Bio­Haven hopes to soothe Chi­nese headaches with Shang­hai sub­sidiary

Cap­i­tal­iz­ing on the bur­geon­ing bio­phar­ma in­ter­est in Chi­na, neu­ro-fo­cused drug de­vel­op­er Bio­Haven $BHVN is set­ting up shop in Shang­hai with a sub­sidiary called BioShin that will be tasked with shep­herd­ing the Con­necti­cut-based com­pa­ny’s ar­se­nal of late-stage mi­graine and neu­rol­o­gy prod­ucts in mar­kets across the Asia-pa­cif­ic re­gion.

Vlad Coric

Bio­Haven, which ear­li­er this week said it had sub­mit­ted a US ap­pli­ca­tion to mar­ket a sub­lin­gual for­mu­la­tion of the ALS drug rilu­zole, is gear­ing up to re­port key da­ta from a piv­otal late-stage tri­al test­ing its acute mi­graine drug, rimegepant, be­fore the end of the year in the Unit­ed States. The com­pa­ny’s in­ter­est is Chi­na is not un­ex­pect­ed, giv­en that large swathes of the re­gion’s im­mense pop­u­la­tion suf­fer from mi­graine and oth­er cen­tral ner­vous sys­tem dis­or­ders, al­though pa­tients have not ben­e­fit­ed from the heady pace of med­ical in­no­va­tion their US coun­ter­parts have en­joyed.

“Al­most 90 mil­lion in­di­vid­u­als in Chi­na alone suf­fer from mi­graine and could ul­ti­mate­ly ben­e­fit from our late-stage mi­graine de­vel­op­ment plat­form,” said Bio­Haven chief Vlad Coric.

Once a breed­ing ground for sci­en­tists that em­i­grat­ed to the Unit­ed States, Chi­na is now at­tract­ing top re­searchers and en­tre­pre­neur­ial tal­ent back to its shores as fi­nan­cial in­cen­tives, gov­ern­men­tal sup­port, in­dus­tri­al in­fra­struc­ture, reg­u­la­to­ry re­forms and a large, age­ing pop­u­la­tion pro­vide the ide­al back­drop for rapid drug dis­cov­ery and de­vel­op­ment.

Don­nie Mc­Grath

BioShin will be led by Don­nie Mc­Grath, a for­mer Bris­tol-My­ers $BMY ex­ec who has served as Bio­Haven’s chief of cor­po­rate strat­e­gy and busi­ness de­vel­op­ment since 2017, along with fel­low ex-Bris­tol-My­ers ex­ec Karl Lin­tel who has been ap­point­ed COO. With the sup­port of Bio­Haven, BioShin can fur­ther build its team and “raise cap­i­tal from both the pri­vate and pub­lic mar­kets in main­land Chi­na and Hong Kong,” Mc­Grath said in a state­ment on Wednes­day.

BioShin is ex­pect­ed to sub­mit an ap­pli­ca­tion to eval­u­ate rimegepant in hu­man tri­als in Chi­na next quar­ter, and ad­di­tion­al INDs for oth­er in­ves­ti­ga­tion­al drugs are al­so planned for sub­mis­sion in 2019. Mean­while, in the Unit­ed States, pos­i­tive Phase III rimegepant da­ta will al­low Bio­Haven to sub­mit an ap­pli­ca­tion to mar­ket the as-need­ed oral CGRP treat­ment for mi­graine in mid-2019, trail­ing be­hind Al­ler­gan $AGN that has re­cent­ly re­it­er­at­ed it is on track to sub­mit its ap­pli­ca­tion for a ri­val oral CGRP by the first quar­ter of next year.

