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Thursday, October 17, 2024

Another Duane Reade set to close on UES as NYC pharmacies grapple with crime

 It’s a hard pill to swallow.

Yet another Duane Reade is set to close on the Upper East Side next month — part of a string of closures affecting big-box pharmacies grappling with rampant crime.

The closure of at least five other big-box pharmacies in the neighborhood over the last year has stoked residents’ fears over organized shoplifting — as they also face longer lines and extended travel times to get their prescriptions.

A handful of big-box pharmacies have closed their doors on the Upper East Side within the last year, residents say – and another is set to close next month.Michael Nagle

“My local Duane Reade, which is the only surviving nearby drug store, tells me that they get robbed about once an hour,” Andrew Fine, who serves as the co-vice president of the East 86th Street Association civic group, said in an X post in July.

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“In the last five years or so, [crime has] definitely picked up,” Fine told The Post in a recent interview. “Obviously it’s a revolving door of justice, nobody spends any real time … and I think the criminals have figured this out. It’s a lot more organized.”

An employee at the soon-to-be-shuttered Duane Reade location at 1524 Second Ave., told East Side Feed that criminals are “stealing more than we’re selling.”

The store’s anticipated Nov. 12 closure comes months after a major robbery took place right outside of the store in January, the blog added.

An enraged shoplifter smashed windows and a customer in the hand with a hammer at the 1241 Lexington Ave. CVS location last year after his stealing spree was foiled – and that store shuttered within months.

when you lose business, it also promotes blight, it’s a concern,” Fine told The Post. “Somebody keeping up the sidewalk, you don’t have somebody removing graffiti. You lose some quality of life.”Michael Nagle

That CVS along with two others, at 1223 Second Ave. and at 150 East 86th St., as well as a Rite Aid on 1849 Second Ave. are some of the other recent closures.

Fine called the string of closures “a big problem for neighborhoods all over Manhattan” — including the “definitely longer lines” observed at surviving, albeit overburdened, pharmacies.

“And it’s unfortunate that when you lose business, it also promotes blight, it’s a concern,” Fine told The Post. “Somebody keeping up the sidewalk, you don’t have somebody removing graffiti. You lose some quality of life.”

“My older neighbors have mentioned it, there’s a few places that have closed,” one Upper East Sider said. “I don’t know how far they’ll have to travel now.”Michael Nagle

Another Upper East Sider, who would only give his first name, Bobby, suggested the decision lock up basic products on the part of businesses trying to ward off shoplifters is at least in part what has driven customers out of brick-and-mortar stores.

“It takes a couple minutes if you want to get shampoo or whatever,” Bobby said of the typical pharmacy shopping experience, “but these are systemic problems and have more to do with legislation and the liberal population’s tolerance, and they’re going to choose inconvenience over punitive measures.”

The mass shutdown comes as CVS announced it will close 10% of its US locations by the end of 2024. Walgreens, which has owned Duane Reade since 2010, has publicized similar plans to close 1,200 stores, as well as Rite Aid – which filed for Chapter 11 bankruptcy in 2023 and is slated to close 500 locations.

A closed CVS store at 1241 Lexington Ave.Michael Nagle

In fact, about 25% of Walgreens stores aren’t currently profitable, CEO Tim Wentworth said this summer. “We are at a point where the current pharmacy model is not sustainable.”

The news also comes after both CVS and Walgreens settled a $13.8 billion national opioid settlement in 2023.

“Our retail pharmacy business is central to our go-forward business strategy,” a spokesperson for Walgreens told The Post. “However, increased regulatory and reimbursement pressures are weighing on our able cover the costs associated with rent, staffing, and supply needs.”

While big-box stores like CVS and Duane Reade are reducing their presence in the area, smaller pharmacies told The Post they’re seeing an uptick in business due to transferred prescriptions. 

“There are more prescriptions being transferred,” a pharmacy worker at Vital Health Apothecary told The Post, adding that many of the new scripts are coming from CVS.

A former Rite Aid store at 1535 2nd Ave.Michael Nagle

An employee at Zitomers on Madison Avenue said they have seen an “increase, absolutely” in new prescriptions.

“My older neighbors have mentioned it, there’s a few places that have closed,” one Upper East Sider, who declined to provide his name, told The Post Monday. “They have their spots that they’ve preferred for years, they’re familiar with the premises and the workers there and they’re comfortable with them.

“I don’t know how far they’ll have to travel now,” he added.

“It’s New York, it’s high population density. If they all close, new ones will pop up and they’ll address whatever their cost issues are,” one Upper East Sider mused.Michael Nagle

Pharmacies have been closing “all over” the neighborhood for a while, noted longtime Upper East Sider Victor Rottner, 86.

