Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

No­var­tis $NVS may have giv­en up, but Am­gen $AMGN and Al­ler­gan $AGN are plow­ing ahead with their knock­off of Roche’s block­buster bi­o­log­ic Rit­ux­an in the Unit­ed States.

Their copy­cat, ABP 798, was found to have a clin­i­cal­ly equiv­a­lent im­pact as Rit­ux­an — meet­ing the main goal of the study in­volv­ing CD20-pos­i­tive B-cell non-Hodgkin’s lym­phoma pa­tients. This is the sec­ond tri­al sup­port­ing the pro­file of the biosim­i­lar. In Jan­u­ary, it came through with pos­i­tive PK re­sults in pa­tients with rheuma­toid arthri­tis.

Rit­ux­an is one of Roche’s top-sell­ing med­i­cines, it gen­er­at­ed about $6.9 bil­lion in glob­al sales last year.

In the Unit­ed States, Cell­tri­on and Te­va’s $TE­VA Rit­ux­an biosim­i­lar, Trux­i­ma, was ap­proved last No­vem­ber by the FDA. The month pri­or, No­var­tis threw in the tow­el on get­ting its copy­cat  US ap­proval — af­ter the health reg­u­la­tor de­mand­ed ex­tra in­for­ma­tion, which skewed its time­line to the fin­ish line and en­abled its ri­vals to leapfrog it. This Ju­ly, Pfiz­er’s $PFE Rit­ux­an knock­off, Rux­ience, se­cured its FDA ap­proval.

In re­cent years, Roche has been feel­ing the heat — and bat­ting away — biosim­i­lar ri­vals eat­ing in­to rev­enues for its big Rit­ux­an, Her­ceptin and Avastin fran­chis­es.

In Eu­rope, where Rit­ux­an is brand­ed as MabThera, sales de­clined by 47% in 2018 as Cell­tri­on and No­var­tis’s knock­offs took a bite out of its mar­ket share.

But in the Unit­ed States, the mag­ni­tude of dis­counts of­fered by biosim­i­lar mak­ers dwarf the cuts seen in Eu­rope, lead­ing some crit­ics to con­clude that the US biosim­i­lar mar­ket is bro­ken.

“Even to­day there are bare­ly a dozen biosim­i­lars on the U.S. mar­ket and no com­peti­tors on the hori­zon for dozens of bi­o­log­ic drugs. The bar­ri­ers to en­try are so high that even the hun­dreds of mil­lions in sales these un­con­test­ed prod­ucts gen­er­ate isn’t enough to at­tract even one com­peti­tor,” in­flu­en­tial re­searcher Pe­ter Bach, Di­rec­tor of the Drug Pric­ing Lab at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, wrote in an opin­ion piece pub­lished in the Wall Street Jour­nal on Wednes­day, along with co-au­thor Mark Trusheim, who serves as strate­gic di­rec­tor of MIT’s New Drug De­vel­op­ment Par­a­digms.

Bach and Trusheim al­so pre­scribed an an­ti­dote: gov­ern­ment price reg­u­la­tion that gives a man­u­fac­tur­er a ‘fair price’ af­ter the bi­o­log­ic’s pe­ri­od of ex­clu­siv­i­ty ends.

“Most is­sues in drug pric­ing are con­tentious. End­ing mo­nop­oly pric­ing af­ter a com­pa­ny has been re­ward­ed for in­no­va­tion isn’t. Pur­su­ing biosim­i­lars might seem like a so­lu­tion, but this ap­proach is draw­ing pa­tients away from stud­ies of new­er ther­a­pies even as it fails to con­trol costs. Price reg­u­la­tion may be a tough sell in some quar­ters, but it’s the best way to keep the promise of Amer­i­ca’s ex­tra­or­di­nary phar­ma­ceu­ti­cal in­dus­try alive,” they con­clud­ed.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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UP­DAT­ED: Ac­celeron of­fers thumbs up on a PhII suc­cess for would-be block­buster drug — and shares rock­et up

There’s no public data yet, but Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.