J&J buys in­to Pro­tag­o­nist’s next-gen pep­tide sto­ry with $50M up­front and $940M in mile­stones

J&J’s ven­ture arm par­tic­i­pat­ed in the start­up rounds for Pro­tag­o­nist Ther­a­peu­tics’ ear­ly de­vel­op­ment, fu­el­ing its work on a new group of oral pep­tide ther­a­pies built to with­stand a per­ilous jour­ney in the gut. And that front row seat J&J took is now pay­ing added div­i­dends with a Big Phar­ma li­cens­ing pact for the Newark, CA-based biotech’s $PT­GX sec­ond drug in the pipeline.

J&J has come in with a $50 mil­lion up­front — a siz­able amount for a pre­clin­i­cal pro­gram — and a full slate of mile­stones worth up to $940 mil­lion to gain ex­clu­sive world­wide li­cens­ing rights to Pro­tag­o­nist’s PTG-200. The IL-23 pep­tide an­tag­o­nist is be­ing built to treat Crohn’s dis­ease, one of its top in­flam­ma­to­ry bow­el dis­ease tar­gets.

Pro­tag­o­nist’s shares shot up 37% on the news.

This drug has a long way to go. It’s slat­ed to go in­to a Phase I tri­al with healthy hu­mans be­fore be­ing steered in­to an IBD study. But Pro­tag­o­nist has a more ad­vanced lead drug in the clin­ic, which like­ly pro­vid­ed some of the proof-of-con­cept da­ta J&J was look­ing for on the drug class.

Pro­tag­o­nist will part­ner with J&J on the de­vel­op­ment work through Phase II, giv­ing the phar­ma gi­ant rights to car­ry it on from there. And the lit­tle biotech is hang­ing on to co-de­tail mar­ket­ing rights in the US.

In an 8-K fil­ing Tues­day morn­ing, Pro­tag­o­nist pro­vid­ed some key de­tails on the pact you won’t find in the re­lease.  J&J is pay­ing 80% of the shared de­vel­op­ment costs on this drug. If the phar­ma part­ner de­cides to stay on af­ter Phase IIa, J&J will hand over $125 mil­lion. And if it picks up the op­tion for Phase III, J&J will add $200 mil­lion more.

Di­nesh Pa­tel

Pro­tag­o­nist CEO Di­nesh Pa­tel took the com­pa­ny pub­lic in 2016, watched shares dou­ble up and then slide to a lack­lus­ter $8.22 on Fri­day’s close, well be­low its IPO price.

As Pa­tel told me a cou­ple of years ago, the biotech set out to build a new kind of oral pep­tide ther­a­py which could with­stand the harsh en­vi­ron­ment of the stom­ach to do its work. Its lead ther­a­py is PTG-100, an al­pha-4-be­ta-7 (α4β7) in­te­grin-spe­cif­ic pep­tide drug now in a mid-stage pro­gram for ul­cer­a­tive col­i­tis.

Su­san B. Dil­lon, the im­munol­o­gy chief at Janssen, says this part­ner­ship is the lat­est in sev­er­al steps the biotech and phar­ma gi­ant have tak­en to­geth­er.  “To­geth­er with John­son & John­son In­no­va­tion, we have forged a strong re­la­tion­ship with the Pro­tag­o­nist Ther­a­peu­tics team over the course of sev­er­al years.”

“Our oral pep­tide PTG-200 works by block­ing the IL-23 path­way, a mech­a­nism which has been proven by in­jectable an­ti­bod­ies, in­clud­ing an ap­proved drug and oth­ers in dif­fer­ent stages of clin­i­cal de­vel­op­ment,” said David Y. Liu, Pro­tag­o­nist’s chief sci­en­tif­ic of­fi­cer and head of R&D. “As ev­i­denced by PTG-200, we be­lieve our tech­nol­o­gy plat­form is val­i­dat­ed in its abil­i­ty to gen­er­ate po­ten­tial first-in-class oral pep­tides as the next gen­er­a­tion of tar­get­ed ther­a­py drugs for IBD.”

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

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

On Monday 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.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

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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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

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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