CEO in­ter­rupt­ed: No­var­tis chief Narasimhan looks to new ethics czar to clean up af­ter the lin­ger­ing Co­hen mess

Strug­gling to shed a bad rep for a string of ethics scan­dals capped by the ex­plo­sive ac­cu­sa­tions of sev­er­al US Sen­a­tors that com­pa­ny ex­ecs re­cent­ly mis­rep­re­sent­ed the cozy re­la­tion­ship be­tween for­mer CEO Joe Jimenez and Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen, No­var­tis is once again look­ing to clean up its act.

CEO Vas Narasimhan has re­cruit­ed a promi­nent Ger­man at­tor­ney to lead their ethics, risk and com­pli­ance ef­forts.

Klaus Moos­may­er will now be charged with keep­ing the com­pa­ny clear of any new ethics scan­dals, which have come fast and fre­quent­ly at the phar­ma gi­ant. The lawyer has spent the past few years as chief com­pli­ance of­fi­cer at Siemens and chairs the An­ti-Cor­rup­tion Task­force of the Busi­ness and In­dus­try Ad­vi­so­ry Com­mit­tee at the Or­ga­ni­za­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment.

Moos­may­er is tak­ing the place of Shan­non Thyme Klinger, new­ly pro­mot­ed to group gen­er­al coun­sel in the wake of Fe­lix Ehrat’s abrupt res­ig­na­tion dur­ing the cri­sis that hit No­var­tis as it strug­gled with rev­e­la­tions about their $1.2 mil­lion in pay­ments to Co­hen.

No­var­tis’ ex­pla­na­tion — echoed by new­ly re­tired CEO Jimenez — was that this was a sim­ple way to gain in­sights in­to Trump’s new ad­min­is­tra­tion and its health­care poli­cies. But some com­pa­ny in­sid­ers viewed it more like a sim­ple way to pay for ac­cess.

A few weeks ago, a group of De­moc­rats in the Sen­ate re­leased their own quick re­port, con­clud­ing that the com­pa­ny’s con­tention that top ex­ecs had on­ly a brief, in­con­se­quen­tial ex­change with Co­hen and were forced to pay out the con­tract mis­rep­re­sent­ed the nu­mer­ous con­tacts Jimenez had with Co­hen.

“What he was sell­ing was a line of ac­cess to the Trump ad­min­is­tra­tion,” said Sen. Ron Wyden in an in­ter­view with ABC News in Ju­ly. “That would be how I would char­ac­ter­ize it.” Wyden and his col­leagues out­lined nu­mer­ous con­tacts Jimenez had with Co­hen.

Af­ter ini­tial­ly be­moan­ing the need to do bet­ter in fol­low-up meet­ings with staff, Narasimhan and his top staff now in­sist that the whole is­sue is be­hind them. 

The 600-pound go­ril­la, though, re­mains in the room, even if it’s not re­ferred to in the com­pa­ny’s state­ment on its new hire.

Not help­ing much is that No­var­tis shook up its ethics and com­pli­ance op­er­a­tions last fall in the wake of kick­back and bribery ac­cu­sa­tions. A Ko­re­an in­ves­ti­ga­tion de­ter­mined com­pa­ny ex­ecs had been con­duct­ing a kick­back scheme in that coun­try while No­var­tis al­so faced cor­rup­tion charges in Greece.

The chain of scan­dals has se­vere­ly in­ter­rupt­ed Narasimhan’s cam­paign to make over No­var­tis’ rep and present the com­pa­ny as a gi­ant ea­ger to do right by pa­tients and health­care sys­tems, pur­su­ing the lat­est in dig­i­tal strate­gies to im­prove care.

“As we as­pire to reimag­ine med­i­cine, we must hold our­selves to (the) high­est eth­i­cal stan­dards and al­ways aim to win and main­tain the trust of so­ci­ety and our many stake­hold­ers,” the CEO said in a state­ment. “Klaus has ex­ten­sive ex­pe­ri­ence in lead­ing Com­pli­ance for large glob­al or­gan­i­sa­tions and is in­ter­na­tion­al­ly rec­og­nized in his field.”


Im­age: Klaus Moos­may­er. SIEMENS

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.

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.

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.

Endpoints News

Basic subscription required

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

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.

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.