The mul­ti-bil­lion dol­lar US mi­graine mar­ket is al­ready re­plete with in­jectable med­ica­tions from Te­va $TE­VA, Eli Lil­ly $LLY, and one from Am­gen $AMGN and No­var­tis $NVS, which are all de­signed to be used as pre­ven­ta­tive treat­ments and are cu­ri­ous­ly priced iden­ti­cal­ly. For those pa­tients who still ex­pe­ri­ence mi­graine at­tacks de­spite pre­ven­ta­tive an­ti-CGRP ther­a­py, acute, as-need­ed treat­ments will still be re­quired, which is where rimegepant and Al­ler­gen’s ri­val ubro­gepant could come handy. If ap­proved, the two acute drugs could po­ten­tial­ly al­so be used in com­bi­na­tion with their an­ti-CGRP in­jectable ri­vals.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Tasly Bio­phar­ma pitch­es long-await­ed IPO — will it trig­ger an­oth­er $1B gold rush on HKEX?

In the run up to the Hong Kong stock ex­change’s an­tic­i­pat­ed rule change — open­ing the door for Chi­nese pre-rev­enue biotechs to go pub­lic clos­er to home — more than a year ago, Tasly Bio­phar­ma was one of the big play­ers whose ru­mored in­ter­est helped stoke en­thu­si­asm for the new list­ing venue. The com­pa­ny has since kept the drum­roll rum­bling in the back­ground, rais­ing a pre-IPO round and con­vinc­ing part­ner Trans­gene to swap own­er­ship in a joint ven­ture for eq­ui­ty. Now the oth­er shoe has fi­nal­ly dropped as ex­ecs out­line plans for a pipeline dom­i­nat­ed by car­dio­vas­cu­lar drugs.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three ma­jor buy­outs an­nounced: Take­da/Shire; Bris­tol-My­ers/Cel­gene and now Ab­b­Vie/Al­ler­gan. And with this lat­est deal it’s in­creas­ing­ly clear that the sharp fall from grace suf­fered by high-pro­file play­ers which have seen their share prices blast­ed has cre­at­ed an open­ing for the growth play­ers in big phar­ma to up their game — in sharp con­trast to the pop­u­lar bolt-on deals that have been dri­ving the growth strat­e­gy at No­var­tis, Mer­ck, Roche and oth­ers.

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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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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.

SQZ, Ery­tech kick off $57M cell ther­a­py part­ner­ship; Jean-Paul Kress lands new CEO gig at Mor­phoSys

→ In a mar­riage of two tech­nolo­gies meant to make cell ther­a­pies more pow­er­ful, SQZ Biotech is team­ing up with France’s Ery­tech Phar­ma for a col­lab­o­ra­tion, with $57 mil­lion re­served for the first project and $50 mil­lion for each sub­se­quent ap­proval (prod­uct or in­di­ca­tion). Hav­ing ac­cess to Ery­tech’s method of fash­ion­ing ther­a­peu­tics from red blood cells, the Cam­bridge, MA-based com­pa­ny said, will am­pli­fy SQZ’s cell en­gi­neer­ing ca­pa­bil­i­ties and al­low them to de­vleop a new class of im­munomod­u­la­to­ry ther­a­pies. Its own tech — so far ap­plied in can­cer but al­so has po­ten­tial in di­a­betes — tem­po­rary dis­rupts the cell mem­brane by squeez­ing the cell, thus cre­at­ing a brief win­dow for tar­get ma­te­ri­als such as anti­gens to en­ter.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 far­ing?

With 22 biotech IPOs on the books and four more set to price in the last week of June, in­vest­ment ad­vis­er Re­nais­sance Cap­i­tal has tak­en the pulse of the re­cent rush.

By the IPO ex­perts’ count, 25 out of 32 health­care of­fer­ings this year have been from biotechs — dif­fer­ing slight­ly from Brad Lon­car’s tal­ly — and the over­all pic­ture is one of un­der­per­for­mance. While they av­er­aged a first-day re­turn of 9.0%, col­lec­tive­ly they have trad­ed down to a 5.9% re­turn. Turn­ing Point $TP­TX and Cor­texyme $CRTX emerged on top at the half-year mark, ris­ing 135% and 109% re­spec­tive­ly.