GSK grabs FDA OK for new shin­gles vac­cine, which will now tack­le a key Mer­ck fran­chise

Watch out Mer­ck. Glax­o­SmithK­line is com­ing for a chunk of your shin­gles vac­cine fran­chise.

Em­ma Walm­s­ley

Late on Fri­day the FDA an­nounced that it had green-light­ed Shin­grix, one of its biggest de­vel­op­ment pro­grams from the com­pa­ny’s vac­cines group. To­geth­er with the new COPD three-in-one com­bo Trel­e­gy El­lip­ta — ap­proved in Sep­tem­ber — and an HIV ther­a­py head­ed to a like­ly ap­proval, Shin­grix rep­re­sents one of GSK’s best shots at carv­ing our sig­nif­i­cant new rev­enue for it­self from new prod­ucts.

The Phase III pro­gram for Shin­grix was big and ex­pen­sive, en­rolling some 38,000 peo­ple to prove that the vac­cine had a 90% ef­fi­ca­cy rate in pre­vent­ing shin­gles.

Mer­ck earned $685 mil­lion from Zostavax last year, a vac­cine that scored on­ly a 51% rate of pro­tec­tion. GSK, which has a top phar­ma mar­ket­ing group, is ex­pect­ed to go af­ter that ri­val vac­cine ag­gres­sive­ly in look­ing to build sales rapid­ly. And the com­pa­ny, along with some an­a­lysts, be­lieve they can do bet­ter than Mer­ck, hit­ting the $1 bil­lion mark in 2022.

With three new prod­ucts to boast about, but lit­tle true in­no­va­tion seen from its phar­ma group pipeline, new CEO Em­ma Walm­s­ley could buy her­self some time in revving up a new R&D strat­e­gy at GSK, where she re­cent­ly shook up the pipeline in an­tic­i­pa­tion of kick­start­ing a more ag­gres­sive ap­proach in the can­cer field. GSK’s big cash cow Ad­vair is fac­ing a steadi­ly grow­ing gener­ic threat ex­pect­ed to have a big im­pact on rev­enue.

Shin­gles is trig­gered by a resur­gent vari­cel­la zoster virus, which is re­ac­ti­vat­ed as the hu­man im­mune sys­tem grad­u­al­ly weak­ens with age, ex­pos­ing it to the painful con­di­tion while al­so spurring pos­ther­pet­ic neu­ral­gia.

Luc De­bruyne, pres­i­dent of the glob­al vac­cines group at GSK, said:

We be­lieve Shin­grix will pro­vide con­fi­dence in the pro­tec­tion one can ex­pect from a shin­gles vac­cine. GSK is com­mit­ted to part­ner­ing with the pub­lic health and med­ical com­mu­ni­ty to help ad­dress the gaps in vac­cine cov­er­age among adults that per­sist in the Unit­ed States.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.