As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

As­traZeneca has made a stride to­ward re­al­iz­ing its am­bi­tions in Chi­na as reg­u­la­tors green­light Imfinzi as a treat­ment for non-small cell lung can­cer.

In par­tic­u­lar, the PD-L1 agent is fill­ing a void for im­munother­a­pies in Stage III un­re­sectable case, the com­pa­ny said, where the can­cer has not spread to the rest of the body. It is to be used, with cu­ra­tive in­tent, in pa­tients whose can­cer hasn’t pro­gressed fol­low­ing con­cur­rent plat­inum-based chemother­a­py and ra­di­a­tion ther­a­py.

Dave Fredrick­son

“This ap­proval il­lus­trates our long-stand­ing com­mit­ment to im­prov­ing health out­comes in Chi­na, where more than one-third of the world’s lung can­cer di­ag­noses and deaths oc­cur,” said Dave Fredrick­son, who heads As­traZeneca’s on­col­o­gy busi­ness unit, in a state­ment.

Imfinz’s ap­proval al­so marks the en­try of a PD-L1 in­hibitor to the coun­try, where PD-1 drugs have been pil­ing up. Bris­tol-My­ers Squibb scored the first-ever Chi­nese ap­proval for a check­point in­hibitor in June 2018, with Op­di­vo in­di­cat­ed for sec­ond-line treat­ment of NSCLC, and Mer­ck has been rack­ing up OKs for dif­fer­ent reg­i­mens in­volv­ing Keytru­da.

Then there are the do­mes­tic ri­vals, whose drugs are cur­rent­ly lim­it­ed to lym­phoma or melanoma but al­so have plans for a lu­cra­tive lung can­cer mar­ket. And they are ea­ger to com­pete on price.

Leon Wang

For As­traZeneca, this is just more rea­son to roll up its sleeves and get to ne­go­ti­at­ing with pay­ers. Its head of Chi­na, Leon Wang, has pre­vi­ous­ly told Bloomberg that he sees new treat­ments con­tribut­ing to 60% of all its Chi­na rev­enue with­in five years. To il­lus­trate that dri­ve, Wang of­fered the ex­am­ple of its first-gen EGFR-tar­get­ing lung can­cer Ires­sa, in which they won the drug sup­ply con­tract in by slash­ing the price more than 70%.

Quick ap­provals for third-gen EGFR TKI Tagris­so (which is now on the Na­tion­al Re­im­burse­ment Drug List), as well as the PARP in­hibitor Lyn­parza, helped — and now it’s time for Imfinzi to shine. No­tably, Roche’s PD-L1 Tecen­triq — which gained FDA ap­proval ear­li­er than Imfinzi — is not yet avail­able in Chi­na.

In the Phase III PA­CIF­IC tri­al, Imfinzi cut the risk of death by 32% and pro­longed pro­gres­sion-free sur­vival by 11.2 months ver­sus place­bo (me­di­an PFS 16.8 vs 5.6 months), when paired with chemo or ra­di­a­tion ther­a­py. At the three-year mark, 57% of pa­tients on the Imfinzi arm are still alive com­pared to 43.5% on place­bo, ac­cord­ing to a post hoc analy­sis pre­sent­ed at AS­CO.

Imfinzi sales have gone over the $1 bil­lion mark in the first three quar­ters of the year, grow­ing 182% com­pared to the same pe­ri­od last year.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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