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.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

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We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

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