Big Phar­ma vet John Hohnek­er takes the reins at Anokion; Hep­tares co-founder Fiona Mar­shall re­signs from par­ent com­pa­ny So­sei

John Hohnek­er

→ Hav­ing worked in a slate of se­nior po­si­tions in phar­ma and biotech, John Hohnek­er is now tak­ing the reins of Anokion as pres­i­dent and CEO. Most re­cent­ly he was pres­i­dent of R&D at For­ma Ther­a­peu­tics, where he guid­ed the com­pa­ny from dis­cov­ery stage to clin­i­cal tri­als. In Hohnek­er, the Lau­sanne, Switzer­land-head­quar­tered biotech gets an ex­pe­ri­enced ex­ec who’s spent a com­bined 20 years at GSK and No­var­tis. He’s been in­volved with the de­vel­op­ment, ap­proval and com­mer­cial­iza­tion of such drugs as Cosen­tyx, Gleevec, and Afin­i­tor. His fo­cus will be on de­vel­op­ing the biotech’s im­mune tol­er­ance plat­form for au­toim­mune dis­ease, which has at­tract­ed Cel­gene to ink a col­lab­o­ra­tion deal with an op­tion to buy.

→ Rid­ing on the ex­cite­ment of the ear­ly OK for Rho­pres­sa, Aerie Phar­ma­ceu­ti­cals $AERI has made two new hires to help lead reg­u­la­to­ry and sales ef­forts. Nils Haupt­mann will be­come di­rec­tor of reg­u­la­to­ry af­fairs and phar­ma­covig­i­lance, sup­port­ing — as he did at Avanir, Fi­bro­Gen and Spec­trum Phar­ma — the prepa­ra­tion of clin­i­cal doc­u­ments. He will al­so pro­vide over­sight of post-mar­ket­ing pro­mo­tion­al ac­tiv­i­ties. Mean­while, Al­ler­gan vet Tim Swan will man­age the teams that in­ter­act with health­care providers and or­ga­ni­za­tions as di­rec­tor of sales and trans­paren­cy op­er­a­tions. Bring­ing more hands on deck is a nat­ur­al next step for the oph­thalmic com­pa­ny, as it plans to launch its first drug and file an NDA for its sec­ond by Q2.

Hep­tares co-founder Fiona Mar­shall has re­signed from her po­si­tion as EVP and CSO at So­sei to as­sume a role out­side the com­pa­ny. She is set to de­part in Feb­ru­ary, al­most ex­act­ly three years af­ter So­sei ac­quired the G pro­tein-cou­pled re­cep­tors tar­get­ing biotech that she helped cre­ate. Mal­colm Weir, Hep­tares co-founder and CEO and So­sei’s EVP and chief R&D of­fi­cer, will con­tin­ue to lead these ac­tiv­i­ties. Sup­port­ing him in man­ag­ing the Japan­ese/UK bio­phar­ma’s pipeline will be Tim Tasker, who has been pro­mot­ed to EVP and CMO.

→ Af­ter a stint ad­vis­ing bio­phar­ma com­pa­nies, Robert Lutz is div­ing back in­to a biotech role of his own as the new CSO of Glythera, a next-gen an­ti­body drug con­ju­gate de­vel­op­er based in News­cas­tle, Eng­land. Be­fore be­com­ing a con­sul­tant, Lutz spent over 20 years at Im­muno­Gen, where he helped ad­vance sev­er­al ADC can­di­dates — in­clud­ing Kad­cy­la — and was most re­cent­ly VP of trans­la­tion­al re­search and de­vel­op­ment. In its quest to de­vel­op new tar­get­ed treat­ments for hard-to-treat tu­mors, Glythera has al­so re­cruit­ed med­i­c­i­nal chemist Jon Rof­fey to its sci­en­tif­ic ad­vi­so­ry board from Can­cer Re­search UK’s com­mer­cial part­ner­ships team.

Phy­ton Biotech, a con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion most known for mak­ing Pa­cli­tax­el and Do­c­etax­el, has pro­mot­ed Col­in Marr as its new pres­i­dent. Marr has worked in the Van­cou­ver of­fice for a cou­ple years as VP of busi­ness de­vel­op­ment, so his man­date of over­see­ing the com­pa­ny’s Cana­di­an and Ger­man di­vi­sions and de­vis­ing a longterm growth and di­ver­si­fi­ca­tion strat­e­gy won’t be en­tire­ly new to him.

