Up­dat­ed: Al­ny­lam pro­motes long­time ex­ec Kevin FitzGer­ald to CSO; In­tel­lia Ther­a­peu­tics brings on Lau­ra Sepp-Loren­zi­no

Kevin FitzGer­ald Linkedin

Kevin FitzGer­ald has been with Al­ny­lam since 2005, and with his ex­pe­ri­ence of “lead­ing suc­cess­ful teams on de­liv­ery tech­nolo­gies, tar­get se­lec­tion, and pro­grams in clin­ic,” he’s been pro­mot­ed to CSO of the com­pa­ny.

“Our tech­nol­o­gy is at such an ex­cit­ing stage and there are so many ap­pli­ca­tions for pa­tients in need, pri­or­i­tiz­ing what we do first (and at times, what we do not do) will be a very im­por­tant chal­lenge,” said FitzGer­ald via email.

Al­ny­lam has come a long way from its in­cep­tion in 2002. Last Au­gust the com­pa­ny re­ceived the first and on­ly ever FDA ap­proval for the treat­ment of the polyneu­ropa­thy of hered­i­tary transthyretin-me­di­at­ed (hAT­TR) amy­loi­do­sis in adults with its RNAi ther­a­peu­tic, On­pat­tro (patisir­an) — a lipid com­plex in­jec­tion.  

“Dur­ing my time at Al­ny­lam, we have gone from RNAi is a cool and ex­cit­ing pos­si­bil­i­ty, to clin­i­cal proof of con­cept that the tech­nol­o­gy works ro­bust­ly in man, to a com­mer­cial com­pa­ny with an ap­proved RNAi ther­a­peu­tic prod­uct with sev­er­al oth­ers in Phase III tri­als,” said FitzGer­ald.

FitzGer­ald joined Al­ny­lam af­ter a stint at Bris­tol-My­ers Squibb. When asked why he de­cid­ed to hop on board with the com­pa­ny, FitzGer­ald said “It may sound made up, but from the very be­gin­ning I was look­ing for a tech­nol­o­gy that could change med­i­cine. One of my men­tors told me, ‘If you are go­ing to spend a lot of time, maybe years of your life… ded­i­cat­ed to work­ing on a prob­lem, make sure at the oth­er end of it, some­thing big is the re­sult.’ I saw RNAi as an evo­lu­tion­ary con­served mech­a­nism, that if we could har­ness it, had the po­ten­tial to change how we treat hu­man dis­ease. I be­lieved way back then, but af­ter all these years… and now an ap­proved prod­uct, I am more ex­cit­ed than ever and be­lieve we are at the cusp of re­al­iz­ing what RNAi ther­a­peu­tics could do for hu­man dis­ease.”

Kel­ley Bouch­er Linkedin

In ad­di­tion to FitzGer­ald’s pro­mo­tion, Al­ny­lam has ap­point­ed Kel­ley Bouch­er as the com­pa­ny’s se­nior vice pres­i­dent, chief hu­man re­sources of­fi­cer. Bouch­er has a back­ground of over 15 years of hu­man re­sources and tal­ent ac­qui­si­tion/man­age­ment ex­pe­ri­ence in the biotech sec­tor. Be­fore Al­ny­lam, Bouch­er had a stint at Abio­med. And be­fore that, she spent 10 years at Shire.

“This tran­si­tion, along with the ad­vance­ment of the Com­pa­ny’s ro­bust and di­verse pipeline, will be en­abled by con­tin­ued in­vest­ment in glob­al growth, scal­a­bil­i­ty, and peo­ple de­vel­op­ment,” Bouch­er said. “I hope to help fos­ter this growth by en­sur­ing that we are an em­ploy­er of choice and that we con­tin­ue to cul­ti­vate an in­clu­sive and di­verse cul­ture con­ducive to for­ward think­ing and in­no­va­tion.”

→ CRISPR/Cas9 tech­nol­o­gy pi­o­neer In­tel­lia Ther­a­peu­tics wel­comed Lau­ra Sepp-Loren­zi­no as its new ex­ec­u­tive vice pres­i­dent and CSO. Sepp-Loren­zi­no joins the com­pa­ny af­ter a stint at Ver­tex Phar­ma­ceu­ti­cals as vice pres­i­dent, head of nu­cle­ic acid ther­a­pies, re­search lead­er­ship and a mem­ber of the ex­ter­nal in­no­va­tion team. Pri­or to Ver­tex, Sepp-Loren­zi­no de­vel­oped and im­ple­ment­ed the he­pat­ic in­fec­tious dis­ease strat­e­gy at Al­ny­lam and helped the com­pa­ny strength­en its RNA pipeline. Be­fore that, she spent 14 years at Mer­ck ad­vanc­ing RNAi as a nov­el ther­a­peu­tic modal­i­ty.

