of mak­ing an im­pact for pa­tients,” CEO Jack­ie Fouse said in a state­ment.

That in­cludes test­ing Agios’ re­cent­ly ap­proved rare blood dis­or­der drug Pyrukynd in mul­ti­ple oth­er in­di­ca­tions. The drug, al­so known as mi­tapi­vat, won FDA ap­proval in Feb­ru­ary for pyru­vate ki­nase de­fi­cien­cy.

The Pyrukynd nod was Agios’ sec­ond FDA green­light, but it’s the on­ly com­mer­cial drug re­main­ing in the biotech’s port­fo­lio af­ter sell­ing off Tib­so­vo and the com­pa­ny’s en­tire on­col­o­gy pipeline in De­cem­ber 2020. Servi­er swooped up the ther­a­pies for about $2 bil­lion.

Agios said it has the funds to con­tin­ue study­ing mi­tapi­vat in reg­is­tra­tion-en­abling clin­i­cal pro­grams in tha­lassemia, sick­le cell dis­ease and pe­di­atric pyru­vate ki­nase de­fi­cien­cy. The com­pa­ny al­so has the mon­ey need­ed to bankroll a Phase IIa tri­al in low- to in­ter­me­di­ate-risk myelodys­plas­tic syn­drome and pre­clin­i­cal stud­ies of oth­er as­sets in PAH sta­bi­liza­tion in phenylke­tonuria, and for BCAT in­hi­bi­tion in methyl­malonic and pro­pi­onic acidemias, Fouse said.

Un­like oth­er pub­lic biotechs that have re­cent­ly gone back to the mar­ket to raise heaps of cap­i­tal af­ter re­leas­ing pos­i­tive clin­i­cal da­ta or fil­ing their drug for ap­proval, Agios will not tap in­vestors for more mon­ey.

“Agios con­tin­ues to ex­pect that its cash, cash equiv­a­lents and mar­ketable se­cu­ri­ties will en­able the com­pa­ny to ex­e­cute its op­er­at­ing plan through ma­jor cat­a­lysts and to cash-flow pos­i­tiv­i­ty with­out the need to raise ad­di­tion­al eq­ui­ty,” the com­pa­ny said in its press re­lease.

That fig­ure stood at $1.2 bil­lion at the end of March, the com­pa­ny said in its lat­est earn­ings re­port on May 5.

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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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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

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.

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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.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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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 Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, 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.

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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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