Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

Af­ter sting­ing FDA set­back, Glax­o­SmithK­line's Vi­iV fi­nal­ly notch­es US ap­proval for long-act­ing HIV in­jec­tion

Glax­o­SmithK­line’s HIV unit Vi­iV was dealt a sting­ing loss back in late 2019 when the FDA slammed the brakes on its ap­pli­ca­tion for a once-month­ly in­jec­tion based on man­u­fac­tur­ing is­sues. Now, with that road­block in the rearview, Vi­iV has fi­nal­ly made good on its promise to change the HIV game.

The FDA on Thurs­day ap­proved Vi­iV’s Cabe­nu­va (cabote­gravir and rilpivirine) as a long act­ing, once-month­ly ther­a­py for HIV-pos­i­tive adults who are vi­ro­log­i­cal­ly sup­pressed and on a sta­ble an­tivi­ral reg­i­men.

Cabe­nu­va is the first FDA-ap­proved in­jectable for HIV on the mar­ket and will look to re­place the dai­ly oral pills that are cur­rent­ly stan­dard of care in treat­ing HIV-pos­i­tive adults. The agency based its re­view on da­ta from the Phase III AT­LAS and FLAIR stud­ies, which found Cabe­nu­va helped main­tain vi­ral sup­pres­sion af­ter one year of treat­ment.

The agency al­so ap­proved oral cabote­gravir (Vo­cabria) in tan­dem with the dual in­jectable for vi­ral­ly sup­pressed HIV adults. The com­pa­ny plans to file that mol­e­cule as an in­jectable in the pre-ex­po­sure pro­phy­lax­is (PReP) set­ting and has a clutch of da­ta back­ing its use over block­buster Tru­va­da from Gilead.

Sold as a two-shot kit, Cabe­nu­va is rec­om­mend­ed for treat­ment af­ter pa­tients have re­ceived oral cabote­gravir and rilpivirine for at least a month to de­ter­mine po­ten­tial side ef­fects, Vi­iV said in a re­lease.

Cabe­nu­va’s road to an ap­proval took sur­pris­ing­ly long af­ter the FDA hit the com­pa­ny with a CRL back in De­cem­ber 2019, cit­ing man­u­fac­tur­ing con­cerns. Kim­ber­ly Smith, Vi­iV’s head of R&D, said that de­lay was “ob­vi­ous­ly dis­ap­point­ing,” but was — in hind­sight — a bless­ing as it al­lowed the drug­mak­er to add even more long-term safe­ty da­ta to its re­worked ap­pli­ca­tion.

“It was a re­lief that the is­sue was around the man­u­fac­tur­ing process and not around the safe­ty of the prod­uct,” Smith told End­points News. “We worked very close­ly with our col­leagues in CMC to make sure we clar­i­fied to the FDA to what the ques­tions were and how we ad­dressed them. It was par­tic­u­lar­ly im­por­tant for us to make sure that we nailed it.”

Cabe­nu­va’s month­ly in­jectable for­mu­la­tion will be a game-chang­er for the HIV pop­u­la­tion, end­ing the of­ten la­bo­ri­ous process of keep­ing up with a dai­ly pill, Smith said. While in­jec­tions will re­quire pa­tients to go to an HCP, Smith said her team had heard noth­ing but pos­i­tive re­views about the dos­ing re­quire­ments.

“What we learned (from reach­ing out to doc­tors) was es­sen­tial­ly that it wasn’t go­ing to be as tough as they ex­pect­ed,” Smith said.

The drug­mak­er said some clin­ics have es­tab­lished spe­cial lines for pa­tients to re­ceive their in­jec­tions dur­ing Covid-19 and oth­ers had cre­at­ed des­ig­nat­ed park­ing spaces for pa­tients to get the shots with­out en­ter­ing the build­ing.

With the ini­tial ap­proval out of the way, Vi­iV plans to soon file an amend­ed ap­pli­ca­tion for a once-every-two-months reg­i­men for Cabe­nu­va with the ground­work laid at the FDA, Smith said. That up­dat­ed reg­i­men would get pa­tients clos­er to a “nor­mal fre­quen­cy of vis­its to an HCP,” she said.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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