Mallinck­rodt just got its hand slapped for il­le­gal­ly pro­tect­ing an 85,000% price hike

Bioreg­num
The view from End­points

More than three years ago, Quest­cor paid No­var­tis $135 mil­lion to gain US rights to a ther­a­py that posed a di­rect threat to its Ac­thar drug fran­chise. It was the deal of the decade, block­ing a com­peti­tor that could have carved in­to a block­buster fran­chise. An­drew Pol­lack at The New York Times laid it all out in sim­ple terms in a venue that no one who cared about drug pric­ing could have missed.

There was al­so no doubt what the deal on Syn­ac­then De­pot — a syn­thet­ic ver­sion of Ac­thar — meant to Quest­cor, which had been jack­ing up the price of Ac­thar by an as­tro­nom­i­cal amount that helped jus­ti­fy Mallinck­rodt’s $5.6 bil­lion ac­qui­si­tion a year lat­er. Its stock jumped 15% when the news came down.

“We be­lieve the ac­qui­si­tion re­moves a key over­hang as a po­ten­tial com­peti­tor to Ac­thar is re­moved,” not­ed an­a­lyst Biren Amin at the time.

Over 15 years the price on Ac­thar has gone up 85,000%, ac­cord­ing to the FTC, which just won a $100 mil­lion set­tle­ment from Mallinck­rodt for il­le­gal­ly main­tain­ing a drug mo­nop­oly. To put that set­tle­ment in per­spec­tive, it’s the about same amount as the an­nu­al in­crease of Ac­thar net sales in fis­cal 2016, when the drug earned $1.16 bil­lion — mak­ing it eas­i­ly the biggest drug in their port­fo­lio.

When Mallinck­rodt bought Quest­cor, Ac­thar cost $28,000 a vial. To­day, a lit­tle more than two years lat­er, the FTC says it’s $34,000 a vial.

Mallinck­rodt, for its part, has been scram­bling to shed a rep as a price grout­ing bio­phar­ma com­pa­ny, joined the pric­ing pledge that Al­ler­gan’s Brent Saun­ders start­ed, vow­ing to keep an­nu­al price hikes to sin­gle dig­its.

That would still al­low a price hike on Ac­thar that would equal what the FTC is get­ting in the set­tle­ment.

The com­pa­ny is al­so swear­ing to dou­ble its R&D bud­get, which hit $262 mil­lion in its last fis­cal year.

Per­haps the biggest penal­ty the com­pa­ny faces is an or­der to sell the li­cense on the com­pet­ing ther­a­py in a mat­ter of months. That su­per­vised trans­ac­tion will set up an even­tu­al com­peti­tor, but it will not nec­es­sar­i­ly do any­thing to sig­nif­i­cant­ly re­duce the price of the ther­a­py, as even a dis­count stick­er could still com­mand a price wild­ly high­er than the old list price for Ac­thar.

De­vel­op­ment al­so can take time, and the agree­ment does noth­ing im­me­di­ate to re­duce the cost of the drug.

Iron­i­cal­ly, Mar­tin Shkre­li is get­ting cred­it as the whis­tle blow­er in the case, which oc­curred when short sell­ers were try­ing every­thing to top­ple Quest­cor’s stock price. (Shkre­li’s Retrophin was out­bid on the No­var­tis drug, which he had his own plans for.) Shkre­li knows a thing or two about price goug­ing on old drugs, which he prac­ticed at Retrophin and Tur­ing. He’s now pri­mar­i­ly oc­cu­pied with a fed­er­al fraud case, which is com­ing up for tri­al this sum­mer.

But the fed­er­al case has noth­ing to do with price goug­ing Dara­prim or any oth­er drug. Shkre­li’s 5,000% price hike re­mains in force, as it was com­plete­ly le­gal. And he con­tin­ues to seek out high pro­file in­ter­views that al­low him to de­fend the price.

For now, goug­ing re­mains a lu­cra­tive and large­ly non-threat­en­ing en­deav­or which the feds have lit­tle pow­er to con­trol. It re­mains to be seen if new in­com­ing Trump ad­min­is­tra­tion will change that. PEO­TUS fa­mous­ly ac­cused phar­ma com­pa­nies with “get­ting away with mur­der” on drug prices.

Mallinck­rodt and the FTC helped make that case for him.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

Alexis Borisy (file photo)

EQRx and Ex­sci­en­tia, a pair of self-styled dis­rup­tors, team up to over­turn the drug pric­ing ap­ple cart

The biotech industry has seen no shortage of innovation in recent years, but in one area — drug pricing — the field has been anything but innovative. Now, two brash startups taking different roads to upset the drug pricing model will partner up to create a sort of “super-disruptor.”

EQRx and UK-based AI specialist Exscientia will team up on a discovery-through-commercialization collaboration the partners hope will work better than the sum of its parts to bring cheaper medicines to patients faster, the companies said Thursday.