Mer­ck spin­out grabs some as­sets and launch­es a quest for the Holy Grail in an­tibi­otics R&D

Ter­ry Roe­mer

Ter­ry Roe­mer did a lot more than clean out his desk when he de­cid­ed to leave Mer­ck af­ter a 13-year ca­reer de­vel­op­ing an­ti­bod­ies at the phar­ma gi­ant. With R&D chief Roger Perl­mut­ter’s bless­ings, he al­so gath­ered some pre­clin­i­cal pro­grams to take with him that now form the pipeline at his new, up­start biotech based in Union, New Jer­sey. And he’s work­ing with a small team of ex-Mer­ck sci­en­tists ready to get things mov­ing to­ward the clin­ic.

Like the rest of the big phar­mas, Mer­ck has more R&D pro­grams than it can con­sume. And it had al­ready demon­strat­ed a lim­it­ed ap­petite for an­tibi­otics re­search af­ter bag­ging Cu­bist three years ago for $9.5 bil­lion, shut­ter­ing the ear­ly-stage work right af­ter the deal went through. So a spin­out — with a promised pay­back from mile­stones and roy­al­ties — makes good sense here for ac­cel­er­at­ing the de­vel­op­ment side of things.

Roe­mer’s new com­pa­ny is Prokary­otics, which has tak­en up res­i­dence at a New Jer­sey in­cu­ba­tor where he and his sci­en­tif­ic col­leagues have be­gun the busi­ness of de­vel­op­ing some lead as­sets that they be­lieve are the es­sen­tial in­gre­di­ents to an en­tire­ly nov­el an­tibi­ot­ic class that can con­quer the drug re­sis­tance that fre­quent­ly thwarts ex­ist­ing prod­ucts.

“To be hon­est,” Roe­mer tells me, “we have a ways to go. The pro­grams we in-li­censed are up to lead op­ti­miza­tion. De­pend­ing on the pro­gram, we have mul­ti­ple years ahead of us to get in­to the clin­ic. But I’m not too con­cerned about that.”

What he is con­cerned about: Com­ing up “with the next new an­tibi­otics class; a first-in-class agent. It’s a tremen­dous chal­lenge, there’s a lot in­volved.”

Roe­mer and his col­leagues at Mer­ck caused a stir in re­search cir­cles in the spring of 2016 with their pre­clin­i­cal work on a new ap­proach to de­feat­ing dead­ly, drug-hes­i­tant MR­SA. They iden­ti­fied small mol­e­cules — tarocins — that threw a mon­key wrench in­to the con­struc­tion of MR­SA cell walls, mak­ing them vul­ner­a­ble to the usu­al run of be­ta-lac­tam an­tibi­otics now in use. But Roe­mer stressed the team has broad am­bi­tions to go far be­yond the con­fines of tarocins and de­vel­op com­plete­ly new gram neg­a­tive pro­grams for the next gen­er­a­tion of be­ta-lac­tams.

Kei­th Bos­t­ian

Kei­th Bos­t­ian, an ex­pe­ri­enced biotech vet who set up the in­cu­ba­tor where Prokary­otics is based, is tak­ing the CEO spot in the com­pa­ny. He says that the plan now is to get start­ed with some non-di­lu­tive fund­ing, look­ing to a va­ri­ety of sources like BAR­DA and the Well­come Trust ea­ger to ex­tend sup­port to vet­er­an teams out to de­vel­op some break­through an­tibi­otics. Lat­er, he says, they can get in­volved in some more tra­di­tion­al fundrais­ing and al­liances.

Pub­lic health of­fi­cials have been rais­ing the alarm for years that drug-re­sis­tant su­per­bugs threat­en more and more peo­ple each year around the globe, but de­spite a num­ber of reg­u­la­to­ry in­cen­tives, much of the ear­ly-stage work re­mains in the hands of biotechs. R&D is chal­leng­ing in this field, it’s ex­pen­sive, and the mar­ket can still re­ly on some stan­dard reme­dies — in­clud­ing some in­cred­i­bly cheap ones — for most cas­es.

But as Prokary­otics con­tin­ues its work, Roe­mer and his team be­lieve that the de­mand for new an­tibi­otics can on­ly grow, putting him on the right course for right now.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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