Ac­celeron poach­es ex-Abl­ynx CMO Robert Zeldin; Deb­o­rah Dun­sire leaves for Lund­beck­'s top job af­ter XTu­it im­plo­sion

Deb­o­rah Dun­sire

→ Af­ter bounc­ing around the high-risk biotech world in Boston/Cam­bridge for the past few years, ex-Mil­len­ni­um chief Deb­o­rah Dun­sire is now tak­ing the top seat at Den­mark’s Lund­beck, left va­cant af­ter Kåre Schultz jumped to Te­va. A high-pro­file ex­ec in the US, Dun­sire left Mil­len­ni­um as Take­da ab­sorbed and re­struc­tured the com­pa­ny, mak­ing it a cen­tral part of their US hub. She lat­er took the helm at Fo­rum Phar­ma­ceu­ti­cals, leav­ing not long af­ter the com­pa­ny was hit by a clin­i­cal hold on Alzheimer’s and a failed clin­i­cal pro­gram in schiz­o­phre­nia. Her next stop, XTu­it, was a com­bi­na­tion can­cer/fi­bro­sis com­pa­ny that has now fall­en off the map, with most of its se­nior staffers mi­grat­ing to new po­si­tions, the web­site down and the voice mail full, with no vis­i­ble signs of ac­tiv­i­ty. Dun­sire’s com­pa­ny email ad­dress is de­funct. Lund­beck, though, of­fers Dun­sire a chance to take a new, high-pro­file po­si­tion in the bio­phar­ma world — the kind in­volv­ing a vi­able com­pa­ny with rev­enue. Lund­beck Chair­man Lars Ras­mussen told Reuters that Dun­sire’s biggest re­spon­si­bil­i­ty will be in R&D, which is where she’s had the least suc­cess. As for Dun­sire, she’s look­ing to grow the pipeline, which may mean some new deals on the hori­zon.

→ SGI-DNA, a La Jol­la spin­out from J. Craig Ven­ter’s com­pa­ny Syn­thet­ic Ge­nomics, has named a new leader to the helm. Todd Nel­son, the for­mer CEO of San Fran­cis­co Bay Area’s Dis­cov­erX Cor­po­ra­tion, is join­ing SGI-DNA as CEO. Nel­son has led sev­er­al com­pa­nies through phas­es of growth, in­clud­ing eBio­science, which was ac­quired by Affymetrix (now Ther­mo Fish­er); and MP Bio­med­icals, which was ac­quired by Valeant Fine Chem­i­cals. The news of Nel­son’s ap­point­ment comes just weeks af­ter SGI-DNA’s for­mer pres­i­dent Nathan Wood an­nounced he was leav­ing the com­pa­ny for a new gig at Swift Bio­sciences.

→ Now that the cur­tain is drawn on Sanofi’s ac­qui­si­tion of Abl­ynx, the biotech’s CMO is mov­ing on to his next chap­ter as well. Robert Zeldin will now take on the same role at Ac­celeron $XL­RN, the Cel­gene part­ner that re­cent­ly got some at­ten­tion for stel­lar Phase III re­sults on its ane­mia drug, lus­pa­ter­cept. He suc­ceeds Matthew Sher­man, who will see a Phase III be­ta-tha­lassemia tri­al through the read­out but leaves plen­ty of oth­er ear­ly- and mid-stage pro­grams in his hands. They span hema­tol­ogy, neu­ro­mus­cu­lar and pul­monary dis­eases — a di­ver­si­ty in ther­a­peu­tic area that match­es Zeldin’s own ex­pe­ri­ence across Mer­ck, No­var­tis and French phar­ma Stal­ler­genes.

Park­er “Pe­te” Pe­tit

→ Be­sieged by shorts with a Jus­tice De­part­ment probe re­port­ed­ly un­der way, the purge at MiMedx $MDXG has now led to the ex­it of CEO Park­er “Pe­te” Pe­tit and COO William “Bill” Tay­lor. The au­dit com­mit­tee at the biotech has been do­ing its own in­ter­nal in­ves­ti­ga­tion, which has al­ready led to the de­par­ture of the CFO and trea­sur­er. David Coles was named in­ter­im CEO. “The Board is con­fi­dent that now is the right time for MiMedx to tran­si­tion its lead­er­ship team as we look to the fu­ture and pre­pare our Com­pa­ny for its next chap­ter,” said chair­man Charles Evans. The biotechs shares swooned on the lat­est news, plung­ing 26%.

→ Af­ter guid­ing His­toIn­dex’s piv­ot from a med­ical de­vice com­pa­ny to a clin­i­cal ser­vice provider spe­cial­iz­ing in non­al­co­holic steato­hep­ati­tis (NASH), founder Gideon Ho is pass­ing on the CEO role to fo­cus on the com­mer­cial side of things. His suc­ces­sor is Poon Thong Yuen, a Sin­ga­pore-based in­vestor who’s been ad­vis­ing Ho in re­fin­ing the com­pa­ny’s rev­enue mod­el. Hav­ing served on the boards of both biotech and medtech com­pa­nies, Poon is al­so tasked with ce­ment­ing His­toIn­dex’s — and its sub­sidiary Hangzhou Choutu Tech­nol­o­gy’s — rep­u­ta­tion in di­ag­nos­tics.

