Sunao Man­abe takes top job at Dai­ichi Sankyo in wake of As­traZeneca deal; CAR-T play­er Celyad pro­motes Fil­ip­po Pet­ti to CEO

Sunao Man­abe

→ Bare­ly a day af­ter Dai­ichi Sankyo wrapped a mam­moth col­lab­o­ra­tion deal with As­traZeneca, the Japan­ese phar­ma an­nounced a suc­ces­sion plan for its CEO. George Nakaya­ma, who’s keep­ing his chair­man seat, is pass­ing the reins to Sunao Man­abe, cur­rent­ly pres­i­dent and COO. This marks one of the fi­nal tran­si­tions as Nakaya­ma winds down his decades-long ca­reer run with the com­pa­ny, start­ing at Dai­ichi sub­sidiary Sun­to­ry in 1979. He del­e­gat­ed the pres­i­dent role two years ago.

Celyad, the Bel­gian biotech now mak­ing a low-pro­file run for off-the-shelf CAR-T suc­cess along­side more promi­nent peers like Cel­lec­tis, Servi­er and Al­lo­gene, has pro­mot­ed CFO Fil­ip­po Pet­ti to CEO. He re­places Chris­t­ian Hom­sy, who’s step­ping aside to a non-ex­ec­u­tive, sup­port­ing role af­ter lead­ing the com­pa­ny through a tran­si­tion from stem cell ther­a­py for the heart to im­muno-on­col­o­gy dur­ing his 12-year tenure.

→ Palm Beach Gar­dens, Flori­da-based Xcov­ery has tapped two Big Phar­ma vets for top posts at its on­col­o­gy op­er­a­tion. Li Mao, a long time aca­d­e­m­ic, is tak­ing the helm af­ter a stint as head of the John­son & John­son Chi­na Lung Can­cer Cen­ter. Gio­van­ni Sel­vag­gi, who’s served roles at Glax­o­SmithK­line, No­var­tis and Bris­tol-My­ers Squibb in the past nine years, joins as CMO. To­geth­er, they will steer de­vel­op­ment of en­sar­tinib and vorolanib, Phase III and Phase I/II drugs for ALK-pos­i­tive non-small cell lung can­cer and tho­racic can­cer, re­spec­tive­ly — both in­di­ca­tions that Sel­vag­gi be­came fa­mil­iar with over the course of both his med­ical and in­dus­try ca­reers.

Willem Scheele

→ As Imara gets up to full speed with its mid-stage pro­gram for sick­le cell dis­ease, the biotech has wooed Pfiz­er’s rare dis­ease head to be its per­ma­nent CMO. Hav­ing scored a $63 mil­lion round co-led by Ar­ix and Or­biMed just days ago, the Cam­bridge, MA-based biotech is an­tic­i­pat­ing some da­ta on its ex­per­i­men­tal med IMR-687, a phos­pho­di­esterase-9 in­hibitor, by June. Scheele re­places Shi Yin Foo, an ex­ec of the or­phan drug ac­cel­er­a­tor Cy­dan who was help­ing out on an in­ter­im ba­sis.

Rekha Hem­ra­jani is join­ing Ar­cus Bio­sciences $RCUS as chief op­er­at­ing and fi­nan­cial of­fi­cer, a role that com­bines her ex­pe­ri­ence at FLX Bio and 3-V Bio­sciences. The biotech, led by Ter­ry Rosen’s crew at Flexus, is busy eval­u­at­ing sev­er­al Phase I read­outs for its slate of can­cer drugs: AB928, a dual A2a/A2b re­cep­tor an­tag­o­nist; AB154, an an­ti-TIG­IT an­ti­body, and AB680, a small-mol­e­cule CD73 in­hibitor.

Shree­r­am Arad­hye has fol­lowed his old col­league Bill Hin­shaw out No­var­tis’ doors and in­to Ax­cel­la’s C-suite. As EVP and chief de­vel­op­ment of­fi­cer, Arad­hye will steer the Flag­ship-found­ed biotech’s non-IND clin­i­cal stud­ies fo­cused on re­pro­gram­ming me­tab­o­lism with en­doge­nous meta­bol­ic mod­u­la­tors. Karen Lewis, Bio­gen’s for­mer head of hu­man re­sources, has al­so come on board in a sim­i­lar role.

