Flex sends out an SOS sig­nal, scrap­ping stud­ies and slash­ing staff as it hunts a sur­vival strat­e­gy — shares crater

Flex Phar­ma to­day said that its lead drug has a big prob­lem that is forc­ing the lit­tle biotech to scrap mid-stage stud­ies and hun­ker down — slash­ing 60% of its work­force as it search­es for a way out of the dilem­ma.

Christoph West­phal

The prob­lem, not dis­closed un­til now, is that the cramp­ing drug FLX-787 is not tol­er­a­ble to a sub­set of pa­tients at 30 mg. Now they need to go back and do some ba­sic for­mu­la­tion and dos­ing work to fix the is­sue — but with a beat­en down share price, the com­pa­ny doesn’t have the cash to do it alone.

It has even less room to move to­day, with its stock cra­ter­ing 75%, wip­ing out the bulk of the $75 mil­lion mar­ket cap it start­ed the day with. The stock is down to about $1, a far cry from the $16 it priced at in 2015, when Christoph West­phal took the com­pa­ny he found­ed pub­lic, tout­ing the in­volve­ment of No­bel Prize-win­ning neu­ro­sci­en­tist and ath­lete Rod MacK­in­non.

Bill McVicar

The com­pa­ny al­so de­vel­oped a con­sumer an­ti-cramp­ing prod­uct called Hot­Shot, an­oth­er strat­e­gy that West­phal has em­ployed in the past, with mixed suc­cess. West­phal — best known for sell­ing Sir­tris to GSK for $720 mil­lion — left the CEO job at Flex a year ago. He al­so briefly ran GSK’s ven­ture group, SR One, then set up Ve­rastem, which wound up hit­ting a brick wall of its own be­fore go­ing in a new di­rec­tion. 

Flex will now op­er­ate with a skele­ton crew while they go out in search of a deal, and they’d be hap­py to con­sid­er a buy­out of­fer.

Please.

“In the past few months we have re­port­ed pos­i­tive ef­fi­ca­cy da­ta in two se­ri­ous and dis­tinct­ly dif­fer­ent neu­ro­log­i­cal dis­eases: mul­ti­ple scle­ro­sis (MS) and ALS. We be­lieve that these clin­i­cal da­ta demon­strate the clear po­ten­tial of FLX-787 as a symp­to­matic ther­a­py to re­duce painful cramps and spasms in these pa­tient pop­u­la­tions,” stat­ed Bill McVicar, who took the helm af­ter West­phal left.

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.