Zosano Phar­ma CEO pass­es ba­ton down to suc­ces­sor; James Sapirstein takes the helm at Azur­Rx

→ Two years af­ter Zosano Phar­ma re­port­ed pos­i­tive Phase III da­ta for its mi­cronee­dle patch sys­tem for de­liv­er­ing an old mi­graine drug — set­ting up a cam­paign to file an NDA — the com­pa­ny has brought on Steven Lo to the helm as pres­i­dent and CEO. Lo will be suc­ceed­ing John Walk­er, who is re­tir­ing af­ter 48 years in the health­care in­dus­try. Walk­er will re­main as the chair­man of the board of di­rec­tors. Lo most re­cent­ly served as the CCO at Puma Biotech­nol­o­gy, where he helped with the launch of the com­pa­ny’s first prod­uct, Ner­l­ynx — whose Q1 sales fell un­com­fort­ably short of Wall Street es­ti­mates. In ad­di­tion, Lo was the CCO of Cor­cept Ther­a­peu­tics, where he led the es­tab­lish­ment of their first prod­uct, Ko­r­lym, a treat­ment for Cush­ing’s syn­drome. Ear­li­er in his ca­reer, Lo held stints at Genen­tech and As­traZeneca. Lo’s ap­point­ment comes a few weeks af­ter the com­pa­ny wel­comed Dushyant Pathak as SVP of busi­ness de­vel­op­ment. 

James Sapirstein Busi­ness Wire

→ Gas­troin­testi­nal dis­ease-fo­cused Azur­Rx Bio­Phar­ma has a new face run­ning the com­pa­ny af­ter CEO Thi­js Spoor an­nounced his res­ig­na­tion. James Sapirstein is join­ing the com­pa­ny as the new CEO af­ter a stint in the same po­si­tion at Con­traVir Phar­ma­ceu­ti­cals (now He­p­i­on Phar­ma­ceu­ti­cals). Sapirstein has par­tic­i­pat­ed in 23 prod­uct launch­es and he’ll bring this ex­pe­ri­ence to help with the com­pa­ny’s lead prod­uct can­di­date, MS1819-SD — a re­com­bi­nant li­pase for ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy. Pri­or to Con­traVir, Sapirstein served as the CEO of Alli­qua Ther­a­peu­tics, the found­ing CEO of To­bi­ra Ther­a­peu­tics and as EVP, meta­bol­ic en­docrinol­o­gy at Serono Lab­o­ra­to­ries. His oth­er stints in­clude roles at Gilead Sci­ences and Bris­tol-My­ers Squibb. Spoor will re­main on the com­pa­ny’s board of di­rec­tors. 

CRO Pharm-Olam has tapped Robert Davie to suc­ceed David Grange — who has been with the com­pa­ny since April 2017 — as CEO. Grange will re­main a di­rec­tor and vice chair­man of the com­pa­ny’s board of di­rec­tors. Davie brings ex­pe­ri­ence from his time as vice pres­i­dent and gen­er­al man­ag­er, glob­al clin­i­cal de­vel­op­ment at Co­v­ance, where he man­aged the over­sight of clin­i­cal op­er­a­tions in 60 coun­tries with more than 6,000 em­ploy­ees un­der his guid­ance. Pri­or to his time at Co­v­ance, Davie served at Proc­ter & Gam­ble in OTC Health­care. Be­fore jump­ing in­to biotech, Davie fo­cused on the study of GI phys­i­ol­o­gy, in­clud­ing met­al ion trans­port and the trans­port of bile acids in pa­tients with in­flam­ma­to­ry bow­el dis­ease. 

→ At the same time that it pre­sent­ed new da­ta for two of its clin­i­cal stud­ies, Pre­ci­sion Di­a­betes has tapped Er­ic But­ton to the helm as CEO. But­ton is the cur­rent pres­i­dent of Neo­Mark Ven­tures and has pre­vi­ous­ly served as head of di­ag­nos­tics at Metabolon. Some of his oth­er stints in­clude SVP of new prod­uct strat­e­gy at True Health Di­ag­nos­tics and as pres­i­dent and founder of both Gly­co­Mark and Am­plis­tar.

