Fra­zier adds $780M fund for its ‘growth buy­out’ team; FDA push­es back its dead­line on Ab­b­Vie's elagolix; Promethera buys NASH drug

Fra­zier Health­care Part­ners has put to­geth­er a $780 mil­lion fund for its “growth buy­out” group to in­vest. A busy life sci­ences in­vestor, this new fund is their sec­ond aimed at prof­itable health­care com­pa­nies in the low­er end of the mid­dle mar­ket. Fra­zier, with of­fices in Sil­i­con Val­ley and Seat­tle, planned to in­vest this mon­ey in health­care and phar­ma­ceu­ti­cal ser­vices, med­ical prod­ucts and re­lat­ed sec­tors. “We are ap­pre­cia­tive of the con­tin­ued sup­port from our ex­ist­ing in­vestors and pleased to have added a few new se­lect blue-chip lim­it­ed part­ners that to­geth­er rep­re­sent a world-class group of in­vestors,” said Nad­er Nai­ni, man­ag­ing part­ner at Fra­zier Health­care Part­ners. “The com­mit­ment and con­fi­dence they have shown in our team is di­rect­ly re­lat­ed to our rich 27-year his­to­ry of de­vel­op­ing cat­e­go­ry-lead­ing health­care com­pa­nies. The team is par­tic­u­lar­ly grat­i­fied by the over­whelm­ing re­sponse to this of­fer­ing.”

Ab­b­Vie $AB­BV isn’t go­ing to get a pri­or­i­ty re­view for its late-stage drug elagolix af­ter all. The phar­ma com­pa­ny said Tues­day that the FDA needs more time to eval­u­ate the da­ta it pro­vid­ed on the drug, ex­tend­ing the PDU­FA date by 3 months and shov­ing a de­ci­sion in­to Q3. The drug was filed for en­dometrio­sis-re­lat­ed pain. “Based on our re­view of the da­ta, we re­main con­fi­dent in our New Drug Ap­pli­ca­tion for elagolix in the treat­ment of en­dometrio­sis-as­so­ci­at­ed pain,” said R&D chief Michael Sev­eri­no.

→ Bel­gium’s Promethera Bio­sciences has ac­quired a Swiss biotech called Balio­pharm, adding a TNF-R1 drug for their pro­gram on NASH. The biotechs are keep­ing the terms un­der wraps, but Promethera al­so raised $11.5 mil­lion through the sale of con­vert­ible bonds. New Japan­ese in­vestors sub­scrib­ing the bonds were Shibuya Cor­po­ra­tion and Shin­sei Cor­po­rate In­vest­ment. 

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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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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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.