Oh, no we aren’t! Ab­b­Vie says it isn’t re­think­ing pric­ing pledge at all

Ge­of­frey Porges, Leerink

Late last week Leerink’s Ge­of­frey Porges caused quite a stir when he out­lined a re­cent sit-down with the top ex­ecs at Ab­b­Vie. With the brouha­ha over drug pric­ing at the be­gin­ning of the year set­tling down, Porges said CEO Rick Gon­za­lez and CFO Bill Chase sound­ed like they were be­gin­ning to waf­fle over their pledge to lim­it price hikes on Hu­mi­ra to the sin­gle dig­its, once a year — break­ing from a steady dri­ve of price in­creas­es that has made Hu­mi­ra in­to a mas­sive block­buster.

Gon­za­lez and Chase are in­tent on mak­ing Hu­mor a $20 bil­lion an­nu­al earn­er, and maybe their ear­li­er “com­mit­ment ap­plies on­ly to 2017 and could be re­vis­it­ed in 2018,” the promi­nent an­a­lyst wrote.

The sto­ry be­gan to make the rounds, and now Ab­b­Vie ex­ecs want you to know they aren’t think­ing about any­thing dif­fer­ent, for 2018 any­way.

Richard Gon­za­lez

Their state­ment to StreetInsid­er:

State­ments made by Ab­b­Vie man­age­ment about drug pric­ing have been in­cor­rect­ly char­ac­ter­ized in mul­ti­ple sources. We eval­u­ate spe­cif­ic pric­ing de­ci­sions on an an­nu­al ba­sis, with care­ful con­sid­er­a­tion of a va­ri­ety of fac­tors. For 2018, Ab­b­Vie will take one sin­gle dig­it price in­crease and will con­tin­ue to act re­spon­si­bly with re­spect to drug pric­ing.

Pric­ing re­straint be­came all the rage at the end of last year as the con­tro­ver­sy over drug prices — fed by some cas­es of clear price goug­ing — raged dur­ing the elec­tion year. We’ll have to see whether the change of heart is per­ma­nent, or a tem­po­rary re­treat in the wake of pub­lic out­rage.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Covid-19 roundup: Mod­er­na dos­es first pa­tients in PhII vac­cine tri­al; Eli Lil­ly touts clin­i­cal en­try of Ab­Cellera-dis­cov­ered an­ti­body

With an eye on kick-starting Phase III for its mRNA vaccine in July, Moderna said it’s dosed the first participants of each age cohort enrolled in the Phase II study.

Moderna is responsible for the whole trial, which is designed to recruit 600 healthy volunteers — 300 between the ages of 18 and 55, and another 300 older than 55. Two doses (50 μg and 100 μg) will be tested alongside placebo, and each participant receives two shots.

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Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.

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With a Bristol Myers Squibb endorsement in tow, Versant-backed cancer drug developer Repare Therapeutics has set its sights on a Nasdaq debut.

On Friday, the Montreal-based company with operations in Cambridge, Massachusetts that is yet to enter the clinic, unveiled plans for a $100 million IPO, banking on its “synthetic lethality” platform.

The basic idea is to target the genetic basis of tumors, a common idea across precision oncology medicines. But instead of targeting the perpetrator mutation directly, the compound is designed to go after the other gene in the gene pair. The rationale is based on the decades-old genetic principle that indicates two mutations are lethal only when combined together.

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Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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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

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Lynn Seely, Myovant CEO

My­ovant’s re­l­u­golix wins a piv­otal prostate can­cer show­down with an old stan­dard — com­ing down to the wire on ap­provals

Myovant $MYOV has rounded the final turn in its development race to get relugolix down to the regulatory wire at the FDA. And the biotech joined the virtual crowd at ASCO with the kind of data needed to keep the investor crowd’s attention.

Much of the attention on the drug has been focused on uterine fibroids, where AbbVie just scored a regulatory win for their rival drug Oriahnn (elagolix) as the biotech posted results in prostate cancer at the ASCO meeting.

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