Japan­ese bil­lion­aire Mik­i­tani takes full con­trol of Rakuten As­pyr­i­an; HOX Ther­a­peu­tics taps Karl Kee­gan as CEO

→ Hav­ing in­fused $150 mil­lion in­to Rakuten As­pyr­i­an weeks ago, Hi­roshi “Mick­ey” Mik­i­tani is step­ping up his con­trol on the biotech he’s been chair­ing since 2016. The Japan­ese bil­lion­aire, known for build­ing a leg­endary e-tail­er from scratch, is tak­ing over the CEO role so that Miguel Gar­cia-Guz­man can con­tin­ue to build the pho­toim­munother­a­py pipeline as CSO and vice chair­man. As the San Diego-based com­pa­ny turns the cor­ner on a Phase III study, it’s al­so ap­point­ed Takashi Toraishi, who was man­ag­ing its Japan of­fices, as COO to over­see clin­i­cal tri­als and com­mer­cial­iza­tion.

→ With Jack­ie Fouse gone to take the reins of Agios, Der­ma­vant Sci­ences — a der­ma­tol­ogy fo­cused unit of Vivek Ra­maswamy’s Roivant Sci­ences — has hired in­dus­try vet­er­an Todd Za­vod­nick as its CEO, as the com­pa­ny pre­pares to be­gin a late-stage tri­al of its lead ex­per­i­men­tal drug, tap­inarof. Za­vod­nick comes with over two decades of ex­pe­ri­ence, hav­ing worked at ZEL­TIQ Aes­thet­ics be­fore it was ac­quired by Al­ler­gan $AGN as well as Gal­der­ma, among oth­er firms.

→ Can­cer biotech HOX Ther­a­peu­tics has ap­point­ed new CEO Karl Kee­gan to lead its en­try in­to the clin­ic. In a ca­reer span­ning prod­uct de­vel­op­ment at SmithK­line Beecham, in­vest­ment an­a­lyst in Lon­don and CFO/cor­po­rate de­vel­op­ment roles at Pharm­ing, Vec­tura and Shield Ther­a­peu­tics, the com­pa­ny notes, he’s amassed sig­nif­i­cant ex­pe­ri­ence in fi­nanc­ing com­pa­nies, busi­ness de­vel­op­ment and cor­po­rate M&A. He is now ex­pect­ed to bring it all to the ta­ble at Guild­ford, UK-based HOX, which is fo­cused on a type of “con­trol” genes cen­tral to em­bryo­ge­n­e­sis called HOX.

→ Se­r­i­al en­tre­pre­neur Pe­ter Suz­dak is out at Rex­ahn Phar­ma­ceu­ti­cals, pass­ing the pres­i­dent and CEO ba­ton to Dou­glas Swirsky. Swirsky, who joined the can­cer drug de­vel­op­er at the be­gin­ning of the year, will car­ry on be­ing CFO. A for­mer in­vest­ment banker, Swirsky was chief ex­ec­u­tive at Gen­Vec for four years un­til it was sold to In­trex­on.

→ Af­ter a decade with Thomas Van­Cott at the helm, ABL is turn­ing a new leaf by pro­mot­ing chief com­mer­cial of­fi­cer Jar­lath Keat­ing to pres­i­dent and CEO. While Keat­ing is a re­cent hire, he’s a vet­er­an of the con­tract re­search and man­u­fac­tur­ing ser­vice in­dus­try, hav­ing held com­mer­cial roles at Mil­li­pore­Sig­ma and tech­ni­cal roles at Lon­za Bi­o­log­ics. His ap­point­ment, the com­pa­ny says, is a “clear re­flec­tion of ABL’s com­mit­ment to a long-term glob­al ex­pan­sion strat­e­gy.”

→ Four new ex­ecs are com­ing on board Flag­ship-seed­ed Sig­ilon Ther­a­peu­tics’ pur­suit of the Holy Grail in di­a­betes: get­ting stem cells to trans­form in­to in­sulin pro­duc­ing pan­cre­at­ic be­ta cells with­out trig­ger­ing a se­vere im­mune re­ac­tion. Deya Cor­zo has joined as CMO af­ter work­ing up her clin­i­cal tri­al mus­cles at So­journix, uniQure, Cel­gene, Take­da and Sanofi/Gen­zyme; Vi­a­Cyte vet Olivia Kel­ly is named VP of islet cell ther­a­py re­search; Martha Rook is jump­ing from Mil­li­pore­Sig­ma to be­come head of man­u­fac­tur­ing; and Vanya Sagar, for­mer­ly of Bio­gen, will be VP of HR.  

