An­oth­er old, cheap gener­ic is be­ing prepped for an FDA ap­pli­ca­tion — made over in­to a ‘new’ drug for AD­HD and nar­colep­sy

Alex Zwyer

Can an old, cheap gener­ic obe­si­ty drug pulled years ago from the US mar­ket be tweaked and made over in­to a brand new ther­a­peu­tic able to com­pete for a share of the multi­bil­lion-dol­lar AD­HD mar­ket?

NLS Phar­ma aims to find that out.

Mazin­dol was first de­vel­oped way back in the 1960s by San­doz as an im­me­di­ate-re­lease obe­si­ty drug de­signed to shed pounds fast. A lit­tle less than a decade ago, the FDA de­ter­mined that while the ther­a­py — sold as Sanorex —  had been pulled from the US mar­ket, it wasn’t due to safe­ty or ef­fi­ca­cy rea­sons, leav­ing it wide open to a gener­ic ap­pli­ca­tion from a dis­count sup­pli­er.

But now Swiss biotech NLS says it has tweaked the ag­ing gener­ic with a con­trolled re­lease for­mu­la­tion and has gath­ered promis­ing mid-stage da­ta to show how it can work as an al­ter­na­tive to the am­phet­a­mines used in cur­rent­ly mar­ket­ed AD­HD drugs.

Gre­go­ry Mat­ting­ly, an NLS study in­ves­ti­ga­tor, told Reuters that in a Phase II with 85 pa­tients the drug re­duced symp­toms of AD­HD by more than half, much bet­ter than the 15.8% rate of pa­tients in the place­bo arm.

NLS got its IND ap­proved for this drug — which acts like the brain chem­i­cal orex­in and is now dubbed NLS-1 — by the FDA last year, say­ing that it al­so had plans to de­vel­op the ther­a­py for rare cas­es of nar­colep­sy. And on Ju­ly 11, the biotech an­nounced that the FDA had fol­lowed up with an or­phan drug des­ig­na­tion for mazin­dol, which pro­vides a pack­age of in­cen­tives aimed at en­cour­ag­ing the de­vel­op­ment of new drugs.

NLS has tout­ed the drug as an al­ter­na­tive to the am­phet­a­mines used in drugs like Adder­all from Shire, able to es­cape the con­trolled sub­stance reg­u­la­tions that can make it hard­er to mar­ket these ther­a­pies. It is, in its orig­i­nal form, a stim­u­lant, in­creas­ing heart rate and blood pres­sure while tamp­ing down on ap­petite.

NLS CEO Alex Zwyer isn’t hid­ing just how old this drug is. In fact, he’s high­light­ed it as a def­i­nite plus in the com­pa­ny’s fa­vor. Zwyer not­ed in a re­lease last year:

Mazin­dol has been used off-la­bel in nar­colep­sy since the 1970’s, and it is our goal to make it avail­able to all nar­colep­tic pa­tients.

NLS still has reg­is­tra­tion stud­ies to com­plete be­fore it can an­gle for an ap­proval, but if it makes the last leg of the clin­i­cal jour­ney it has the po­ten­tial to re­mind peo­ple of Marathon, which took an over­seas gener­ic, hus­tled it through an ab­bre­vi­at­ed de­vel­op­ment plan for Duchenne mus­cu­lar dy­s­tro­phy and came up with an ap­proval to sell it for $89,000. The re­sult­ing scan­dal brought Marathon’s house down, and PTC Ther­a­peu­tics bought it for $140 mil­lion in cash. They’re pro­ceed­ing with the launch.

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Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

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One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

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Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

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AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

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The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

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In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

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The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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