Ery­tech shares soar on pos­i­tive re­sults for PhI­Ib pan­cre­at­ic can­cer tri­al; Ar­Qule’s tivan­ti­nib fails yet again in PhI­II can­cer study

→ France’s Ery­tech Phar­ma says it gar­nered pos­i­tive da­ta in a Phase IIb study of eryas­pase com­bined with chemo for sec­ond-line metasta­t­ic pan­cre­at­ic can­cer, send­ing shares $ERYP rock­et­ing up 75%. The drug hits its co-pri­ma­ry end­points with sig­nif­i­cant im­prove­ments for pro­gres­sion-free sur­vival as well as over­all sur­vival. Pas­cal Ham­mel, prin­ci­pal in­ves­ti­ga­tor of the study, com­ment­ed: “These re­sults gen­er­at­ed by eryas­pase in com­bi­na­tion with the stan­dard of care are high­ly en­cour­ag­ing and com­pare fa­vor­ably to gem­c­itabine or FOL­FOX treat­ment ad­min­is­tered alone. The re­sults of this study sup­port eryas­pase as a po­ten­tial treat­ment op­tion for pa­tients with metasta­t­ic pan­cre­at­ic can­cer in the sec­ond-line set­ting.”

→ You can score an­oth­er flop for Ar­Qule’s tivan­ti­nib. The biotech and its part­ners at Ky­owa Hakko say that the drug failed a Phase III study for 190 Japan­ese pa­tients with c-Met di­ag­nos­tic-high in­op­er­a­ble he­pa­to­cel­lu­lar car­ci­no­ma. That like­ly came as no great sur­prise to the biotech’s al­ready dis­ap­point­ed in­vestors, who had to deal with an­oth­er Phase III bomb for the same drug in liv­er can­cer back in Feb­ru­ary. That fail­ure fol­lowed tri­al set­backs in 2013 and 2012.

→ In­di­an CRO Mi­cro Ther­a­peu­tic Re­search Labs has been busy mis­rep­re­sent­ing study da­ta while mis­han­dling doc­u­men­ta­tion re­lat­ed to hun­dreds of gener­ic drugs now on the mar­ket, and the EMA wants to jerk them off phar­ma­cy shelves un­til reg­u­la­tors can get a han­dle on the sit­u­a­tion. The EMA says that da­ta from a 4-year stretch are un­re­li­able and wants to see new bioe­quiv­a­lence da­ta be­fore re­turn­ing sus­pect drugs to the mar­ket. Any gener­ics now un­der re­view from the CRO should be shelved.

→ Shares of Im­pax Lab­o­ra­to­ries $IPXL shot up 20% this morn­ing, af­ter the com­pa­ny named Paul M. Bis­aro as its pres­i­dent and CEO, ef­fec­tive March 27. Bis­aro will suc­ceed J. Kevin Buchi, who has served as in­ter­im CEO since De­cem­ber of 2016. Bis­aro, the for­mer CEO at Ac­tavis, is a high-pro­file ex­ec in the in­dus­try. Im­pax was caught up in a price-fix­ing probe last fall.

As­traZeneca’s Tagris­so, a bright spot in the phar­ma gi­ant’s can­cer fran­chise, has won ap­proval in Chi­na.

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.

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.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

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.

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.