Ed­ward Con­ner Linkedin

Au­dentes, which is hop­ing to ri­val Sarep­ta Ther­a­peu­tics with its gene ther­a­py for DMD, has un­veiled new mem­bers of its se­nior ex­ec­u­tive team. The San Fran­cis­co-based com­pa­ny has hired for­mer Sang­amo ex­ec­u­tive Ed­ward Con­ner as CMO, and pro­mot­ed Ful­vio Mav­ilio to se­nior VP of trans­la­tion­al sci­ence. Mean­while, Au­dentes’ CMO Suyash Prasad and chief tech­nol­o­gy of­fi­cer John Gray are leav­ing the com­pa­ny.

Brent Hatzis-Schoch Black Di­a­mond

David Ep­stein-led can­cer up­start Black Di­a­mond Ther­a­peu­tics has an­nounced the ap­point­ment of Brent Hatzis-Schoch as COO and gen­er­al coun­sel of the com­pa­ny. Hatzis-Schoch has over 20 years of ex­pe­ri­ence in le­gal af­fairs at com­mer­cial and de­vel­op­ment-stage phar­ma­ceu­ti­cal and biotech­nol­o­gy com­pa­nies. He joins Black Di­a­mond af­ter stints at Ra­dius Health and Merz Phar­ma in Frank­furt, Ger­many. 

In ad­di­tion, Black Di­a­mond has made new ap­point­ments to its se­nior lead­er­ship team in prepar­ing to en­ter its lead pro­gram in­to the clin­ic next year. These ap­point­ments in­clude: Karsten Witt — who was in­volved in the clin­i­cal de­vel­op­ment of NSCLC drug Tarce­va — as se­nior vice pres­i­dent of clin­i­cal de­vel­op­ment, Nigel Wa­ters as vice pres­i­dent of pre­clin­i­cal de­vel­op­ment, As­traZeneca vet Carl Cook, vice pres­i­dent of clin­i­cal op­er­a­tions — cred­it­ed for lead­ing piv­otal stud­ies for Ires­sa — and Mer­sana vet San­na Be­lorusets as vice pres­i­dent of fi­nance.

The com­pa­ny was launched last De­cem­ber and ear­li­er this year, the com­pa­ny had raised $85 mil­lion in a Se­ries B round, bring­ing the funds raised by the first com­pa­ny out of Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel to $105 mil­lion. 

Jo­han­na Merci­er Linkedin

Gilead chief Daniel O’Day has been mak­ing quite a few changes to his ex­ec­u­tive team and now he’s ax­ing his EVP of world­wide com­mer­cial ops chief Lau­ra Hamill — who ar­rived less than a year ago from Am­gen and will be re­ceiv­ing $1.75 mil­lion in sev­er­ance up­on her for­mal de­par­ture from the com­pa­ny Ju­ly 1 — and bring­ing Jo­han­na Merci­er on board. The 10-year Bris­tol-My­ers vet has been cap­tain on large mar­kets in the US, Eu­rope and Japan. Merci­er will tack­le Gilead’s HIV mar­ket — which has faced heavy crit­i­cism for the price of its drugs — and its cell ther­a­py pipeline.

“She is a tal­ent­ed leader with a deep un­der­stand­ing of the phar­ma­ceu­ti­cal in­dus­try, across ther­a­peu­tic mar­kets and ge­o­gra­phies,” not­ed O’Day, “as well as a proven abil­i­ty to in­put the com­mer­cial per­spec­tive in­to de­vel­op­ment strate­gies.”

Pas­cal Tou­chon Co­gen

Atara Bio­ther­a­peu­tics CEO Isaac Ciechanover made a sur­prise de­ci­sion to leave the com­pa­ny in Jan­u­ary and it’s been an­nounced Tues­day that No­var­tis vet Pas­cal Tou­chon will of­fi­cial­ly join the com­pa­ny June 24. At No­var­tis, Tou­chon worked with­in on­col­o­gy as glob­al head, cell & gene and as a mem­ber of the on­col­o­gy ex­ec­u­tive com­mit­tee, where he was in charge of the glob­al roll­out of Kym­ri­ah. Pre­vi­ous­ly, Tou­chon has worked at Servi­er, Sanofi and Glaxo.

Isaac Ciechanover Atara

Ciechanover has joined the board of SQZ Biotech­nolo­gies, a cell ther­a­py biotech prep­ping a clin­i­cal en­try. “SQZ’s in­no­v­a­tive cell ther­a­py plat­form and the ther­a­peu­tics the com­pa­ny is cre­at­ing have great promise for pa­tients and can im­pact mul­ti­ple dis­eases,” he said. “Cou­pled with their ad­vances in ef­fi­cient cell ther­a­py man­u­fac­tur­ing, this is a tru­ly unique op­por­tu­ni­ty, and I am en­thu­si­as­tic about be­ing a part of the team at this piv­otal stage.”

