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John Oyler, Founder & CEO of BeiGene, at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube

As Bris­tol-My­ers/Cel­gene tie up loose ends, BeiGene pock­ets $150M from PD-1 breakup

As soon as Bristol-Myers Squibb announced its $74 billion buyout for Celgene, BeiGene emerged as a prominent example of a player whose pact with the big biotech could sour, as its PD-1 candidate seems to overlap with Opdivo. After six months of suspense, the partners say they are finally bringing the 2-year-old deal to an amicable end.

BeiGene $BGNE gets $150 million for the termination in addition to full global rights to tislelizumab. In 2017 Celgene had paid $263 million in upfront license fees to develop the PD-1 inhibitor for solid cancers in the US, Europe, Japan and the rest of the world outside Asia. It also threw in a $150 million equity investment in exchange for BeiGene handling its commercial operations — think Abraxane, Revlimid and Vidaza — in China.

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Gene ther­a­py R&D deals turn red hot as Big Phar­ma steps up to play

This September will mark the 20th anniversary of the death of Jesse Gelsinger, a young man suffering from X-linked genetic disease of the liver. He was killed in a gene therapy study conducted by Penn’s James Wilson, and the entire field endured a lengthy deep freeze as the field grappled with the safety issues inherent in the work.

Some thought gene therapy R&D would never survive. But it did. And this year marked a landmark approval for Zolgensma, a new gene therapy for spinal muscular atrophy Novartis priced at $2.1 million.

“Gene therapy is the hottest item on the block now. But there was a time when we first got into this trial, where there wasn’t a person in the world who believed that gene therapy would work. We have to remember that,” noted gene therapy investigator Jerry Mendell told SMA News Today.

We’re still right on the pioneering frontier when it comes to getting approvals for gene therapies and launching marketing campaigns with the European green light for bluebird’s leading program last Friday underscoring the nascent nature of the field. But gene therapy R&D is booming, and has been for several years now.

The rapid growth of gene therapy clinical development is well known, but we decided to put some numbers on it, to quantify what’s going on. DealForma chief Chris Dokomajilar took a lot over the past 10 years, as the number of deals, R&D partnerships and buyouts steadily gained steam, spiking last year and on track to maintain the surge in 2019.

The upfronts and totals for the dollars on deals so far in 2019 is already close to the 2018 mark, underscoring a new phase of negotiations as the major players step up to gain a piece of the late-stage and commercial action.

Once again, we’re looking at an “overnight” biotech success story, decades in the making.

At some point, that may start to brake the numbers we’re seeing. But for now, as rivals line up to compete for frontline prominence across a range of diseases, the arrows are all pointed north.

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Albert Bourla appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Pfiz­er CEO Al­bert Bourla is back in the M&A game, but why is he pay­ing $11.4B for Ar­ray?

Pfiz­er $PFE has cut short its time on the side­lines of bio­phar­ma M&A.

Mon­day morn­ing the phar­ma gi­ant un­veiled an $11.4 bil­lion deal to ac­quire Ar­ray Bio­Phar­ma, beef­ing up its on­col­o­gy work and adding a new re­search hub in Boul­der, Col­orado to its glob­al op­er­a­tions.

At $48 a share, Ar­ray $AR­RY in­vestors will be get­ting a 62% pre­mi­um off the Fri­day close of $29.59.

Pfiz­er, which has strug­gled to gain all the up­side promised in past buy­outs like Medi­va­tion, high­light­ed the ac­qui­si­tion of 2 ap­proved drugs in the deal — Braftovi (en­co­rafenib) and Mek­tovi (binime­tinib).

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Cue the M&A chat­ter: UniQure is scout­ing for a buy­out deal as gene ther­a­py field siz­zles — re­port

All the en­thu­si­asm that’s been whipped up in the gene ther­a­py field this past year has helped stoke the ru­mor mill about all sorts of pos­si­bil­i­ties for uniQure $QURE, which has seen a quick run-up on its share price. And now the biotech’s back­ers are get­ting a big boost from Bloomberg to keep the run go­ing.

There’s no deal to re­port, but sources are telling the busi­ness news ser­vice that uniQure has brought in ad­vis­ers to see what might be done — in­clud­ing a sale — with the phar­ma gi­ants now prowl­ing the clin­i­cal play­ers for part­ners and ac­qui­si­tions.

Jennifer Doudna and Jonathan Weissman. BARBARA RIES for UCSF

GSK's Bar­ron joins hands with Doud­na, Weiss­man to de­ploy CRISPR tech in drug dis­cov­ery

When Hal Bar­ron un­veiled his grand plan to turn Glax­o­SmithK­line’s R&D group around, he cham­pi­oned ge­net­ics as one of two key fo­cus­es for the UK phar­ma gi­ant, an­nounc­ing a dis­cov­ery deal with 23andme and pledg­ing to fo­cus more on CRISPR tech as well as ma­chine learn­ing. A year lat­er, the R&D chief is build­ing on that promise as he seals a new pact with two promi­nent CRISPR re­searchers in his neigh­bor­hood in San Fran­cis­co.

