As­traZeneca sells off more as­sets from its is­land of mis­fit drugs in $1.6B Pfiz­er deal

As­traZeneca has com­plet­ed an­oth­er stage in its sys­tem­at­ic re­treat from the an­tibi­otics busi­ness, sell­ing a port­fo­lio of mar­ket­ed and ex­per­i­men­tal small mol­e­cule an­tibi­otics to an ac­quis­i­tive Pfiz­er for $725 mil­lion in cash and an­oth­er $850 mil­lion in mile­stones.

As­traZeneca CEO Pas­cal So­ri­ot

The first stage in the re­treat start­ed in 2014, as it be­gan to wind down its ear­ly-stage an­tibi­otics re­search group in Waltham, MA, which had 175 staffers when Pas­cal So­ri­ot took over as CEO at the phar­ma gi­ant. In­dus­try sources at the time tipped me off to the com­pa­ny’s de­ci­sion to see if it could find a buy­er for the group. But when no deal emerged, As­traZeneca de­cid­ed to spin out a small group of sur­vivors in a new ven­ture dubbed En­ta­sis, with a $40 mil­lion round to get it set up.

This new deal gives Pfiz­er Za­v­icef­ta, Zin­foro and Mer­rem, with a pair of ex­per­i­men­tal pro­grams – a Phase III-ready CXL, an in­jectable bac­te­ri­ci­dal β-lac­tam/β-lac­ta­mase in­hibitor com­bi­na­tion of Zin­foro and Avibac­tam (AVI, NXL104) and ATM-AVI, a bac­te­ri­ci­dal, in­jectable com­bi­na­tion of aztre­on­am (ATM) and a β-lac­ta­mase in­hibitor, Avibac­tam (AVI, NXL104). Just a few weeks ago As­traZeneca flagged a suc­cess­ful Phase III ef­fort for Za­v­icef­ta  (cef­tazidime-avibac­tam), which fol­lowed close on the heels of an ap­proval in Eu­rope. Al­ler­gan has been part­nered with As­traZeneca on the ef­fort and holds North Amer­i­can rights.

Not in­clud­ed: A fi­nal group of bi­o­log­ics un­der Med­Im­mune’s ban­ner in Mary­land as well as its stake in En­ta­sis.

As­traZeneca has been run­ning a brisk busi­ness in sell­ing off as­sets it ei­ther no longer sees as a good fit for So­ri­ot’s core drug strat­e­gy or drugs that have lost a con­sid­er­able amount of lus­ter. The sales in­clude a deal to hive off anes­thet­ics to As­pen for up to $770 mil­lion. The re­jects ex­iled to its is­land of mis­fit as­sets in­clude lesin­u­rad and bro­dalum­ab, which pro­duced mixed da­ta in the clin­ic and were then li­censed out. And now there’s a ques­tion whether selume­tinib might wind up at the bar­gain base­ment as well af­ter back-to-back late-stage fail­ures.

There has been some in­ter­est in an­tibi­otics among the phar­ma ma­jors, wit­nessed by Mer­ck’s ac­qui­si­tion of Cu­bist. But Mer­ck al­so shut­tered ear­ly stage ef­forts there and Big Phar­ma in gen­er­al has been deeply skep­ti­cal of a field that typ­i­cal­ly de­liv­ers on­ly small mar­gins. An­tibi­ot­ic re­sis­tance, mean­while, has on­ly grown worse around the globe.

As­traZeneca has been beef­ing up weak rev­enue with these deals as it con­tin­ues a years-long ef­fort to re­tool in a turn­around aimed at adding bil­lions of dol­lars in new sales. The phar­ma gi­ant sees its can­cer pipeline, in­clud­ing the re­cent­ly ap­proved Tagris­so as well as the late-stage check­point dur­val­um­ab, as its best chance for a come­back. Pfiz­er, on the oth­er hand, has been buy­ing, pur­su­ing an ac­qui­si­tion strat­e­gy high­light­ed by its $14 bil­lion buy­out of Medi­va­tion.

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.

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.

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.

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.

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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Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

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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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.