Di­et­mar Berg­er Atara

Af­ter hop­ping out of Atara Bio­ther­a­peu­tics, Di­et­mar Berg­er has joined Sanofi. Berg­er will be the head of de­vel­op­ment and will over­see the com­pa­ny’s clin­i­cal port­fo­lio across all ther­a­py ar­eas and help the com­pa­ny bring trans­for­ma­tive new med­i­cines to pa­tients. Pri­or to join­ing Atara, Berg­er was the head of de­vel­op­ment for Genen­tech’s hema­tol­ogy and on­col­o­gy unit and is cred­it­ed with play­ing a lead role for top pro­grams like Gazy­va, Cotel­lic, Ale­cen­sa, Tecen­triq and Hem­li­bra. And be­fore Genen­tech, he was at Bay­er and Am­gen for over 16 years.

Jef­frey Sprouse Linkedin

Sanofi CSO John Reed is shift­ing away from ma­jor league part­ners like Re­gen­eron and Al­ny­lam to fo­cus on the com­pa­ny’s own on­col­o­gy pipeline.

Howard Federoff Linkedin

Ju­ve­nes­cence’s new ven­ture, Sou­vien Ther­a­peu­tics — which is cre­at­ing in­no­v­a­tive med­i­cines to ad­dress neu­rode­gen­er­a­tive dis­eases by tar­get­ing the epi­ge­net­ic un­der­pin­nings of neu­rode­gen­er­a­tion — an­nounced two new ap­point­ments. Jef­frey Sprouse — who led pre­clin­i­cal pro­grams at both Pfiz­er and Lund­beck — will join the com­pa­ny as its CEO and Howard Federoff — pro­fes­sor of neu­rol­o­gy at the Uni­ver­si­ty of Cal­i­for­nia, Irvine, Col­lege of Med­i­cine and for­mer CEO of UCI Health Sys­tem — as its chair.

Matthew Har­baugh Mallinck­rodt

→ While Mallinck­rodt Phar­ma­ceu­ti­cals re­cent­ly up­dat­ed plans for its spin-off com­pa­ny, it al­so put a full man­age­ment team in place. Matthew Har­baugh, cur­rent pres­i­dent of Mallinck­rodt’s spe­cial­ty gener­ics busi­ness and for­mer CFO of the com­pa­ny is pro­ject­ed to be­come pres­i­dent and CEO of the new com­pa­ny up­on com­ple­tion of the sep­a­ra­tion. Er­ic Slusser — who has for­mer­ly served as CFO for com­pa­nies such as Ex­press Scripts, Gen­ti­va Health Ser­vices and Cen­tene Cor­po­ra­tion —  is pro­ject­ed to serve as CFO. In ad­di­tion, the an­tic­i­pat­ed board of di­rec­tors of the new spe­cial­i­ty gener­ics com­pa­ny will con­sist of nom­i­nat­ed in­de­pen­dent chair­man James Su­lat — who has served as CEO of both Maxy­gen and Mem­o­ry Phar­ma­ceu­ti­cals — and nom­i­nat­ed chair of the au­dit com­mit­tee of the new board of di­rec­tors Michael Atieh — who was the for­mer ex­ec­u­tive vice pres­i­dent and CFO of Oph­thotech Cor­po­ra­tion.

June Al­menoff Linkedin

Red­Hill Bio­Phar­ma — a bio­phar­ma­ceu­ti­cal com­pa­ny fo­cused on gas­troin­testi­nal dis­eases — has ap­point­ed June Al­menoff as its first CSO. Al­menoff has served in var­i­ous roles, in­clud­ing stints at Fu­riex and GSK. At Fu­riex — ac­quired by Ac­tavis, now Al­ler­gan — Al­menoff worked as pres­i­dent and CMO of the com­pa­ny where the lead prod­uct, Viberzi, was ap­proved by the FDA in 2015 for the treat­ment of ir­ri­ta­ble bow­el syn­drome with di­ar­rhea (IBS-D).

John Renger Cerev­el

Cerev­el ther­a­peu­tics ex­pands their ex­ec­u­tive team with three new ap­point­ments, which in­clude John Renger as CSO, Kathy Yi as CFO and Ken DiP­i­etro as chief hu­man re­sources of­fi­cer.

Kathy Yi Cerev­el

“Cerev­el Ther­a­peu­tics was pur­pose-built to fo­cus on the unique needs of peo­ple im­pact­ed by dev­as­tat­ing ner­vous sys­tem dis­eases—a mod­el that is at­tract­ing busi­ness lead­ers with di­verse back­grounds from across the in­dus­try,” said Tony Coles, ex­ec­u­tive chair­man of Cerev­el Ther­a­peu­tics. “John, Kathy, and Ken each have a proven track record in their re­spec­tive ar­eas of ex­per­tise and will be in­stru­men­tal in ac­cel­er­at­ing our pur­suit of lead­ing-edge so­lu­tions that can mean­ing­ful­ly im­pact pa­tients’ lives.”

