Deaths, ac­cu­sa­tions of in­sid­er trad­ing and an ear­ly warn­ing from Boehringer stir Han­mi con­tro­ver­sy

Con­tro­ver­sy over a lethal can­cer drug de­vel­oped by Han­mi and Boehringer In­gel­heim con­tin­ues to bub­ble up in Ko­rea.

In re­cent days a mem­ber of the op­po­si­tion Min­joo par­ty — Rep. Jung Choun-sook — cir­cu­lat­ed a let­ter from Boehringer In­gel­heim dat­ing back to Au­gust 23rd stat­ing that they were halt­ing en­roll­ment and stud­ies of ol­mu­tinib at the rec­om­men­da­tion of the Da­ta Mon­i­tor­ing Com­mit­tee, ac­cord­ing to a re­port in the Ko­rea Her­ald. And he ac­cused the coun­try’s food and drug safe­ty min­istry of al­low­ing tri­als to con­tin­ue even af­ter the dan­gers be­came ap­par­ent.

That was more than a month be­fore Boehringer an­nounced that it was wash­ing its hands of their part­ner­ship with Han­mi — though the Ger­man com­pa­ny on­ly lat­er ac­knowl­edged that Ko­re­an of­fi­cials had cit­ed at least one death and two se­vere ad­verse events in stud­ies of the drug. An­oth­er re­port cit­ed by the op­po­si­tion said three pa­tients had died.

As Boehringer ear­li­er ac­knowl­edged to me, there were “two cas­es of tox­ic epi­der­mal necrol­y­sis, one of them fa­tal, and one case of Stevens-John­son-Syn­drome in which the pa­tient sub­se­quent­ly died due to dis­ease pro­gres­sion and pneu­mo­nia.”

The drug was ap­proved in Ko­rea on May 17 — an oc­ca­sion that Boehringer trum­pet­ed with con­sid­er­able fan­fare as it pro­mot­ed its own plans for a rapid de­vel­op­ment ef­fort — and is still on the mar­ket.

Boehringer’s an­nounce­ment that it was pulling out of the deal came on Sep­tem­ber 30. But Han­mi is un­der in­ves­ti­ga­tion for de­lay­ing the news to ac­com­mo­date in­sid­er trad­ing. The Na­tion­al Pen­sion Ser­vice, which took a hit when Han­mi stock plunged af­ter the news hit, is threat­en­ing to take ac­tion if the ru­mors of in­sid­er trad­ing are con­firmed. Some re­ports from Ko­rea say that word of the set­back was spread by a mo­bile mes­sen­ger ser­vice ahead of the for­mal an­nounce­ment.

Rep. Kim Myung-yeon of the Saenuri Par­ty told the Ko­rea Times that six funds sold Han­mi shares from 9 am to 9:13 am. The news broke at 9:28 am on Sep­tem­ber 30.

At that point, the ink had bare­ly dried on a new pact that Genen­tech signed with Han­mi to part­ner on HM95573, a pan-RAF in­hibitor now in Phase I. The big Roche sub­sidiary struck their deal on Sep­tem­ber 28, pay­ing $80 mil­lion up­front to part­ner on the drug, the lat­est in a long line­up of mar­quee part­ners who have signed with Han­mi as the Ko­re­an com­pa­ny mount­ed a big ef­fort to de­vel­op brand­ed ther­a­pies. And a com­pa­ny spokesper­son at Genen­tech said that they’re stick­ing with the deal.

“Our de­ci­sion to col­lab­o­rate with Han­mi was based on a rig­or­ous re­view of the sci­en­tif­ic da­ta and our be­lief in the po­ten­tial of the in­ves­ti­ga­tion­al med­i­cine HM95573,” Genen­tech said in an email to me. “Genen­tech be­came aware of the re­cent news re­gard­ing the Han­mi/BI col­lab­o­ra­tion (ol­mu­tinib EGFR in­hibitor), as well as al­le­ga­tions of in­sid­er trad­ing when they were re­port­ed in the news in the past week. While the al­le­ga­tions against Han­mi are se­ri­ous, they have noth­ing to do with our agree­ment.”

Boehringer didn’t an­swer queries about the doc­u­ment con­cern­ing the Da­ta Mon­i­tor­ing Com­mit­tee or when it first be­came aware of the ad­verse events re­port­ed in the stud­ies. Nei­ther did Pasi A. Jänne, a promi­nent re­searcher at Dana-Far­ber who’s list­ed on clin­i­cal­tri­als.gov as one of the pri­ma­ry in­ves­ti­ga­tors on one of the stud­ies for ol­mu­tinib.

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

Credit: Shutterstock

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.

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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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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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.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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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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