The long legal battle, lasting over four years, between Cel-Sci and inVentiv, now known as Syneos Health, has finally come to an end, with Cel-Sci emerging victorious. Cel-Sci states in a press release that the arbitrator concluded that inVentiv materially breached its contract with Cel-Sci and intentionally misled Cel-Sci with respect to enrollment projections, which the arbitrator found to be “fraudulent.”
In 2010, Cel-Sci Corporation, a biotechnology company, hired Clinical Research Organization (CRO), inVentiv Clinical, to manage their global Phase 3 study of Multikine for the treatment of head and neck cancer. The trial was planned to run from 2011 to 2015.
However, in 2013, Cel-Sci filed an arbitration claim against inVentiv. Due to inVentiv’s failure to enroll the number of study participants agreed to under the contract, Cel-Sci terminated their involvement with the CRO, replacing it with ICON and Ergomed Clinical Research. Cel-Sci claims that during the two year time period between January 2011 and April 2013, a total of 117 patients were enrolled in the trial.
Cel-Sci cited breach of contract, fraud in the inducement, and common law fraud as reasons for the arbitration. Additionally, the company was seeking $50 million in damages.
Working with Ergomed and ICON, Cel-Sci was able to enroll 928 patients in a study that became the world’s largest Phase 3 study in head and neck cancer. However, according to Cel-Sci, because of the set back with inVentiv, enrollment wasn’t completed until September 2016, a year after the original Phase 3 trial was scheduled to conclude.
In a press release, Geert Kersten, CEO of Cel-Sci comments, “inVentiv’s actions slowed down the clinical development process of our Phase 3 cancer immunotherapy Multikine. The delays in the study caused by inVentiv not only delayed the potential approval of this investigational cancer drug by years, but it caused investors to wonder about the utility of the drug. This affected the reputation and share price of the Company. Usually small companies do not win long legal battles against multi-billion dollar opponents, but we persevered and won our claim for breach of contract.”
In 2016, inVentiv was acquired by Advent International, and then in 2017, merged with INC Research, becoming Syneos Health. According to Syneos Health, the merger allowed both companies to offer more comprehensice, end-to-end solutions for its pharmaceutical customers.
For more information on the legal case and the Phase 3 cancer study, see the Cel-Sci press release.