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).


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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.