Ken DiP­i­etro Cerev­el

MiMedx — a com­pa­ny spe­cial­ized in wound care — has adopt­ed a com­pre­hen­sive plan — de­vel­oped by the com­pa­ny’s largest share­hold­ers, Pre­science Point Cap­i­tal Man­age­ment — to re­fresh the com­po­si­tion of its board of di­rec­tors. This comes af­ter the com­ple­tion of the com­pa­ny’s au­dit com­mit­tee’s in­de­pen­dent in­ves­ti­ga­tion in­to al­leged wrong­do­ing by the pri­or se­nior man­age­ment team and en­gage­ment of BDO USA as the com­pa­ny’s new in­de­pen­dent reg­is­tered pub­lic ac­count­ing firm.

“It is time to be­gin the Board tran­si­tion and re­fresh­ment process. […] With the Au­dit Com­mit­tee’s in­ves­ti­ga­tion com­plete and a plan to re­fresh the Board in place, the Com­pa­ny is now in a po­si­tion to fo­cus on its fu­ture and en­hance its busi­ness, for the ben­e­fit of all stake­hold­ers,” said Charles Evans, chair­man of the board.

M. Kath­leen Behrens Wilsey Linkedin

The com­pa­ny says that un­der the plan, “six new di­rec­tors, in­clud­ing MiMedx’s new CEO, Tim­o­thy Wright, would be added to the board. The re­fresh­ment plan in­cludes the ap­point­ment of three of Pre­science Point’s nom­i­nees, in­clud­ing M. Kath­leen Behrens Wilsey, as the new chair­woman of the board, as well as K. Todd New­ton, who is ex­pect­ed to be­come the chair­man of the au­dit com­mit­tee af­ter the com­pa­ny’s 2019 an­nu­al meet­ing of share­hold­ers. Oth­er ap­point­ments/nom­i­na­tions for elec­tion to the board in­clude Richard Bar­ry and James Bier­man.


An ear­li­er ver­sion of the sto­ry did not in­clude ap­point­ments at Black Di­a­mond Ther­a­peu­tics

Vas Narasimhan. Getty Images

Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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Photo credit: Jacquelyn Martin

Where are the in­ter­change­able biosim­i­lars?

In June 2017, Leah Christl, former biosimilar lead at FDA, told a conference in Chicago that interchangeable biosimilars were likely coming to the US market within two years.

And although no interchangeable biosimilar has been approved by FDA yet, and Christl has since moved on to Amgen, progress on interchangeable biosimilars has been slow in the intervening years.

Most recently, Boehringer Ingelheim announced that it has completed, as of last April, a switching study necessary for launching an interchangeable biosimilar for Humira (adalimumab), although the company did not offer any further details on the timing of its submission to FDA or whether there will be an advisory committee to review the data. Boehringer already has an adalimumab biosimilar approved by FDA, which it will launch in the US on 1 July 2023.

FDA re­buffs lit­tle As­ser­tio Ther­a­peu­tic­s' long-act­ing ACTH for­mu­la­tion, shares sink

Tiny Assertio Therapeutics’ shares plunged pre-market on Tuesday, after the FDA has spurned its man-made version of the hormone ACTH, which was being reviewed as a diagnostic for patients presumed to have adrenocortical insufficiency.

The Lake Forest, Illinois-based drugmaker said its development partner West Therapeutic Development had received a complete response letter from the US regulator, which indicated that that certain “pharmacodynamic parameters were not adequately achieved” for the product.

UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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That $335M JV Bay­er set up on CRISPR/Cas9? They’re let­ting the biotech part­ner car­ry on

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J's block­buster Ste­lara wins US ap­proval for ul­cer­a­tive col­i­tis

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.

Drug com­pa­nies reach $260M set­tle­ment just ahead of opi­oid tri­al; Oys­ter Point set terms for $85M IPO

→ Hours before the first federal opioid trial was set to begin, three drug distributors and an opioid manufacturer agreed to a $260 million agreement settlement, the Wall Street Journal was the first to report. The deal — which will see McKesson, Cardinal Health and AmerisourceBergen pay $215 million to Summit and Cuyahoga counties, and Teva deal out $35 million in cash and addiction treatments — does not resolve the pending, nationwide litigation that may result in a settlement worth upwards of $40 billion. Negotiators in that case, brought by 2,300 tribes, counties and cities nationwide and led by several states’ attorneys general, worked through much of Friday without success. Josh Stein, the attorney general for North Carolina, said they were trying to put together a $48 billion deal.