Don­ald Trump is start­ing to win over bio­phar­ma

It would ap­pear that Don­ald Trump is start­ing to win over the minds — though per­haps not the hearts — of the bio­phar­ma in­dus­try.

Af­ter we ran two ear­li­er polls re­flect­ing a deep dis­taste for the Re­pub­li­can, Trump’s up­set vic­to­ry fol­lowed by a surge in in­dus­try stocks was fol­lowed by a re­spectable show of sup­port in our lat­est poll of biotech and phar­ma­ceu­ti­cal in­dus­try read­ers.

With 165 votes in, close to half (46%) felt that bio­phar­ma would be bet­ter off un­der Trump a year from now. That com­pares to 28% who felt it will be worse and 26% who felt that it will be no dif­fer­ent on the an­niver­sary of his win.

 

“I re­spond­ed to an ear­li­er sur­vey you held by vot­ing that Hi­lary would be bet­ter for bio­phar­ma than Trump, but my rea­son­ing for that re­sponse was that Trump was just go­ing to be a thin-skinned dis­as­ter as a pres­i­dent and that he would get us in­to a war or ma­jor cri­sis that would hurt the econ­o­my se­vere­ly,” not­ed one read­er. “Look­ing at Trump more close­ly, I think he’ll be more of a pos­i­tive, at least short term.”

An­oth­er thumbs up, fol­lowed by a thumbs down: ”Less reg­u­la­tion and price con­trols. So, bet­ter be­cause the in­dus­try will make more mon­ey and more re­search & ad­vance­ments will hap­pen. Worse, be­cause when a few bad ac­tors take ad­van­tage of this, there will be even big­ger rep­u­ta­tion hits for the in­dus­try. Think Shkre­li with a big­ger biotech.”

And don’t un­der­es­ti­mate the un­der­ly­ing dis­taste many of our read­ers have for Trump.

Vot­ing worse, a read­er notes: “The stock mar­ket will go down once he’s in of­fice. We will be in a pe­ri­od of in­sta­bil­i­ty. If his tax cuts go for­ward we will have an­oth­er re­ces­sion which will im­pact the abil­i­ty to raise mon­ey.”

One rea­son for the change of pos­i­tive sen­ti­ment can be seen in vot­ers thoughts on the like­ly shift ahead in M&A. A clear ma­jor­i­ty of re­spon­ders felt that Trump’s eco­nom­ic and tax poli­cies would help spur greater M&A in the in­dus­try, which can help over­all stock val­ues.

Here are some com­ments fa­vor­ing in­creased M&A, in which a num­ber of read­ers high­light­ed the like­li­hood of tax re­form:

“Par­tic­u­lar­ly if the tax code changes to en­cour­age com­pa­nies with cash trapped out­side the US to bring it back.”

“I as­sume he will ne­go­ti­ate a fa­vor­able phar­ma/biotech repa­tri­a­tion pol­i­cy (hel­lo Re­pub­li­can con­gress and sen­ate!) for ex-US dol­lars which will fu­el M&A.”

Here’s a note of cau­tion:

“We don’t quite know what are his eco­nom­ic poli­cies.”

The pres­i­dent-elect has clear­ly in­di­cat­ed that he wants to speed up the FDA and new drug ap­provals, but most read­ers aren’t ex­pect­ing any kind of dra­mat­ic change soon. Two-thirds said they don’t ex­pect a change in the next year. But 28% did be­lieve the FDA will be prod­ded in­to act­ing more quick­ly.

The same pro­por­tion of peo­ple be­lieve that the stock ral­ly will in­evitably flat­ten out, with the same num­ber look­ing for a con­tin­u­ing bull mar­ket.

“There will be lots of rhetoric but over­all no change, es­pe­cial­ly if the com­mis­sion­er stays in place.”

“I ex­pect some type of re­form, and some di­vi­sions sure need to speed up, but oth­ers (on­col­o­gy) al­ready are mov­ing at warp speed.”

“Sub­ject to the se­lec­tion of a trans­for­ma­tion­al leader whom I can­not iden­ti­fy, the agency will chug along al­most with­out re­gard to ad­min­is­tra­tion change. Four years is ac­tu­al­ly a pret­ty short time in FDA terms. Once the pub­lic learns that even “The Don­ald” can’t de­liv­er (no Wall, no pmt from Mex­i­co, lit­tle re­form, few jobs), he may be turfed out with the same en­thu­si­asm with which he was elect­ed. “

Fi­nal­ly, a sig­nif­i­cant mi­nor­i­ty of 43% said they ex­pect for­eign-born sci­en­tists will start leav­ing the US af­ter Trump takes of­fice. Slight­ly more than half said they ex­pect things will stay the same on that score. And you could hear a com­mon theme among many of the com­ments we re­ceived. Trump, many be­lieve, can’t be as bad as he made him­self out to be.

“As long as Trump is not a com­plete id­iot – I sus­pect he does not re­al­ly in­tend to do a lot of the things he said dur­ing the cam­paign.”

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.