FDA approves the first generic for Amarin's Vascepa — but is a fish oil price war imminent?
Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.
Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.
Analysts suggested that there was a low probability of a Hikma launch anytime soon.
“Given AMRN’s ongoing appeal of the district court’s ruling invalidating Vascepa’s patents on obviousness and the fact the trial has been expedited by the court, we think it is unlikely Hikma will launch at-risk and risk potential treble damages if AMRN were to prevail on the appeal,” Stifel analysts wrote in a note.
At the moment, Amarin does not have an injunction in place to stop any potential at-risk launch, although the company could file one now, Jefferies’ analysts said.
“Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision and a preliminary injunction pending appeal to…prevent launch of generic versions of Vascepa in the United States,” company chief John Thero said in a March press release.
Amarin management has also indicated that with an expedited appeal a new ruling could potentially come by the end of 2020 or early 2021.
“It’s hard to definitively know whether Hikma will launch in the near-term and there is always the possibility of the other generic filer — Dr. Reddy’s — also receiving approval for their generic Vascepa and potentially launching at-risk. The next major update in the appeal will be around 6/16 when the generics file their response briefs,” Stifel analysts added.
Endpoints News has contacted Hikma for comment on its launch plans and reached out to Amarin inquiring about whether it intends to file an injunction blocking the Hikma launch.
Amarin’s Vascepa, known chemically as icosapent ethyl and an omega-3 fatty acid derived from fish oil composed solely of EPA, was originally endorsed by the US regulator as a treatment for elevated triglycerides. However, in December the FDA sanctioned its use in a much broader patient population after a landmark trial — REDUCE-IT — which showed the pill triggered a 25% reduction in the risk for the first occurrence of a major cardio event, and a 26% reduction for 3-point MACE, a composite of cardiovascular death, nonfatal heart attack and nonfatal stroke. Analysts predicted the new label could skyrocket sales to the $2 billion peak mark.
But a stunning setback in late March seemingly reversed Amarin’s fortunes, when generic challengers including Hikma and Dr. Reddy’s won a suit challenging five of Amarin’s patents that were set to expire by 2030. Teva, another challenger, signed a settlement with Amarin to delay its generic launch until 2029.
Jefferies Michael Yee has previously suggested that generic challengers still face a significant hurdle to bring their wares to the market, including developing manufacturing plants to produce pure EPA. Amarin currently has three such facilities, it is unclear whether the generic challengers have access to one, he added.
As for Amarin, management suggested an EU filing for Vascepa is in the works and is slated for the end of the year. The company has been looking for a partner for the drug in Europe, but Cowen’s Ken Cacciatore asserted that selling the EU rights would be the most prudent route.
“We continue to believe the most wealth-creating decision would be to sell, as opposed to license. And we believe a CVR could be established to realize the potential optionality of a U.S. appeal reversal,” he wrote. “Given that the working assumption must be that an appeal in the U.S. will not be successful, a license agreement for the remaining ex-U.S. rights could set up a situation where Amarin is simply a publicly-traded royalty company.”
Social image: John Thero, president and chief executive officer of Amarin Corp., smiles during an interview in New York, U.S., on Wednesday, Aug. 28, 2019. Thero discussed the company’s plans for its cardiovascular drug Vascepa. Photographer: Christopher Goodney/Bloomberg via Getty Images