J&J ad­vances through PhII with a promis­ing hep C triple and 100% cure rate

Cur­ing he­pati­tis C is a done deal now. But J&J is step­ping through the clin­ic with a new com­bo that the phar­ma gi­ant hopes will prove it can do it all faster, and pre­sum­ably cheap­er, than what’s avail­able now.

Achillion CEO Milind Desh­pande

In a new batch of da­ta put out Fri­day morn­ing by J&J part­ner Achillion $ACHN, J&J’s team scored a 100% cure rate in three co­horts of pa­tients get­ting a triple com­bi­na­tion of odalasvir, AL-335 and Oly­sio (simepre­vir). A fourth co­hort that ex­clud­ed simepre­vir achieved a 90% cure rate at SVR12, 12 weeks af­ter treat­ment. And one of the triplet co­horts achieved 100% cure for 20 pa­tients af­ter just 6 weeks of treat­ment.

That last fig­ure could be cru­cial, says Baird’s Bri­an Sko­r­ney:

Suc­cess at six weeks has the po­ten­tial to make this reg­i­men a se­ri­ous com­peti­tor to Gilead’s reg­i­mens, which cure in eight to 12 weeks.

The Phase IIa re­sults fixed the dose that J&J $JNJ will use in the next step, a Phase IIb that will en­roll both treat­ment-naive and treat­ment-ex­pe­ri­enced non-cir­rhot­ic pa­tients chron­i­cal­ly in­fect­ed with he­pati­tis C virus which runs the slate of geno­types 1, 2, 4, 5, and 6. In­ves­ti­ga­tors will al­so ex­pand the IIa to in­clude a broad­er mix of pa­tients as they push ahead to­ward piv­otal stud­ies and what looks like a prob­a­ble ap­proval.

Gilead, as we know, changed the treat­ment stan­dard with its break­through hep C drugs, be­gin­ning with So­val­di and con­tin­u­ing with Har­voni. Gilead al­so has a triple in the works, and has a rep­u­ta­tion as a tough com­peti­tor in any mar­ket it plays in. Gilead’s suc­cess was al­so fol­lowed up by new com­bos from Mer­ck and Ab­b­Vie, which fur­ther com­pli­cate the ar­rival of any new ther­a­pies. While whole­sale prices have been drop­ping, putting Gilead past the peak rev­enue stage, J&J still sees some big com­mer­cial up­side in a world where mil­lions of these slow-burn­ing cas­es have yet to be di­ag­nosed.

That strat­e­gy drove a deal to li­cense in Achillion’s NS5A drug odalasvir (ACH-3102) 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.

It’s not all good news for the hep C team, though. Jef­feries’ Bri­an Abra­hams was quick to note that there are still unan­swered ques­tions on how this sec­ond-wave ri­val­ry will play out, and whether J&J can suc­cess­ful­ly carve out a piece of the mar­ket. And he not­ed:

Based on two vi­ral re­bounds ob­served in the 8 week dual NS5A arm, we have con­firmed that ACHN/JNJ will no longer pur­sue a dual-reg­i­men — slight­ly dis­ap­point­ing, giv­en re­sults of the pi­lot “proxy” odalasvir-so­fos­bu­vir study, which had shown 100% SVRs with an odalasvir con­tain­ing dual-reg­i­men with both 8- and even 6-week treat­ment du­ra­tions, and could have been a dif­fer­en­ti­at­ing fea­ture. (We spec­u­late this may be due to ei­ther AL-335 be­ing less po­tent than so­fos­bu­vir, or to odalasvir dos­ing/ex­po­sure still be­ing op­ti­mized). The 6 week triple-reg­i­men showed promis­ing 100% EoT sup­pres­sion, and giv­en JNJ’s plan to ex­plore a 6 week reg­i­men in ph.IIb, we be­lieve SVR da­ta avail­able at the meet­ing in 2 weeks could look promis­ing and in­di­cate a po­ten­tial fu­ture path for the cock­tail.

Not­ed Achillion CEO Milind Desh­pande:

“Based on these in­ter­im re­sults, Janssen plans to ad­vance a phase 2b pro­gram for the triple com­bi­na­tion to fur­ther un­der­stand the po­ten­tial of this 3DAA drug com­bi­na­tion to short­en the du­ra­tion of treat­ment for pa­tients suf­fer­ing from HCV. De­spite re­cent ther­a­peu­tic ad­vances, we be­lieve there re­mains a sig­nif­i­cant un­met need in ad­dress­ing the glob­al bur­den of he­pati­tis C virus in those liv­ing with the dis­ease.”

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.