Pralu­ent Odyssey: Re­gen­eron/Sanofi gun for mar­ket break­out with first-ever mor­tal­i­ty ben­e­fit — and a big price dis­count

Few drug ri­val­ries have been car­ried out with more di­rect, hand-to-hand fight­ing than the scrap over the PC­SK9 mar­ket. Mar­gin­al as the mar­ket is now, the com­bined forces of Re­gen­eron and Sanofi al­lied against Am­gen have nev­er­the­less punched it out in court and the play­ing field in the de­vout be­lief that bil­lions are at stake. And all three have had to strug­gle with a pay­ers’ back­lash against the two drugs they’re sell­ing.

Now Re­gen­eron/Sanofi are launch­ing a full scale as­sault, armed with new da­ta from the 18,924-pa­tient Odyssey Out­comes study high­light­ing ground­break­ing ev­i­dence of a mor­tal­i­ty ben­e­fit for Pralu­ent that they be­lieve will give them an edge. And they’re fol­low­ing through by dra­mat­i­cal­ly mark­ing down the pub­lic price they are propos­ing to charge for pay­ers will­ing to fi­nal­ly dis­man­tle the hur­dles they’ve erect­ed to stop their mem­bers from tak­ing their cho­les­terol treat­ment.

Just as Am­gen won ku­dos for its work to con­vince pay­ers to do the same with mon­ey-back guar­an­tees, this new round marks the in­dus­try’s in­creas­ing will­ing­ness to ne­go­ti­ate over what it charges — a trend that is cre­at­ing a sea change over some drugs that have to sur­vive in a com­pet­i­tive scene.

First, here’s the long-await­ed Odyssey Out­comes da­ta, re­leased at the Amer­i­can Col­lege of Car­di­ol­o­gy’s sci­en­tif­ic meet­ing in Or­lan­do.

Re­searchers say they have con­clu­sive ev­i­dence that Pralu­ent not on­ly sig­nif­i­cant­ly re­duced the num­ber of car­dio in­ci­dents ex­pe­ri­enced by pa­tients on the LDL drug, with the vast ma­jor­i­ty al­so on high-in­ten­si­ty statins, they al­so have a clear re­duc­tion in deaths — the goal that elud­ed Am­gen when it float­ed their Fouri­er da­ta last sum­mer.

— Look­ing at MACE (Ma­jor Ad­verse Car­diac Events) among pa­tients with an LDL lev­el over 100 mg/dL, there was a drop of 3.4 points be­tween the place­bo arm and Pralu­ent rates — 14.9% to 11.5%, a risk re­duc­tion of 24%.

— For CV death the rate dropped from 4.2% to 2.9%.

— And for all-cause deaths the de­crease was 5.7% to 4.1%, with a 1.7 point drop; a 29% drop in risk.

To put it an­oth­er way, for every 1,000 pa­tients who met this pro­file and were on drug, 17 peo­ple would still be alive. And that, say the part­ners, should be the telling dif­fer­ence for pay­ers.

To dri­ve that mes­sage home, Sanofi to­day has agreed to cut their price of Pralu­ent to $4,460 to $7,975 a year for pay­ers who are will­ing to stop throw­ing up road­blocks to this drug, drop­ping to a price that on the low end is not much high­er than the $10-a-day cost of the old gen­er­a­tion of statins be­fore they went gener­ic. At the high end, it still marks a sharp drop from the $14,000 whole­sale price that had been the mar­ket stan­dard used to peg dis­counts against.

“Too many pa­tients in ur­gent need of ad­di­tion­al treat­ment op­tions on top of statins have faced tremen­dous hur­dles to gain ac­cess to this im­por­tant med­i­cine. We are pre­pared to change this by im­prov­ing ac­cess and af­ford­abil­i­ty, elim­i­nat­ing these bur­den­some bar­ri­ers for high-risk pa­tients in need,” said Sanofi CEO Olivi­er Brandi­court in a state­ment. “We will be­gin work­ing with pay­ers to en­sure that high-risk pa­tients have ap­pro­pri­ate ac­cess. This is the right thing to do for pa­tients.”

That was not an easy con­ces­sion for Sanofi, but these drugs are earn­ing on­ly a frac­tion of what an­a­lysts had ex­pect­ed.

At this point, there’s vir­tu­al­ly no ques­tion that these drugs work as billed, slash­ing LDL lev­els safe­ly. In fact, many an­a­lysts would al­so tell you that they are re­mark­ably sim­i­lar. Per­haps they were a lit­tle too sim­i­lar for a judge who once or­dered Re­gen­eron and Sanofi to yank their drug dur­ing their court bat­tle with Am­gen over the patents in­volved. That rul­ing was over­turned, but the le­gal fight con­tin­ues.

Re­gen­eron/Sanofi are com­ing out with a dif­fer­en­ti­at­ed pro­file now, though, af­ter Am­gen hus­tled its Repatha out­comes da­ta out last year, trum­pet­ing sig­nif­i­cant re­duc­tions in car­dio events but no mor­tal­i­ty ben­e­fit. And pay­ers re­mained unim­pressed.

Why did Odyssey Out­comes suc­ceed on that mor­tal­i­ty score?

Bob Pordy, the vice pres­i­dent of car­dio­vas­cu­lar and me­tab­o­lism ther­a­peu­tics at Re­gen­eron, says you can mark that down to the fact they fo­cused on a group of ACS pa­tients who were by far at the high­est risk, with a sig­nif­i­cant­ly longer du­ra­tion of treat­ment in the study.

“Odyssey Out­comes stud­ied Pralu­ent in the high­est risk pa­tients,” echoes Jay Edel­berg, Sanofi’s head of car­dio de­vel­op­ment. “They re­main at high risk of re­cur­ring heart at­tacks. By study­ing these high­est risk pa­tients, we were able to demon­strate re­duc­tions in MACE and a re­duc­tion in mor­tal­i­ty.”

While most of the at­ten­tion in the cho­les­terol mar­ket has cen­tered on the two PC­SK9 drugs, the two key com­pa­nies aren’t alone here. Es­pe­ri­on CEO Tim Mayleben has made it clear that they plan to charge un­der $4,000 for their late-stage cho­les­terol pill, now in late-stage de­vel­op­ment. That price point may not look like so much of a bar­gain now. And The Med­i­cines Com­pa­ny has been putting all their eggs in one RNAi bas­ket on LDL cho­les­terol as well, which may al­so face al­tered prospects.

This kind of pub­lic dis­cus­sion about re­tail drug prices is a re­mark­able change for an in­dus­try that has ben­e­fit­ed enor­mous­ly by keep­ing their true prices as opaque as pos­si­ble. But now da­ta aren’t enough, as pay­ers find new ways to put some dis­tance be­tween them­selves and the mass mar­ket drugs that threat­en to eat in­to their mar­gins.

Now you al­so have to pub­licly com­pete on the stick­er price, on oc­ca­sion.

Im­age: Sanofi CEO Olivi­er Brandi­court on Jan­u­ary 31, 2018  Alek­sey Nikol­skyi/Sput­nik via AP

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.