Agenus’ $AGEN in-house mid-stage check­points and can­cer vac­cines may still have a long path to com­mer­cial­iza­tion, but the Lex­ing­ton, MA-based biotech wants to be sure it’s ready for it. Jen­nifer Buell is now chief op­er­at­ing of­fi­cer, a role that com­bines all three po­si­tions she’s held in her five years at the com­pa­ny: She has a broad man­date cov­er­ing re­search, clin­i­cal de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial op­er­a­tions. Al­li­son Jeynes-El­lis, bio­phar­ma vet and Avil­lion CEO, has been ap­point­ed as a board di­rec­tor.  

El­liot Ehrich

Kevin For­rest has brought in a new part­ner from 5AM Ven­tures — where he used to be a prin­ci­pal — to his team at Ex­pan­sion Ther­a­peu­tics. El­liot Ehrich, the new­ly mint­ed CMO, had re­cent­ly joined the ven­ture firm af­ter a 17-year run at Alk­er­mes that cul­mi­nat­ed in the top R&D and med­ical role. His ex­pe­ri­ence in dri­ving drug as­sets from ear­ly re­search through ap­proval will be “in­stru­men­tal” for Ex­pan­sion, CEO For­rest says, which is still in dis­cov­ery stage with its RNA-tar­get­ing small mol­e­cule med­i­cines de­signed to treat a set of ge­net­ic dis­eases called ex­pan­sion re­peat dis­or­ders.

→ As Asha Das makes an abrupt de­par­ture from Toca­gen to tend to “un­fore­seen and im­me­di­ate per­son­al mat­ters,” it’s tapped a board mem­ber to fill in as the act­ing CMO. Lori Kunkel, who has three CMO stints from Loxo On­col­o­gy, Phar­ma­cyclics and Pro­te­olix un­der her belt, will take charge of ad­vanc­ing Toca­gen’s Phase III high grade glioma pro­gram and the rest of its pipeline un­til the San Diego-based biotech finds a per­ma­nent hire.

→ Now that As­cle­tis has some­what stead­ied its po­si­tion on the Hong Kong Stock Ex­change — al­beit not an en­vi­able one, cur­rent­ly trad­ing around half of its de­but price — it’s ready to move on with a new CFO on the team. Lin­di Tan brings 15 years of as a health­care an­a­lyst, with stints at SeaTown Hold­ings and Temasek.  

Mer­ck vet Joel Lebowitz has joined Schrödinger as CFO at a time the com­pu­ta­tion­al drug dis­cov­ery shop is dou­bling down on big bio­phar­ma part­ner­ships, marked by a joint ven­ture with WuXi AppTec launched days ago. Lebowitz, who spent much of his time at the phar­ma gi­ant eval­u­at­ing the port­fo­lio and do­ing pipeline val­u­a­tion, will al­so play a key role in busi­ness de­vel­op­ment.

→ Af­ter a decade at now trou­bled Idera, Louis Ar­cu­di is mov­ing on to his next CFO role. The sea­soned ex­ec will be en­ter­ing Mil­len­do Ther­a­peu­tics with Michael Yeh, an alum­ni of So­bi and Bio­gen who’s just been ap­point­ed VP of med­ical af­fairs.

→ Ox­nard, CA-based CURE Phar­ma has tapped ven­ture cap­i­tal­ist Alex Katz to over­see its fi­nan­cial func­tions as CFO. Katz, a for­mer man­ag­ing part­ner for ff Ven­ture Cap­i­tal and Dif­fer­en­tial Ven­ture Part­ners, has been work­ing with the drug de­liv­ery in­no­va­tor as an ad­vis­er.

→ On the heels of a much an­tic­i­pat­ed up­date that keeps the con­tro­ver­sy burn­ing over NK­TR-214/Op­di­vo, Nek­tar $NK­TR an­nounced it has re­cruit­ed Genen­tech vet Wei Lin to spear­head its on­col­o­gy pro­grams. As SVP of clin­i­cal de­vel­op­ment, Lin will have over­sight not just on NK­TR-214 com­bo tri­als but al­so the rest of the I/O pipeline.

→ We fi­nal­ly know where Lisa Suen­nen is head­ed af­ter a sur­pris­ing ex­it from GE Ven­tures.  Man­att Phelps & Phillips, a lead­ing law and con­sult­ing firm with a health-fo­cused branch, an­nounced Suen­nan will head up its dig­i­tal and tech­nol­o­gy busi­ness­es and as well as the firm’s ven­ture cap­i­tal fund from its San Fran­cis­co of­fice.

De­nali CMO Ca­r­ole Ho has tak­en a board seat at Beam Ther­a­peu­tics, the base edit­ing biotech found­ed by CRISPR trail­blaz­ers Feng Zhang, David Liu and J Kei­th Joung.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.