Af­ter dis­ap­point­ing in­vestors, Sil­la­Jen gets in­to trou­ble with Ko­re­an pros­e­cu­tors on sus­pect­ed in­sid­er trad­ing

Sil­la­Jen in­vestors suf­fered a bad rout when the stock took a freefall ear­li­er this month in the wake of a no­tice that the com­pa­ny is aban­don­ing a Phase III for its on­colyt­ic virus, shav­ing more than $800 mil­lion off a mul­ti-bil­lion mar­ket cap in less than 2 hours.

Ex­ec­u­tives at the biotech, though, ap­par­ent­ly avoid­ed that loss by sell­ing stock ahead of the bad news — and Ko­re­an au­thor­i­ties have re­port­ed­ly raid­ed their of­fices for an ap­par­ent in­ves­ti­ga­tion.

Dis­trict pros­e­cu­tors seized com­put­ers and doc­u­ments at Sil­la­Jen’s Seoul of­fice as well as Bu­san head­quar­ters, ac­cord­ing to Ko­rea Bio­med­ical Re­view.

“The scope of the search and seizure was lim­it­ed to sev­er­al ex­ec­u­tives,” the news out­let quot­ed a state­ment. “The in­ves­ti­ga­tion is lim­it­ed to on­ly some of the em­ploy­ees, and we in­tend to co­op­er­ate with the in­ves­ti­ga­tion ful­ly.”

One of them could be CSO Shin Hyun-Pil, who in­vestors say sold all of his 167,777 shares be­tween Ju­ly 1 and Ju­ly 8, bag­ging about $7.25 mil­lion (8.8 bil­lion won).

That raised some se­ri­ous sus­pi­cion of in­sid­er trad­ing, as Shin might have al­ready known that the PHO­CUS study had failed the fu­til­i­ty test — the rea­son why the in­de­pen­dent mon­i­tor­ing board ad­vised Sil­la­Jen to give up. The Phase III tri­al was test­ing a com­bo of their Pexa-Vec with Bay­er’s Nex­avar in liv­er can­cer.

The coun­try’s pros­e­cu­tors have been busy go­ing af­ter not just rogue biotech play­ers but the Ko­re­an stock mar­ket it­self, first with ac­cu­sa­tions of in­sid­er trad­ing around Han­mi’s can­cer drug that lat­er proved lethal — trig­ger­ing a fall­out with part­ner Boehringer In­gel­heim. More re­cent­ly they launched a probe in­to the events around Sam­sung Bi­o­Log­ics’ IPO, where the stock mar­ket op­er­a­tor was sus­pect­ed of soft­en­ing reg­u­la­tions to al­low the big bio­phar­ma man­u­fac­tur­er to list. The high-pro­file raids of the stock ex­change, in turn, fol­lowed a sus­pen­sion of Sam­sung Bi­o­Log­ics’ stock and a $7.04 mil­lion fine, cit­ing ac­count­ing vi­o­la­tions dur­ing its 2016 pub­lic de­but.

Sil­la­Jen’s stock on KOS­DAQ has plunged 19% since news of the raids broke Wednes­day, now trad­ing at 10,200 won or $8.41.

So­cial im­age: Sil­la­Jen

A New Fron­tier: The In­ner Ear

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

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

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.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

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.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

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.”