GSK dumps a late-stage HIV drug; MIT of­fers sup­port for tech start-ups; Ra Phar­ma clos­es flat af­ter $92M IPO

An­drew Wit­ty, GSK

Glax­o­SmithK­line didn’t just kill losmapi­mod on Wednes­day. The phar­ma gi­ant was al­so forced to dump a late-stage HIV drug ac­quired from Bris­tol-My­ers late last year in a $1.46 bil­lion deal. Here’s the ex­pla­na­tion from CEO An­drew Wit­ty, dur­ing the Q3 call: “We ter­mi­nat­ed 795. It’s re­al­ly a tol­er­a­bil­i­ty is­sue. We didn’t feel it was good enough from that point of view. In fact, we have at least two more back­ups and they come from both Bris­tol-My­ers and GSK labs ac­tu­al­ly. And I don’t think we are go­ing to lose a lot of time. We ob­vi­ous­ly lose a bit of time here but not a lot of time. So I think we feel like the over­all pro­gram is re­al­ly still very much sub­stan­tive as a num­ber of op­por­tu­ni­ties in it and even at the time where we did the trans­ac­tion with Bris­tol-My­ers, while we didn’t know the tol­er­a­bil­i­ty pro­file of this lead as­set, we were par­tic­u­lar­ly in­trigued by a cou­ple of the back­ups. So even at the time of the trans­ac­tion, we’ve been in­creas­ing our fo­cus on the back­ups. As it turns out the leader from BMS wasn’t what we hoped it would be but the re­al­i­ty is I think the pro­gram re­mains very much in­tact. I don’t think the time li­a­bil­i­ty is go­ing to be very ma­te­r­i­al and the back­ups come from both BMS and GSK which is good be­cause that gives you a bit of di­ver­si­ty of chem­istry and it gives us a big­ger so­lu­tion set to be able to come up with the right kind of prod­uct.”

MIT is revving up The En­gine, a new ven­ture that will look to raise “hun­dreds of mil­lions” of dol­lars and pro­vide sup­port and work­ing space to dozens of ear­ly-stage tech com­pa­nies in the heart of the Cam­bridge, MA biotech hub. MIT is launch­ing the ini­tia­tive by chip­ping in $25 mil­lion for the first $150 mil­lion fund. The plan is to re­serve 25,000 square feet of space to get start­ed and add more than 200,000 more square feet as the re­sources be­come avail­able.

Ra Phar­ma­ceu­ti­cals’ IPO $RARX raised close to $92 mil­lion on Wednes­day, clos­ing flat on its first trad­ing day at $13 a share. That $13 price marks a suc­cess­ful mid-range hit for the Cam­bridge, MA-based biotech, which has a lead drug in the pipeline for PNH. The com­pa­ny sold 7 mil­lion shares in the up­sized of­fer­ing.

Make that 201 com­bo stud­ies for Keytru­da. The UK’s Adap­ti­m­mune $ADAP is match­ing its lead NY-ESO SPEAR (Spe­cif­ic Pep­tide En­hanced Affin­i­ty Re­cep­tor) T-cell ther­a­py with Mer­ck’s PD-1 check­point in­hibitor Keytru­da for mul­ti­ple myelo­ma. The ear­ly-stage ex­plorato­ry study is slat­ed to start in H1 2017. Mer­ck re­cent­ly re­viewed the 360 on­go­ing im­muno-on­col­o­gy stud­ies it has in the clin­ic, which in­cludes 200 com­bos.

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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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.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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