Bris­tol-My­ers hands over $100M in cash for a new fi­bro­sis drug, beef­ing up NASH fo­cus

It’s not all check­points all the time at Bris­tol-My­ers Squibb. The big biotech has been ramp­ing up an am­bi­tious ef­fort in fi­bro­sis and NASH and this morn­ing it’s tak­ing the wraps off an­oth­er deal in the field, pay­ing $100 mil­lion to Japan’s Nit­to Denko for an ear­ly-stage drug can­di­date that now be­comes part of their port­fo­lio.

The key drug in this pack­age deal is ND-L02-s0201, a siR­NA that is de­signed to in­hib­it heat shock pro­tein 47. By hit­ting HSP47, their in­ves­ti­ga­tors be­lieve that they can cut the pro­duc­tion of col­la­gen that plays a role in fi­bro­sis and NASH, while help­ing cor­rect at least some of the dam­age that has al­ready been done to pa­tients.

The drug is un­der­go­ing a 5-week Phase Ib study now to give them a bet­ter idea of how the drug works for fi­bro­sis caused by NASH, an epi­dem­ic fat­ty liv­er dis­ease, and he­pati­tis C. And Bris­tol-My­ers gets the rights to Nit­to Denko’s port­fo­lio in the field, bag­ging ex­clu­sive rights for fi­bro­sis in a va­ri­ety of dis­eases.

The deal in­cludes mile­stones, which weren’t dis­cussed in their state­ment.

Nit­to Denko is a cen­tu­ry-old di­ver­si­fied ma­te­ri­als man­u­fac­tur­er based in Os­a­ka with a new­found in­ter­est in di­ver­si­fy­ing in­to biotech. Ear­ly this year the com­pa­ny es­tab­lished a biotech sub­sidiary called Nit­to Bio­Phar­ma, with fa­cil­i­ties in San Diego and plans to con­tin­ue to pur­sue R&D in IPF and oth­er dis­eases.

Bris­tol-My­ers ex­ecs have been putting a brave face on their re­cent de­ba­cle in front­line non-small cell lung can­cer for their PD-1 pi­o­neer Op­di­vo. The late-stage fail­ure left a bad scar, but the com­pa­ny points to its R&D work in fi­bro­sis/NASH and heart fail­ure as ex­am­ples of a more di­ver­si­fied pipeline.

Back in Au­gust, 2015, the am­bi­tious R&D group struck a $1.25 bil­lion deal — $150 mil­lion up front — to gain an op­tion to ac­quire Prome­dior if its mid-stage fi­bro­sis pro­gram comes through.

Bris­tol-My­ers has its sights set on PRM-151, a re­com­bi­nant form of hu­man pen­trax­in-2 pro­tein in de­vel­op­ment for id­io­path­ic pul­monary fi­bro­sis and myelofi­bro­sis. The com­pa­ny scored an­oth­er pro­vi­sion­al buy­out agree­ment for Den­mark’s Galec­to in 2014, agree­ing to pay up to $444 mil­lion for the com­pa­ny. That deal cen­tered on TD139, an in­hibitor of galectin-3, which binds to car­bo­hy­drate struc­tures, play­ing a role in IPF that can be de­railed by this new drug. TD139 joined BMS-986020, a lysophos­pha­tidic acid 1 (LPA1) re­cep­tor an­tag­o­nist al­so in stud­ies for fi­bro­sis. Bris­tol-My­ers al­so struck re­search deals with the Cal­i­for­nia In­sti­tute for Bio­med­ical Re­search (Cal­i­br) and The Med­ical Uni­ver­si­ty of South Car­oli­na.

Michel Vounatsos, Getty Images

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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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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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.

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.