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.”

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experiences. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.

Vas Narasimhan. Getty Images

Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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Take­da tees up $420M deal for celi­ac an­ti­dote, con­tin­u­ing R&D re­fo­cus

Sometime in the 1st century AD, a patient presented to Arataeus looking like a varicose ghost. He was “emaciated and atrophied, pale, feeble and incapable of performing any of his accustomed works,” the Greek physician wrote, with hollow temples and huge veins running all over his body.

A dysfunctional digestive system, Arataeus concluded – an imbalance he attributed to a “heat” deficiency in a system he and other Greeks regarded as functioning similarly to an oven – and coined a term: coeliac disease, after the Greek word for abdomen.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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