→ Can­cer test­ing start­up Grail — which had a top ex­ec change up, when then CEO Jen­nifer Cook stepped down for fam­i­ly health rea­sons and left the com­pa­ny in the hands of Hans Bish­ophas named Matthew Young as COO and CFO. Young joins the com­pa­ny from Jazz Phar­ma­ceu­ti­cals, where he served as EVP and CFO. Pri­or to his time at Jazz, Young hed po­si­tions at Bar­clays Cap­i­tal, Cit­i­group Glob­al Mar­kets and Lehman Broth­ers

AEON Bio­phar­ma — a com­pa­ny fo­cused on the ther­a­peu­tic tox­in mar­ket — has re­cruit­ed Chris Carr as CFO and Scott Akamine as gen­er­al coun­sel. Carr most re­cent­ly served as CFO, EVP of fi­nance and IT and board mem­ber of Den­dreon Phar­ma­ceu­ti­cals. Pri­or to that, he held stints at Ab­bott Lab­o­ra­to­ries, PerkinElmer and Gen­zyme. Akamine jumps over af­ter a stint as vice pres­i­dent and as­so­ciate gen­er­al coun­sel at Core­L­og­ic. Be­fore that, Akamine worked at In­ci­pio, Al­ler­gan and the law firm Lath­am & Watkins

→ Oph­thalmic phar­ma­ceu­ti­cal com­pa­ny Aerie Phar­ma­ceu­ti­cals — fo­cused on the treat­ment of pa­tients with open-an­gle glau­co­ma and oth­er reti­nal dis­eases — has brought a new face aboard with the ap­point­ment of Char­lene Davis as vice pres­i­dent and chief com­pli­ance of­fi­cer. Davis makes the jump af­ter a stint at Sun Phar­ma­ceu­ti­cal In­dus­tries

Amer­i­can BriV­i­sion — fo­cused on the de­vel­op­ment of ther­a­pies in on­col­o­gy/hema­tol­ogy, CNS and oph­thal­mol­o­gy — has wel­comed Chih­liang “Andy” An as CFO. An joins from a stint as man­ag­ing di­rec­tor of the in­vest­ment team at Yinyai In­vest­ment in Hong Kong. Pri­or to his time at Yinyai, An served as a se­nior di­rec­tor of sales and op­er­a­tions at Go­ertek and as a con­sul­tant and di­rec­tor of fi­nance at BioKey. In ad­di­tion, he’s al­so held stint at Flex­tron­ics, Chardan Cap­i­tal and Op­to­plex

An­ish Suri Cue

Cue Bio­phar­ma — work­ing on in­jectable bi­o­log­ics to se­lec­tive­ly en­gage and mod­u­late tar­get­ed T cells with­in the body — has named An­ish Suri pres­i­dent in ad­di­tion to his cur­rent role as CSO of the com­pa­ny. Pri­or to join­ing the com­pa­ny in Ju­ly 2018, Suri held stints at Janssen Phar­ma­ceu­ti­cal, Bris­tol-My­ers Squibb and was as­sis­tant pro­fes­sor of pathol­o­gy and im­munol­o­gy at Wash­ing­ton Uni­ver­si­ty School of Med­i­cine. In ad­di­tion to Suri’s ap­point­ment, the com­pa­ny plans to bring in a num­ber of new hires through 2020 in light of the re­cent clear­ance of the com­pa­ny’s lead drug can­di­date, CUE-101, in­to clin­i­cal de­vel­op­ment.

An­gela Jus­tice TCR²

→ Can­cer-fo­cused TCR² Ther­a­peu­tics has wel­comed An­gela Jus­tice to the com­pa­ny as chief peo­ple of­fi­cer. Jus­tice hails from Surgery Part­ners, where she served as EVP and chief hu­man re­sources of­fi­cer. Pri­or to that, she served as se­nior di­rec­tor of glob­al med­ical af­fairs, as well as the chief learn­ing of­fi­cer at Bio­gen, where she cre­at­ed and led a cen­tral­ized learn­ing or­ga­ni­za­tion sup­port­ing 14,000 peo­ple across all de­part­ments and ge­o­gra­phies. Her oth­er stints in­clude roles at EMD Serono, the Na­tion­al MS So­ci­ety and as a man­age­ment con­sul­tant at McK­in­sey & Com­pa­ny.

