Vas Narasimhan

No­var­tis down­played the painful news yes­ter­day that the FDA had spurned its ap­pli­ca­tion for canakinum­ab as a car­dio drug, im­per­il­ing its lat­est block­buster am­bi­tions for a heart drug. 

Ex­ecs would much pre­fer to talk about Lu­tathera, their ra­dioiso­tope can­cer drug which is al­ready on the mar­ket and was show­cased in an ear­ly pre­sen­ta­tion at ES­MO in Mu­nich Fri­day.

The drug — lutetium Lu 177 dotatate — is a small mol­e­cule that de­liv­ers a ra­dioac­tive el­e­ment to kill can­cer cells. In a new analy­sis of NET­TER-1 tri­al da­ta for the drug, ap­proved for neu­roen­docrine tu­mors, re­searchers spot­light­ed high­ly sig­nif­i­cant pro­gres­sion-free sur­vival re­sults for pa­tients tak­ing the drug, re­gard­less of liv­er tu­mor bur­den.

That’s an­oth­er pos­i­tive for a drug that No­var­tis bought in their $3.9 bil­lion ac­qui­si­tion of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, which No­var­tis CEO Vas Narasimhan boast­ed to in­vestors Thurs­day was en­joy­ing “ex­plo­sive growth.” 

“It’s off to a strong start in the US,” the CEO told an­a­lysts, show­ing off the lat­est set of num­bers to an­a­lysts. “You can see here num­ber of dos­es per quar­ter, and this trend is re­al­ly I think very en­cour­ag­ing. And we’re now start­ing to roll out the med­i­cine in Eu­rope. In the U.S., we have 85 cen­ters that are ac­tive­ly pre­scrib­ing. We have 70% cov­er­age of the rel­e­vant lives. And in the UK now, we have 18 cen­ters ac­tive­ly pre­scrib­ing. And I think, see­ing the strength of the per­for­mance in Lu­tathera, feel­ing now that it’s a po­ten­tial block­buster med­i­cine.

The CEO’s bull­ish­ness ex­plains why No­var­tis just snapped up lit­tle En­do­cyte for $2.1 bil­lion, pay­ing a sig­nif­i­cant pre­mi­um for an­oth­er ra­dioiso­tope ther­a­py that the biotech had in-li­censed for on­ly $12 mil­lion up front.

You can ex­pect to hear a lot more about the plat­form and the com­mer­cial prospects. No­var­tis oc­cu­pies a big place among the phar­ma gi­ants of the world, which are judged by their late-stage de­vel­op­ment pipelines rather than the qual­i­ty of their sci­en­tif­ic bench.

Im­age: ES­MO, John Car­roll End­points News

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.