Wel­come Case­bia, the $335M gene edit­ing JV hatched by Bay­er and CRISPR Ther­a­peu­tics

The new gene edit­ing joint ven­ture be­ing formed by Bay­er and CRISPR Ther­a­peu­tics is tak­ing shape. Now dubbed Case­bia Ther­a­peu­tics, the fledg­ling op­er­a­tions has be­gun hir­ing dozens of new staffers, tak­ing up a tem­po­rary res­i­dence while its new home is be­ing built in Kendall Square in Cam­bridge, MA.

The up­start biotech ef­fort just inked a lease on 33,000 square feet of space at 610 Main Street North, a nine-sto­ry build­ing cur­rent­ly un­der con­struc­tion near Kendall Square and ad­ja­cent to the MIT cam­pus. This is the sec­ond MIT-owned build­ing here, with Pfiz­er R&D oc­cu­py­ing the first. The com­pa­ny will be co-lo­cat­ed with CRISPR Ther­a­peu­tics’ R&D ops in the cen­ter of a thriv­ing biotech clus­ter that will be home for up to 80 staffers, while an­oth­er group will be lo­cat­ed in Bay­er’s Mis­sion Bay cam­pus in San Fran­cis­co.

Un­der con­struc­tion: 610 Main Street North

True to its glob­al na­ture, with a pos­si­ble nod to tax re­al­i­ties, the com­pa­ny will be a UK en­ti­ty.

Bay­er and CRISPR an­nounced back at the end of last year that they were form­ing this JV, with the Ger­man phar­ma com­pa­ny com­mit­ting $300 mil­lion to the com­pa­ny. CRISPR is adding $35 mil­lion. The new com­pa­ny will con­cen­trate on blood dis­or­ders, blind­ness and con­gen­i­tal heart dis­eases and Bay­er plans to use this R&D base to take a deep dive in­to gene edit­ing for ag pur­pos­es.

CRISPR Ther­a­peu­tics is one of a hand­ful of gene edit­ing star­tups that have come along to take the aca­d­e­m­ic work in­volved in the field and trans­late that in­to new ther­a­pies. CEO Rodger No­vak re­cent­ly added a large­ly un­need­ed $38 mil­lion to its B round with a group of crossover in­vestors in tow — sig­nal­ing that their S-1 just about ready to roll. Ver­tex Phar­ma­ceu­ti­cals and Bay­er Glob­al In­vest­ments led the fundrais­ing, which brings the to­tal in the B round to a whop­ping $140 mil­lion

Bay­er’s Ax­el Bou­chon will take the helm at Case­bia as in­ter­im CEO. He’s al­so head of the Bay­er Life­Science Cen­ter (BLSC) and new group in­side Bay­er that has been charged with hunt­ing down new life sci­ence deals.

He couldn’t have found a bet­ter place to do that work. Bou­chon re­marked:

“We are ex­cit­ed to en­gage the broad­er life sci­ence com­mu­ni­ty in Boston now through Case­bia. As we es­tab­lish and grow Case­bia’s ther­a­peu­tic pro­grams, this new lo­ca­tion will pro­vide us with state-of-the-art in­fra­struc­ture, ac­cess to the vi­brant biotech en­vi­ron­ment of the Kendall Square area, and fa­cil­i­tate close col­lab­o­ra­tion with CRISPR Ther­a­peu­tics.”

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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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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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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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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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.