Tan­isha Co­ri­na

→ Af­ter an­a­lysts were blind­sided last month with the sur­prise ex­it of Alex­ion‘s CFO, Paul Clan­cy — who was be­ing re­placed by Arad­hana Sarin as strat­e­gy and busi­ness chief — the com­pa­ny has brought on Tan­isha Cari­no as EVP and chief cor­po­rate af­fairs of­fi­cer. In ad­di­tion, she will serve on the com­pa­ny’s ex­ec­u­tive com­mit­tee. Pri­or to jump­ing on board Alex­ion, Cari­no served as the ex­ec­u­tive di­rec­tor of Faster­Cures, a cen­ter of the Milken In­sti­tute. Be­fore that, she served in roles at GSK and Avalere Health.

→ Toron­to-based Cycli­ca — of­fer­ing a drug dis­cov­ery plat­form fo­cused on polyphar­ma­col­o­gy — has an­nounced the ap­point­ment of Vern De Bi­asi as VP, glob­al head of strate­gic part­ner­ships. Pri­or to jump­ing aboard Cycli­ca, De Bi­asi held var­i­ous roles at GSK, in­clud­ing head of emerg­ing plat­forms, head of dig­i­tal da­ta and an­a­lyt­ics and head of plat­form tech­nol­o­gy and sci­ence at GSK R&D, Asia in Shang­hai. 

→ Lon­don-based cell ther­a­py play­er Au­to­lus Ther­a­peu­tics has made changes to its lead­er­ship team. The com­pa­ny an­nounced that Jim Faulkn­er, SVP, head of prod­uct de­liv­ery, and Neil Bell, SVP, head of clin­i­cal op­er­a­tions, will be hit­ting the ex­it. The two will be suc­ceed­ed by David Brochu and Vishal Mehta, re­spec­tive­ly. Brochu pre­vi­ous­ly held the po­si­tion of vice pres­i­dent of tech­ni­cal op­er­a­tions at Au­to­lus and pri­or to join­ing the com­pa­ny held po­si­tions at Kedri­on, Tale­cris Bio­Ther­a­peu­tics (for­mer­ly Bay­er Health­care) and Bay­er. Mehta joined Au­to­lus at the be­gin­ning of the year from Cel­gene, where he led the plan­ning and ex­e­cu­tion of mul­ti­ple clin­i­cal stud­ies for CAR T prod­ucts in B cell ma­lig­nan­cies and mul­ti­ple myelo­ma. Pri­or to Cel­gene, Mehta had stints at No­var­tis and ICON.

→ The med­ical der­ma­tol­ogy com­pa­ny Ver­ri­ca Phar­ma­ceu­ti­cals has ap­point­ed Eu­gene Scav­ola as EVP, tech­ni­cal op­er­a­tions. Most re­cent­ly, Scav­ola was a man­ag­ing part­ner at PBM Cap­i­tal Group. In ad­di­tion, Scav­ola has served in var­i­ous po­si­tions at Wyeth/Pfiz­er.

Karl Brad­shaw Metabolon

Metabolon — fo­cused on, you guessed it, metabolomics — has ap­point­ed Karl Brad­shaw as VP of bio­phar­ma strat­e­gy and part­ner­ing, who joins the com­pa­ny af­ter a stint as se­nior di­rec­tor of cor­po­rate strat­e­gy and de­vel­op­ment at As­traZeneca. Pri­or to his time there, Brad­shaw was vice pres­i­dent of eq­ui­ty and re­search at Mor­gan Stan­ley

Flem­ming Orn­skov

→ A week pri­or to win­ning FDA ap­proval for its top­i­cal retinoid cream, tri­farotene, in the use of ac­ne — dif­ferin mak­er Gal­der­ma made some new ad­di­tions to its ex­ec­u­tive team with the ap­point­ments of Shire vets Flem­ming Orn­skov as CEO and Thomas Dit­trich as CFO. Orn­skov as­sumes the po­si­tion as CEO from Stu­art Raet­z­man, who is mov­ing to a po­si­tion on the com­pa­ny’s board. Dur­ing his time at Shire, Orn­skov helped grow the com­pa­ny from a $4 bil­lion rev­enue busi­ness to $15 bil­lion in five years, be­fore the com­pa­ny was ac­quired by Take­da. Dit­trich held the same po­si­tion of CFO at Shire. In ad­di­tion to the new ex­ecs, the com­pa­ny has wel­comed for­mer CEO of No­var­tis Thomas Ebel­ing as chair­man of its board of di­rec­tors and for­mer CEO of Avon Prod­ucts and for­mer vice chair­man of John­son & John­son, Sheri Mc­Coy as di­rec­tor of the com­pa­ny. 