“A lot of people have been impacted, but so far we haven’t been,” another Upper East Sider, who frequents a Walgreens near St. Catherine’s Park, said.

Bobby, however, maintains that there is still “no dearth of pharmacies in the area,” including big-box stores.

As of October 2024, there are still three CVS pharmacy locations and about half a dozen Walgreens pharmacies in the neighborhood.

“It’s New York, it’s high population density. If they all close, new ones will pop up and they’ll address whatever their cost issues are,” Bobby said, adding that many pharmacies – including CVS and Walgreens competitors Amazon and Capsule – deliver directly to residents’ doors.

“Quit moaning and whining about inaccessibility,” he added, “and pay the extra for the convenience.”

https://nypost.com/2024/10/17/us-news/another-duane-reade-set-to-close-on-ues-as-nyc-pharmacies-grapple-with-crime-and-surviving-drug-store-is-robbed-about-once-an-hour/

Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

 As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss pharma’s top-selling drug Entresto.

In a court decision filed this week in Washington, D.C., U.S. District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s July approval of MSN’s Entresto generic was unlawful. In issuing the decision, the judge upheld MSN’s generic green light.

Novartis’ complaint largely came down to issues around labeling and the active ingredients in MSN’s generic. However, MSN’s product is “consistent with FDA regulatory and statutory requirements” on both of those issues, Friedrich wrote in the order denying Novartis’ motion for summary judgment.

The case is the latest in a string of challenges around the so-called practice of skinny labeling, which allows drugmakers to get their generic medicines approved for one or several—but not all—approved indications of their brand-name counterparts.

Novartis disagrees with the decision and has appealed the ruling, a spokesperson said.

MSN’s generic version of Entresto is still barred from launching at risk thanks to separate stays put in place by the U.S. Court of Appeals for the D.C. Circuit and the U.S. Court of Appeals for the Federal Circuit, the Novartis spokesperson added.

Entresto—which combines the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker Valsartan—was first approved by the FDA in 2015. Originally cleared to curb death and hospitalization risks in heart failure patients with reduced ejection fraction (HFrEF), Entresto eventually gained approval in heart failure patients with preserved ejection fraction (HFpEF) as well.

In patients who with HFrEF, the heart’s left ventricle loses its ability to contract normally. For patients with HFpEF, the heart muscle contracts properly but the ventricles don’t relax, causing diminished blood flow.

According to FDA records, Novartis holds multiple patents on the drug, with some set to expire in 2025, 2026 and 2027. Novartis executives said during the company's second-quarter earnings call in July that they expect Entresto generics to hit the scene in mid-2025.

In order to get its generic approved with a skinny label, MSN only included the non-patent-protected HFrEF use in its filing, according to Novartis. The Swiss drugmaker took issue with the fact that MSN and the FDA allegedly reverted to an older label that had been suspended and replaced.

“Simply because the language of the generic label tracks Entresto’s original superseded label, it does not follow that the FDA 'reverted back' to Entresto’s original label,” Friedrich wrote in her decision.

Novartis additionally argued that MSN’s product is not a one-to-one generic of Entresto given the way the copycat product’s active ingredients are a physical mixture of “two independent salts” versus the brand-name product, in which the ingredients take the form of a “co-crystal.”

But, to hear Friedrich tell it, drug ingredients “need not have the same solid state physical form to have the same chemical identity.”

The judge issued her decision after Novartis filed suit against the FDA in D.C. federal court in late July.

Elsewhere, the Swiss pharma had separate infringement claims against MSN shot down in Delaware district court in mid-August. The judge in that decision also denied Novartis’ request for an injunction barring a potential generic launch.

Novartis first sued MSN in 2022 in a complaint that also named Viatris, Alembic, Crystal and Nanjing Noratech as defendants.

Multiple drugmakers, including Alembic and Crystal, have managed to eke out generic Entresto approvals in 2024, though none of the copycat products have launched.

Aside from looming exclusivity challenges, Entresto is one of 10 drugs that will face government-negotiated prices in 2026 as part of the Inflation Reduction Act. Entresto will be subject to a 53% cut in its list price for Medicare patients, according to a list of negotiated prices published over the summer.

Entresto is Novartis’ bestselling drug: For all of 2023, the heart failure blockbuster brought home a little more than $6 billion in sales. 

https://www.fiercepharma.com/pharma/judge-upholds-msns-generic-entresto-approval-novartis-continues-attempts-defend-heart