Bris­tol-My­ers takes an­oth­er hit on Op­di­vo/Yer­voy com­bo as CHMP turns thumbs down on front­line kid­ney can­cer

BIO 2018 Pan­elist Thomas Lynch CSO of Bris­tol-Mey­ers Squibb
Pho­to: Rob Tan­nen­baum, End­points News

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Bris­tol-My­ers Squibb $BMY con­tin­ues to run in­to some stiff head­winds with its com­bi­na­tion of Op­di­vo and Yer­voy.

Dur­ing their quar­ter­ly call with an­a­lysts Thurs­day, the top ex­ec­u­tive crew re­vealed that the EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use in Eu­rope had set­tled on a neg­a­tive opin­ion for the front­line use of the com­bi­na­tion for kid­ney can­cer. And that took a bite out of the com­pa­ny’s stock, while ding­ing their rep on I/O as Mer­ck con­tin­ues to chew up mar­ket ter­rain on its way to fron­trun­ner sta­tus.

Bris­tol-My­ers, which has a cham­pi­on’s ti­tle at stake, is not tak­ing this ly­ing down. R&D chief Tom Lynch, who learned about the set­back on Wednes­day, is prep­ping an ap­peal — but the odds are not in its fa­vor. 

Bris­tol-My­ers shares took a quick hit on the neg­a­tive read through.

Why would the EU turn thumbs down on the com­bo af­ter the FDA ap­proved it in April based on the Check­Mate-214 study, which demon­strat­ed sig­nif­i­cant help for poor-risk pa­tients over suni­tinib?

“(T)he ba­sis for their find­ing or their dis­cus­sion was re­al­ly that they did not feel that we had demon­strat­ed the con­tri­bu­tion of com­po­nents suf­fi­cient­ly well to grant this,” Lynch told an­a­lysts. “And they were wor­ried about es­tab­lish­ing a prece­dent in that set­ting.”

He con­tin­ued:

We be­lieve strong­ly that the com­bi­na­tion of Op­di­vo/Yer­voy is an ex­treme­ly im­por­tant reg­i­men, some­thing doc­tors are go­ing to want to be able to treat their pa­tients with. And when we de­signed the study, we se­ri­ous­ly con­sid­ered whether or not a sin­gle agent arm would make sense. And af­ter dis­cussing with key opin­ion lead­ers around the world, we felt it did not make sense giv­en the low sin­gle agent ac­tiv­i­ty we had seen. Now, our re­ac­tion to this is we’re go­ing to pro­ceed with ask­ing for a re-ex­am­i­na­tion and we look for­ward to a dis­cus­sion with the CHMP re­gard­ing this ap­pli­ca­tion.

There’s been end­less dis­cus­sion about check­point/CT­LA-4 com­bi­na­tions, dri­ven in part by the CT­LA-4 class’ well known pro­file on se­vere tox­i­c­i­ty. That has al­so hurt As­traZeneca as the phar­ma gi­ant con­tin­ues to try to prove that Imfinzi plus treme­li­mum­ab has a big com­mer­cial fu­ture ahead.

That’s not go­ing to be easy, es­pe­cial­ly as Mer­ck con­tin­ues to make progress with their strat­e­gy com­bin­ing Keytru­da with chemo.

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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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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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.

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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

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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

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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.