Am­gen prices bone builder Eveni­ty at $21,900/year to com­pete on con­ve­nience, not cost

A week af­ter fi­nal­ly get­ting its bone-build­ing drug across the fin­ish line, Am­gen on Mon­day un­veiled the an­nu­al price tag car­ried by the in­ject­ed os­teo­poro­sis treat­ment Eveni­ty: $21,900.

One in two post­menopausal women in the Unit­ed States have weak­ened bones that make them high­ly sus­cep­ti­ble to frac­tur­ing. Eveni­ty func­tions pre­dom­i­nant­ly as a bone an­a­bol­ic agent that stim­u­lates bone growth by in­hibit­ing a pro­tein called scle­rostin, which ceas­es the pro­duc­tion of bone and en­hances its break­down.

El­liott Levy

The cur­rent stan­dard of care for the 10 mil­lion Amer­i­cans with os­teo­poro­sis is a fam­i­ly of drugs called bis­pho­s­pho­nates — such as al­en­dronate (orig­i­nal­ly sold un­der the brand name Fos­amax by Mer­ck $MRK) — which thwart cells called os­teo­clasts that break down bone tis­sue but do not re­build it.

Last Tues­day, the FDA ap­proved the once-month­ly Eveni­ty for post­menopausal women with os­teo­poro­sis who car­ry a high risk of frac­ture, or pa­tients who have failed or are in­tol­er­ant to ex­ist­ing os­teo­poro­sis ther­a­pies with a boxed warn­ing high­light­ing that the use of the drug may in­crease the risk of heart at­tack, stroke and car­dio­vas­cu­lar death.

Ri­val an­a­bol­ic agents be­long­ing to a class of treat­ments called parathy­roid hor­mone drugs — Ra­dius Health’s Tym­los (priced at $21,900 per year) and Lil­ly’s $LLY For­teo (priced at $41,100 per year) — must be tak­en every day and have longer cours­es of ther­a­py. In ad­di­tion, For­teo gener­ics are loom­ing.

Eveni­ty priced in the Unit­ed States at $1,825 per dose makes the price for a full course of ther­a­py (12 months) 34% to 74% low­er than cur­rent­ly avail­able an­a­bol­ic agents over their full course of ther­a­py (dai­ly dos­es for 18-24 months), Am­gen $AMGN un­der­scored in a state­ment on Tues­day.

Eveni­ty will not have a cost ad­van­tage, but will in­stead com­pete on con­ve­nience: month­ly in­jec­tions ver­sus dai­ly and short­er treat­ment du­ra­tion, BMO Cap­i­tal Mar­kets an­a­lyst Do Kim wrote in a note on Mon­day. “Our Eveni­ty es­ti­mates re­main con­ser­v­a­tive, with US peak sales of $475 mil­lion, giv­en the black box warn­ing for high­er CV risk.”

In ad­di­tion, there are some key dif­fer­ences be­tween Eveni­ty and its ri­vals.

Al­though For­teo and Tym­los car­ry black box warn­ings for os­teosar­co­ma, the find­ings were in an­i­mal stud­ies and not ver­i­fied in hu­mans. Eveni­ty’s CV sig­nal was seen in a large late-stage tri­al. “Al­though Eveni­ty showed greater bone min­er­al den­si­ty im­prove­ments than For­teo, we be­lieve the black box warn­ing for CV risk will lim­it up­take to the high­est-risk pa­tients with mul­ti­ple pri­or frac­tures,” Kim wrote in a note last week.

Al­though Eveni­ty’s la­bel re­flects its su­pe­ri­or bone-build­ing ef­fect, clin­i­cal da­ta showed the treat­ment did not trans­late in­to re­duced frac­ture risk for non-ver­te­bral frac­tures (e.g., hip and wrist frac­tures) which are the most con­se­quen­tial com­pli­ca­tions of os­teo­poro­sis, SVB Leerink’s Ge­of­frey Porges point­ed out in a note last week. “Tym­los and For­teo had a sig­nif­i­cant rel­a­tive risk re­duc­tion for non-ver­te­bral frac­tures of 43-53%, while Eveni­ty had a non-sig­nif­i­cant re­duc­tion of 25%.”

Mean­while, Pro­lia, Am­gen’s old­er os­teo­poro­sis treat­ment, is in­tend­ed for chron­ic use, as it works by in­creas­ing bone mass for as long as the pa­tient re­ceives it. Eveni­ty is used to rapid­ly in­crease bone min­er­al den­si­ty and re­duce frac­ture risk in pa­tients with im­mi­nent risk of frac­ture; it is then fol­lowed by an an­tire­sorp­tive agent such as Pro­lia, said El­liott Levy, Am­gen’s se­nior VP of glob­al de­vel­op­ment, in an in­ter­view with End­points News ahead of the FDA de­ci­sion.

In post­menopausal os­teo­poro­sis, bone re­sorp­tion ex­ceeds bone for­ma­tion, and an­tire­sorp­tive agents can help re­store skele­tal bal­ance by re­duc­ing bone turnover, pri­mar­i­ly at the tis­sue lev­el.

In the US, one in two women over the age of 50 will ex­pe­ri­ence an os­teo­porot­ic frac­ture — an in­ci­dence that sur­pass­es that of heart at­tack, stroke and breast can­cer com­bined, ac­cord­ing to the Na­tion­al Os­teo­poro­sis Foun­da­tion, which es­ti­mates os­teo­poro­sis will be re­spon­si­ble for three mil­lion frac­tures re­sult­ing in $25.3 bil­lion in costs by 2025.


Im­age: Kristof­fer Trip­plaar for Sipa AP

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