Backed by gi­ants, an­tibi­otics up­start Macrolide gets $20M and an ex-No­var­tis ex­ec as CEO

An an­tibi­otics start­up found­ed by the same guy who start­ed boom-and-bust an­tibi­otics com­pa­ny Tetraphase has hauled in $20 mil­lion in new cap­i­tal and a long­time No­var­tis ex­ec­u­tive as its new pres­i­dent and CEO.

Ma­hesh Karande

With cash in hand and a new chief at the helm, the com­pa­ny plans to tack­le some of the most dan­ger­ous su­per­bugs around by tweak­ing an old class of an­tibi­otics.

Wa­ter­town, MA-based Macrolide Phar­ma­ceu­ti­cals raised the Se­ries B round from three phar­ma gi­ants, in­clud­ing the ven­ture arms of Glax­o­SmithK­line (SR One), No­var­tis (No­var­tis Ven­ture Fund), and Roche (Roche Ven­tures), among oth­er in­vestors.

Macrolide al­so has a big phar­ma ex­ec­u­tive on board with the re­cruit­ment of Ma­hesh Karande, who spent sev­er­al years hop­ping around the world lead­ing No­var­tis’ in­ter­na­tion­al busi­ness units. He was a VP and on­col­o­gy busi­ness head in the US, pres­i­dent and phar­ma head for Africa and Egypt, and head of strat­e­gy and busi­ness de­vel­op­ment for Asia-Pa­cif­ic, Mid­dle East and Africa. But Karande left No­var­tis last year to join Intar­cia as VP and gen­er­al man­ag­er — a role he left to take the helm at Macrolide.

As its name sug­gests, Macrolide (the com­pa­ny) is fo­cused on macrolides, a class of an­tibi­otics that has been wide­ly used for decades to treat pneu­mo­nia and oth­er bac­te­r­i­al in­fec­tions. The ef­fec­tive­ness of these an­tibi­otics has been neg­a­tive­ly im­pact­ed by bac­te­ria’s frus­trat­ing abil­i­ty to be­come im­mune to drugs.

An­drew My­ers

But Macrolide says its found a way to en­gi­neer a so­lu­tion. The start­up was found­ed on tech from the lab of An­drew My­ers, a Har­vard Uni­ver­si­ty chemist. You might rec­og­nize My­ers as the guy who co-found­ed Tetraphase, an an­tibi­otics mak­er that grew to a pub­lic val­u­a­tion of over $1 bil­lion be­fore crash­ing hard fol­low­ing a Phase III flop of its lead an­tibi­ot­ic.

Macrolide has an ex­clu­sive li­cense from My­ers’ lab that gives the start­up ac­cess to tech­nol­o­gy to en­gi­neer syn­thet­ic macrolides from scratch. Macrolide says its tech can ex­pand the ther­a­peu­tic range of these drugs to in­clude not just gram-pos­i­tive in­fec­tions, but al­so gram-neg­a­tive ones — those dan­ger­ous in­fec­tions for which treat­ments are lim­it­ed.

The new fi­nanc­ing round is meant to sup­port work that will back up an IND ap­pli­ca­tion for its lead pro­gram for re­sis­tant gram-neg­a­tive pathogens.

“This po­si­tions Macrolide to fur­ther the pi­o­neer­ing work the team has done to date in ad­vanc­ing new macrolide an­tibi­otics with Gram-neg­a­tive ac­tiv­i­ty,” Karande said in a state­ment. “We be­lieve that ad­vanc­ing first-in-class an­tibi­otics that are ac­tive against lethal mul­ti-drug re­sis­tant bac­te­ria opens the door to a new and mean­ing­ful way to ad­dress the grow­ing pub­lic health is­sue of treat­ment gaps due to an­tibi­ot­ic re­sis­tance.”

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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