Two weeks after siding with Takeda in the Japanese pharma giant's spat with Lupron partner AbbVie, a Delaware judge has issued a separate ruling in favor of AbbVie.
In his newest ruling, Vice Chancellor Sam Glasscock III found that Takeda is guilty of breach of contract for failing to supply its partner with the prostate cancer drug under their prior deal.
AbbVie claims that Takeda is responsible for supply chain problems that have led to worldwide shortages of the hormone drug. AbbVie developed the medicine and distributes it in the United States and Canada, while Takeda is the drug’s lone manufacturer globally, supplying it worldwide from its plant in Hikari, Japan.Two weeks ago, Glasscock ruled that the court didn’t have the jurisdiction to order Takeda to live up to its supply agreement. But in this week's decision, Glasscock ruled that Takeda failed to fulfill orders, maintain the plant in compliance with good manufacturing practices and maintain a safety stock of the drug.
Lupron has been in short supply worldwide since 2019 when the company and the FDA discovered “protocol violations” at the plant, Glasscock wrote.
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An FDA warning letter issued in June 2020 slapped Takeda for poor equipment maintenance, faulty documentation and quality shortfalls. Takeda has worked to resolve the issues but the shortages of Lupron still remain.
“Takeda’s attempts to remedy the results of the inspection led to delays—to be sure, delays that were occasioned in a sincere attempt to bring the Hikari facility back into compliance with cGMP and to satisfy regulators—but these delays led to an unavailability of product that has affected AbbVie’s ability to timely provide Lupron to patients,” Glasscock wrote.
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The legal maneuverings in the case are far from over. Glasscock told the companies on Wednesday that a second trial is needed to determine the extent of the damages caused by Takeda.
Right now, the FDA lists most Lupron Depot dose forms as "available" in the U.S., but there's one dose that's not expected to become available until next January.
