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.

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.