Mark Alles, former CEO of Celgene, testifies by video conference before the House Committee on Oversight and Reform on Wednesday (Pool via AP)

Dems slam drug pric­ing strate­gies as 18-month probe comes to an end

The House Over­sight Com­mit­tee held a pair of hear­ings this week on drug prices. And the De­moc­rats on the pan­el did not hold back.

Ex­ec­u­tives from Bris­tol My­ers Squibb (and Cel­gene), Te­va, Am­gen, No­var­tis and Mallinck­rodt tes­ti­fied be­fore Con­gress in the cul­mi­na­tion of an 18-month in­ves­ti­ga­tion in­to ris­ing drug prices.  The pro­ceed­ings, built on work from the late Eli­jah Cum­mings, pro­duced more than one mil­lion doc­u­ments from the com­pa­nies and large­ly con­clud­ed that prof­it was the main dri­ving force be­hind the in­creas­es.

“The drug com­pa­nies are bring­ing in tens of bil­lions of dol­lars in rev­enues, mak­ing as­tro­nom­i­cal prof­its, and re­ward­ing their ex­ec­u­tives with lav­ish com­pen­sa­tion pack­ages—all with­out any ap­par­ent lim­it on what they can charge,” com­mit­tee chair Car­olyn Mal­oney (D-NY) wrote.

The hear­ings were split up over two days, with Cel­gene, BMS and Te­va ex­ecs ap­pear­ing Wednes­day and Am­gen, No­var­tis and Mallinck­rodt tes­ti­fy­ing Thurs­day. Cel­gene was ac­quired by BMS last year, and though BMS CEO Gio­van­ni Caforio tes­ti­fied, most of the ques­tion­ing dealt with Cel­gene’s busi­ness prac­tices be­fore the ac­qui­si­tion.

Be­fore Wednes­day’s meet­ing, the com­mit­tee re­leased two re­ports that out­lined how Cel­gene and Te­va me­thod­i­cal­ly raised prices of the block­busters revlim­id and co­pax­one, re­spec­tive­ly, in or­der to meet sales tar­gets. The re­port cites one in­stance from March 2014, when Cel­gene ex­ec Mark Alles — who lat­er be­came CEO — ex­pressed dis­ap­point­ment in Revlim­id’s sales that quar­ter and di­rect­ed a 4% price in­crease in re­sponse.

“Mr. Alles emailed his team to en­sure that the price in­crease would go in­to ef­fect as quick­ly as pos­si­ble to have the max­i­mum im­pact on sales,” the re­port wrote. Alles lat­er said in an email, “Can we take the in­crease tonight so that it im­pacts sales be­gin­ning to­mor­row?”

Af­ter Cel­gene ap­proved that change, it im­ple­ment­ed the in­crease the same evening.

Te­va, mean­while, con­tract­ed with mid­dle­men to try to block low­er-cost gener­ics from reach­ing the mar­ket and en­gaged in high-dol­lar lob­by­ing ef­forts to con­vince doc­tors to keep us­ing their more ex­pen­sive drugs, ac­cord­ing to the re­ports. About 55% of Te­va’s 2019 rev­enue came from the gener­ics mar­ket.

On Thurs­day, the oth­er three com­pa­nies en­tered the ring and saw re­ports on their own busi­ness­es prac­tices re­leased. No­var­tis, like Te­va, was sin­gled out for its ap­par­ent open­ness to dis­cussing mid­dle­man con­tracts as a way to keep gener­ic com­pe­ti­tion at bay for Gleevec. The com­mit­tee al­so found that No­var­tis in­creased Gleevec’s price at a faster rate to­ward the end of their mar­ket ex­clu­siv­i­ty win­dow.

Am­gen was not found to have en­gaged in such mid­dle­men strate­gies when pric­ing En­brel. Rather, the com­mit­tee said Am­gen con­duct­ed “shad­ow pric­ing” plans by at­tach­ing their En­brel in­creas­es to those of its ma­jor com­peti­tor, Ab­b­Vie’s Hu­mi­ra. The com­mit­tee chid­ed Am­gen for not set­ting their prices low­er than Hu­mi­ra to gain mar­ket share as would be nor­mal­ly ex­pect­ed in a com­pet­i­tive mar­ket, it said.

“Short­ly af­ter Ab­b­Vie in­creased the price of Hu­mi­ra by 9.7% in Jan­u­ary 2018, Am­gen ex­e­cut­ed an iden­ti­cal 9.7% price in­crease, more than dou­ble what it had orig­i­nal­ly planned,” one of the re­ports said.

Mallinck­rodt faced ques­tions about the pric­ing tac­tics of its HP Ac­thar Gel and ac­qui­si­tion of Quest­cor, which owned the rights to the drug.

Quest­cor raised the price of Ac­thar to $31,000 per vial, up from $40 in 2001. Mallinck­rodt then in­creased the price by an­oth­er $8,200.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.

News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.