Deborah Waterhouse, ViiV Healthcare CEO

Un­der pres­sure from ad­vo­cates, Vi­iV strikes a deal to make its long-act­ing HIV in­jectable more ac­ces­si­ble

A week af­ter ad­vo­cates called up­on Vi­iV Health­care to low­er the price of its long-act­ing HIV in­jectable Apre­tude, the com­pa­ny has struck a deal to make the drug more ac­ces­si­ble in low- and mid­dle-in­come coun­tries.

Vi­iV and the Med­i­cines Patent Pool (MPP) signed a vol­un­tary li­cens­ing agree­ment that will al­low gener­ic man­u­fac­tur­ers in 90 coun­tries to de­vel­op, man­u­fac­ture and sup­ply their own ver­sions of Apre­tude, “sub­ject to re­quired reg­u­la­to­ry ap­provals be­ing ob­tained,” the part­ners an­nounced on Thurs­day.

The news comes just over a week af­ter more than 70 ad­vo­cates — rang­ing from ac­tors to CEOs —  signed a let­ter to Vi­iV chief ex­ec­u­tive Deb­o­rah Wa­ter­house re­quest­ing a low­er price for the com­pa­ny’s long-act­ing HIV in­jectable for pre-ex­po­sure pro­phy­lax­is (PrEP).

The let­ter, pub­lished by the Joint Unit­ed Na­tions Pro­gramme on HIV/AIDS, said that Apre­tude should be priced “as close as pos­si­ble to that of oth­er HIV pre­ven­tion med­i­cines,” or around $60 per year, End­points News pre­vi­ous­ly re­port­ed. Apre­tude is first giv­en as two in­jec­tions a month apart from each oth­er, and then every two months af­ter. The list price is cur­rent­ly $3,700 per dose, ac­cord­ing to GoodRx.

Vi­iV’s oth­er HIV drug, the long-act­ing treat­ment Cabe­nu­va, cost around $4,000 a month when it was first ap­proved last year, ac­cord­ing to the New York Times. While the drug was ini­tial­ly ap­proved as part of a month­ly reg­i­men, the FDA cleared it for use once every two months ear­li­er this year.

Wa­ter­house said in a state­ment on Thurs­day:

To­day’s an­nounce­ment rep­re­sents a po­ten­tial­ly game-chang­ing mo­ment in HIV pre­ven­tion. En­abling at-scale ac­cess to gener­ic cabote­gravir LA for PrEP could play a sig­nif­i­cant role in avert­ing the trans­mis­sion of HIV, par­tic­u­lar­ly amongst women and ado­les­cent girls and help end the HIV epi­dem­ic. I am proud that through our long-stand­ing part­ner­ship with MPP, we con­tin­ue to play our part in widen­ing ac­cess for peo­ple in re­source-lim­it­ed coun­tries to new in­no­v­a­tive med­i­cines.

Ac­cord­ing to the World Health Or­ga­ni­za­tion, 38.4 mil­lion peo­ple were liv­ing with HIV/AIDS world­wide in 2021, and 650,000 peo­ple died of the con­di­tion.

The Joint Unit­ed Na­tions Pro­gramme on HIV and AIDS set a goal back in 2019 to end the HIV epi­dem­ic by 2030. How­ev­er, progress has been slow­ing, ad­vo­cates say. Back in May, Vi­iV said it was in talks with the UN-backed Med­i­cines Patent Pool (MPP) for patent rights to its HIV in­jectable in low- and mid­dle-in­come coun­tries.

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

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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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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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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.

Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

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.

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.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.