Novo Nordisk fight with KBP Bio will go to arbitration

The Singapore Court of Appeal has retained an injunction against KBP Bio and its founder, Dr Huang Zhenhua, and ruled that a lawsuit brought by Novo Nordisk will be taken to arbitration.

Last year, Novo Nordisk accused Singapore-based biotech KBP of concealing clinical data ahead of a $1.3 billion licensing agreement between the two companies focused on blood pressure drug candidate ocedurenone, claiming breach of warranty and misrepresentation, and seeking $830 million in damages.

The freezing order on KBP Bio and Huang's assets is intended to avert the risk of funds being moved or hidden before an arbitration judgment, and the appeals court has not issued any conclusions about the merits of the lawsuit, saying: "The judge is not making a finding of dishonesty: that is a matter for the [arbitration] decision-maker at a trial."

In a statement, KBP said in a statement that it is disappointed by the decision to maintain the injunction, but insisted that "Novo Nordisk's allegations of fraud remain unproven. The company is confident that these allegations of fraud will be firmly rejected when the matter is finally adjudicated."

In its complaint, Novo Nordisk contends that KBP knowingly failed to disclose interim data from a phase 2 clinical trial dating back to 2022 that Novo Nordisk claims shows that ocedurenone was unlikely to show efficacy, and also concealed quality and compliance issues at an investigation site that produced "anomalous positive results."

KBP claims the appeals court has "confirmed that Novo Nordisk had access to documents from KBP," including raw, patient-level data, and the company maintains that "provided all material information necessary for Novo Nordisk to make an informed decision to acquire ocedurenone."

At the time the licensing agreement was signed in October 2023, ocedurenone was being tested in the phase 3 CLARION-CKD trial in patients with uncontrolled hypertension and advanced chronic kidney disease (CKD).

Novo Nordisk announced in June 2024 that it was halting CLARION-CKD after an independent data monitoring committee concluded that the trial met the criteria for futility, i.e. it did not meet its primary endpoint of change in systolic blood pressure from baseline to week 12.

The company took a DKK 5.7 billion ($797 million) charge in its interim results as a result, and confirmed it was abandoning the project a few months later.

"We…believe that Novo's decision to terminate the phase 3 clinical trial and discontinue the ocedurenone programme was wrong and without any legitimate basis," said Huang.

"This abrupt termination not only contravenes established scientific principles and sound clinical judgment, but also prevented a drug that had the potential to obtain regulatory approval and benefit a broad patient population from reaching the market."

The arbitration proceedings are due to be held in New York City under the auspices of the International Chamber of Commerce.

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