Dai­ichi Sankyo adds $484M pact to its on­go­ing Zymeworks col­lab­o­ra­tion; Sur­face spins out of Im­prim­is with $20M raise

Ali Tehrani

→ Af­ter work­ing with Zymeworks as a part­ner over the past two years, Dai­ichi Sankyo has come back for more, pay­ing $18 mil­lion up­front and promis­ing $466.7 mil­lion more for li­cens­es to de­vel­op two more as­sets. Van­cou­ver-based Zymeworks has scored a num­ber of part­ner­ship deals with big play­ers — think Cel­gene and J&J — with Azy­met­ric, its plat­form tech which trans­forms mono­spe­cif­ic an­ti­bod­ies in­to bis­pe­cif­ic an­ti­bod­ies.

Dai­ichi and Zymeworks’ col­lab­o­ra­tion dates back to 2016, in which Zymeworks gave away rights to one ther­a­peu­tic in ex­change for mile­stone pay­ments and a li­cense to Dai­ichi’s own im­muno-on­col­o­gy an­ti­bod­ies. The Japan­ese drug­mak­er kept the terms, as well as sub­se­quent de­vel­op­ment, to them­selves, though it did an­nounce the achieve­ment of a “re­search mile­stone” in 2017, trig­ger­ing a $1 mil­lion pay­ment.

“Ex­pand­ing our re­la­tion­ship with a lead­ing glob­al phar­ma­ceu­ti­cal part­ner like Dai­ichi Sankyo is ex­treme­ly sat­is­fy­ing as it un­der­scores the pow­er, ver­sa­til­i­ty, and at­trac­tive­ness of our tech­nol­o­gy plat­forms,” said Zymeworks CEO Ali Tehrani in a state­ment. “Hav­ing al­ready used our plat­forms to dis­cov­er one bis­pe­cif­ic an­ti­body, Dai­ichi Sankyo now has in­creased ac­cess to our tech­nol­o­gy to cre­ate ad­di­tion­al ther­a­peu­tic can­di­dates. We are pleased to be work­ing with a health­care pi­o­neer with a proven track record of over 100 years of in­no­va­tion lead­ing to ma­jor break­throughs in pa­tient care.”

→ Out to carve in­to Al­ler­gan’s Resta­sis fran­chise, San Diego-based Sur­face Phar­ma­ceu­ti­cals has of­fi­cial­ly spun out of Im­prim­is Phar­ma with $20 mil­lion in Se­ries A fund­ing. Fly­ing L Part­ners, an in­vestor spe­cial­iz­ing in oph­thalmic in­no­va­tions, pur­chased all the stock in the pri­vate plac­ing. Ac­cord­ing to its prin­ci­pal William Link: “There are an es­ti­mat­ed 30 mil­lion Amer­i­cans who suf­fer from some form of Dry Eye Dis­ease, but on­ly ap­prox­i­mate­ly 4 mil­lion pre­scrip­tions were dis­pensed in 2017, leav­ing a large un­met need in the mar­ket.” And Sur­face will go af­ter sev­er­al tar­gets, with plans to ad­vance clin­i­cal de­vel­op­ment and seek FDA ap­proval for three drug can­di­dates for up to five in­di­ca­tions. Mean­while, its col­leagues at Im­prim­is will be con­tend­ing with a law­suit from Al­ler­gan, which al­leged last year that Im­prim­is was un­law­ful­ly man­u­fac­tur­ing and sell­ing un­ap­proved drugs. Im­prim­is — claim­ing that its drugs will be cheap­er and less painful to use than Al­ler­gan’s — dis­missed it as a des­per­ate at­tempt to block them from en­ter­ing the mar­ket.

→ DNA se­quenc­ing gi­ant Il­lu­mi­na has ac­quired one of San Diego’s most pop­u­lar star­tups, Edi­co Genome, for $100 mil­lion. Edi­co Genome start­ed out as a chip mak­er, sell­ing a proces­sor called Dra­gen that could quick­en the analy­sis of ge­nom­ic in­for­ma­tion. The prod­uct com­bined soft­ware and hard­ware de­signed to an­a­lyze the mas­sive work­loads as­so­ci­at­ed with DNA se­quenc­ing. Since its found­ing in 2013, Edi­co Genome had inked tech part­ner­ships with Dell, In­tel, Ama­zon Web Ser­vices, and oth­ers to de­vel­op cloud-based ser­vices for an­a­lyz­ing and stor­ing ge­nom­ic da­ta. Hav­ing found suc­cess in re­search labs, Edi­co an­nounced plans ear­li­er this year to move in­to the clin­i­cal space. “Our ac­qui­si­tion of Edi­co Genome is a big step to­ward re­al­iz­ing the vi­sion of re­duc­ing se­quenc­ing da­ta ac­qui­si­tion and analy­sis to a push-but­ton, stan­dard­ized process,” said Su­san Tou­si, SVP of prod­uct de­vel­op­ment at Il­lu­mi­na, in a state­ment. “We ex­pect to build on the sol­id foun­da­tion of Dra­gen to de­liv­er a more stream­lined and in­te­grat­ed sam­ple to an­swer ex­pe­ri­ence for our cus­tomers.”

→ A spin­out from the in­no­va­tion arm of Uni­ver­si­ty of Birm­ing­ham launched Tues­day, tack­ling rheuma­toid arthri­tis (RA) with new re­search on a syn­thet­ic pep­tide it’s call­ing PEPITEM. That stands for Pep­tide In­hibitor of Trans-En­dothe­lial Mi­gra­tion, which the com­pa­ny, called Vi­atem, says can pre­vent RA in an­i­mal mod­els and re­store reg­u­la­tion of white blood cell mi­gra­tion in hu­man tis­sues. PEPITEM is a 14 amino acid pep­tide — a me­di­a­tor in the adiponectin path­way, which con­trols the re­cruit­ment of im­mune cells to in­flamed tis­sue. Ac­cord­ing to Jonathan Watkins, head of IP at Uni­ver­si­ty of Birm­ing­ham En­ter­prise, it was the foun­da­tion­al na­ture of the sci­ence that first at­tract­ed the at­ten­tion of the Uni­ver­si­ty’s tech­nol­o­gy trans­fer and com­mer­cial­iza­tion teams. “It is ex­treme­ly rare that a com­plete­ly new reg­u­la­to­ry path­way is dis­cov­ered, and that it is pos­si­ble to mod­u­late it through an iden­ti­fied tar­get.”

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.

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.

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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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.

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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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.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.