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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Elcin Barker Ergun, Menarini Group CEO

Amid Roche and Sanofi's oral SERD set­backs, Menar­i­ni gets speedy re­view at FDA

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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