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. 

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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FDA re­view­ers head back to White Oak in 2023, with lead­er­ship look­ing to ap­pease a new Con­gress

Republicans have taken a stand against the pandemic era habit of lax work-from-home schedules. Now that they’ve wrestled control of the House majority, the FDA’s leadership is playing ball, sending many of the agency’s more than 18,000 employees back to their desks early next year.

Whether this exodus back to White Oak in Silver Spring, MD (many staff will still be allowed to work from home for multiple days per week) will mean more defections to industry and elsewhere remains to be seen.