Judge sets late-breaking rules for AstraZeneca's last stand on Crestor

When the FDA decides whether to approve new Crestor generics, AstraZeneca--and its would-be copycats--will find out behind closed doors.

The Big Pharma, fighting to protect its blockbuster statin med from an onslaught of copycat competition, filed a citizen petition with the agency last month, and then sued as generics D-Day approached. AstraZeneca asked the court to stop those copycat drugs in their tracks.

It's high-stakes time for AstraZeneca, which collected $5 billion from Crestor last year. At a hearing last week, the argument came down to fine points of administrative procedure, FDA approval processes and generics-launch strategy. With AstraZeneca’s citizen petition still pending--and generics approvals pending, too--the court was in a bind: How could a judge rule on the possibility that the FDA would deny the petition and approve a slew of brand-depleting generics, too?

But as AstraZeneca pointed out, if the court waited to act until the FDA issued its generics approvals, the half-dozen generics makers chasing the Crestor market could roll out their products within a few hours’ time. That would flood the market, dragging down Crestor’s blockbuster brand--and AstraZeneca’s stock price--even if the court ended up ruling in the company’s favor.

On the other hand, the generics makers have rights, too. Including the right to get a timely answer on their approval applications, and to launch their meds accordingly.

The compromise? The FDA will give U.S. District Judge Randolph Moss 24 hours’ notice before announcing its decision on AstraZeneca’s petition. The judge will call a closed hearing, with the FDA, AstraZeneca, and generics makers all invited, and their lawyers have to be ready to appear with just two hours’ notice.

At that closed hearing, the agency will unveil its verdict on the petition--and any decisions it has made about generics approvals. The FDA will also share copies of the final labeling on those potential copycats.

All this juicy material will remain under seal until the court rules on AstraZeneca’s bid for a reprieve.

AstraZeneca’s motive for fighting Crestor generics is clear--the blockbuster statin med remains one of the company’s top sellers, despite the arrival of an authorized generic. Evercore ISI analyst Umer Raffat recently charted brand and generic Crestor script numbers since the copycat launched May 1, and the trend lines show the generic quickly gaining market share--and Crestor losing it--but those changes leveled off early this month, with Crestor’s brand scripts at just over 200,000 and the generic’s at just over 150,000.

When and if the gates open to the half-dozen follow-up generics, the brand will quickly tank, leaving AstraZeneca billions of dollars in the hole.

For the generics makers, the stakes are high, too. Knockoff versions of mass-market blockbusters like Crestor are their bread and butter, with sales and earnings estimates often depending on big launches like this.

And for the rest of pharma, the AstraZeneca case presents a tantalizing opportunity. AstraZeneca’s argument rests on a new orphan drug approval granted to Crestor in recent weeks--one that, under FDA rules, gives the drug years of additional exclusivity on the market. 

In previous cases, such as Otsuka’s similar strategy with the big-selling antipsychotic Abilify, the FDA has approved generics despite orphan drug status by leaving orphan drug data off the generics’ official labeling.

AstraZeneca and its partner IPR Pharmaceuticals say that labeling approach isn’t legal. It violates the agency’s own rules on including pediatric information in drug product labels, among other things, the drugmakers’ legal complaint contends. If AstraZeneca successfully argues that Crestor’s case is different, then that could give other branded drugmakers their own opportunities to develop meds for orphan indications and extend their monopoly market position far beyond patent expirations.

Meanwhile, AstraZeneca is doing what it can to retrench in the face of the Crestor generics threat and boost brand sales as much as it can. Earlier this year, the drugmaker unveiled a restructuring plan designed to save $1.1 billion annually; it includes sales and administrative cutbacks, and continued “streamlining” of its manufacturing network. The company is also promoting a co-pay assistance program that limits the costs of a Crestor prescription to $3 per 30-day supply for 12 months, for eligible patients. 

- see the latest court filing (PDF)

Related Articles:
With no time to waste, AstraZeneca sues FDA to block Crestor copycats
AstraZeneca files Hail Mary petition urging FDA to block more Crestor generics till 2023
AstraZeneca plots cost cuts to save $1.1B as Crestor generics loom
AstraZeneca to 'reshape' manufacturing as part of $1.5B cost-cutting effort
Big Pharma's cardiovascular sales ain't what they used to be
AstraZeneca zaps another Crestor generic threat with Actavis settlement
Otsuka scrambles to persuade judge to block Abilify copycats