The C-suite shuf­fle: On­copep­tides, Zymeworks re­place ex­ecs to start 2023

Two biotechs are shuf­fling their C-suites as the cal­en­dar turns to the new year: On­copep­tides and Zymeworks.

Jakob Lind­berg

On­copep­tides an­nounced Wednes­day that it’s re­plac­ing CEO Jakob Lind­berg with Mon­i­ca Shaw as Lind­berg re­turns to the chief sci­ence po­si­tion. Zymeworks, mean­while, re­moved chief med­ical of­fi­cer Neil Joseph­son with­out nam­ing a re­place­ment. The biotech said Jef­frey Smith, the Alder Bio­Phar­ma­ceu­ti­cals founder who en­gi­neered a $2 bil­lion sale to Lund­beck in 2019, will take over ear­ly R&D.

Nei­ther stock re­act­ed much to the news. On­copep­tides shares fell a lit­tle over 1% on Wednes­day, while Zymeworks $ZYME — which an­nounced a large help­ing of oth­er new-year up­dates — was up about 1%.

For On­copep­tides, the move comes af­ter a back-and-forth with the FDA over a dan­gling ac­cel­er­at­ed ap­proval for its can­cer drug Pepax­to. US reg­u­la­tors pulled the drug’s in­di­ca­tion in a late-line mul­ti­ple myelo­ma set­ting af­ter a fiery ad­vi­so­ry com­mit­tee hear­ing at which the agency crit­i­cized oth­er com­pa­nies amid a broad­er push for ac­cel­er­at­ed ap­proval re­form.

Mon­i­ca Shaw

Lind­berg, in an in­ter­view with End­points News af­ter the in­di­ca­tion was yanked, said the com­pa­ny was lean­ing to­ward giv­ing up the fight to keep it ap­proved, em­pha­siz­ing a le­gal bat­tle like­ly wouldn’t be worth it. He al­so lament­ed the “piss­ing con­test” that en­sued be­tween On­copep­tides and the FDA over Pepax­to’s ap­proval.

Neil Joseph­son

Shaw now takes over af­ter Lind­berg spent a lit­tle over a year at the helm. She is a GSK and Leo Phar­ma vet, with On­copep­tides tout­ing her ex­pe­ri­ence in bring­ing 15 drugs through Phase III stud­ies to the mar­ket in a press re­lease.

Zymeworks’ shake­up comes just a few weeks af­ter the com­pa­ny se­cured an opt-in from a deal with Jazz Phar­ma­ceu­ti­cals to col­lab­o­rate on zanidatam­ab, a drug be­ing de­vel­oped for mul­ti­ple HER2-ex­press­ing can­cers. Jazz forked over $325 mil­lion up­front and promised up to $1.76 bil­lion in mile­stones, plus roy­al­ties po­ten­tial­ly reach­ing up to 20%.

It’s the sec­ond zanidatam­ab bench­mark Zymeworks and Jazz reached in the fourth quar­ter of 2022, fol­low­ing an ini­tial $50 mil­lion up­front deal reached last Oc­to­ber.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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