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.”

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.