Pro­men­tis clos­es $26M round and en­ters clin­ic; Pelle­Phar­ma gets break­through/or­phan sta­tus; Shire ap­points Dit­trich as CFO

→ Mil­wau­kee-based Pro­men­tis Phar­ma­ceu­ti­cals has closed the fi­nal tranche of its pre­vi­ous­ly-an­nounced $26 mil­lion Se­ries C round. Or­biMed, F-Prime Cap­i­tal Part­ners (for­mer­ly Fi­deli­ty Bio­sciences) and Ais­ling Cap­i­tal led the round. Ex­ist­ing in­vestors, in­clud­ing Black Pearl GmbH, the Gold­en An­gel Net­work and in­di­vid­ual in­vestors, al­so par­tic­i­pat­ed. The biotech’s lead prod­uct can­di­date is SXC-2023 — a small mol­e­cule de­signed to en­gage Sys­tem Xc-, a CNS tar­get ad­dress­ing glu­ta­mater­gic dys­func­tion and ox­ida­tive stress  — for the treat­ment of ob­ses­sive-com­pul­sive and re­lat­ed dis­or­ders. The prod­uct has en­tered Phase I tri­als in pa­tients with tri­chotil­lo­ma­nia, a con­di­tion char­ac­ter­ized by re­cur­rent hair pulling which leads to no­tice­able hair loss.

Bay Area’s Pelle­Phar­ma just got break­through ther­a­py and or­phan drug des­ig­na­tions for its top­i­cal ver­sion of patideg­ib, a skin can­cer treat­ment for per­sis­tent­ly de­vel­op­ing basal cell car­ci­no­mas in pa­tients with a rare ge­net­ic dis­ease known as Gor­lin syn­drome or Basal Cell Car­ci­no­ma Ne­vus Syn­drome. Break­through sta­tus was grant­ed based on Phase II safe­ty and ef­fi­ca­cy re­sults. Since Gor­lin Syn­drome is a rare con­di­tion af­fect­ing rough­ly 10,000 peo­ple in the US, the FDA al­so grant­ed Pelle­Phar­ma or­phan sta­tus. Pelle­Pharm in­tends to ini­ti­ate a Phase III clin­i­cal tri­al for patideg­ib in Gor­lin syn­drome in 2018.

Thomas Dit­trich

→ Af­ter toy­ing with a spin­off idea in Au­gust, Shire $SH­PG has tapped Thomas Dit­trich to re­place cur­rent CFO Jeff Poul­ton, who is leav­ing at the end of this year. Where­as his most re­cent stint was at an in­dus­tri­al en­gi­neer­ing firm, Dit­trich had pre­vi­ous­ly worked in fi­nance roles at Am­gen for al­most a decade. He joins the rare dis­ease biotech as it pre­pares for a show­down with a fierce ri­val Roche on the he­mo­phil­ia A front.

Mary Lynne Hed­ley and Lon­nie Moul­der, co-founders of Waltham, MA-based Tesaro, has been named EY Na­tion­al En­tre­pre­neurs of the Year. Their se­lec­tion as the over­all win­ner came af­ter they al­ready won the award in the life sci­ences cat­e­go­ry. EY not­ed that the bio­phar­ma com­mer­cial­ized two drugs in sev­en years — in­clud­ing Varu­bi, the IV ver­sion of which was al­so re­cent­ly ap­proved. “In ad­di­tion to want­i­ng to build a mean­ing­ful on­col­o­gy com­pa­ny, they were just as com­mit­ted to one with a busi­ness cul­ture based on col­lab­o­ra­tion,” EY wrote.

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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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.

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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The top 15 mega-deals in bio­phar­ma: Ab­b­Vie and Bris­tol-My­ers ac­qui­si­tions stir fresh de­bate over what's too big to buy

The debate over what’s too big to buy in biotech is back. A number of top analysts went right after AbbVie’s rationale for the Allergan deal today, just as Bristol-Myers Squibb stirred immediate debate over the worth and wisdom of acquiring Celgene.

To help provide some added context to this discussion, we asked DealForma chief Chris Dokomajilar to look over the past decade of major M&A in biopharma to decipher the top 15 plays.

The new numbers, unadjusted for inflation, harken back to the days of the Pfizer-Wyeth buyout and Merck’s decision to absorb Schering-Plough — both triggered in 2009. The heat over those acquisitions made the big pharma mega-deal highly unpopular for most everyone — except Pfizer — as industry leaders swore off almost all but the handy bolt-on acquisition.

Until recently.

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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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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.

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.