With Am­gen hot on its heels, Ra­dius races to get a jump on os­teo­poro­sis drug ri­val­ry

This week, Ra­dius Health $RDUS will open a brand new chap­ter in its his­to­ry, armed with an FDA ap­proval for its os­teo­poro­sis drug Tym­los (abaloparatide).

Bob Ward, Ra­dius Health

Ra­dius is launch­ing its very first drug on­to the mar­ket, about to set the price on their ther­a­py (that ar­rives ear­ly Mon­day) and map­ping out a com­mer­cial strat­e­gy that will have to take in­to ac­count Eli Lil­ly’s ag­ing For­teo with the ri­val ro­mosozum­ab from Am­gen and UCB be­ing steered in­to a Ju­ly 19 PDU­FA date.

Leerink’s Ge­of­frey Porges thinks that Ra­dius and Am­gen might fo­cus their com­mer­cial strate­gies on dif­fer­ent mar­kets, with Ra­dius fol­low­ing its da­ta sug­gest­ing greater ef­fi­ca­cy for re­duc­ing the risk of non-ver­te­brae frac­tures for post­menopausal women vs Am­gen’s fo­cus on ver­te­brae frac­tures, which could po­ten­tial­ly boost sales for Am­gen to $868 mil­lion in 2023.

Ra­dius’ drug sliced the risk of ver­te­brae frac­tures 86% and non-ver­te­brae frac­tures 43% com­pared with place­bo. The ab­solute risk re­duc­tions were 3.6% and 2.0%, re­spec­tive­ly. The la­bel in­cludes a warn­ing for women who are at risk of bone sar­co­mas.

Am­gen, mean­while, tracked a 73 per­cent re­duc­tion in the rel­a­tive risk of a new ver­te­brae (spine) frac­ture through 12 months but missed sta­tis­ti­cal sig­nif­i­cant on non-vertabrae frac­tures.

“While FDA ap­proval is pos­i­tive, we con­tin­ue to see sig­nif­i­cant com­mer­cial hur­dles as like­ly giv­en com­pe­ti­tion (For­teo on mar­ket; ro­mosozum­ab PDU­FA date of 7/19/17; po­ten­tial gener­ic For­teo en­try in 2019),” not­ed Eun Yang at Jef­feries. “In ad­di­tion, wide use of Am­gen’s (AMGN, Hold) Pro­lia has been de­lay­ing use of an­a­bol­ic agents (e.g., For­teo, Tym­los).”

The way Ra­dius CEO Bob Ward looks at this, it’s not about watch­ing the mar­ket frag­ment by ver­te­brae and non-ver­te­brae frac­ture risk. Ra­dius is go­ing af­ter the en­tire mar­ket, in­clud­ing a move in­to front­line use for physi­cians and pa­tients who want to get a jump on bone build­ing. As for dos­ing reg­i­mens, he’s hap­py with his chances of a self-ad­min­is­tered drug ver­sus one you get at the doc­tor’s of­fice (which is ro­mo, For­teo is self-ad­min­is­tered like Tym­los).

“I don’t think the mar­ket re­al­ly seg­ments on site of frac­ture,” he tells me. “It will on pa­tients that want to self-ad­min­is­ter.”

And where an­a­lysts see the com­pet­i­tive land­scape shift­ing dra­mat­i­cal­ly over the year as Am­gen and UCB line up ro­mo, Ward sees a low com­pet­i­tive en­vi­ron­ment, par­tic­u­lar­ly af­ter Mer­ck and Lil­ly both scrapped po­ten­tial ri­vals, with a like­ly 10-year run at cap­i­tal­iz­ing on the ap­proval as the biotech brings along oth­er drugs in the pipeline.

As for peak sales pro­jec­tions, Ward is quick to note that this is a big mar­ket, and every drug ap­proved for it has gone on to block­buster sta­tus. He’s re­cruit­ed a sales force of more than 200 to tack­le the US mar­ket, and he’s in the process of strik­ing a Eu­ro­pean part­ner­ship to han­dle that launch, ex­pect­ed lat­er in the year.

An­a­lysts don’t nec­es­sar­i­ly agree. Eval­u­atePhar­ma’s sell-side con­sen­sus on Tym­los es­ti­mat­ed 2022 rev­enue at $467 mil­lion. And some an­a­lysts have been point­ing to the rad­i­cal­ly dif­fer­ent dos­ing sched­ules — Am­gen at once a month, Ra­dius dai­ly — as like­ly to have an im­pact on the race in Am­gen’s fa­vor.

As The New York Times re­port­ed re­cent­ly, pa­tients are gen­er­al­ly start­ed on bis­pho­s­pho­nates like Fos­amax, which are old and cheap. But they’re al­so lim­it­ed, un­able to build bone the way For­teo and these new drugs are de­signed to do.

Lil­ly, mean­while, has been rapid­ly jack­ing up the price of For­teo ahead of its loss of patent pro­tec­tion. The Times re­ports that the whole­sale price has soared to $3,100 a month, more than three times its price in 2010. Lil­ly has been in­creas­ing the price twice a year, for six years. And they’ve had plen­ty of time to eval­u­ate how best to counter new en­tries with the ar­rival of drugs from Ra­dius and Am­gen this year.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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