→ As its three pre­clin­i­cal projects ap­proach clin­i­cal de­vel­op­ment, Swe­den’s Al­li­ga­tor Bio­science (Nas­daq Stock­holm: ATORX) has ap­point­ed Anu Bal­en­dran as its VP of busi­ness de­vel­op­ment. Specif­i­cal­ly, Bal­en­dran, who is cur­rent­ly ex­ter­nal in­no­va­tion di­rec­tor at As­traZeneca, will help so­lid­i­fy Al­li­ga­tor’s out-li­cense mod­el by seek­ing part­ner­ships. His ap­point­ment fol­lows those of CMO Char­lotte Rus­sell and VP of dis­cov­ery Pe­ter Ell­mark last month, con­tin­u­ing a pe­ri­od of growth through both deals and in-house clin­i­cal work.

→ Gene con­trol spe­cial­ist Syn­promics has brought in Sarah Haeck­er Meeks as VP of busi­ness de­vel­op­ment, in charge of po­si­tion­ing and find­ing part­ners for its plat­form tech­nol­o­gy, which har­ness­es syn­thet­ic pro­mot­ers to reg­u­late gene ex­pres­sion. In con­junc­tion, the Ed­in­burgh, Scot­land biotech has al­so a sub­sidiary in the US, from where Meeks from lead busi­ness ac­tiv­i­ties cov­er­ing all ter­ri­to­ries.

Aslan Phar­ma­ceu­ti­cals, a Sin­ga­pore­an can­cer fight­er with dual am­bi­tions in Asia and US/Eu­rope, has tapped Boehringer In­gel­heim vet Stephen Doyle to be head of Chi­na. As Aslan ex­plores po­ten­tial mar­kets for its lead as­set var­l­i­tinib, li­censed from Ar­ray Bio­phar­ma — which it has been de­vel­op­ing for a while but on­ly re­cent­ly got com­mer­cial­iza­tion rights to — Chi­na has be­come an im­por­tant tar­get. It has al­so ac­cel­er­at­ed its de­vel­op­ment time­line there. Be­tween Boehringer and Sanofi, Doyle has led both reg­u­la­to­ry and mar­ket­ing/sales sides of things. In his new role, he will have broad re­spon­si­bil­i­ty with op­er­a­tions and pipeline de­vel­op­ment.

→ Af­ter a decade in the CFO seat at im­munother­a­py com­pa­ny Gen­ti­cel (now Genky­otex), Eli Lil­ly vet Mar­tin Koch is switch­ing it up by tak­ing the role of COO at In­otrem. Dur­ing that time, Koch played roles in Gen­ti­cel’s fi­nanc­ing, IPO and ul­ti­mate merg­er. In line with his pre­vi­ous ex­pe­ri­ence, Koch will su­per­vise fi­nan­cial ac­tiv­i­ties and ex­e­cute the busi­ness plan at Paris-based In­otrem, which is de­vel­op­ing Motrem, a sep­tic shock drug aimed at mod­u­lat­ing the im­muno­log­i­cal mech­a­nism lead­ing to it.

→ Tai­wan’s JHL Biotech — an up­start de­vel­op­er and man­u­fac­tur­er of bi­o­log­ics — has named Rong Chen its new CMO. Hav­ing worked in the Chi­na of­fices of Sanofi and Glax­o­SmithK­line, Chen joins from Phagelux in Shang­hai, a bi­o­log­ics com­pa­ny where he was al­so CMO.

→ Zurich-based In­ositec has re­cruit­ed Roche vet Frits van Alphen to the com­pa­ny as chief med­ical of­fi­cer. Alphen had head­ed the op­er­a­tional ex­cel­lence team at Roche.

Vi­raTher­a­peu­tics CEO Heinz Schw­er has joined the ad­vi­so­ry board of Ger­many’s am­cure, giv­ing ad­vice to the Karl­sruhe In­sti­tute of Tech­nol­o­gy spin­off as it pre­pares to move its pep­tide-based can­cer ther­a­py through the clin­ic.

Albert Bourla appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

UP­DAT­ED: Pfiz­er CEO Al­bert Bourla is back in the M&A game, but why is he pay­ing $11.4B for Ar­ray?

Pfiz­er $PFE has cut short its time on the side­lines of bio­phar­ma M&A.

Mon­day morn­ing the phar­ma gi­ant un­veiled an $11.4 bil­lion deal to ac­quire Ar­ray Bio­Phar­ma, beef­ing up its on­col­o­gy work and adding a new re­search hub in Boul­der, Col­orado to its glob­al op­er­a­tions.

At $48 a share, Ar­ray $AR­RY in­vestors will be get­ting a 62% pre­mi­um off the Fri­day close of $29.59.

Pfiz­er, which has strug­gled to gain all the up­side promised in past buy­outs like Medi­va­tion, high­light­ed the ac­qui­si­tion of 2 ap­proved drugs in the deal — Braftovi (en­co­rafenib) and Mek­tovi (binime­tinib).

