J&J hands Tra­con two drugs, out­lines buy­back; Zymeworks does a cross-li­cens­ing deal with Dai­ichi Sankyo

Typ­i­cal­ly we see Big Phar­mas in-li­cens­ing ex­per­i­men­tal drugs from small biotechs. But in a re­verse of those roles, San Diego-based Tra­con Phar­ma­ceu­ti­cals bagged a cou­ple of pro­grams from phar­ma gi­ant J&J. And J&J is al­so in­vest­ing $5 mil­lion in an eq­ui­ty stake for its new part­ner. This is a two-way deal, though, as J&J al­so out­lined some spe­cif­ic deal terms if it wants these drugs back. J&J agreed to pay Tra­con $45 mil­lion up­front and up to $137.5 mil­lion in mile­stones to re­trieve JNJ-63576253, a prostate can­cer ther­a­py. And JNJ-64290694 for hema­to­log­ic ma­lig­nan­cies can be roped back af­ter ne­go­ti­a­tions. If Tra­con keeps that drug, it will be on the hook for up to $60 mil­lion in mile­stones. Ku­dos on the in­no­v­a­tive deal struc­ture.

Zymeworks CEO Ali Tehrani

Van­cou­ver-based Zymeworks con­tin­ues to wheel and deal its way in­to new col­lab­o­ra­tions. This lat­est deal to­day in­cludes a new part­ner­ship to de­vel­op a bi-spe­cif­ic an­ti­body for Dai­ichi Sankyo us­ing Zymeworks’ Azy­met­ric and Ef­fec­tor Func­tion En­hance­ment and Con­trol Tech­nol­o­gy plat­forms. And Zymeworks is li­cens­ing im­muno-on­col­o­gy an­ti­bod­ies from Dai­ichi Sankyo. Terms were not put on pub­lic dis­play. I asked CEO Ali Tehrani about the deal. His re­ply: “This deal, sim­i­lar to the oth­er deals we have signed, has strate­gic im­por­tance for Zymeworks be­yond the fi­nan­cial terms. The strate­gic ben­e­fit of this deal is re­flect­ed in the li­cense to unique im­muno-on­col­o­gy an­ti­bod­ies that Dai­ichi Sankyo is grant­i­ng to Zymeworks, en­abling Zymeworks to build ad­di­tion­al nov­el and po­ten­tial­ly high­ly dif­fer­en­ti­at­ed im­muno-on­col­o­gy rel­e­vant bi-spe­cif­ic ther­a­peu­tics for our in­ter­nal pipeline.”

Cam­bridge, MA-based Eleven Bio­ther­a­peu­tics $EBIO has raised $13.5 mil­lion, ac­cord­ing to a new Form D filed with the SEC. The biotech re­cent­ly re­or­ga­nized, hand­ing the shell over to a new op­er­a­tor and a new R&D fo­cus. Eleven’s lead drug failed bad­ly, twice, and af­ter out­li­cens­ing a re­main­ing pro­gram opt­ed to go in a new di­rec­tion.

Do you want to punch Mar­tin Shkre­li in the face? Stand in line. Or go on­line and make a bid. Shkre­li says he’s auc­tion­ing off a slap down to raise mon­ey for the fam­i­ly of a friend and for­mer PR ex­ec who died in his sleep. Af­ter rais­ing the price of an old med more than 5000% and set­ting off the moth­er of all drug pric­ing con­tro­ver­sies, he’s like­ly to find plen­ty of com­pe­ti­tion. Shkre­li, now fac­ing a lengthy line­up of fed­er­al fraud charges, has been pro­mot­ing the pitch on his Twit­ter ac­count, but I can’t see it. Like many oth­er jour­nal­ists, I’ve been blocked.

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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