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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.