Just a few months af­ter phar­ma gi­ant No­var­tis part­nered up with Sci­ence 37 on its vir­tu­al ap­proach to clin­i­cal tri­al work, Re­code re­ports that the would-be CRO dis­rup­tor is in talks with Soft­Bank ex­ecs on a $150 mil­lion in­vest­ment.

Noah Craft, Sci­ence 37 CEO

Soft­Bank, which pro­vid­ed Roivant chief Vivek Ra­maswamy with more than a bil­lion dol­lars to in­vest in biotech, ev­i­dent­ly has been drawn to Sci­ence 37’s promise that it can ef­fi­cient­ly and ef­fec­tive­ly re­cruit pa­tients for clin­i­cal tri­als with­out forc­ing them in­to a tri­al site. Us­ing new telemed­i­cine tech, they say they can ac­cu­mu­late clean datasets to show whether or not new drugs are work­ing — hop­ing to dis­rupt the big play­ers who now dom­i­nate the CRO world.

Quot­ing sources, Re­code notes that Sci­ence 37 is plan­ning to val­ue it­self at $300 mil­lion for this deal, up about $100 mil­lion since Lux Cap­i­tal and Google’s GV helped back the com­pa­ny a lit­tle more than a year ago. 

Soft­Bank’s big, $98 bil­lion Vi­sion Fund has made re­peat­ed for­ays in­to the world of drug de­vel­op­ment and tech­nol­o­gy. Aside from Roivant, the group par­tic­i­pat­ed in the mas­sive $500 mil­lion round to back George Scan­gos’ Vir, which is work­ing on an in­fec­tious dis­ease drug pipeline.

The CRO busi­ness has un­der­gone a decade of shak­ing out as pri­vate eq­ui­ty groups moved in to buy up the out­sourc­ing com­pa­nies and meld them in­to a set of large and ag­gres­sive glob­al play­ers, of­ten with big staffs. Shak­ing them up with a new tech ap­proach won’t come eas­i­ly in an R&D world where safe and de­pend­able are key watch­words in the high-risk world of drug de­vel­op­ment.

But Sci­ence 37 con­tin­ues to build up a head of steam to give it a try.

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

As the mayor of New York City, Mike Bloomberg had a few modest ideas about lowering prescription drug prices in the Big Apple that gained little traction. Now on the campaign trail on a faint hope of clinching the Democratic presidential nomination, the billionaire has some bigger plans — including one that would alter the patent system central to the biopharma business.

In a barebones drug pricing plan posted on Monday, Bloomberg came out blasting President Donald Trump for failing to deliver his promise to lower drug prices, and then making misleading claims about them. The price of over 3,000 drugs still increased at a rate five times higher than inflation in the first six months of 2019, he wrote.