Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis' ra­dio­phar­ma drug wins ap­proval in tough-to-treat prostate can­cer pa­tients

One of the key ways in which No­var­tis CEO Vas Narasimhan hopes to stave off gener­ic com­pe­ti­tion took a gi­ant leap for­ward Wednes­day af­ter­noon.

The FDA ap­proved Lu-PS­MA-617, No­var­tis’ ra­di­oli­gand pro­gram ac­quired in the $2.1 bil­lion buy­out of En­do­cyte back in 2018, to treat PS­MA-pos­i­tive metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer. No­var­tis will brand the drug as Plu­vic­to, and a spokesper­son told End­points News that the drug’s whole­sale ac­qui­si­tion cost will be set at $42,500 per dose.

Pa­tients will be capped at six dos­es ad­min­is­tered six weeks apart, lead­ing to a po­ten­tial max­i­mum cost per pa­tient of $255,000, the spokesper­son added.

Narasimhan tout­ed Lu-PS­MA-617 dur­ing No­var­tis’ R&D day in De­cem­ber as a po­ten­tial big sales dri­ver, putting the drug un­der its “high ev­i­dence” um­brel­la among oth­er mid- and late-stage as­sets. The de­ci­sion proved no­table as No­var­tis is an­tic­i­pat­ing gener­ics will cut in­to sales of its pre­vi­ous­ly ap­proved drugs by $9 bil­lion over the next five years.

Reg­u­la­tors ap­proved the drug based on Phase III da­ta No­var­tis pre­sent­ed at AS­CO last June, which showed the drug re­duced pa­tients’ risk of death by 38% on top of stan­dard of care. Lu-PS­MA-617 al­so post­ed a 60% re­duc­tion in tu­mor size or death com­pared to the stan­dard on its own, and hit on every oth­er sec­ondary mea­sure in the Phase III study.

No­var­tis had pre­vi­ous­ly de­scribed the da­ta as “ground­break­ing” and won break­through ther­a­py des­ig­na­tion for the drug short­ly af­ter AS­CO. The com­pa­ny said at the end of Sep­tem­ber that the drug had been ac­cept­ed for pri­or­i­ty re­view, putting Wednes­day’s ap­proval right around the six-month mark.

Su­sanne Schaf­fert

In an in­ter­view with End­points last month ahead of the de­ci­sion, No­var­tis On­col­o­gy pres­i­dent Su­sanne Schaf­fert said about 80% of those with prostate can­cer see their tu­mors be­come metasta­t­ic, with a five-year sur­vival rate of rough­ly 30%. That makes the med­ical need — and the po­ten­tial com­mer­cial op­por­tu­ni­ty — sub­stan­tial.

Ad­di­tion­al­ly, Schaf­fert ad­dressed some of the safe­ty con­cerns that come along with ra­dio­phar­ma drugs, not­ing the com­pa­ny’s ex­pe­ri­ence with Lu­tathera will help in­form de­ci­sions with Plu­vic­to.  The lig­and used with Lu­tathera has a half-life of on­ly 72 hours, while the one used with Plu­vic­to lasts about five days.

The short lengths could help ad­verse events sub­side af­ter on­ly a short while, but al­so means clin­i­cians will have to dose pa­tients quick­ly af­ter re­ceiv­ing the drugs.

“We, as No­var­tis, may have on­ly 24 hours to de­liv­er it to still de­liv­er enough ra­dioac­tiv­i­ty to pa­tients,” Schaf­fert told End­points. “And that, of course, is some­thing you have to care­ful­ly set up, you need to be able to get this prod­uct to the pa­tient. And it’s in­di­vid­ual, it’s not ware­house, it’s re­al­ly in­di­vid­ual by or­der to the pa­tient.”

No­var­tis has been at the fore­front of the ra­dio­phar­ma push, ac­quir­ing the French com­pa­ny Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions in late Oc­to­ber 2017 for $3.9 bil­lion that gave it Lu­tathera and a ra­dio­phar­ma plat­form. The buy­out was fol­lowed by the En­do­cyte deal about a year lat­er, and VC and more Big Phar­ma cash has poured in­to the space in the years since.

Ver­sant and ven­Bio teamed up in 2020 to back a $45M launch round for San Diego biotech Rayze­Bio, and Bay­er bought out two tiny com­pa­nies in June in its own for­ay in­to the space.

This ar­ti­cle has been up­dat­ed to clar­i­fy the max­i­mum cost per pa­tient and the half-lives of No­var­tis’ re­spec­tive ra­dio­phar­ma­ceu­ti­cal drugs. 

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.