J&J scraps a multi­bil­lion-dol­lar he­pati­tis C pro­gram af­ter ri­vals divvy up the mar­ket

Af­ter com­mit­ting bil­lions of dol­lars to a new he­pati­tis C cock­tail that had the po­ten­tial to com­pete with the al­ready deeply en­trenched ri­vals on the mar­ket, J&J is call­ing it quits.

Drawn to he­pati­tis C at a time when the field was un­der­go­ing a dra­mat­ic shift in com­ing up with a pain­less res­o­lu­tion of the dis­ease, that work is now done. Gilead led the way in cur­ing hep C, fol­lowed by a slew of com­peti­tors who have been whit­tling down the cost as they scram­bled to find new and bet­ter ways to do the job ever quick­er.

J&J had been a lead­ing fig­ure in that bet­ter/faster/cheap­er field, but is now bow­ing out af­ter re­port­ing stel­lar Phase IIa da­ta a year ago. Once the mid-stage pro­gram is done, says J&J {JNJ}, they’ll sus­pend their work in hep C.

Milind Desh­pande

That’s a dis­as­ter for Achillion $ACHN, which part­nered its NS5A drug odalasvir (ACH-3102) with the phar­ma gi­ant in a $1.1 bil­lion pact. The phar­ma gi­ant al­so bought out Alios for $1.75 bil­lion, gain­ing the nu­cleotide NS5B in­hibitor AL-335, which was added to a port­fo­lio that al­so in­clud­ed the NS3/4A pro­tease in­hibitor Oly­sio, an ap­proved ther­a­py in-li­censed from Medi­vir.

Medi­vir not­ed that the crash of J&J’s cock­tail pro­gram does not change the terms of its li­cens­ing pact with J&J, but it cer­tain­ly will have an im­pact on its po­ten­tial in this crowd­ed mar­ket.

Medi­vir’s shares dropped about 8% on the news {STO: MVIR-B} while Achillion stock dropped 6%.

Achillion found out about the de­ci­sion on Sat­ur­day, giv­ing it some time to pull to­geth­er its own re­sponse to the abrupt ter­mi­na­tion of the cock­tail ef­fort in an ef­fort to calm in­vestors. Said Achillion CEO Milind Desh­pande:

While we be­lieve that pa­tients world­wide would ben­e­fit from con­ve­nient, short-du­ra­tion ther­a­pies like JNJ-4178, we re­main ful­ly fo­cused on ad­vanc­ing our fac­tor D port­fo­lio of com­ple­ment al­ter­na­tive path­way in­hibitors in ar­eas where pa­tient needs are great­est, and us­ing our strong bal­ance sheet of al­most $370 mil­lion in cash and cash equiv­a­lents at June 30, 2017 to do so.”

J&J ex­ecs say they’ll now shift all their fo­cus to a func­tion­al cure for he­pati­tis B.

“Go­ing for­ward, our he­pati­tis R&D ef­forts will fo­cus on chron­ic he­pati­tis B, where a high un­met med­ical need still ex­ists. Our sci­en­tists are en­er­gized by this chal­lenge and our re­search am­bi­tion is to achieve a func­tion­al cure of he­pati­tis B which af­fects over a quar­ter of a bil­lion peo­ple glob­al­ly,” said Lawrence Blatt, the head of in­fec­tious dis­ease at Janssen. “At Janssen, we fo­cus our re­search and de­vel­op­ment on ar­eas of great­est un­met med­ical need where we can com­bine our ex­cel­lent in­ter­nal sci­ence with the best avail­able ex­ter­nal in­no­va­tion to bring op­ti­mized so­lu­tions and max­i­mum ben­e­fit to pa­tients.”

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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