An­drew Rit­ter gath­ers the reins as his com­pa­ny preps PhI­II; Sol­id Bio co-founder Gi­lad Hay­eem re­tires

An­drew Rit­ter

→ The se­ries of ex­ec­u­tive hir­ing at Rit­ter Phar­ma­ceu­ti­cals $RT­TR has cul­mi­nat­ed in co-founder An­drew Rit­ter’s ap­point­ment as CEO. Michael Step is step­ping down af­ter four years at the helm, but will con­tin­ue of­fer­ing guid­ance as a con­sul­tant and board di­rec­tor. This the com­pa­ny says, is all in prepa­ra­tion for the launch of a con­fir­ma­to­ry Phase III study that they hope would put their lac­tose in­tol­er­ance drug at the FDA’s door. In a Phase IIb/III study re­port­ed last year, the com­pa­ny was able to claim a win af­ter chang­ing the pri­ma­ry end­point and re­cal­cu­lat­ing the da­ta. With the tiny biotech’s fate rest­ing on the drug’s suc­cess (or not), Rit­ter, who now holds both the pres­i­dent and chief ex­ec­u­tive ti­tles and leads new col­leagues in­clud­ing CFO John Beck and R&D head Di­ane Plotkin, has big tasks ahead of him.  

→ As CEO Vipin Garg gets ready to leave Neos Ther­a­peu­tics $NEOS, the Dal­las-based biotech has found his suc­ces­sor in Jer­ry McLaugh­lin, a sea­soned com­mer­cial ex­ec who’s re­cent­ly had his first taste of the chief ex­ec­u­tive role at AgeneBio. From Garg, McLaugh­lin in­her­its a pub­lic, com­mer­cial op­er­a­tion — with three AD­HD prod­ucts on the mar­ket — which he is ex­pect­ed to grow. The En­do Phar­ma vet will al­so be re­spon­si­ble for shep­herd­ing Neos’ pre­clin­i­cal as­sets for gas­troin­testi­nal and cen­tral ner­vous sys­tem dis­eases to clin­i­cal de­vel­op­ment. If the past is any in­di­ca­tion, McLaugh­lin might al­so have to field buy­out of­fers, in­clud­ing some from stub­born bid­der PDL Bio­Phar­ma. Garg will as­sist with the tran­si­tion through the end of Ju­ly.

An­dre Turenne

→ Hav­ing eval­u­at­ed Voy­ager Ther­a­peu­tics $VY­GR from the oth­er side of the ta­ble, An­dre Turenne is tak­ing up the in­vi­ta­tion to be its next pres­i­dent and CEO. Co-founder Steve Paul is leav­ing him with a Phase II-ready gene ther­a­py pro­gram for Parkin­son’s dis­ease — which showed promise in ear­ly da­ta from a small tri­al — and a slate of pre­clin­i­cal gene ther­a­py can­di­dates for oth­er neu­ro­log­i­cal in­di­ca­tions. A few of those pro­grams are part­nered with Ab­b­Vie and Sanofi Gen­zyme, some­thing that Turenne will have no trou­ble pick­ing up giv­en the ex­ten­sive busi­ness de­vel­op­ment back­ground he’s de­vel­oped over 12 years at Sanofi.

→ Just days af­ter an­nounc­ing his of­fi­cial de­par­ture from Take­da-ac­quired TiGenix, Ed­uar­do Bra­vo has land­ed his next CEO job at Nordic Nanovec­tor. In this new role he will shift his fo­cus from stem cell ther­a­pies to hema­to­log­i­cal can­cers, but lean on his pre­vi­ous ex­pe­ri­ence in cor­po­rate and prod­uct de­vel­op­ment. Nordic Nanovec­tor’s lead drug, Be­la­lutin, is an an­ti­body ra­dionu­clide con­ju­gate that tar­gets CD37 for the treat­ment of re­cur­rent NHL, cur­rent­ly in ear­ly-stage stud­ies. While the com­pa­ny head­quar­ters are in Oslo, Bra­vo will be based in Lon­don.

