A scientist works in a laboratory at the Novavax facility in Gaithersburg, Maryland (Jon Cherry/Bloomberg via Getty Images)

No­vavax tem­pers its rev­enue ex­pec­ta­tions as it un­veils PhI­II da­ta for bi­va­lent boost­er

As No­vavax re­ports third quar­ter re­sults, the vac­cine mak­er is tem­per­ing its ex­pec­ta­tions once again on Covid-19 sales.

The com­pa­ny re­port­ed that it net­ted $725 mil­lion in Q3 and ad­min­is­tered around 94 mil­lion dos­es so far, but it has low­ered its fi­nan­cial guid­ance for the year fur­ther to an even $2 bil­lion from an ex­pect­ed $2.3 bil­lion just last quar­ter. The com­pa­ny al­so low­ered its guid­ance from an es­ti­mat­ed $5 bil­lion dur­ing its Q2 re­sults.

This is cer­tain­ly not what in­vestors want to hear, as the com­pa­ny’s stock price $NVAX finds it­self trad­ing be­low $20 a share and down 86% since the start of the year.

No­vavax’s vac­cine roll­out ear­li­er this year had been com­pound­ed by months of de­lays due to fil­ings and man­u­fac­tur­ing con­cerns, but even as the com­pa­ny got the cov­et­ed EUA from US reg­u­la­tors and the shot serves as an al­ter­na­tive to the more com­mon mR­NA vac­cines, it still came with some lim­i­ta­tions. The EUA not­ed that in­creased risks of my­ocardi­tis and peri­cardi­tis, along with faint­ing and oth­er ad­verse ef­fects, may oc­cur with the shot.

De­spite falling de­mand for boost­er shots, No­vavax is forg­ing ahead against chop­py winds with its boost­er can­di­date to counter the Omi­cron vari­ant.

The topline re­sults from its Phase III tri­al showed that No­vavax’s BA.1 vac­cine can­di­date had met the pri­ma­ry “strain-change end­point,” dis­play­ing a “neu­tral­iz­ing” re­sponse. How­ev­er, the da­ta al­so showed no ben­e­fit for the No­vavax bi­va­lent vac­cine can­di­date com­pared to the BA.1 vac­cine can­di­date or “pro­to­type vac­cine” in the over­all pop­u­la­tion.

The re­port­ed an­ti­body re­spons­es coun­ter­ing BA.1 showed “sim­i­lar re­spons­es across the three vac­cine groups.” For the BA.5 strain, re­spons­es al­so showed there was “no ben­e­fit” for the BA.1 or bi­va­lent can­di­dates when com­pared to the pro­to­type vac­cine.

Gre­go­ry Glenn

On the re­sults, Gre­go­ry Glenn, the pres­i­dent of Re­search and De­vel­op­ment at No­vavax said:

To­day’s re­sults show that use of our pro­to­type vac­cine as a boost­er in­duces cross-re­ac­tive re­spons­es to a broad range of vari­ants with the po­ten­tial to pro­tect against fu­ture strains. This is a hall­mark of our vac­cine tech­nol­o­gy and shows the suit­abil­i­ty of our cur­rent pro­to­type vac­cine as a boost­er even as the COVID-19 land­scape con­tin­ues to evolve. Our vac­cine, which pro­vides a broad im­mune re­sponse even in the face of evolv­ing vari­ants, presents a po­ten­tial strat­e­gy to pro­tect against COVID-19 now and in­to the fu­ture.

The most com­mon symp­tom of the can­di­date was pain or ten­der­ness, with fa­tigue al­so be­ing re­port­ed.

The ini­tial vac­cine showed that it was 80% ef­fec­tive at pre­vent­ing symp­to­matic dis­ease in pa­tients 12 to 17 years old, but the vac­cine had been faced with man­u­fac­tur­ing de­lays as well as play­ing catch up with the Omi­cron vari­ant.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.