Earlier this week, when Hanmi Pharmaceutical launched its Nexium copy in the U.S. at-risk, it faced the possibility of paying a high price if AstraZeneca ($AZN) won a bid to defend its patent. An appeals court ruling in Hanmi's favor has let it off the hook, at least for now. If AstraZeneca wants to collect, it will have to convince the Supreme Court to hear the case--and it will have to win.
Hanmi's Nexium copy differs from the original in salt form only, but that was apparently enough to persuade a federal circuit appeals court to uphold a lower court's ruling that it didn't step on the pharma giant's patent, Reuters reports. And while AstraZeneca doesn't feel the same way, it's left without recourse, save a trip to the country's highest court--something it says isn't out of the question.
"AstraZeneca respectfully disagrees with the court's decision. We are reviewing the opinion and considering our options, including further appeal," an AstraZeneca spokesperson told FiercePharma.
The ruling is great news for Hanmi, which can for now go on selling its version of the stomach drug worry-free. Despite receiving FDA approval in August, the South Korean drugmaker's hands were tied until October, when a federal court lifted an injunction on its rollout. With the stay out of the way, Hanmi moved forward, launching its drug just days ago despite the threat of a double penalty if the appeals court sided with AZ.
But whether Hanmi's drug will gain traction in the U.S. remains to be seen. The copy won't be directly substitutable for Nexium, meaning doctors will have to prescribe it specifically over the heartburn blockbuster. While sales of Nexium declined last year, it still brought in nearly $4 billion; it looks on track to replicate that haul for 2013, having generated nearly $2 billion in the first half of the year.
Unfortunately for AstraZeneca, those are revenues it badly needs to hang on to before Nexium loses patent protection in May. The British company is still feeling the sales sting induced last year when copycat drugs ripped into revenues of antipsychotic Seroquel. CEO Pascal Soriot has been working out deals to strengthen the company's pipeline, but it doesn't have a product ready to step up in Nexium's place; and while an OTC version of Nexium should see the market when the generic floodgates open next year, rights to that belong to Pfizer ($PFE), which bought them for $250 million.
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