John Amos, Vivus CEO

Vivus’ Qsymia beats out weight loss com­peti­tors in pric­ing watch­dog's lat­est cost-ef­fec­tive­ness analy­sis

Cost-ef­fec­tive­ness watch­dog ICER took a look at sev­er­al dif­fer­ent drugs ap­proved for obe­si­ty and weight loss — and to them, there is a clear win­ner.

ICER de­ter­mined that Vivus’ Qsymia, the brand name for the ap­petite sup­pres­sant phen­ter­mine com­bined with the an­ti­con­vul­sant top­i­ra­mate, was more cost ef­fec­tive for weight loss than oth­er com­peti­tors such as No­vo Nordisk’s Sax­en­da and We­govy.

“When treat­ments were com­pared with each oth­er, phen­ter­mine/top­i­ra­mate plus lifestyle mod­i­fi­ca­tion was less cost­ly and more ef­fec­tive than bupro­pi­on/nal­trex­one plus lifestyle mod­i­fi­ca­tion,” the re­view­ers said in their analy­sis.

ICER not­ed in its draft re­port pub­lished Wednes­day, “Med­ica­tions for Obe­si­ty Man­age­ment: Ef­fec­tive­ness and Val­ue,” that med­ical costs re­lat­ed to obe­si­ty can be cost­ly. It’s es­ti­mat­ed that an­nu­al costs as far back as 2016 were around $260 bil­lion.

The new analy­sis from the cost-ef­fec­tive­ness watch­dog group comes more than two weeks af­ter FDA ex­pand­ed Qsymia’s la­bel to now in­clude ado­les­cents ages 12 and up. Grant­ed, the ap­proval was on the con­di­tion that the drug is giv­en on top of both a re­duced-calo­rie di­et and in­creased phys­i­cal ac­tiv­i­ty.

Vivus nabbed ap­proval for Qsymia in adults in 2012, then saw poor sales num­bers. The com­pa­ny end­ed up fil­ing for bank­rupt­cy and be­com­ing a sub­sidiary of Ic­ahn En­ter­pris­es LP.

Out­side Qsymia, the au­thors ex­am­ined three oth­er drugs: Bupro­pi­on and nal­trex­one, a com­bi­na­tion of an an­ti­de­pres­sant drug and an an­ti-ad­dic­tion drug mar­ket­ed by Cur­rax Phar­ma­ceu­ti­cals as Con­trave, and two of No­vo Nordisk’s di­a­betes/weight loss drugs, GLP-1 an­tag­o­nists li­raglu­tide (Sax­en­da) and semaglu­tide (We­govy).

While ICER crowned Qsymia the over­all win­ner, oth­er op­tions may come in handy for dif­fer­ent pa­tients, the re­view­ers said.

“For pa­tients not achiev­ing de­sired weight loss or un­able to tol­er­ate phen­ter­mine/top­i­ra­mate, bupro­pi­on/nal­trex­one may be a cost-ef­fec­tive al­ter­na­tive,” they not­ed, adding that semaglu­tide, while more ef­fec­tive, was more cost­ly and did not meet “com­mon­ly-ac­cept­ed cost-ef­fec­tive­ness thresh­olds.”

“As such, semaglu­tide might be con­sid­ered in pa­tients not achiev­ing de­sired weight loss or un­able to tol­er­ate phen­ter­mine/top­i­ra­mate and bupro­pi­on/nal­trex­one, but on­ly with a sig­nif­i­cant dis­count,” the au­thors said. The whole­sale ac­qui­si­tion cost (WAC) for the drug is more than $17,000 for a year’s sup­ply.

Al­though Qsymia has a WAC of on­ly $2,382 for a year’s sup­ply, the drug can cause fe­tal harm if tak­en while preg­nant, in­clud­ing an in­creased risk of cleft lips and cleft palates. The drug al­so won’t have mar­ket ex­clu­siv­i­ty for too much longer. Gener­ics play­ers Ac­tavis (part of Te­va) and Dr. Red­dy’s reached deals with Vivus in 2017 that will al­low Qsymia gener­ics to en­ter the mar­ket start­ing in De­cem­ber 2024 and in­to 2025.

Bupro­pi­on and nal­trex­one re­port­ed a WAC of $7,393 for a year’s sup­ply, and the oth­er No­vo drug (Sax­en­da) was not too far be­low semaglu­tide’s $17,000-plus year­ly price, clock­ing in at $15,795.

ICER al­so not­ed in its re­port that there were a few lim­i­ta­tions to its analy­sis, in­clud­ing the full im­pact of the drugs in pa­tients with chron­ic kid­ney dis­eases or oth­er con­di­tions where weight loss may be ben­e­fi­cial, such as can­cer.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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