Rigel co-founder, R&D staff jet­ti­soned in the long-await­ed lead up to an FDA pitch

Rigel didn’t quite man­age to con­vince an­a­lysts a cou­ple of weeks ago that its Syk in­hibitor was as ap­peal­ing as it made it out to be in a late-stage study for im­mune throm­bo­cy­tope­nia. But the biotech $RIGL is ab­solute­ly de­ter­mined to shift over to a com­mer­cial op­er­a­tion to back a prospec­tive fos­ta­ma­tinib launch, and it’s jet­ti­son­ing its re­search group to clear the way for the tran­si­tion, well ahead of any de­ci­sion from the FDA.

The South San Fran­cis­co-based biotech, which has had its prat­falls over the years, says it is ax­ing 46 staffers — 38% of the work force — as it carves back in R&D and starts to de­vel­op a com­mer­cial group to sell fos­ta­ma­tinib. The de­par­tures in­cludes com­pa­ny co-founder and R&D chief Don­ald G. Payan, who is “re­tir­ing” in the changeover.

Payan’s spot in the com­pa­ny hi­er­ar­chy is be­ing tak­en by El­don C. May­er III, who’s been re­cruit­ed to lead com­mer­cial­iza­tion work, if they get an ap­proval.

At the end of Au­gust, the com­pa­ny re­port­ed an 18% re­sponse rate for ITP, the low end of what was need­ed to get to the FDA. That en­cour­aged some an­a­lysts, who now ex­pect that the sec­ond Phase III, with a read­out due with­in a cou­ple of months, should al­so be pos­i­tive.

“While the ef­fect size is not nu­mer­i­cal­ly high (18% re­spon­ders),” not­ed Jef­feries Eun Yang at the time, “pos­i­tive da­ta from first Ph3 of fos­ta­ma­tinib (fos­ta) in an or­phan in­di­ca­tion ITP is a much-need­ed pos­i­tive event for RIGL. Both RIGL/study PI note a high like­li­hood of 2nd Ph3 suc­cess in ~Oct/Nov.”

The biotech’s share price hasn’t ben­e­fit­ed much from the progress it’s re­port­ed. It’s now trad­ing just un­der its 12-month high.

Back in 2013 fos­ta­ma­tinib flopped in a Phase III study of rheuma­toid arthri­tis, forc­ing As­traZeneca to wash its hands of their part­ner­ship and leav­ing Rigel to un­der­go an over­haul, shed­ding staff and re­or­ga­niz­ing around dry eye dis­eases (R348) and lu­pus (R333). They both quick­ly failed Phase II. An­oth­er drug, R118, had to be aban­doned af­ter in­ves­ti­ga­tors tracked some se­ri­ous side ef­fects.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

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.