Sol­id Bio $SLDB is wrap­ping two tu­mul­tuous quar­ters at the biotech with a high-lev­el switchup. Co-founder and pres­i­dent Gi­lad Hay­eem is re­tir­ing, con­cen­trat­ing the pow­ers in the hands of CEO Ilan Gan­ot, who al­so helped found the com­pa­ny on a quest to find a gene ther­a­py cure for Duchenne mus­cu­lar dy­s­tro­phy. This comes on the heels of the good news that the FDA has lift­ed a clin­i­cal hold three months af­ter is­su­ing it, ap­par­ent­ly hap­py with the changes Sol­id Bio is putting in place in an­tic­i­pa­tion of fu­ture ad­verse events. The com­pa­ny at­tempt­ed to soft­en the blow by an­nounc­ing that in­dus­try vet Mar­tin Freed is join­ing the board, but might do lit­tle to ap­pease alarmed in­vestors.

William Welch has re­signed from pre­ci­sion can­cer meds com­pa­ny Trovagene $TROV for per­son­al rea­sons af­ter two years in the CEO and di­rec­tor seats. Thomas Adams, the long­time chair­man who briefly held the reins be­fore Welch was hired, is once again step­ping in as the in­ter­im CEO. While the com­pa­ny search­es for a leader, Adams said, the team will march on with on­go­ing com­bo tri­als of lead com­pound PCM-075.

→ Fol­low­ing a round of lay­offs that saw 57% of its staff go, Prothena $PR­TA CFO Tran Nguyen is dou­bling as COO. The com­pa­ny was vague about what this new­ly cre­at­ed role en­tails, ex­cept what CEO Gene Kin­ney de­scribes as “strate­gic con­tri­bu­tion and lead­er­ship.” Still reel­ing from a dam­ag­ing Phase IIb im­plo­sion of its lead drug, Prothena has turned its at­ten­tion to its oth­er neu­ro­science pro­grams.

→ Big Phar­ma vet Jessie Eng­lish has de­cid­ed to lend her drug dis­cov­ery ex­per­tise to the young team at Ti­los Ther­a­peu­tics work­ing on an­ti-LAP an­ti­bod­ies. As CSO, she has a siz­able man­date to man­age the pre­clin­i­cal work on lead drug TSL-01 while in­ves­ti­gat­ing the ther­a­peu­tic po­ten­tial of Ti­los’ im­mune reg­u­la­tion tech be­yond on­col­o­gy. The for­ay in­to fi­bro­sis and au­toim­mune dis­eases might be new to Eng­lish, who spent her years at Mer­ck KGaA, Mer­ck and Pfiz­er fo­cused on can­cer drugs. Her ex­per­tise con­duct­ing pre­clin­i­cal trans­la­tion­al stud­ies for clin­i­cal pro­grams — no­tably at Dana-Far­ber and Har­vard Med­ical School — will be a “sig­nif­i­cant as­set,” said Bar­bara Fox, founder and CEO of the Cam­bridge, MA-based biotech.

Sanofi has ap­point­ed Jean-Bap­tiste Chas­seloup de Chatil­lon as EVP and CFO, suc­ceed­ing Jérôme Con­t­a­mine, the long­time ex­ec who will re­tire at the end of the year. Chas­seloup de Chatil­lon jumps from French au­to­mo­tive mak­er PSA Group, where he held the same po­si­tions.

→ With a Phase III study hap­pen­ing in earnest, On­cono­va Ther­a­peu­tics $ON­TX is giv­ing CMO Steven Frucht­man more re­spon­si­bil­i­ties. Fresh­ly pro­mot­ed to pres­i­dent, Frucht­man will now over­see the en­tire prod­uct port­fo­lio and as­sist CEO Ramesh Ku­mar in run­ning oth­er ar­eas of the com­pa­ny. The plan is to hire an­oth­er CMO, but un­til then Frucht­man — a hema­tol­o­gist/on­col­o­gist by train­ing — will main­tain his du­ties there.

→ Waltham, MA-based Eloxx Phar­ma $ELOX has poached two ex­ecs with thick re­sumes to join its C-suite. COO Greg Williams was most re­cent­ly at Ra­dius Health, where, as with The Med­i­cines Co, he led the de­vel­op­ment and even­tu­al ap­proval of a drug. Eloxx ex­ecs are count­ing on his reg­u­la­to­ry ex­pe­ri­ence as they ad­vance lead drug can­di­date, ELX-02, in­to Phase 2 clin­i­cal tri­als in cys­tic fi­bro­sis and cysti­nosis. David Snow, an­oth­er Ra­dius Health staffer who’s been brought on as CBO to scout glob­al col­lab­o­ra­tions op­por­tu­ni­ties, was a 15-year As­traZeneca vet who di­vid­ed his tenure be­tween its US and Chi­na op­er­a­tions.

