Say what? Trump de­clares a big vic­to­ry in the war on drug prices — for De­cem­ber, any­how

Pres­i­dent Don­ald Trump wants you to know he’s win­ning the war on drug prices.

For one month, in any case.

“Al­ready,” Trump said dur­ing the State of the Union ad­dress Tues­day night, “as a re­sult of my ad­min­is­tra­tion’s ef­forts, in 2018 drug prices ex­pe­ri­enced their sin­gle largest de­cline in 46 years.”

That com­ment may take a lot of peo­ple in the bio­phar­ma in­dus­try by sur­prise. Yes, drug price in­creas­es have mod­er­at­ed, as most any phar­ma ex­ec will quick­ly tell you, but there’s been no rush by the drug mak­ers to slash prices.

AP fact check­ers tack­led this one quick­ly. They con­clud­ed that Trump’s boast was con­nect­ed to the De­cem­ber CPI on pre­scrip­tion drug prices, which dropped 0.6% — and which scores as the biggest drop in close to half a cen­tu­ry. But if you look at all of last year, the price fig­ure jumped 1.6%.

Paul Hugh­es-Cromwick of Al­tarum, a non­prof­it re­search or­ga­ni­za­tion, told the AP: “It could be that some­thing quirky hap­pened in De­cem­ber.”

An AP analy­sis al­so found “2,712 price in­creas­es in the first half of this Jan­u­ary, as com­pared with 3,327 in­creas­es dur­ing the same pe­ri­od last year.”

Trump will take cred­it for the De­cem­ber num­ber. But he al­so wants Con­gress to pass leg­is­la­tion that di­rect­ly tack­les drug costs. 

I am ask­ing the Con­gress to pass leg­is­la­tion that fi­nal­ly takes on the prob­lem of glob­al free­load­ing and de­liv­ers fair­ness and price trans­paren­cy for Amer­i­can pa­tients. We should al­so re­quire drug com­pa­nies, in­sur­ance com­pa­nies, and hos­pi­tals to dis­close re­al prices to fos­ter com­pe­ti­tion and bring costs down.

The ad­min­is­tra­tion has been push­ing a new pro­pos­al to strip away the safe har­bor pro­tec­tions that safe­guard the re­bates built in­to the drug pric­ing sys­tem we have now from an­ti-kick­back pro­vi­sions. Trump’s health­care team is ask­ing for a new fee-based sys­tem with dis­counts di­rect to con­sumers. And HHS Sec­re­tary Alex Azar wants leg­is­la­tion that would ap­ply these changes to pub­lic and pri­vate op­er­a­tions.

Drug pric­ing has emerged as a bi­par­ti­san is­sue in a di­vid­ed Con­gress. De­moc­rats have been propos­ing new laws while Re­pub­li­can Chuck Grass­ley and De­mo­c­rat Ron Wyden in the Sen­ate have been try­ing to line up the top CEOs in the in­dus­try to tes­ti­fy lat­er this month. So far, on­ly Mer­ck CEO Ken Fra­zier has pub­licly agreed to take the hot seat. The sen­a­tors say they have an­oth­er one, still anony­mous, and Olivi­er Brandi­court’s peo­ple are re­port­ed­ly check­ing his sched­ule to see if he can make it.

“This is an op­por­tu­ni­ty for com­pa­nies that pro­duce life-sav­ing treat­ments to ex­plain how they price these treat­ments and whether the sta­tus quo is ac­cept­able,” Grass­ley said in a state­ment. “Pa­tients and tax­pay­ers de­serve to hear from lead­ers in the in­dus­try about what’s be­hind this un­sus­tain­able trend and what can be done to low­er costs.”

The top ex­ecs at Ab­b­Vie, As­traZeneca, Bris­tol-My­ers Squibb, J&J and Pfiz­er al­so qual­i­fied for the least cov­et­ed in­vi­ta­tions in Wash­ing­ton, DC.

The pres­i­dent is like­ly to find con­sid­er­able warmth for his pro­pos­al on Tues­day to spend $500 mil­lion on re­search in­to new ther­a­pies for child­hood can­cer as well as a com­mit­ment to wip­ing out HIV/AIDS in 10 years.

Im­age: Pres­i­dent Don­ald Trump de­liv­er­ing the State of the Union.AP IM­AGES

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.