Severin Schwan, Roche CEO (AP Images)

Roche to read out even more da­ta on megablock­buster Ocre­vus in MS

It’s been three years since Roche hit the mar­ket with its megablock­buster MS drug Ocre­vus — but the Swiss phar­ma isn’t done build­ing on the pro­gram that CEO Sev­erin Schwan has called the most suc­cess­ful launch in the com­pa­ny’s 124-year his­to­ry.

Roche says it’s go­ing to MSVir­tu­al2020 next week­end with new ef­fi­ca­cy da­ta for the treat­ment of mul­ti­ple scle­ro­sis (MS) and neu­romyelitis op­ti­ca spec­trum dis­or­der (NMOSD) pa­tients. Plus, it’s ini­ti­at­ing a Phase II­Ib study to eval­u­ate Ocre­vus at a high­er dose for re­laps­ing and pri­ma­ry pro­gres­sive MS pa­tients, and a Phase IV CHIMES study which will fo­cus on the drug’s ef­fi­ca­cy in African Amer­i­can, His­pan­ic and Lat­inx Amer­i­can pa­tients.

Levi Gar­raway

“While con­di­tions of the ner­vous sys­tem are some of the most com­plex to un­der­stand and treat, we are com­mit­ted to fol­low­ing the sci­ence to re­duce re­laps­es in NMOSD and slow and even­tu­al­ly stop dis­ease pro­gres­sion in MS,” Roche CMO and head of glob­al prod­uct de­vel­op­ment Levi Gar­raway said in a state­ment. “From the suc­cess of our first-in-class B-cell MS ther­a­py OCRE­VUS, we are poised to con­tin­ue ad­vanc­ing the sci­ence in MS with our new in­ves­ti­ga­tion­al BTK in­hibitor fene­bru­ti­nib, and in NMOSD with the re­cent FDA ap­proval of EN­SPRYNG.”

When Ocre­vus got the FDA OK for MS in 2017, it was the on­ly ap­proved drug to treat both pri­ma­ry pro­gres­sive as well as the re­laps­ing re­mit­ting forms of the dis­ease. Roche priced Ocre­vus for mar­ket pen­e­tra­tion at $65,000 a year, a 25% dis­count to ri­val Rebif. In its first year on the mar­ket, Ocre­vus reeled in $2.4 bil­lion in world­wide sales.

Since then, new MS drugs like No­var­tis’ Mayzent and Mer­ck KGaA’s Maven­clad have en­tered the mar­ket — but Roche has claimed the com­pe­ti­tion on­ly boost­ed its own sales.

Bill An­der­son

“Yes, we have seen an im­pact — the im­pact is that Ocre­vus’s share goes up,” phar­ma­ceu­ti­cal head Bill An­der­son told an­a­lysts, per a Reuters re­port. “So, yeah, we hope there are more com­pet­i­tive launch­es like that.”

Roche’s En­spryng was ap­proved in Au­gust as the first sub­cu­ta­neous treat­ment for adults with an­ti-aqua­por­in-4 (AQP4) an­ti­body pos­i­tive NMOSD, a neu­ro­log­i­cal dis­or­der that’s of­ten mis­tak­en for MS. New da­ta have shown that the drug, a hu­man­ized mon­o­clon­al an­ti­body that tar­gets IL-6 re­cep­tor ac­tiv­i­ty, sig­nif­i­cant­ly low­ered the risk and sever­i­ty of re­lapse in NMOSD pa­tients.

“Un­til re­cent­ly, peo­ple liv­ing with NMOSD did not have med­i­cines specif­i­cal­ly test­ed and de­signed to treat the con­di­tion. Many peo­ple with NMOSD re­main mis­di­ag­nosed and un­treat­ed,” Roche an­nounced.

The com­pa­ny is al­so ini­ti­at­ing Phase III de­vel­op­ment of fene­bru­ti­nib, a Bru­ton’s ty­ro­sine ki­nase (BTK) in­hibitor in RMS and PPMS. Roche hopes it can sup­press dis­ease ac­tiv­i­ty and slow pro­gres­sion.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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