UPDATE: Nektar accuses Lilly of botching analysis of eczema, psoriasis clinical trials in lawsuit

Nektar Therapeutics has accused Eli Lilly of botching the analysis of data from phase 1b trials in eczema and psoriasis. Lilly, which has reportedly confirmed the errors, handed back rights to rezpegaldesleukin (rezpeg) earlier this year in the wake of analyses that now appear to have misrepresented the efficacy of the candidate. 

Nektar has also moved to sue Lilly, according to a complaint filed in the U.S. District Court for the Northern District of California. 

"This case involves the all-too-familiar story of a large pharmaceutical company elevating profits over all else," Nektar wrote in the complaint. "Lilly, one of the largest pharmaceutical companies in the world, shirked its clinical and contractual responsibilities to its joint development partner, San Francisco-based Nektar."

Nektar said in a Monday press release that the earlier analyses were "incorrectly calculated by Lilly." In September, the Indianapolis Big Pharma used the European Academy of Dermatology and Venereology meeting to share data from phase 1b clinical trials that tested the IL-2 conjugate rezpeg in patients with atopic dermatitis and psoriasis. Lilly returned rights to rezpeg back to Nektar, along with raw clinical data, in April. 

That marked the first time Nektar had a chance to review the complete patient data files. The review triggered alarm bells. Nektar employed an independent statistical firm to analyze the raw data, leading to new efficacy results. Some of the results diverge dramatically from the findings released by Lilly. 

For the high dose of rezpeg, the placebo-adjusted mean improvement on the eczema scale in Nektar’s atopic dermatitis analysis is 36%, compared to 17% in the Lilly publication. Similarly, the proportion of people on the high dose who experienced a 75% or greater improvement increased from 29% in Lilly’s analysis to 41% in Nektar’s redo. 

Nektar’s analysis also delivered different results for the psoriasis trial. Differences between the Lilly and Nektar analyses include the proportion of patients who had a 75% or greater improvement in symptoms. Lilly put the figure at 11%. Nektar now says it is actually 21%.

According to Nektar, Lilly’s atopic dermatitis analysis “miscalculated for the validated 72-point EASI scoring system and excluded certain available patient data at the time of the interim.” The biotech added that the psoriasis efficacy endpoints “were miscalculated for the validated 72-point PASI scoring system.” Nektar contacted Lilly and reportedly received written confirmation of the errors.

The analyses suggest rezpeg may be more efficacious in eczema and psoriasis than previously thought. That would be a boost to Nektar, which put rezpeg at the heart of its revised R&D plan earlier this year. Shares in the biotech, which is working to recover from its high-profile cancer flop, rose 14.5% to 61 cents in premarket trading Monday. 

"The data further reinforce the importance of Nektar's renewed strategic focus on advancing rezpeg into a robust phase 2b study in biologic-naïve patients with moderate to severe atopic dermatitis by October of this year," CEO Howard Robin said in a statement.

In the lawsuit, Nektar accused Lilly of buying another company—Dermira—with a competing drug candidate and then executing "on a scheme to ensure that rezpeg would never succeed."

"Lilly’s scheme was designed to justify its eventual termination of the parties’ agreement, avoid significant payments due to Nektar thereunder, and tarnish rezpeg, thereby delaying or preventing its introduction into the market to compete against Lilly’s newly-acquired drug candidate," the complaint says. 

Lilly defended the decision to drop rezpeg and the failure of the asset in phase 2 in a statement provided to Fierce Biotech Tuesday morning. 

"The rezpeg phase 2 trial did not meet its primary endpoints for the lead indication [systemic lupus erythematosus] and we therefore made the data-driven decision not to further develop the asset," Lilly said. "Our decision to terminate the collaboration with Nektar was based on the totality of evidence related to the asset, including these phase 2 SLE results."

The statement continued: "Lilly complied and continues to comply with its obligations under the collaboration agreement with Nektar and is committed to the highest scientific and research standards in the development of therapies to advance patient care."

The agreement has now been terminated and Nektar has full control over rezpeg "and the ability to further develop the asset," Lilly concluded. 

Editor's note: This story was updated at 8:05 p.m. ET on Aug. 7 to include details from the lawsuit. This story was updated again at 9:19 a.m. ET on Aug. 8 to include Lilly's statement.