House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images)

Pelosi threat­ens to slide drug pric­ing re­form in­to Biden's bud­get bill, re­jects in­dus­try push­back that in­no­va­tion would suf­fer

Af­ter a re­port re­leased by a key House com­mit­tee showed a pro­ject­ed $1 tril­lion in buy­backs over the next 10 years by Big Phar­ma, Speak­er Nan­cy Pelosi said she wants to at­tach drug pric­ing re­form to the cur­rent bud­get bill, and slammed drug com­pa­nies for sug­gest­ing in­no­va­tion would be harmed as a re­sult.

If passed, the bill would em­pow­er Medicare to ne­go­ti­ate di­rect­ly with drug com­pa­nies to low­er prices, a long­stand­ing goal for De­moc­rats. The House re­port claims the pol­i­cy shift could save tax­pay­ers $456 bil­lion in the next 10 years.

“We have an ex­tra­or­di­nary op­por­tu­ni­ty to do this as we craft this rec­on­cil­i­a­tion bill,” Pelosi said on a con­fer­ence call with re­porters.

The House Over­sight Com­mit­tee re­leased a staff re­port that an­a­lyzed fi­nan­cial da­ta from the 14 largest drug com­pa­nies to eval­u­ate the amount of mon­ey they in­vest in R&D, and the im­pact that has on Medicare price ne­go­ti­a­tions.

From 2016 to 2020, the com­pa­nies spent $56 bil­lion more on stock buy­backs and div­i­dends — $577 bil­lion — than on R&D, the re­port found. The pro­ject­ed num­ber of spend­ing on buy­backs from 2020 to 2029 is $1.15 tril­lion for the same 14 com­pa­nies.

“The Com­mit­tee pre­vi­ous­ly re­leased six staff re­ports show­ing that the phar­ma­ceu­ti­cal in­dus­try has tar­get­ed the Unit­ed States for price in­creas­es for many years, while cut­ting prices in the rest of the world,” the re­port said. “The Unit­ed States is par­tic­u­lar­ly vul­ner­a­ble to these pric­ing tac­tics be­cause cur­rent law pro­hibits Medicare from ne­go­ti­at­ing di­rect­ly with drug com­pa­nies to low­er drug prices.”

The 14 com­pa­nies in­clud­ed the study are Ab­b­Vie, Am­gen, As­traZeneca, Bris­tol My­ers Squibb, Eli Lil­ly, Gilead, GSK, J&J, Mer­ck, No­var­tis, No­vo Nordisk, Pfiz­er, Roche and Sanofi. Be­tween 2016 and 2020, the top ex­ec­u­tives for these com­pa­nies brought home a com­bined salary of $3.2 bil­lion, and eight of those com­pa­nies spent less on R&D com­pared to buy­backs and div­i­dends, the re­port states. Am­gen’s spend­ing on buy­backs was six-fold, com­pared to R&D costs.

“This re­port finds that the world’s lead­ing drug com­pa­nies have used price in­creas­es to boost pay­outs to in­vestors and ex­ec­u­tives while spend­ing less on re­search and de­vel­op­ment,” Rep. Car­olyn Mal­oney (D-NY) said in a press re­lease. “The re­port al­so shows that in­dus­try claims about the po­ten­tial im­pact of pric­ing re­forms are overblown.”

In­dus­try lob­by­ists have played tight de­fense, ar­gu­ing that it would de­ter the cre­ation of new drugs, and hurt pa­tients in the end. Bri­an Newell, a spokesper­son for bio­phar­ma lob­by­ing group PhRMA, told Bloomberg that his or­ga­ni­za­tion was com­mit­ted to work­ing with pol­i­cy­mak­ers on com­mon­sense so­lu­tions that ad­dress the “re­al chal­lenges pa­tients face.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

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