Pritesh Shah just got a pro­mo­tion at Novo­cure $NVCR, put in charge of the can­cer drug de­vel­op­er’s world­wide com­mer­cial strat­e­gy as chief com­mer­cial of­fi­cer. He will con­tin­ue to re­port to CEO Asaf Danziger, just as he had while SVP of the Amer­i­c­as. In that po­si­tion, to­geth­er with man­agers of oth­er re­gion­al mar­kets, he cov­ered the du­ties left be­hind by for­mer CCO Pe­ter Mel­nyk, who re­signed last March. Now in his sixth year at the Jer­sey-based com­pa­ny, as it grap­ples with a prod­uct ap­proved for glioblas­toma and in Phase III for sev­er­al oth­er in­di­ca­tions, the Roche/Genen­tech vet is still mov­ing up the lad­der.

→ Sea­soned BD ex­ec Thorsten Melch­er has jumped from Google’s Cal­i­co to be­come chief busi­ness of­fi­cer at im­muno-on­col­o­gy play­er Xyphos Bio­sciences. The team likes the spec­trum of fundrais­ing and deal­mak­ing ex­pe­ri­ence he’s amassed, from co-found­ing AGY Ther­a­peu­tics and En­Vi­vo Phar­ma (now Fo­rum) to di­rect­ing ven­tures at J&J In­no­va­tion, and they are count­ing on him to get the word out about their next-gen CAR-T tech­nol­o­gy.

→ As Zo­genix $ZGNX lines up its FDA pitch for its late-stage drug ZX008, de­signed to tack­le a se­vere form of child­hood epilep­sy, it wants to be sure it’s ready for the next step as well. Ashish Sagro­likar, who’s just been hired as chief com­mer­cial of­fi­cer, will be their man on it. With 16 years of mar­ket­ing rare dis­ease and spe­cial­ty phar­ma­ceu­ti­cal prod­ucts un­der his belt, most re­cent­ly at Glax­o­SmithK­line and Bax­ter, Sagro­likar is ex­pect­ed to stay laser fo­cused on rolling out the drug to pa­tients with Dravet syn­drome as soon as the ap­proval comes through. If ap­proved, the ther­a­py will face off with GW Phar­ma’s re­cent­ly green-light­ed cannabi­noid drug.

→ Fol­low­ing its $75 mil­lion raise, Bel­gium’s iTeos Ther­a­peu­tics has planned to move its op­er­a­tions to Cam­bridge, MA and ex­pand its top team in the US in prepa­ra­tion for an IPO. That tal­ent search has led them to Scott Chap­pel, who is leav­ing Sur­face On­col­o­gy, a biotech he helped found, to come shep­herd iTeos’ im­muno-on­col­o­gy pro­grams in­to the clin­ic. An ex­pe­ri­enced sci­en­tist and two-time en­tre­pre­neur, he most re­cent­ly served in a tech­nol­o­gy (man­u­fac­tur­ing, process man­age­ment) role. He joins a “top sci­en­tif­ic team” out of Lud­wig Can­cer Re­search and the de Duve In­sti­tute that was a key ap­peal for Se­ries B lead in­vestor MPM Cap­i­tal. The com­pa­ny’s main drug is an adeno­sine A2A an­tag­o­nist.

→ Al­most a year af­ter a dread­ful FDA re­jec­tion that led to lay­offs and study ter­mi­na­tions, Boston-based Intar­cia is gear­ing up for the re­sub­mis­sion of its im­plant­ed di­a­betes drug/de­vice. And they’ve brought on Eli Lil­ly vet Thane Wet­tig as the first chief mar­ket­ing of­fi­cer and meta­bol­ic fran­chise head to start off right. In ad­di­tion to draft­ing the game plan for IT­CA 650, Wet­tig, who led mul­ti­ple launch teams at Lil­ly Di­a­betes, al­so has a broad man­date over all of Intar­cia’s mar­ket­ing ef­forts and the de­vel­op­ment of oth­er meta­bol­ic as­sets in the pipeline.

Nov­e­l­ion Ther­a­peu­tics $NVLN board chair Ja­son Aryeh is leav­ing the rare dis­ease com­pa­ny, hand­ing over his du­ties to board di­rec­tor Mark Cor­ri­g­an, who now as­sumes the ti­tle ex­ec­u­tive chair. Aryeh, Cor­ri­g­an and COO Jeff Hack­man to­geth­er formed the Of­fice of the CEO that was put in place when for­mer chief Mary Szela re­signed last No­vem­ber. Hack­man will now be in­ter­im CEO, though there’s no word on when a per­ma­nent leader might be in­stalled.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Novavax site in Gaithersburg, MD. Novavax

Beef­ing up its new gene ther­a­py unit, Catal­ent inks $18M deal to snap up No­vavax fa­cil­i­ties

Catal­ent’s hunt for rapid growth on the gene ther­a­py front — ce­ment­ed with a $1.2 bil­lion ac­qui­si­tion of Paragon Bio­sciences two months ago — has led them to the vac­cine mak­ers at No­vavax.

With an $18 mil­lion pay­ment, Paragon is tak­ing over two No­vavax sites in Gaithers­burg, MD, in­clud­ing more than 100 of the em­ploy­ees al­ready work­ing there. That’s in ad­di­tion to a sig­nif­i­cant re­duc­tion in op­er­at­ing costs, says the com­pa­ny, as No­vavax shifts to re­ly on Paragon for GMP ma­te­ri­als in clin­i­cal tri­als and, even­tu­al­ly, com­mer­cial sup­ply of their prod­ucts.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.