UP­DAT­ED: Third time's the charm: Adamis nabs ap­proval of high-dose nalox­one in­jec­tion af­ter two CRLs

If at first you don’t suc­ceed, and at sec­ond you don’t suc­ceed, try, try again.

That’s been the un­of­fi­cial mantra for Adamis Phar­ma­ceu­ti­cals’ high dose nalox­one in­jec­tion, which re­ceived two CRLs in the span of a year be­tween the No­vem­bers of 2019 and 2020. But on Mon­day, word came through that the FDA ap­proved the drug on Adamis’ third at­tempt, giv­ing doc­tors an­oth­er tool to treat in­di­vid­u­als who over­dose on opi­oids.

The drug will be mar­ket­ed as Zimhi, and there’s no word yet on the price. An Adamis spokesper­son told End­points News via email that the drug will be priced by US WorldMeds which will set it “com­pet­i­tive­ly.”

“The high­er in­tra­mus­cu­lar dos­es of nalox­one in ZIMHI should re­sult in more rapid and high­er lev­els of nalox­one in the sys­temic cir­cu­la­tion, which in turn, should re­sult in more suc­cess­ful re­sus­ci­ta­tions,” said Jef­frey Galinkin, for­mer FDA ad­comm mem­ber and paid Adamis con­sul­tant, in a pre­pared state­ment. He added the drug will par­tic­u­lar­ly help the ris­ing num­ber of fen­tanyl-re­lat­ed over­dos­es.

In­vestors wel­comed the news for the small-cap play­er, send­ing Adamis shares $ADMP up 17% in ear­ly Mon­day trad­ing to $1.33 per share. The stock price has yet to re­cov­er from a Feb­ru­ary 2019 re­jec­tion, how­ev­er, when reg­u­la­tors shot down a pitch for an erec­tile dys­func­tion drug.

Nalox­one, gen­er­al­ly sold un­der the brand name Nar­can, has proven a key el­e­ment to try­ing to curb the opi­oid epi­dem­ic in the US, be­ing used by first re­spon­ders and emer­gency room doc­tors to im­me­di­ate­ly in­ter­vene dur­ing an over­dose. De­vel­oped by Adapt Phar­ma and now owned by Emer­gent BioSo­lu­tions, Nar­can is avail­able at a 40% dis­count to state and lo­cal gov­ern­ments and non-prof­it or­ga­ni­za­tions.

Adamis, mean­while, cen­ters its strat­e­gy on of­fer­ing low­er-cost al­ter­na­tives to drugs that are al­ready out there. Nar­can and oth­er nalox­one-based prod­ucts like Evzio gen­er­al­ly use less of the drug than Zimhi’s 5 mg/0.5 mL dose.

For Zimhi, the biotech ran in­to man­u­fac­tur­ing head­winds both times it re­ceived re­jec­tions, but the FDA has os­ten­si­bly been sat­is­fied with the com­pa­ny’s reme­dies. Pri­or to the sec­ond CRL, Adamis had en­tered in­to a dis­tri­b­u­tion agree­ment for the pro­gram that would have, pend­ing ap­proval, to­taled up to $26 mil­lion in up­front cash and mile­stone pay­ments. It’s un­clear whether that agree­ment will take ef­fect with Mon­day’s news.

Adamis’ main prod­uct is an ep­i­neph­rine in­jectable called Sym­jepi, which is used to treat al­ler­gic re­ac­tions and ana­phy­lac­tic shock sim­i­lar to My­lan’s block­buster EpiPen. Re­searchers for­mu­lat­ed a way to use the same de­liv­ery sys­tem for Zimhi as Sym­jepi, and the biotech is al­so de­vel­op­ing treat­ments for a range of res­pi­ra­to­ry dis­eases, such as Covid-19, in­fluen­za, asth­ma and COPD.

Pre­vi­ous­ly, the FDA had al­so ap­proved a gener­ic ver­sion of Nar­can nasal spray to be used by those with­out med­ical train­ing in April 2019.

This ar­ti­cle has been up­dat­ed to in­clude Zimhi pric­ing in­for­ma­tion and to clar­i­fy that Jef­frey Galinkin is a paid con­sul­tant for Adamis.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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