Re­port: Han­mi’s fail­ure to re­port pa­tient death in ol­mu­tinib study broke South Ko­rea’s med­ical laws

A Ko­re­an pa­tient tak­ing Han­mi’s can­cer drug ol­mu­tinib died from a rare case of Stevens-John­son syn­drome a full 14 months be­fore it was re­port­ed to the coun­try’s health au­thor­i­ties, trig­ger­ing a scram­ble that ul­ti­mate­ly caused its part­ner Boehringer In­gel­heim to abrupt­ly with­draw from their $730 mil­lion part­ner­ship on the drug. And to­day Ko­re­an of­fi­cials de­ter­mined that Han­mi broke two med­ical laws re­lat­ed to mon­i­tor­ing and re­port­ing clin­i­cal tri­als, ac­cord­ing to a re­port from the Ko­re­an Her­ald.

The crux of the case dates back to the death in Ju­ly 2015, when a pa­tient tak­ing ol­mu­tinib and two oth­er drugs died from the lethal skin con­di­tion. The physi­cians in­volved in the case de­cid­ed that it was trig­gered by the oth­er drugs and re­port­ed the case to a mon­i­tor­ing agency.

But it was not re­port­ed as an un­ex­pect­ed se­ri­ous ad­verse event.

Han­mi and the mon­i­tor­ing agency fi­nal­ly re­port­ed the death to health of­fi­cials in Sep­tem­ber, 2016, ac­cord­ing to the Ko­re­an news­pa­per, but on­ly af­ter Han­mi said it first be­came aware of the in­ci­dent.

The case spurred ac­cu­sa­tions from the op­po­si­tion par­ty in Ko­rea that the in­flu­en­tial Han­mi — which has pacts with a va­ri­ety of high-pro­file com­pa­nies, in­clud­ing Genen­tech — had in­ten­tion­al­ly de­layed re­port­ing the death so it could get the drug ap­proved in Ko­rea. But in­ves­ti­ga­tors say they found no ev­i­dence of that, re­ports the Her­ald. Han­mi says it re­port­ed the in­ci­dent once it be­came aware of the death.

Boehringer trum­pet­ed the news that ol­mu­tinib had been ap­proved in South Ko­rea on May 17, 2016, for pa­tients with epi­der­mal growth fac­tor re­cep­tor (EGFR) T790M mu­ta­tion-pos­i­tive non-small cell lung can­cer. That was close to a year af­ter the death from SJS. On Sep­tem­ber 30 Boehringer pulled out of the pact, with­out any ex­pla­na­tion of the safe­ty is­sues. Boehringer has said it had kept the ap­pro­pri­ate reg­u­la­tors aware of all rel­e­vant is­sues.

The news trig­gered head­lines in South Ko­rea, but on­ly af­ter a num­ber of traders had a chance to dump their shares ahead of the news.

Boehringer has nev­er of­fered its own time­line of what it knew about the drug’s side ef­fects, and when. Me­dia con­tacts have failed to re­spond to re­peat­ed queries on that top­ic. In a state­ment last fall, they told me that South Ko­re­an of­fi­cials had tracked “two cas­es of tox­ic epi­der­mal necrol­y­sis, one of them fa­tal, and one case of Stevens-John­son-Syn­drome (non-fa­tal).”

That would ap­pear to be in­cor­rect.

This morn­ing, the com­pa­ny has yet to re­spond to a fol­lowup query about the lat­est re­port on ol­mu­tinib.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.