Tel Aviv, Israel, Sept. 18, 2018 (GLOBE NEWSWIRE) -- Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, today announced that, following a filing by Kitov’s Chairman of the Board and Chief Medical Officer, Dr. Paul Waymack, of a motion to quash a subpoena for documents and testimony served on Dr. Waymack by the Securities and Exchange Commission (“SEC”), the SEC has commenced an action to enforce the subpoena.
As stated by the SEC, “The application does not reflect a determination by the SEC or its staff that Waymack or Kitov Pharmaceuticals has violated any provisions of the federal securities laws or any provisions at issue in the Israel Securities Authority's investigation”. The formal order issued by the SEC, which authorizes the SEC Staff to issue subpoenas and take testimony, states that the Israel Securities Authority (“ISA”) has requested assistance in connection with an investigation and does not cite any other reason for issuing the formal order. Furthermore, counsel for the SEC has confirmed to Dr. Waymack’s counsel that the sole purpose of the SEC’s involvement in this matter is to facilitate obtaining documents and testimony from Dr. Waymack on behalf of the ISA, pursuant to the assistance memorandums between the SEC and ISA, which, as previously announced by Kitov, is conducting an ongoing investigation of Kitov and certain of its principals.
Kitov Pharma’s board of directors has expressed its full support of our management, including Dr. Waymack. Kitov looks forward to the conclusion of this Israeli investigation by ISA in the most expeditious manner possible.
According to Dr. Waymack’s filing, the SEC subpoena should be quashed because the SEC’s assistance to the ISA in this matter would prejudice the public interest of the United States; that in conducting the underlying investigation, the ISA has violated both Israeli and United States law that would normally prohibit the ISA’s conduct in certain matters in connection with the investigation; that Dr. Waymack’s rights under American law as an American citizen and a respected member of the medical community would not be respected and preserved by the SEC providing assistance to the ISA; that to allow the SEC’s subpoena to stand would result in an abuse of process; and, that the subpoena is also overly broad and unduly burdensome to both Dr. Waymack and Kitov.
While this matter is between the SEC, acting for the ISA, and Dr. Waymack, Kitov fully understands Dr. Waymack’s position and reaffirms its full support for Dr. Waymack, who is one of the founders of Kitov, a former transplant surgeon and FDA Medical Officer who has over twenty years of experience in drug development and in conducting and overseeing clinical trials, and also previously served as an Associate Professor of Surgery at leading medical schools in the USA, and as a major in the U.S. Army Medical Corps.
As previously announced by Kitov, it has not yet been advised by the ISA of the full scope and focus of the ISA investigation; however, as previously disclosed by Kitov, it is Kitov’s understanding that the ISA is investigating certain circumstances surrounding the post-trial internal dissemination of the statistical analysis of the Phase III clinical trial data of Consensi™, and whether or not, according to Israeli Law, this led to any misleading disclosures in any of the Company’s public filings.
Kitov believes that the ISA’s concerns are misguided and not consistent with industry accepted U.S. Food and Drug Administration (“FDA”) regulatory requirements, nor with the procedures for the conduct of clinical trials for the purposes of New Drug Application submissions to the FDA. Furthermore, Kitov believes that the ISA is not the regulatory body authorized to evaluate the materiality of events and the completeness of public disclosures made by us in compliance with United States federal securities laws.
In addition, Kitov strongly disputes the legal ramifications of any possible concerns of the ISA with respect to its disclosures in these matters. Kitov firmly believes that the information relating to the post-trial internal dissemination of the statistical analysis of the Phase III clinical trial data of Consensi™ is not material, and was not material at the time of the Company’s announcement of the final clinical trial results. This matter had no impact whatsoever on the validity of the analysis of the Consensi™ Phase III clinical trial data, which successfully met its primary efficacy endpoint with statistical significance. In addition, the statistical analysis was further validated by the Consensi™ Phase III/IV renal function clinical trial data, which had a similar primary efficacy endpoint. Finally, the statistical analysis was included in the final Phase III clinical study report which was part of Kitov’s NDA submission for Consensi™ subsequently filed and approved for marketing by the FDA in May 2018.