Med­i­cines Co scores FDA OK for new an­tibi­ot­ic, now up on the auc­tion block

Clive Mean­well, The Med­i­cines Com­pa­ny

The Med­i­cines Com­pa­ny’s in­fec­tious dis­ease busi­ness just got more valu­able.

The FDA has come through with an ac­cel­er­at­ed ap­proval of Vabomere — the com­bo of vabor­bac­tam, a new be­ta-lac­ta­mase in­hibitor, and meropen­em, the lead­ing car­bapen­em — which should help its deals team as the com­pa­ny hunts up a buy­er for all or part of that busi­ness group.

Tech­ni­cal­ly, the OK went to Rem­pex, which The Med­i­cines Com­pa­ny bought in 2013 for up to $474 mil­lion.

The biotech $MD­CO large­ly won the OK based on the da­ta from TAN­GO-1, hit­ting the pri­ma­ry end­point by demon­strat­ing su­pe­ri­or­i­ty over piperacillin-tazobac­tam for com­pli­cat­ed uri­nary tract in­fec­tions and acute pyelonephri­tis. And just a few weeks ago re­searchers say the an­tibi­ot­ic al­so scored in a sep­a­rate Phase III, TAN­GO-2, for car­bapen­em-re­sis­tant En­ter­obac­te­ri­aceae in­fec­tions, wrap­ping the study ear­ly.

Dur­ing the re­cent Q2 call with an­a­lysts, The Med­i­cines Com­pa­ny CEO Clive Mean­well told an­a­lysts:

While we’re not at this time go­ing to dis­close spe­cif­ic de­tails re­gard­ing trans­ac­tion struc­tures, we be­lieve we’re on track to com­plete well be­fore the end of the year a trans­ac­tion that will re­sult in a mon­e­ti­za­tion of the ID (in­fec­tious dis­ease) busi­ness.

That deal is due to ar­rive be­fore the end of the year as the biotech re­mains square­ly fo­cused on de­vel­op­ing in­clisir­an, its LDL-low­er­ing RNA drug from Al­ny­lam.

Just yes­ter­day The Med­i­cines Com­pa­ny re­port­ed that their drug suc­cess­ful­ly slashed bad lev­els of LDL for up to a year with just two in­jec­tions — a key fea­ture of its plan to sup­plant lead­ing PC­SK9 drugs when it’s piv­otal stud­ies are up in 2019. In the mean­time, the biotech has been re­struc­tur­ing its busi­ness, sell­ing off or shelv­ing drugs and go­ing all in all LDL, which would ap­pear more valu­able as more stud­ies — like Mer­ck’s anace­trapib tri­al — high­light the im­por­tance of cut­ting LDL over boost­ing HDL in de­liv­er­ing longterm car­dio ben­e­fits.

That leaves their new an­tibi­ot­ic on the mar­ket for any­one in the busi­ness. Big Phar­ma large­ly bowed out of an­tibi­ot­ic de­vel­op­ment over the past decade, un­hap­py with the mar­gins. That may change, though, as rates of drug re­sis­tance grow and a de­mand for new prod­ucts ris­es in com­ing years.

Big Phar­ma may be large­ly side­lined, but there’s been plen­ty of ac­tiv­i­ty on that front in biotech. Paratek $PRTK just re­port­ed­ly put it­self on the sales block as it nears a reg­u­la­to­ry pitch for a new an­tibi­ot­ic. Melin­ta beefed up its pipeline with the ac­qui­si­tion of a trou­bled Cem­pra. And Tetraphase $TTPH has been work­ing on a come­back af­ter reg­u­la­tors frowned on their ap­pli­ca­tion for the an­tibi­ot­ic er­ava­cy­cline.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

(L-R) Dr. Robert Redfield, director of the Centers for Disease Control and Prevention; Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases; Adm. Brett P. Giroir, Assistant Secretary for Health; and Dr. Stephen M. Hahn, commissioner of the Food and Drugs Administration prepare to testify at a hearing of the House Committee on Energy and Commerce on Capitol Hill on June 23, 2020 in Washington, DC. The committee is investigating the Trump administration's response to the COVID-19 pandemic. (Photo by Kevin Dietsch-Pool/Getty Images)

Trump neuters FDA's at­tempt to strength­en vac­cine guide­lines, call­ing it 'ex­treme­ly po­lit­i­cal'

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.