No­var­tis shows a hole card in a high-stakes PhI­II pok­er game for MS drugs


No­var­tis float­ed a new, pos­i­tive da­ta point from its re­cent­ly com­plet­ed Phase III study of sipon­i­mod (BAF312), an S1P re­cep­tor drug that is be­ing ad­vanced for sec­ondary pro­gres­sive mul­ti­ple scle­ro­sis (SPMS).

In­ves­ti­ga­tors for the phar­ma gi­ant turned up at the an­nu­al meet­ing of the Eu­ro­pean Com­mit­tee for Treat­ment and Re­search in Mul­ti­ple Scle­ro­sis to say that they tracked a 21% re­duc­tion in the risk of dis­abil­i­ty pro­gres­sion in the drug arm, com­par­ing it to the place­bo group. They al­so mapped a “sig­nif­i­cant” im­prove­ment in pa­tients’ an­nu­al­ized re­lapse rate but failed to see the da­ta pan out for an im­prove­ment in a 25-foot walk­ing test, a clas­sic way to check for im­prove­ments in phys­i­cal func­tion.

The goal now is to run the num­bers by reg­u­la­tors, to see if they’re in­clined to ap­prove the drug now. But reg­u­la­tors are like­ly No­var­tis’s least con­cern in the high stakes game of MS drug de­vel­op­ment.

For No­var­tis, an ap­proval would help pro­tect its $3 bil­lion in threat­ened Gilenya rev­enue, which has been grow­ing fast. An­a­lysts are ex­pect­ing gener­ic ri­vals to crowd in­to the block­buster mar­ket in a lit­tle more than 2 years, and No­var­tis is lin­ing up a new prod­uct while Te­va has been mount­ing a fi­nal, los­ing de­fense against knock­offs of Co­pax­one.

Roche, mean­while, is ex­pect­ed to hit pay dirt with Ocre­vus (ocre­lizum­ab), which has been suc­cess­ful for both re­laps­ing/re­mit­ting MS — where the bulk of the mar­ket is — and pri­ma­ry pro­gres­sive MS pa­tients (PPMS). In PPMS, pa­tients track along a steady de­cline. Sec­ondary pro­gres­sive MS, or SPMS, is made up of the large seg­ment of RRMS pa­tients whose dis­ease de­vel­ops over time in­to a pro­gres­sive form of the dis­ease.

The progress at Roche is adding pres­sure on Bio­gen, which had to ac­knowl­edge in June that opicinum­ab failed a crit­i­cal Phase II study, bad­ly dam­ag­ing its stock price. Their fo­cus is turn­ing to MT-1303, an­oth­er S1P drug it in­li­censed from Mit­subishi Tan­abe last fall with plans to hus­tle it in­to a late-stage pro­gram. Bio­gen — which has a lead­ing mar­ket po­si­tion in MS — has had a hard time pla­cat­ing an­a­lysts who have grown in­creas­ing­ly rest­less with the ero­sion of rev­enue fore­casts for its flag­ship drug Tec­fidera.

One oth­er play­er in this S1P game is Cel­gene, which paid $7.2 bil­lion in cash to buy Re­cep­tos last year to get its hands on ozan­i­mond, now in its own Phase III au­toim­mune pro­gram.

In pre­pared text, Vas­ant Narasimhan, Glob­al Head Drug De­vel­op­ment and Chief Med­ical Of­fi­cer for No­var­tis, added, “there are very few avail­able treat­ment op­tions to de­lay dis­ease pro­gres­sion in SPMS, and there is a high un­met need for ef­fec­tive ther­a­pies with an ac­cept­able safe­ty pro­file for peo­ple with the con­di­tion.”

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.

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.

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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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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Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.

Green-light­ed in Japan, FDA quick­ly spurns Dai­ichi Sanky­o's flawed ap­pli­ca­tion for AML drug

Three days af­ter win­ning Japan­ese ap­proval for its acute myeloid leukemia drug quizar­tinib, Dai­ichi Sankyo is be­ing forced to en­dure an em­bar­rass­ing re­jec­tion at the hands of the FDA.

US reg­u­la­tors wast­ed no time in bat­ting back quizar­tinib af­ter first high­light­ing the messy da­ta in its ap­pli­ca­tion in an in­ter­nal re­view, that in turn per­suad­ed a large ma­jor­i­ty of out­side ex­perts to rec­om­mend a re­jec­tion for the drug, which tar­gets FLT3-ITD–pos­i­tive AML cas­es.

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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HIV, pneu­mo­coc­cal — and what? Mer­ck­'s un­ex­pect­ed pipeline high­light ex­cites a lit­tle biotech

In an R&D update dominated by oncology — mostly Keytruda, followed by Lynparza and Lenvima — Merck chose to highlight a program in sensory pathology, an HIV drug, and a group of pneumococcal vaccines. And that has made at least one biotech very happy.

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