No­var­tis-backed Cona­tus high­lights a sil­ver lin­ing, but PhI­Ib NASH-re­lat­ed set­back caus­es whiplash in share price

The fairy tale sto­ry at Cona­tus Phar­ma­ceu­ti­cals has tak­en a nasty twist.

A lit­tle more than a year af­ter phar­ma gi­ant No­var­tis stepped in with an up­front pay­ment to bag li­cens­ing rights to its liv­er drug that was as big as the biotech’s mar­ket cap, their first Phase IIb tri­al for liv­er dis­ease failed the pri­ma­ry end­point. And their stock price $CNAT im­me­di­ate­ly tanked, plung­ing 34%.

Steven Men­to

There was vir­tu­al­ly no dif­fer­ence be­tween the re­sponse rate in the over­all pop­u­la­tion tak­ing em­ri­c­as­an com­pared to a place­bo. In­ves­ti­ga­tors, though, did find some en­cour­age­ment in sub­group analy­sis, not­ing some bet­ter num­bers for ad­vanced fi­bro­sis and ear­ly cir­rho­sis. But there were al­so sev­er­al miss­es as well.

That’s clear­ly not what the San Diego-based biotech was look­ing for when they start­ed the POLT-HCV-SVR tri­al about 4 years ago. No­var­tis pro­vid­ed a $50 mil­lion up­front, agreed to pay half of the Phase IIb costs for part of the over­all pro­gram and said it would pro­vide an­oth­er $7 mil­lion if it de­cid­ed to ex­er­cise its op­tion in the deal.

Ac­cord­ing to an SEC fil­ing at the time, No­var­tis al­so said it would pro­vide up to $650 mil­lion in mile­stones for the work, which in­cludes two oth­er Phase IIb tri­als. No­var­tis is look­ing for drugs it can com­bine with an in­ter­nal Far­ne­soid X re­cep­tor (FXR) ag­o­nist in clin­i­cal de­vel­op­ment for NASH. The phar­ma gi­ant is al­so on the hook to ex­e­cute Phase III, if it choos­es to move ahead.

Cona­tus CEO Steven Men­to stayed fo­cused on the pos­i­tive:

We are par­tic­u­lar­ly en­cour­aged by the 95% re­sponse rate in a sub­group of ad­vanced fi­bro­sis and ear­ly cir­rho­sis pa­tients with a fa­vor­able two-year safe­ty pro­file. In ad­di­tion, in pa­tients with the po­ten­tial to con­tin­ue wors­en­ing, those less than F6 at base­line, on­ly 2 of 26 (7.7%) on em­ri­c­as­an com­pared with 5 of 17 (29.4%) on place­bo showed an in­crease in fi­bro­sis score at year 2 – a treat­ment dif­fer­ence of 21.7 per­cent­age points. We al­so plan to eval­u­ate re­spons­es in ad­di­tion­al sub­groups in a va­ri­ety of sec­ondary and ex­plorato­ry end­points to learn as much as pos­si­ble from this da­ta-rich tri­al.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.