FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Lawsuit: Vtesse Misused Confidential Data to Develop Breakthrough Drug

Jan. 22, 2018

The parents of twin girls with a rare genetic disorder sued a drugmaker for misappropriating the children’s trial data to secure a breakthrough therapy designation.

The plaintiffs, Christine and Hugh Hempel, said they supplied medical data from their daughters, who have Niemann-Pick disease Type C (NPC), to rare disease therapy accelerator Cydan, and claim the company violated a confidentiality agreement and set up a new company to develop a treatment using their data.

After their daughters’ diagnosis, the Hempels began exploring cyclodextrin as a potential treatment. Seeking to create a non-profit to develop the compound, the couple shared data from their efforts to give their daughters IV infusions of cyclodextrin with Cydan, but the company instead used the data to found drug manufacturer Vtesse in 2014, according to the lawsuit.

This violated a September 2013 confidentiality agreement that barred Cydan from using the Hempels’ data for any reason beyond a possible joint venture, the lawsuit claims.

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