Richard Gonzalez, AbbVie CEO (AP Images)

House Over­sight Com­mit­tee sub­poe­nas Ab­b­Vie over 'woe­ful­ly in­ad­e­quate' doc­u­ment pro­duc­tion in price-goug­ing probe

Con­gress is turn­ing up the heat on Ab­b­Vie $AB­BV over its pric­ing poli­cies.

The House Com­mit­tee on Over­sight and Re­form is plan­ning to sub­poe­na the bio­phar­ma as part of a 2019 probe in­to the al­leged price-goug­ing of Hu­mi­ra and Im­bru­vi­ca, ac­cord­ing to a memo re­leased Mon­day. The move comes af­ter the late Eli­jah Cum­mings, who chaired the com­mit­tee, opened the in­ves­ti­ga­tion in­to a dozen drug­mak­ers over 18 months ago and Ab­b­Vie did not pro­vide law­mak­ers with re­quest­ed doc­u­ments.

“Over the course of the Com­mit­tee’s in­ves­ti­ga­tion, Ab­b­Vie re­peat­ed­ly failed to com­ply with the Com­mit­tee’s re­quests and pro­vid­ed in­ad­e­quate re­spons­es re­gard­ing Hu­mi­ra and Im­bru­vi­ca,” chair­woman Car­olyn Mal­oney (D-NY) wrote in the memo. “Ab­b­Vie has pro­duced on­ly lim­it­ed doc­u­ments about its pric­ing prac­tices and strate­gies to pre­serve mar­ket share and pric­ing pow­er for both prod­ucts.”

The news sent Ab­b­Vie shares down a lit­tle over 3.5% in Tues­day trad­ing. Ab­b­Vie flat­ly re­fut­ed the no­tion that it had not com­plied with pre­vi­ous re­quests.

“We’ve been work­ing co­op­er­a­tive­ly with the House Over­sight Com­mit­tee since we re­ceived their ini­tial let­ter in Jan­u­ary 2019,” the com­pa­ny said in a state­ment. “In fact, we’ve pro­vid­ed thou­sands of doc­u­ments and have had nu­mer­ous con­ver­sa­tions with the Com­mit­tee staff. While we are sur­prised and dis­ap­point­ed the Com­mit­tee chose to take this ac­tion, we will con­tin­ue to work in good faith with them on this im­por­tant sub­ject.”

In­vest­ment-wise, some fi­nan­cial an­a­lysts did not see the sub­poe­na as much of a threat to Ab­b­Vie. Ever­core’s Josh Schim­mer that this was an ex­pect­ed Con­gres­sion­al sub­poe­na and, im­por­tant­ly, did not come from the De­part­ment of Jus­tice, which is con­duct­ing its own in­quiries in­to price-goug­ing. Giv­en that this isn’t a crim­i­nal probe, Schim­mer does not ex­pect the gov­ern­ment to levy fines against Ab­b­Vie.

“I’d look at this as an­oth­er shot across the bow from De­moc­rats on drug pric­ing/prac­tices as op­posed to any mean­ing­ful new risks for AB­BV or the in­dus­try,” he wrote in a note to in­vestors.

Hu­mi­ra, a rheuma­toid arthri­tis treat­ment, and Im­bru­vi­ca, a lym­phoma ther­a­py, are both huge block­busters for Ab­b­Vie. Glob­al­ly, the drugs pulled in a com­bined $23 bil­lion-plus in 2019, with Hu­mi­ra net­ting $19.2 bil­lion and Im­bru­vi­ca $4.6 bil­lion.

But they have gar­nered con­tro­ver­sy over the years with Ab­b­Vie ag­gres­sive­ly de­fend­ing patents in court to stave off com­pe­ti­tion. Ac­cord­ing to a Ju­ly analy­sis from the Ini­tia­tive for Med­i­cines, Ac­cess, and Knowl­edge, a non-prof­it that re­search­es drug pric­ing, Ab­b­Vie has filed sev­er­al patents for Im­bru­vi­ca over the years with on­ly in­cre­men­tal changes, giv­ing the com­pa­ny an ex­clu­siv­i­ty win­dow for near­ly three decades. The Com­mit­tee al­so not­ed in its memo that Ab­b­Vie has en­gaged in sim­i­lar prac­tices for Hu­mi­ra, fil­ing 247 patents to ex­tend ex­clu­siv­i­ty for 39 years.

When Cum­mings orig­i­nal­ly opened the in­ves­ti­ga­tion over 18 months ago, it en­snared big-name phar­ma com­pa­nies like As­traZeneca, Eli Lil­ly, J&J, Pfiz­er and Sanofi. Since that time, Cum­mings had writ­ten two fol­low-up let­ters to Ab­b­Vie CEO Richard Gon­za­lez, with the sec­ond claim­ing in Sep­tem­ber 2019 that the com­pa­ny’s re­spons­es con­tin­ued to be “woe­ful­ly in­ad­e­quate.” Tues­day’s memo states that while Ab­b­Vie pro­vid­ed doc­u­ments the next Feb­ru­ary and again lat­er in Ju­ly, those doc­u­ment dumps “failed to show marked im­prove­ment” over pre­vi­ous at­tempts.

Mal­oney al­so not­ed that Ab­b­Vie was the on­ly drug com­pa­ny of the orig­i­nal 12 to re­ceive a sec­ond fol­low-up let­ter. The oth­er com­pa­nies in­volved in the probe are Am­gen, Cel­gene, Mallinck­rodt, No­var­tis, No­vo Nordisk and Te­va.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Artist rendering of the Assembly Square site in Somerville, MA (BioMed Realty)

Bio­Med Re­al­ty snaps up in­no­va­tion cam­pus site with­in earshot of pricey and bustling Boston biotech hub

On the short list of the premier biotech hubs in the world, the Boston area has transformed into a home for innovation — and ridiculously high rent. Now, a real estate firm is seeking tenants for a major site in neighboring Somerville with more than enough elbow room.

Snapped up by BioMed Realty, the land — which consists of an existing 162,000 square-foot office building and a 7.5 acre site — will serve as an “innovation space” for a variety of research, technology and life science tenants, the real estate company said in a press release. Financial terms weren’t disclosed.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.