→ Still hunt­ing for a per­ma­nent CEO, Adicet Bio has re­cruit­ed Stew­art Ab­bot to over­see its pipeline of al­lo­gene­ic cell ther­a­pies as CSO. Ab­bot jumps from im­munother­a­py play­er Fate Ther­a­peu­tics, which, com­bined with his pre­vi­ous role in Cel­gene’s cel­lu­lar ther­a­peu­tics unit like­ly made him a stand­out for the role.

Richard Mala­mut is the new CMO at Brae­burn, join­ing the biotech as it looks for a turn­around on its new opi­oid ad­dic­tion treat­ment. Once a fron­trun­ner in the rush to get new drugs for opi­oid use dis­or­der to the mar­ket — along­side In­di­v­ior and Alk­er­mes — Brae­burn re­ceived a sting­ing com­plete re­sponse let­ter from the FDA in Jan­u­ary, seek­ing “ad­di­tion­al in­for­ma­tion.” The com­pa­ny re­filed its NDA a month ago. Mala­mut, a pain med­i­cine ex­pert for­mer­ly of Avanir, is tasked with build­ing the pipeline and port­fo­lio, which fea­tures a Phase III drug for chron­ic pain.

→ With plans to sub­mit new drug ap­pli­ca­tions in the US and Eu­rope the com­ing year, Karyopharm $KP­TI has hired a CCO, Anand Varadan, to lead the rel­e­vant strat­e­gy and op­er­a­tions. His main job will be to plan the launch of se­linex­or, which scored a pos­i­tive Phase IIb up­date for re­frac­to­ry mul­ti­ple myelo­ma pa­tients back in April.  

→ The FDA may have punt­ed Cat­a­lyst Phar­ma­ceu­ti­cals’ $CPRX NDA be­fore, but this time the com­pa­ny is sure its sub­mis­sion will put Fir­dapse on track for ap­proval. That con­fi­dence has led them to Daniel Bren­nan, who’s been hired as chief com­mer­cial of­fi­cer to lead all sales, mar­ket­ing and com­mer­cial op­er­a­tions. Bren­nan worked on teams that launched new prod­ucts at Lund­beck and Ab­bott be­fore test­ing out op­er­a­tional roles at In­sys and Edge Ther­a­peu­tics.

Evo­lus $EOLS has snapped up yet an­oth­er Al­ler­gan staffer to serve on its C-suite, this time in an­tic­i­pa­tion of a launch — for re­al — for its Botox ri­val. Michael Ja­far, pre­vi­ous­ly VP of med­ical aes­thet­ics at Al­ler­gan in charge of prod­uct de­vel­op­ment and mar­ket as­sess­ment for sev­er­al fran­chis­es, has been ap­point­ed chief mar­ket­ing of­fi­cer. Led by Ja­far’s for­mer boss David Moataze­di, Evo­lus was re­cent­ly hit by a CRL from the FDA, but the man­age­ment has promised a swift re­sponse that will al­low for DWP-450 to launch next spring.  

→ Two ex­ecs have joined Clin­i­pace as the CRO un­veiled a new brand for its clin­i­cal study ser­vices. As chief de­vel­op­ment of­fi­cer, Dawn Sauro is tasked with part­ner­ship strate­gies, lever­ag­ing the clin­i­cal site re­la­tion­ships she’s built up at in­Ven­tiv Health, PRA Health Sci­ences and PPD. Chiltern vet Sharon Moore will serve as chief med­ical of­fi­cer.

→ Fad­ing out of its overnight no­to­ri­ety over plans to sell its ALS med un­der “right to try,” Brain­Storm $BCLI has ap­point­ed Joseph Petroziel­lo from Juno Ther­a­peu­tics as vice pres­i­dent of sci­en­tif­ic & cor­po­rate com­mu­ni­ca­tions, and Pfiz­er vet Su­san Ward as head of clin­i­cal op­er­a­tions.

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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Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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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.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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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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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.