Kitov Pharma Ltd. entered an agreement to settle the Israel Securities Authority's investigation on public disclosures related to the late-stage data for its combination drug Consensi.
Under the settlement deal, Kitov will pay a $430,000 fine, while the company's CEO Isaac Israel, former Chairman Paul Waymack and former CFO Simcha Rock will pay a total of $110,000 in fines.
The Israeli regulator's probe began in February 2017, focused on matters associated with a data monitoring committee appointed to manage the data for a late-stage study evaluating Consensi in osteoarthritis and hypertension.
Consensi, then known as KIT-302, is a combination of celecoxib and amlodipine, two medicines already approved to treat osteoarthritis and hypertension, respectively.
An unintentional error by a service provider caused one of the committee members to receive and examine the study's results later than instructed by Kitov, the company said in a news release. Due to the delay, the voluntary committee did not convene as planned and contrary to what was previously reported by the company.
Kitov noted that the regulator's claims were not related to the validity of the late-stage trial's results. Consensi was approved by the U.S. Food and Drug Administration in May 2018 for the osteoarthritis and hypertension indication.
The Israel Securities Authority's enforcement committee ruled that the allegations did not cause substantive damage to Kitov shareholders and the investigation on the company, as well as its certain executives, has been terminated.