Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oys­ter Point Phar­ma now has its first FDA-ap­proved prod­uct — Tyr­vaya. And the biotech has tak­en a unique route to get there by us­ing an old drug with a sto­ried past.

The New Jer­sey biotech an­nounced this morn­ing that the FDA has ap­proved their nasal spray prod­uct for dry eye dis­ease on Fri­day — the first nasal spray to be ap­proved for the dis­ease. The prod­uct’s ac­tive in­gre­di­ent is 0.03 mg of vareni­cline, al­so known as smok­ing ces­sa­tion aid Chan­tix.

The can­di­date has been in clin­i­cal tri­als since 2018, just a year be­fore Oys­ter Point went pub­lic with an $80 mil­lion IPO in 2019.

The most com­mon ad­verse re­ac­tion re­port­ed in 82% of pa­tients was sneez­ing — and oth­er events that were re­port­ed in 5- 16% of pa­tients were cough­ing; along with throat and nose ir­ri­ta­tion.

Ji Xing Phar­ma, a Shang­hai biotech with Mer­ck vet­er­an Joe Ro­manel­li at the helm, had al­ready bought the rights in Chi­na, Tai­wan, Hong Kong and Macau to the com­pound, al­so known as OC-01, for $17.5 mil­lion up­front and 0.75% com­pa­ny eq­ui­ty in a $204.8 mil­lion biobucks deal in Au­gust. Oys­ter Point CEO Jef­frey Nau told End­points News that the com­pa­ny will re­tain glob­al rights out­side of those mar­kets.

“We’ll as­sess what our plans are go­ing for­ward. We’re fo­cused on mar­kets like Eu­rope and Japan, where there’s a dry eye mar­ket­place there that is quite in­ter­est­ing. We’ve en­gaged with reg­u­la­tors,” Nau said in an in­ter­view. “But at the mo­ment, our fo­cus is get­ting things launched here in the US. We’ve got our part­ner­ship in Greater Chi­na, and then we’ll con­tin­ue to look at oth­er glob­al mar­kets af­ter that.”

The new prod­uct will be avail­able with a pre­scrip­tion start­ing in No­vem­ber — to be ad­min­is­tered twice dai­ly in each nos­tril. Each treat­ment, which is two bot­tles, is 30 days of dos­es.

Tyr­vaya’s ap­proval for 0.03 mg of vareni­cline was on­ly one of two dosages be­ing in­ves­ti­gat­ed in Oys­ter Point’s clin­i­cal tri­als — the oth­er dosage was 0.06 mg of vareni­cline, or dou­ble what was ap­proved by the FDA.

Nau told End­points that Oys­ter Point was look­ing at the sec­ond dosage for an­oth­er in­di­ca­tion: the corneal de­gen­er­a­tive dis­ease neu­rotroph­ic ker­atopa­thy. That dosage of vareni­cline is cur­rent­ly in a Phase II study, which is ex­pect­ing to have a read­out by June of next year.

“So there’s a pos­si­bil­i­ty that that dose does play in the US mar­ket even­tu­al­ly. But the de­ci­sion here with FDA was both dos­es, you know, we con­sid­er both dos­es to be ap­prov­able. The FDA land­ed on the low­er dose based on sim­i­lar ef­fi­ca­cy pro­files, but ob­vi­ous­ly less ex­po­sure for pa­tients at that low­er dose,” Nau said.

Oys­ter Point’s stock price $OYST went up this morn­ing af­ter the an­nounce­ment, open­ing at $14.95 af­ter clos­ing at $13.60 on Fri­day.

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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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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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.

Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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