Re­gen­eron, Sanofi show re­straint on Dupix­ent price hike, but Pfiz­er’s hard charge con­tin­ues to spur calls for a rad­i­cal change-up

BIOREG­NUM — the view from John Car­roll

With the price of drugs front and cen­ter in Wash­ing­ton DC these days, Re­gen­eron and Sanofi are at­tract­ing ku­dos for their de­ci­sion to hold back the price hike on Dupix­ent to a mere 3%, which the phar­ma gi­ant notes is well with­in the rate of med­ical in­fla­tion — their cap on price in­creas­es.

Len Schleifer

Both of these com­pa­nies went through the ringer on PC­SK9 pric­ing — which have come down — and Re­gen­eron CEO Len Schleifer has been a con­sis­tent coun­sel for avoid­ing the big an­nu­al price in­creas­es that is at­tract­ing so much crit­i­cism these days.

Still, note that the over­all price trend is still point­ed up, not down, which is what Pres­i­dent Don­ald Trump promised re­cent­ly with his com­ment that the big chains were about to trig­ger “vol­un­tary mas­sive drops in prices.” That com­ment a month ago was a stumper for the phar­ma in­dus­try, which has promised no such thing. It’s al­so left it to HHS Sec­re­tary Alex Azar to ex­plain that that is not ex­act­ly the case.

And how.

Yes­ter­day’s news that Pfiz­er was in­creas­ing prices across a broad range of drugs has fo­cused at­ten­tion once again on a stan­dard in­dus­try prac­tice: look­ing to please in­vestors with a grow­ing bot­tom line that re­lies heav­i­ly on jack­ing up the cost of its port­fo­lio ther­a­pies. In Pfiz­er’s case, the Fi­nan­cial Times re­port­ed that the av­er­age price in­creas­es for 100 prod­ucts were around 9%, fit­ting un­der a 10% cap that most man­u­fac­tur­ers are hap­py to com­ply with.

That’s not mak­ing con­sumer ad­vo­cates very hap­py, as we saw yes­ter­day with a sug­ges­tion from the Pew Char­i­ta­ble Trusts that states could tax the rev­enue that phar­ma com­pa­nies bring in through tax hikes. So when Ab­b­Vie rais­es its price on Hu­mi­ra, an ag­ing stan­dard of care that ranks as the biggest mon­ey mak­er in the in­dus­try, a state like Cal­i­for­nia could levy a tax on the gain above the in­fla­tion rate.

Last year, re­marks Pew, av­er­age list prices for drugs jumped 6.4% and over­all in­fla­tion was lim­it­ed to a tiny frac­tion of that. They’re sug­gest­ing that states can claw back the cost of an in­crease by tax­ing any­thing over an in­fla­tion-ad­just­ed price — just the way pay­ers can re­quire a re­bate on the in­flat­ed cost.

For ex­am­ple, if a man­u­fac­tur­er in­creas­es the price of a drug from $100 to $115, but in­fla­tion is on­ly 2 per­cent, the in­fla­tion-ad­just­ed price is $102 and the man­u­fac­tur­er must pay Med­ic­aid a $13 in­fla­tion re­bate. A state tax on drug price in­creas­es could be de­signed to mir­ror the cal­cu­la­tions that de­ter­mine the Med­ic­aid in­fla­tion re­bate, re­duc­ing the com­pli­ance bur­den on drug man­u­fac­tur­ers.

The law cur­rent­ly al­lows man­u­fac­tur­ers to price drugs at will, giv­ing the feds no con­trol at all. States, says Pew, don’t have to stand idly by.

Look for the in­dus­try to bat back any­thing like that as fast as they can. The lob­by­ing groups rep­re­sent­ing the in­dus­try far pre­fer a self-polic­ing mech­a­nism while the Trump ad­min­is­tra­tion has tak­en a name-and-shame ap­proach to the most egre­gious price hikes — such as Cel­gene’s 20% hike on Revlim­id with­in one year.

Re­gen­eron and Sanofi — which have scored a slate of new ap­provals to push rev­enue growth — may yet win out with their ap­proach, but many of the biggest play­ers clear­ly don’t want to be bound by any such re­stric­tions. Not every­body has Re­gen­eron’s de­vel­op­ment skills, and some­body has to pay to make up for the in­no­va­tion gap. And with prices still climb­ing north, the de­bate over drug prices just con­tin­ues to heat up.

 

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.