Keen to stay out front in cell ther­a­py, Gilead­'s Kite builds its own vi­ral vec­tor man­u­fac­tur­ing op­er­a­tions

Days af­ter woo­ing Christi Shaw to the helm at Kite, Gilead is once again tout­ing just how se­ri­ous it is about grow­ing its pi­o­neer­ing CAR-T and fol­low-up cell ther­a­py busi­ness. The sub­sidiary is build­ing a new fa­cil­i­ty ded­i­cat­ed to vi­ral vec­tor man­u­fac­tur­ing with­in a bi­o­log­ics site at Ocean­side, Cal­i­for­nia.

Tim Moore BMWS

Right now, Kite gets it vi­ral vec­tors — crit­i­cal start­ing ma­te­r­i­al for edit­ing the T cells to ac­ti­vate can­cer-killing ca­pa­bil­i­ties — from con­tract man­u­fac­tur­ers, said Tim Moore, EVP of tech­ni­cal op­er­a­tions. But amid a cell ther­a­py boom, the lim­its that place on com­mer­cial sup­ply and de­vel­op­ment is be­com­ing more ap­par­ent.

It’s not about ex­it­ing those pacts all to­geth­er, Moore em­pha­sized; rather, the new, 67,000-square-foot fa­cil­i­ty be com­ple­men­tary to what’s al­ready in place.

“We can still lever­age ex­ter­nal man­u­fac­tur­ing ca­pa­bil­i­ties but it’s go­ing to help ac­cel­er­ate our ca­pa­bil­i­ties and high­light our lead­er­ship in cell ther­a­py by leav­ing no stone un­turned,” he told me.

Un­der for­mer CEO John Mil­li­gan, Gilead had ini­ti­at­ed an ag­gres­sive ex­pan­sion on the cell ther­a­py man­u­fac­tur­ing front, plot­ting sites in the Nether­lands, Mary­land and Cal­i­for­nia last May. Daniel O’Day took it a notch up, re­veal­ing in his first an­a­lyst call weeks ago that bring­ing in a new CEO for the stand­alone Kite would be a top pri­or­i­ty. And he went for an in­dus­try heavy­weight in Shaw, the re­cent pres­i­dent of Eli Lil­ly’s Bio­Med­i­cines unit who has a per­son­al sto­ry to tell about can­cer.

Kite ex­pects to have the Ocean­side site com­plete and li­censed in the sec­ond half of 2021, Moore said. There will be some hir­ing for day-to-day op­er­a­tions, though he didn’t spec­i­fy how many.

So­cial im­age: Gilead, AP Im­ages

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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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.

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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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.

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.

Jean-Jacques Bienaimé, BioMarin CEO

One hur­dle down? FDA won't hold ad­comm for Bio­Mar­in's he­mo­phil­ia gene ther­a­py af­ter all

The FDA may be taking its time reviewing BioMarin’s gene therapy for hemophilia A, but at least the biotech now has one fewer thing to worry about.

While the agency has previously planned to convene an external panel of advisors to weigh in on the program, commonly referred to as valrox (or by its brand name, Roctavian), BioMarin said it was recently told that there won’t be an adcomm after all.

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