Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US gov­ern­ment is all set to buy $10.7 mil­lion worth of Siga Tech­nolo­gies’ mon­key­pox oral an­tivi­ral, the com­pa­ny an­nounced Thurs­day.

Of the to­tal dos­es, $5.1 mil­lion worth of oral an­tivi­rals called Tpoxx (tecovir­i­mat) will be de­liv­ered this year, with the US De­part­ment of De­fense hav­ing the op­tion of buy­ing the rest at a lat­er point.

The new con­tract fol­lows an ear­li­er one in which the gov­ern­ment had pur­chased $7.4 mil­lion worth of Tpoxx from the com­pa­ny.

Ear­li­er this month, the CDC ex­pand­ed its guide­lines for ex­pand­ed use of Tpoxx to cur­tail the spread of mon­key­pox. The drug is cur­rent­ly on­ly FDA-ap­proved for the treat­ment of small­pox.

An­tho­ny Fau­ci

How­ev­er, there haven’t been enough stud­ies con­duct­ed to con­firm Tpoxx’s ef­fi­ca­cy for mon­key­pox, so tri­als are un­der­way. The Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID) and the UK have start­ed Phase III tri­als look­ing to en­roll more than 500 par­tic­i­pants each.

“We cur­rent­ly lack ef­fi­ca­cy da­ta that would help us un­der­stand how well this drug may mit­i­gate painful mon­key­pox symp­toms and pre­vent se­ri­ous out­comes. This clin­i­cal tri­al was de­signed to an­swer those im­por­tant ques­tions,” NI­AID di­rec­tor An­tho­ny Fau­ci said in a CDC press state­ment.

Mean­while, the FDA has sug­gest­ed that doc­tors use Tpoxx ju­di­cious­ly, fear­ing that the virus may be­come re­sis­tant to the drug. A small change to the vi­ral pro­tein, which Tpoxx tar­gets, “could have a large im­pact on the an­tivi­ral ac­tiv­i­ty of TPOXX,” the FDA said on its web­site.

Al­though mon­key­pox cas­es have been en­dem­ic in parts of Africa, the dis­ease start­ed spread­ing glob­al­ly in May 2022, prompt­ing the WHO to de­clare the out­break as a glob­al emer­gency on Ju­ly 23. Most cas­es have been in men who have sex with men, al­though women and chil­dren can be­come in­fect­ed, ac­cord­ing to the WHO.

Rochelle Walen­sky

Cur­rent­ly, a two-shot vac­cine called Jyn­neos, man­u­fac­tured by the Dan­ish drug­mak­er Bavar­i­an Nordic, is the on­ly avail­able pro­tec­tion against the dis­ease. Re­cent da­ta by the CDC, how­ev­er, showed that a sin­gle dose of the vac­cine of­fers pro­tec­tion against the virus.

“These new da­ta pro­vide us with a lev­el of cau­tious op­ti­mism that the vac­cine is work­ing as in­tend­ed,” CDC di­rec­tor Rochelle Walen­sky said in a press con­fer­ence on Wednes­day.

Mon­key­pox cas­es have shown a grad­ual de­cline in the US with dai­ly in­fec­tions av­er­ag­ing around 200 this week, as op­posed to 450 cas­es in mid-Au­gust.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Mene Pangalos, AstraZeneca EVP of BioPharmaceuticals R&D (AstraZeneca via YouTube)

In new deal, As­traZeneca places small bet on 'crit­i­cal but chal­leng­ing' tar­get

AstraZeneca has its eyes on NRF2 as a target for inflammatory and respiratory diseases, and it’s handing out $2 million in cash to pluck a preclinical candidate from a drug discovery shop.

It’s so early that C4X Discovery doesn’t have a name for the oral NRF2 activator program just yet. Including the upfront, the biotech is eligible for a total of $16 million in preclinical payments, after which AstraZeneca will take over for clinical development and commercialization. Those future milestones add up to $385.8 million.

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