→ Af­ter work­ing with Abing­worth on a num­ber of co-in­vest­ments (in­clud­ing Wil­son Ther­a­peu­tics and Val­ne­va) as a se­nior part­ner at MVM Part­ners, Bali Mu­ralid­har is join­ing Tim Haines’ promi­nent biotech fund. He will be­come part of a glob­al team spread be­tween Lon­don, Boston and Men­lo Park that iden­ti­fies new in­vest­ment op­por­tu­ni­ties and sup­ports star­tups in the ex­ist­ing port­fo­lio.

Turn­ing Point Ther­a­peu­tics has hired ex­pe­ri­enced health­care com­mu­ni­ca­tor Jim Maz­zo­la to lead cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions as it preps its lead ki­nase in­hibitor for a Phase II tri­al in the sec­ond half of the year.

→ In Abzena’s lat­est ef­fort to beef up its man­age­ment team, the bi­o­log­ics con­tract re­search or­ga­ni­za­tion is ap­point­ing Camp­bell Bunce and Bo Adair to the new po­si­tions of CSO and SVP process and op­er­a­tions. Bunce will keep his oth­er role as the head of Abzena’s Cam­bridge, UK, which he’s filled since 2015. Adair, on the oth­er hand, comes from a reg­u­lar con­sult­ing gig fol­low­ing a re­cent job at Ap­tu­it.

Wind­MIL Ther­a­peu­tics has tapped San­jin Zvonić, a sea­soned ex­ec who most re­cent­ly led Prog­en­i­tor Cell Ther­a­py’s in­te­gra­tion in­to Hi­tachi, to lead its process­es and man­u­fac­tur­ing.   

“At Wind­MIL, we’re al­ways look­ing to the fu­ture of can­cer im­munother­a­py, so San­jin’s abil­i­ty to bridge re­search and man­u­fac­tur­ing makes him an ide­al fit for us as we de­liv­er both the cur­rent gen­er­a­tion of MILs and look to­ward de­vel­op­ing the next gen­er­a­tion,” in­ter­im CEO Don Hay­den said, re­fer­ring to the Bal­ti­more biotech’s mar­row-in­fil­trat­ing lym­pho­cytes tech­nol­o­gy.

→ On the heels of a sec­ond glau­co­ma drug ap­proval, Aerie Phar­ma­ceu­ti­cals $AERI has  re­cruit­ed An­gela Jus­tice (for­mer­ly of Sun Phar­ma) as west­ern re­gion­al di­rec­tor, med­ical sci­ence li­ai­son, and Bri­an Saku­ra­da (for­mer­ly of Intar­cia Ther­a­peu­tics) as di­rec­tor of sci­en­tif­ic mar­ket ac­cess. Con­cur­rent­ly, No­var­tis alum David El­lis is join­ing as di­rec­tor of chem­istry while  Karis­ma Shar­ma has been named VP, hu­man re­sources.

→ Af­ter try­ing out re­search and ear­ly de­vel­op­ment at Roche and No­var­tis, Shao­lian Zhou has re­turned to the CRO world. He is now the SVP and lab di­rec­tor for bio­an­a­lyt­i­cal ser­vices at World­wide Clin­i­cal Tri­als, re­spon­si­ble for the over­all op­er­a­tions of the lab fa­cil­i­ty in Austin.

→ As In­tra-Cel­lu­lar Ther­a­pies plots a turn­around and quick launch for its schiz­o­phre­nia drug lu­mate­per­one, it has ap­point­ed Bris­tol-My­ers Squibb vet John Bar­di to spear­head mar­ket ac­cess, pol­i­cy and gov­ern­ment af­fairs. Bar­di jumps to the New York-based biotech $IT­CI from Ot­su­ka, where he played a sim­i­lar role in bring­ing the an­tipsy­chot­ic Abil­i­fy to mar­ket.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.