→  In the storm of rapid ex­its of its top ex­ecs, Gilead’s CEO Daniel O’Day has brought on Genen­tech SVP of ear­ly clin­i­cal de­vel­op­ment, Mer­dad Parsey, on board as the com­pa­ny’s CMO. Parsey made his way to Genen­tech af­ter a de­tour as CEO of NASH drug de­vel­op­er 3V Bio­sciences (now known as Sagimet) for five years. Gilead has seen a clean sweep of its top ranks since CEO John Mil­li­gan stepped out along­side chair­man John Mar­tin, and not long af­ter oth­ers fol­lowed suit — CSO John McHutchi­son left for a new po­si­tion of CEO at As­sem­bly Bio­sciences, CMO An­drew Cheng left for the helm at Akero and re­search chief Nor­bert Bischof­berg­er left to run his own start­up

Han­dan He

→ Hong Kong-list­ed, Hangzhou-based As­cle­tis has wooed an­oth­er top phar­ma ex­ec from the US to Chi­na as it gets ready to show that its R&D team has what it takes to come up with some first-in-class drugs. In tak­ing up the CSO role Han­dan He is leav­ing be­hind a 22-year stint at No­var­tis, where her last ti­tle was glob­al head of com­pu­ta­tion­al, bio­phar­ma­ceu­tics and trans­la­tion­al PK/PD. Her ar­rival marks an­oth­er big get for CEO Jinzi Wu, who ear­li­er this year re­cruit­ed Mer­ck’s top drug de­vel­op­er in Chi­na as As­cle­tis’ CMO. But health and fam­i­ly con­cerns cut Zhengqing Li’s tenure short, forc­ing him to de­part af­ter on­ly five months. Days ago CFO Lin­di Tan al­so hand­ed in her pa­pers. As­cle­tis is known do­mes­ti­cal­ly for de­vel­op­ing and com­mer­cial­iz­ing Chi­na’s first home-cul­ti­vat­ed he­pati­tis C drug — with some help from Roche — but has made a point to be­come a glob­al play­er, not just in the an­tivi­ral space but al­so can­cer and liv­er dis­eases.

→ As Bio­Marin shoots for the first-ever ap­proval of a he­mo­phil­ia gene ther­a­py — and the multi­bil­lion-dol­lar rev­enue ex­pect­ed to fol­low — the com­pa­ny is pro­mot­ing CSO Lon Car­don to a po­si­tion where he can help sketch the next ren­di­tion of its rare dis­ease port­fo­lio. In the new­ly cre­at­ed role of chief sci­en­tif­ic strate­gic of­fi­cer, Car­don will look be­yond the re­search work that he’s been lead­ing for the past two years to “lead cross func­tion­al ac­tiv­i­ties to build our lead­er­ship po­si­tion in pre­ci­sion med­i­cine,” ac­cord­ing to Bio­Marin. Car­don held a 9-year tenure at GSK where he was the SVP of al­ter­na­tive dis­cov­ery and de­vel­op­ment — lin­ing up a $495 mil­lion al­liance with Aval­on Ven­tures to bankroll some star­tups and buy them out if the sci­ence stands up to due dili­gence.  

Bolt Bio­ther­a­peu­ticswho wel­comed their new CEO Randy Schatz­man last month — has made three ad­di­tions to its sci­en­tif­ic board of di­rec­tors: UCSF pro­fes­sor Lawrence Fong, as­so­ciate di­rec­tor of Yale Can­cer Cen­ter Roy Herb­st and Lip­i­tor in­ven­tor Bruce Roth

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly 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: 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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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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David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

The researcher behind base-editing is out with what some scientists are hailing as the biggest advancement in CRISPR technology since that 2016 breakthrough: “prime editing.” The new molecular gadget is capable of erasing any base pair and stenciling in another and cutting or adding long segments of DNA without breaking both strands of the helix.

David Liu, base editing pioneer and founder of Beam Therapeutics, published the findings in Nature alongside Andrew Anzalone. They estimated that the breakthrough “in principle” puts 89% of human diseases in purview — although experts cautioned that human therapies were a long way off.

Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experiences. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

UP­DAT­ED: Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.