Fed­er­al judge up­holds Cabome­tyx patent in Ex­elix­is' gener­ic bat­tle

A fed­er­al judge up­held a key patent on Ex­elix­is’ can­cer drug Cabome­tyx on Thurs­day, deal­ing a blow to MSN Lab­o­ra­to­ries’ po­ten­tial gener­ic ver­sion.

Ex­elix­is filed suit against MSN back in 2019, af­ter the lat­ter com­pa­ny sub­mit­ted an ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA) for its Cabome­tyx gener­ic. If MSN’s drug wins ap­proval, Ex­elix­is ar­gued in the ini­tial com­plaint that it would in­fringe on at least one or two claims of a patent dubbed ‘776, which ex­pires in 2030, ac­cord­ing to the FDA’s Or­ange Book.

The com­pa­nies dis­put­ed the va­lid­i­ty of that patent, and an­oth­er called ‘473, which ex­pires in 2026.

On Thurs­day, US Judge Richard An­drews up­held the ‘473 patent, de­ter­min­ing that “MSN has not shown by clear and con­vinc­ing ev­i­dence that claim 5 of the ‘473 patent is in­valid as ob­vi­ous.”

How­ev­er, he al­so con­clud­ed that Ex­elix­is failed to prove that MSN will in­fringe on the first claim of the ‘776 patent if its gener­ic ver­sion is ap­proved.

The ‘776 patent fo­cus­es on a spe­cif­ic crys­talline form of cabozan­ti­nib (L)-malate called Form N-2. While MSN ar­gues that its gener­ic in­cludes a dif­fer­ent form, called Form S, Ex­elix­is al­leged that Form S is un­sta­ble and con­verts to N-2 over time, thus in­fring­ing up­on the patent. How­ev­er, An­drews de­ter­mined that Ex­elix­is “failed to prove by a pre­pon­der­ance of the ev­i­dence” that such would be the case.

Jef­frey Hes­sekiel

“While we are dis­ap­point­ed with the court’s de­ci­sion con­cern­ing in­fringe­ment of the ’776 patent, we re­main con­fi­dent in the strength of the cabozan­ti­nib patent es­tate,” Jef­frey Hes­sekiel, Ex­elix­is’ gen­er­al coun­sel and sec­re­tary, said in a news re­lease. “We will con­tin­ue to vig­or­ous­ly de­fend our in­tel­lec­tu­al prop­er­ty, safe­guard­ing the sci­en­tif­ic in­no­va­tion that dri­ves Ex­elix­is’ abil­i­ty to con­tin­ue to dis­cov­er, de­vel­op and ul­ti­mate­ly bring new med­i­cines to pa­tients with dif­fi­cult-to-treat can­cers.”

Cabome­tyx was first ap­proved in 2016 for pa­tients with ad­vanced re­nal cell car­ci­no­ma, and the TKI in­hibitor has since racked up a slate of ap­provals in liv­er and thy­roid can­cer. In 2021, the drug earned Ex­elix­is just over $1 bil­lion. Ac­cord­ing to pre­lim­i­nary full-year 2022 re­sults, the cabozan­ti­nib fran­chise, in­clud­ing Cabome­tyx and Cometriq, raked in $1.4 bil­lion in US sales. Ex­elix­is has been push­ing for new in­di­ca­tions in­clud­ing in com­bi­na­tion ther­a­pies, such as with Roche’s Tecen­triq. How­ev­er, the Tecen­triq com­bo failed a tri­al in pa­tients with metasta­t­ic non-small cell lung can­cer last month.

Ed­i­tor’s Note: A pre­vi­ous ver­sion of the sto­ry stat­ed that Cabome­tyx earned just over $1 bil­lion last year. A cor­rec­tion has been made to clar­i­fy that was in 2021.

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.

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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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

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

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.