Eye­ing Eylea's $5B sales, No­var­tis touts sol­id 12-week dos­ing da­ta for its ri­val RTH258

No­var­tis is rolling out new da­ta that build on its case for the com­pa­ny’s block­buster hope­ful RTH258, an in­ves­ti­ga­tion­al ther­a­py that might carve away a con­sid­er­able chunk of Re­gen­eron’s $5 bil­lion Eylea fran­chise if ap­proved.

Vas Narasimhan

The new da­ta, which came from a sec­ondary analy­sis of two Phase III tri­als, show a com­pelling case for the drug as a treat­ment for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion. The drug al­ready showed im­pres­sive suc­cess in those tri­als last fall, when it per­formed well in a head-to-head com­par­i­son to Eylea. Sim­ply put, No­var­tis’ CEO Vas Narasimhan said the drug was “con­sis­tent­ly su­pe­ri­or” to its Re­gen­eron ri­val.

Now, No­var­tis is call­ing at­ten­tion to RTH258’s con­ve­nience fac­tor com­pared to Eylea and oth­er ther­a­pies.

Dirk Sauer

“Ever since Lu­cen­tis was first in­tro­duced more than 10 years ago as a month­ly in­jec­tion, physi­cians have been try­ing to find a way to space out treat­ments,” said Dirk Sauer, head of No­var­tis’ oph­thal­mol­o­gy unit. “They’re try­ing to find a way to re­duce the bur­den for the pa­tient, but al­so to re­duce the bur­den for the physi­cian — they have lots of pa­tients com­ing back every month for in­jec­tions.”

Re­gen­eron’s Eylea can be tak­en once every 8 weeks, which is nicer for pa­tients and docs, but No­var­tis plans to go a step fur­ther. The com­pa­ny is bet­ting that its 12-week reg­i­men will win over a big slice of the mar­ket. In the da­ta rolled out to­day, No­var­tis said pa­tients in the tri­als had an 87% and 83% prob­a­bil­i­ty of suc­cess­ful­ly con­tin­u­ing a 12-week in­ter­val through week 48.

That’s big, Sauer said, con­sid­er­ing Re­gen­eron and oth­ers’ ap­par­ent dif­fi­cul­ty with this dos­ing sched­ule. Not to be out­done, Re­gen­eron told End­points News back in No­vem­ber that it was test­ing its own 12-week treat­ment cy­cle with Eylea. I checked back with Re­gen­eron last week, and a com­pa­ny spokesper­son said Re­gen­eron’s sBLA for its 12-week Eylea treat­ment was ac­cept­ed by the FDA and has a PDU­FA date of Au­gust 11.

But Sauer said that doesn’t nec­es­sar­i­ly steal No­var­tis’ edge.

“I can’t spec­u­late on the FDA la­bel for Eylea or for ours, but the da­ta are not the same,” Sauer said. “We did a prospec­tive analy­sis, while they went back and did a ret­ro­spec­tive analy­sis. Ret­ro­spec­tive analy­ses, from an an­a­lyt­i­cal and sta­tis­ti­cal point of view, are weak­er.”

Plus, Sauer said, Re­gen­eron doesn’t have 12-week treat­ment da­ta from its first year, on­ly its sec­ond. In the third year, the com­pa­ny went back to an 8-week reg­i­men, Sauer said, which might mean pa­tients lost vi­su­al acu­ity.

Still, Re­gen­eron may be slight­ly ahead in the race for ap­proval. Sauer said RTH258 should be filed with the FDA lat­er this year. But it could take a year to 18 months for the drug ac­tu­al­ly reach­es the mar­ket.

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.