John Amos, Vivus CEO

ICER reaf­firms Qsymia as most cost-ef­fec­tive obe­si­ty treat­ment in fi­nal re­port

Last Ju­ly, the cost-ef­fec­tive­ness drug watch­dog ICER re­leased a pre­lim­i­nary draft re­port that Vivus’ Qsymia was the most cost-ef­fec­tive op­tion for weight loss. That de­ci­sion has now been val­i­dat­ed.

ICER made its fi­nal de­ter­mi­na­tion Wednes­day that Qsymia, the brand name for the ap­petite sup­pres­sant phen­ter­mine com­bined with an­ti­con­vul­sant top­i­ra­mate, was more cost-ef­fec­tive for weight loss than oth­er com­peti­tors such as No­vo Nordisk’s Sax­en­da (li­raglu­tide) and We­govy (semaglu­tide) or Cur­rax Phar­ma­ceu­ti­cals’ Con­trave (bupro­pi­on/nal­trex­one).

Per ICER:

At cur­rent prices and with com­mon­ly ac­cept­ed cost-ef­fec­tive­ness bench­marks, re­sults sug­gest that phen­ter­mine/top­i­ra­mate in ad­di­tion to lifestyle mod­i­fi­ca­tion is cost ef­fec­tive com­pared with lifestyle mod­i­fi­ca­tion alone. The cost ef­fec­tive­ness of treat­ment of obe­si­ty with semaglu­tide or li­raglu­tide, in pa­tients with­out di­a­betes mel­li­tus, ex­ceeds com­mon­ly used thresh­olds.

The watch­dog men­tioned that the health-ben­e­fit price bench­mark for the more fa­mous semaglu­tide, which al­so was more ef­fec­tive than the oth­er No­vo Nordisk drug and Con­trave, is $7,500 to $9,800 per year. But at its cur­rent price point, it would re­quire the drug be dis­count­ed some­where be­tween 44-57% of its whole­sale price.

ICER re­view­ers al­so added that if Qsymia wasn’t per­form­ing well in cer­tain pa­tients, Con­trave may be the next best cost-ef­fec­tive op­tion. The re­view­ers not­ed in their re­port that there were a few lim­i­ta­tions to analy­sis, in­clud­ing the full im­pact of the drugs in pa­tients with chron­ic kid­ney dis­eases or con­di­tions where weight loss may be ben­e­fi­cial.

Vivus nabbed ap­proval for Qsymia in adults in 2012, fol­lowed by a tu­mul­tuous his­to­ry that end­ed up with Vivus fil­ing for bank­rupt­cy. Years lat­er, the FDA ex­pand­ed Qsymia’s weight loss in­di­ca­tion from just adults to use in ado­les­cents. How­ev­er, the reg­u­la­to­ry agency added the con­di­tion that the drug is giv­en on top of both a re­duced-calo­rie di­et and in­creased phys­i­cal ac­tiv­i­ty.

Vivus CEO John Amos told End­points News last month af­ter ICER’s draft re­port that so far, Qsymia is av­er­ag­ing around $40 mil­lion to $42 mil­lion in an­nu­al sales and in the range of 400,000 scripts every year. And in ap­provals, Qsymia has been ap­proved out­side the US in South Ko­rea, the five Nordic coun­tries and Poland — with more ap­provals pend­ing in oth­er Eu­ro­pean coun­tries such as the UK.

ICER’s de­ci­sion comes the same week Cur­rax launched a new ad cam­paign for Con­trave, fo­cused on the drug as a choice for emo­tion­al eat­ing con­nect­ed to obe­si­ty and over­weight con­di­tions.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.