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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.