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 clin­i­cal­tri­ as one of the pri­ma­ry in­ves­ti­ga­tors on one of the stud­ies for ol­mu­tinib.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Michel Vounatsos, Getty Images

UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.