Mer­ck makes a $773M bet on TGFβ, ac­quir­ing a three-year-old biotech

When check­point in­hibitors work, they can per­form won­ders. But for many can­cer pa­tients, in-built or ac­quired re­sis­tance to these im­munother­a­pies im­pedes their ef­fi­ca­cy. Mer­ck, the mak­er of the check­point king Keytru­da, is shelling out up to $773 mil­lion to swal­low Ti­los Ther­a­peu­tics, which is de­vel­op­ing a class of drugs de­signed to mit­i­gate check­point re­sis­tance.

Ti­los Ther­a­peu­tics, found­ed three years ago, is de­vel­op­ing an­ti-LAP an­ti­bod­ies, de­signed to treat can­cer, fi­bro­sis and au­toim­mune dis­eases by un­leash­ing the im­mune sys­tem to at­tack dis­ease. La­ten­cy-as­so­ci­at­ed pep­tide (LAP) is a pro­tein that forms a cage around the trans­form­ing growth fac­tor (TGFβ), hold­ing the po­tent cy­tokine in a la­tent state un­til it is ready to be de­ployed. TGFβ’s mis­reg­u­la­tion can re­sult in tu­mor de­vel­op­ment, and the cy­tokine is thought to play a key role in fi­brot­ic dis­eases.

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In­vestors fret as new reg­u­la­to­ry probes spur fresh de­lays to Roche's $4.3B Spark buy­out

An­oth­er day, an­oth­er de­lay. On Mon­day, Roche re­vealed that in ad­di­tion to the US Fed­er­al Trade Com­mis­sion, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty is prob­ing the Spark Ther­a­peu­tics takeover deal, trig­ger­ing an­oth­er de­lay of the $4.3 bil­lion ac­qui­si­tion an­nounced in Feb­ru­ary.

Spark share­hold­ers now have un­til Ju­ly 31 to ten­der their shares.

Since its last up­date in mid-May, the per­cent­age of shares al­ready sold inched up to 21.1% from 21%, low­er than 26.1% and 29.4% reg­is­tered on pre­vi­ous dead­lines. These num­bers are still a far cry from the 50% re­quired to con­sum­mate the deal, but Roche has main­tained it’s not un­usu­al for “a sig­nif­i­cant por­tion of share­hold­ers” to wait un­til the last days of the of­fer pe­ri­od.

R&D leader Ver­tex ex­e­cutes a $420M cash gam­bit to dom­i­nate gene edit­ing field for Duchenne MD

Vertex sees a big future for itself in using gene editing tech to remedy killer diseases like Duchenne MD, and it’s spending $420 million in cash today to make it a near-term reality.

After the market closed Vertex announced that it will buy gene editing pioneer Exonics — born in the lab of UT Southwestern investigator Eric Olson — for $245 million while plunking down another $175 million to expand its work with CRISPR Therapeutics, the Swiss-based gene editing outfit that was in the first wave of startups in the field.

Last summer, Exonics provided some intriguing details to show how their gene-editing approach works in dogs. Dispatching a Cas9 scalpel with guide RNA inside an AAV delivery vehicle straight to muscle cells, the researchers say that their approach was able to restore dystrophin production that reached up to 92% of normal in a canine model for the disease.

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Vi­cal finds way out of R&D woes via re­verse merg­er with der­ma­tol­ogy biotech Brick­ell

Months af­ter bury­ing its third and fi­nal clin­i­cal pro­gram, Vi­cal has turned to a re­verse merg­er with Brick­ell Biotech to put an end to its mis­ery.

The new com­pa­ny — in which Vi­cal in­vestors will re­tain a 40% own­er­ship — will op­er­ate un­der Brick­ell’s name and agen­da, fo­cus­ing on se­ri­ous der­ma­to­log­ic dis­or­ders like hy­per­hidro­sis, cu­ta­neous T-cell lym­phoma and pso­ri­a­sis. Fol­low­ing the all-stock trans­ac­tion, No­vaQue­st Cap­i­tal Man­age­ment has pledged $25 mil­lion to fund near-term R&D, adding to the $35 mil­lion in cash re­serve that Vi­cal brings.

Am­gen of­fers to swal­low Den­mark-based drug dis­cov­ery part­ner in $167M deal

Am­gen is of­fer­ing to buy its Copen­hagen-based part­ner Nuevo­lu­tion — pop­u­lar with Big Phar­ma leagues for its drug dis­cov­ery en­gine — for about $167 mil­lion.

Nuevo­lu­tion first tied up with the large US biotech in 2016 to work on find­ing fresh can­cer and neu­ro­science drugs for Am­gen, in a deal that made it el­i­gi­ble to re­ceive up to $410 mil­lion in de­vel­op­men­tal mile­stones for any ther­a­py that makes it across the fin­ish line. In 2018, Am­gen opt­ed-in on two pro­grammes and is now cov­er­ing de­vel­op­ment costs, and can ex­er­cis­es its op­tion to li­cense the can­di­dates.