Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Pfiz­er CEO points to IRA as a fac­tor that made Seagen an at­trac­tive tar­get

One of the rea­sons Pfiz­er sought to pur­chase Seagen, as part of a $43 bil­lion deal an­nounced this morn­ing, is that the Seat­tle-based biotech will be able to with­stand the com­ing head­winds of the In­fla­tion Re­duc­tion Act and the Medicare price ne­go­ti­a­tions that come with it.

Un­like some of his phar­ma CEO peers who have lam­bast­ed the new law, Pfiz­er CEO Al­bert Bourla told in­vestors on a call this morn­ing that there are two spe­cif­ic fac­tors per­tain­ing to the IRA that will ac­tu­al­ly help with the com­bo of Pfiz­er and Seagen mov­ing for­ward:

  1. The $2,000 out-of-pock­et cap for se­niors, which takes ef­fect in 2025 and will mean that more of those on Medicare will be able to ac­cess ex­pen­sive can­cer drugs like those de­vel­oped by Seagen. All four of Seagen’s cur­rent­ly mar­ket­ed prod­ucts have list prices of more than $100,000 per year.
  2. All but one of Seagen’s cur­rent­ly mar­ket­ed drugs are bi­o­log­ics, which means longer ex­clu­siv­i­ty than small mol­e­cule drugs (13 years vs. nine years) un­der the IRA, pri­or to the gov­ern­ment be­gin­ning its ne­go­ti­a­tions.

The Con­gres­sion­al Bud­get Of­fice sim­i­lar­ly not­ed in a slide deck from Feb­ru­ary on the IRA’s im­pacts that Medicare Part D en­rollees “will use more drugs be­cause their out-of-pock­et costs will be low­er.”

Bourla al­so not­ed that an­ti­body-drug con­ju­gates like those de­vel­oped by Seagen aren’t like­ly to see the same lev­els of biosim­i­lar com­pe­ti­tion that are cur­rent­ly seen with the mon­o­clon­al an­ti­bod­ies or oth­er bi­o­log­ics.

Lat­er in the call, Bourla took an­oth­er ques­tion on the IRA, say­ing, “It is what it is. This is some­thing that is on the eas­i­er part. I don’t un­der­es­ti­mate the im­pact that the IRA will have on the amount of pre­scrip­tions and the abil­i­ty of pa­tients to pay.”

The Pfiz­er CEO’s com­ments run in con­trast to the way some of his peers have point­ed to the IRA as a rea­son and/or scape­goat for bio­phar­ma pipeline trims. Sev­er­al com­pa­nies, like Al­ny­lam and Eli Lil­ly, have al­ready point­ed to the new law as a ma­jor fac­tor in de­ci­sions to cut de­vel­op­ment pro­grams.

For more on what else needs to be ironed out in the IRA be­fore some of the more cen­tral el­e­ments take ef­fect, check out a re­cent pan­el End­points News held on the top­ic.

Ed­i­tor’s note: This ar­ti­cle has been cor­rect­ed to note that not all of Seagen’s mar­ket­ed drugs are large mol­e­cule bi­o­log­ics as Tukysa (tu­ca­tinib) is a small mol­e­cule pill.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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