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.

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Novavax site in Gaithersburg, MD. Novavax

Beef­ing up its new gene ther­a­py unit, Catal­ent inks $18M deal to snap up No­vavax fa­cil­i­ties

Catal­ent’s hunt for rapid growth on the gene ther­a­py front — ce­ment­ed with a $1.2 bil­lion ac­qui­si­tion of Paragon Bio­sciences two months ago — has led them to the vac­cine mak­ers at No­vavax.

With an $18 mil­lion pay­ment, Paragon is tak­ing over two No­vavax sites in Gaithers­burg, MD, in­clud­ing more than 100 of the em­ploy­ees al­ready work­ing there. That’s in ad­di­tion to a sig­nif­i­cant re­duc­tion in op­er­at­ing costs, says the com­pa­ny, as No­vavax shifts to re­ly on Paragon for GMP ma­te­ri­als in clin­i­cal tri­als and, even­tu­al­ly, com­mer­cial sup­ply of their prod­ucts.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.