My­lan CEO Bresch hopes to tame the mob with a 50% dis­count for the EpiPen

Buck­ling un­der a storm of protest over its move to sys­tem­at­i­cal­ly raise the price of its life-sav­ing EpiPen by 500%, My­lan an­nounced this morn­ing that it will pro­duce a gener­ic of the au­to-in­jec­tor and sell it for $300, or half price to the brand­ed prod­uct.

CEO Heather Bresch, who has been the cen­ter of an in­tense pub­lic spot­light since the con­tro­ver­sy broke out, once again blamed the whole thing on the in­dus­try sup­ply chain. But that nev­er gar­nered much sym­pa­thy from an out­raged pub­lic, which saw the move as yet an­oth­er ex­am­ple of price goug­ing from an in­dus­try un­fet­tered by fed­er­al pric­ing re­stric­tions. One of the com­pa­ny’s few de­fend­ers was Mar­tin Shkre­li, the dis­graced biotech ex­ec oust­ed from two com­pa­nies and now await­ing tri­al on fraud charges. Hillary Clin­ton and a va­ri­ety of lead­ing politi­cians in Wash­ing­ton, DC, though, coun­tered by call­ing Bresch on the car­pet for prof­i­teer­ing, a hot top in drug in­dus­try cir­cles, which has been treat­ed to a steady se­ries of pric­ing scan­dals from Shkre­li, My­lan and Valeant.

At one point last week the con­tro­ver­sy dent­ed biotech stocks in gen­er­al as in­vestors once again were faced with the po­ten­tial for new fed­er­al pric­ing rules that could hold back reg­u­lar price hikes on ag­ing prod­ucts, an in­dus­try stan­dard in bio­phar­ma that is fol­lowed by a large num­ber of com­pa­nies.

My­lan had at­tempt­ed to quell the the furor with a more ag­gres­sive ef­fort to cov­er out-of-pock­et costs for pa­tients, but that wasn’t go­ing to help every­one who re­lies on the EpiPen to pre­vent a po­ten­tial­ly lethal al­ler­gic re­sponse. This dis­count­ed prod­uct will al­so help counter any oth­er gener­ic threat to the mar­ket.

Here’s what Bresch of­fered ear­ly Mon­day:

“Our de­ci­sion to launch a gener­ic al­ter­na­tive to EpiPen is an ex­tra­or­di­nary com­mer­cial re­sponse, which re­quired the co­op­er­a­tion of our part­ner. How­ev­er, be­cause of the com­plex­i­ty and opaque­ness of to­day’s brand­ed phar­ma­ceu­ti­cal sup­ply chain and the in­creased shift­ing of costs to pa­tients as a re­sult of high de­ductible health plans, we de­ter­mined that by­pass­ing the brand sys­tem in this case and of­fer­ing an ad­di­tion­al al­ter­na­tive was the best op­tion. Gener­ic drugs have a long, proven track record of de­liv­er­ing sig­nif­i­cant sav­ings to both pa­tients and the over­all health­care sys­tem. The launch of a gener­ic EpiPen, which fol­lows the steps we took last week on the brand to im­me­di­ate­ly re­duce pa­tients’ out-of-pock­et costs, will of­fer a long-term so­lu­tion to fur­ther re­duce costs and ease the bur­den and com­plex­i­ty of the process on the pa­tient.”

The dis­count­ed gener­ic will like­ly be seen as lit­tle more than a face-sav­ing move by Bresch, who al­ways had the pow­er to drop the price of the brand­ed EpiPen back to a more ac­cept­able price.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Look­ing to move past an R&D fi­as­co, Ipsen poach­es their new CEO from Sanofi

Ipsen has turned to another Paris-based biopharma company for its next CEO.

Sanofi Pasteur chief David Loew — who’s been leading one of the most advanced efforts to develop vaccines for Covid-19 — is making the journey to Ipsen, 5 months after David Meek jumped ship to run a startup in late-stage development.

Loew arrives as Ipsen works to get back on track with their rare bone disease drug palovarotene, picked up in the $1.3 billion Clementia buyout, which was slammed with a partial hold after researchers observed cases of “early growth plate closure” in patients under the age of 14. But they are pushing ahead with the over-14 crowd after writing down slightly more than half of its initial development.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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