Chi­na to cut can­cer drug prices; Nim­bus nabs Gilead­'s Adri­an Ray to serve as SVP of dis­cov­ery bi­ol­o­gy

→ Chi­na’s med­ical in­sur­ance au­thor­i­ties are pledg­ing to slash can­cer drug prices, ac­cord­ing to a week­end re­port from the Com­mu­nist par­ty-run Peo­ple’s Dai­ly. Drugs al­ready cov­ered by state in­sur­ance could have their prices cut by 10%, with pos­si­ble re­duc­tions of up to 50% for oth­er med­ica­tions as a con­di­tion of be­ing added to the state in­sur­ance scheme, ac­cord­ing to a Fi­nan­cial Times re­port. Quot­ing un­named sources “fa­mil­iar with the mat­ter,” the FT said sev­er­al multi­na­tion­al phar­ma com­pa­nies have been in­vit­ed to talks with gov­ern­ment of­fi­cials over prices this week. Can­cer drug price cuts could af­fect the rev­enues for com­pa­nies like Eli Lil­ly, Roche, and No­var­tis, which all launched on­col­o­gy prod­ucts in the re­gion.

→ The plant-de­rived bi­o­log­ics ex­perts at Bei­jing’s CC-Pharm­ing and New York’s iBio $IBIO are bring­ing their plat­forms to­geth­er in a joint de­vel­op­ment agree­ment that will, among oth­er things, pro­duce a “bio-bet­ter” of rit­ux­imab — a plant-made an­ti­body they claim will be su­pe­ri­or in per­for­mance and more af­ford­able in price. “Our first prod­uct se­lec­tion is very im­por­tant but is on­ly the be­gin­ning of what I be­lieve CC-Pharm­ing and iBio can do to­geth­er with our com­bined sci­en­tif­ic ap­proach to the busi­ness of bio­phar­ma­ceu­ti­cals,” said CC-Pharm­ing founder and CSO Kevin Wang, re­fer­ring to new prod­ucts that might be added to the ven­ture in the fu­ture. The Chi­nese up­start is pay­ing iBio $4.7 mil­lion for ac­cess to the process de­vel­op­ment and man­u­fac­tur­ing ser­vices at its Texas fa­cil­i­ty. In re­turn, CC-Pharm­ing will man­age op­er­a­tions in Chi­na, where, with the help of iBio, it plans to even­tu­al­ly build up man­u­fac­tur­ing ca­pa­bil­i­ty. Own­er­ship of the Chi­nese busi­ness is split be­tween the two com­pa­nies. “Chi­na’s bi­o­log­ics de­vel­op­ment and man­u­fac­tur­ing in­fra­struc­ture is gross­ly in­ad­e­quate for the mas­sive pop­u­la­tion it must serve,” said Robert Kay, iBio’s chair­man and CEO.

→ Nim­bus, a small start­up in Cam­bridge, Mass­a­chu­setts, has re­cruit­ed Gilead’s se­nior di­rec­tor of clin­i­cal re­search — Adri­an Ray — to serve as the com­pa­ny’s se­nior vice pres­i­dent of dis­cov­ery bi­ol­o­gy. You might re­mem­ber Nim­bus for the mas­sive NASH deal it inked with Gilead a cou­ple years back — earn­ing a re­mark­able $400 mil­lion up­front. Now, it’s snag­ging Ray, who’s worked at Gilead for the past 15 years, to help lead its own R&D. “Adri­an is an out­stand­ing ad­di­tion to our al­ready world-class team, who will strength­en our ca­pa­bil­i­ties in dis­cov­ery sci­ence root­ed in cut­ting-edge bi­ol­o­gy and hu­man ge­net­ics,” said Don Nichol­son, CEO at Nim­bus, in a state­ment. “Adri­an is a ca­pa­ble leader in tar­get dis­cov­ery through­out the meta­bol­ic-on­col­o­gy-im­munol­o­gy tar­get space, and in the trans­la­tion of these dis­cov­er­ies in­to ef­fec­tive clin­i­cal de­vel­op­ment strate­gies. We’re thrilled to have him.”

→ San Diego’s Mab­Vax $MB­VX has inked a deal with Boehringer In­gel­heim, sell­ing one of its pre­clin­i­cal-stage can­cer drug pro­grams for an up­front pay­ment of $11 mil­lion plus down­stream mile­stone pay­ments. The pro­gram tar­gets a gly­can com­mon­ly over­ex­pressed on mul­ti­ple sol­id tu­mor can­cers. Mab­Vax says it dis­cov­ered the an­ti­body se­ries from bi­o­log­i­cal sam­ples from pa­tients vac­ci­nat­ed against their sol­id tu­mors with a gly­can anti­gen-con­tain­ing vac­cine. “The dis­cov­ery of ful­ly hu­man an­ti­bod­ies di­rect­ly from vac­ci­nat­ed can­cer pa­tients has po­ten­tial ad­van­tages which in­clude greater speci­fici­ty and re­duced tox­i­c­i­ties,” Mab­Vax stat­ed. Boehringer In­gel­heim has ac­quired all rights in and to the pro­gram. Mab­Vax’s stock, which had fall­en in­to the pen­ny ter­ri­to­ry, spiked 234% on the news. That brings the com­pa­ny’s share price to $1.92.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Maze in­ter­im chief Charles Hom­cy pass­es ba­ton to Ja­son Colo­ma; William Col­lier tapped as CEO of Ar­bu­tus

→ Four months in­to Maze Ther­a­peu­tics’ launch, Charles Hom­cy is pass­ing the start­up’s reins to an­oth­er Third Rock col­league. Ja­son Colo­ma, the cur­rent COO, is leav­ing his role at the VC firm to be­come full-time CEO on a mis­sion to trans­late ge­net­ic in­sights in­to new med­i­cines. Equipped with a whop­ping $191 mil­lion with sup­port from Arch, Maze’s big idea is to find and tar­get ge­net­ic mod­i­fiers that play a role in Mendelian dis­eases caused by an­oth­er gene. Colo­ma, a Roche/Genen­tech vet sea­soned in busi­ness de­vel­op­ment, was CBO at Corvus Phar­ma­ceu­ti­cals be­fore join­ing Third Rock in 2017.