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Gene ther­a­py R&D deals turn red hot as Big Phar­ma steps up to play

This September will mark the 20th anniversary of the death of Jesse Gelsinger, a young man suffering from X-linked genetic disease of the liver. He was killed in a gene therapy study conducted by Penn’s James Wilson, and the entire field endured a lengthy deep freeze as the field grappled with the safety issues inherent in the work.

Some thought gene therapy R&D would never survive. But it did. And this year marked a landmark approval for Zolgensma, a new gene therapy for spinal muscular atrophy Novartis priced at $2.1 million.

“Gene therapy is the hottest item on the block now. But there was a time when we first got into this trial, where there wasn’t a person in the world who believed that gene therapy would work. We have to remember that,” noted gene therapy investigator Jerry Mendell told SMA News Today.

We’re still right on the pioneering frontier when it comes to getting approvals for gene therapies and launching marketing campaigns with the European green light for bluebird's leading program last Friday underscoring the nascent nature of the field. But gene therapy R&D is booming, and has been for several years now.

The rapid growth of gene therapy clinical development is well known, but we decided to put some numbers on it, to quantify what’s going on. DealForma chief Chris Dokomajilar took a lot over the past 10 years, as the number of deals, R&D partnerships and buyouts steadily gained steam, spiking last year and on track to maintain the surge in 2019.

The upfronts and totals for the dollars on deals so far in 2019 is already close to the 2018 mark, underscoring a new phase of negotiations as the major players step up to gain a piece of the late-stage and commercial action.

Once again, we’re looking at an “overnight” biotech success story, decades in the making.

At some point, that may start to brake the numbers we’re seeing. But for now, as rivals line up to compete for frontline prominence across a range of diseases, the arrows are all pointed north.

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A uni­corn stalks Wall Street in search of IPO cash; CASI Phar­ma in-li­cens­es CD19 ther­a­py from Chi­na’s Ju­ven­tas

→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

UP­DAT­ED: Sanofi Gen­zyme deserts gene ther­a­py de­vel­op­er Voy­ager Ther­a­peu­tics

While gene ther­a­py com­pa­nies re­joice as the sec­tor gains trac­tion with ap­provals and a flur­ry of M&A ac­tiv­i­ty, one play­er is feel­ing the heat.

Back in 2015, Voy­ager Ther­a­peu­tics joined forces with Sanofi Gen­zyme in a deal worth up to $845 mil­lion ($100 mil­lion up­front + a po­ten­tial $745 mil­lion in mile­stones) to co-de­vel­op gene ther­a­pies for se­vere cen­tral ner­vous sys­tem dis­or­ders. But two years lat­er, the French drug­mak­er re­treat­ed, elect­ing to not pick up the op­tion to work on Voy­ager’s Parkin­son’s dis­ease pro­gram. (Last year, the FDA dis­ap­point­ed Voy­ager, telling the com­pa­ny that it was not open to an ac­cel­er­at­ed fil­ing on the Parkin­son’s drug on the ba­sis of Phase II da­ta — in­stead of re­quir­ing an ad­di­tion­al piv­otal study.)

In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

John Oyler, Founder & CEO of BeiGene, at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube

UP­DAT­ED: As Bris­tol-My­ers/Cel­gene tie up loose ends, BeiGene pock­ets $150M from PD-1 breakup

As soon as Bristol-Myers Squibb announced its $74 billion buyout for Celgene, BeiGene emerged as a prominent example of a player whose pact with the big biotech could sour, as its PD-1 candidate seems to overlap with Opdivo. After six months of suspense, the partners say they are finally bringing the 2-year-old deal to an amicable end.

BeiGene $BGNE gets $150 million for the termination in addition to full global rights to tislelizumab. In 2017 Celgene had paid $263 million in upfront license fees to develop the PD-1 inhibitor for solid cancers in the US, Europe, Japan and the rest of the world outside Asia. It also threw in a $150 million equity investment in exchange for BeiGene handling its commercial operations — think Abraxane, Revlimid and Vidaza — in China.

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Exterior of the 1 million square foot Discovery Labs in Upper Merion, PA (PR Newswire)

Philadel­phia cham­pi­ons life sci­ences 'co-work­ing,' re­viv­ing for­mer GSK cam­pus in $500M makeover

In a boost to Philadel­phia’s thriv­ing life sci­ences scene, a for­mer Glax­o­SmithK­line cam­pus and a near­by site has been turned in­to what its de­vel­op­er calls “the largest cowork­ing ecosys­tem” for health­care com­pa­nies in the coun­try.

The Dis­cov­ery Labs, a com­pa­ny spawned by MLP Ven­tures, has se­lect­ed two lo­ca­tions in the King of Prus­sia area as the $500 mil­lion test case for its strat­e­gy of ac­quir­ing and con­vert­ing old phar­ma­ceu­ti­cal R&D fa­cil­i­ties world­wide. The sites add up to 1.64 mil­lion square feet.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.