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.

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.

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 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. 

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.