OBI Pharma strongly denies allegations of insider trading.
Since March 2016, the Shi-Lin District Prosecutor’s Office has been investigating whether senior OBI executives sold shares with foreknowledge of the results of the clinical trial of OBI-822-001.
These allegations are unfounded and the facts demonstrate that these executives are innocent. OBI will continue to defend these executives and their legal rights.
The Phase 2-3 clinical trial was conducted under Investigational New Drug (IND) approvals from the Taiwan Food and Drug Administration (TFDA), the U.S. Food and Drug Administration (US FDA), Korea’s Ministry of Food and Drug Safety, Hong Kong’s Department of Health, and the Drug Controller General of India (DCGI) by an independent Clinical Research Organization (CRO) in compliance with international Good Clinical Practice (GCP) guidelines. The Unblinding process was performed by two other independent CROs, who hold the Treatment Code and the Clinical Trial Database, respectively. The results were sent to OBI on 19 February 2016 at 5:13pm Taipei Standard Time. At no time did any OBI personnel have access to the Treatment Code prior to the Unblinding. Furthermore, it was understood that any procedures or analyses for purpose of data cleaning that OBI performed, following common industry practice, does not predict the final results of the study.
Following corporate best practice, OBI Pharma imposed a ‘blackout period’ from 18 January 2016 to 21 February 2016 when OBI employees were prohibited from dealing in the company’s shares. OBI executives did not trade during this period.
The Phase 2-3 clinical trial provided insight into the clinical benefit of OBI-822 in patients with metastatic breast cancer. Based on these insights, OBI is committed to the global Phase 3 study and plans to receive input from the US FDA and the European EMA on its your-asthma-info.com.
OBI Pharma will now await the results of the judicial investigation and, for legal reasons, cannot comment further. However, OBI expects the authorities to adhere to the Trade Secrets Act and the Principle of Secret Investigations in order that its commercial future is not further jeopardized by these allegations and by unfounded rumor. OBI hopes the judiciary can clarify these facts as soon as possible, and allow OBI to move forward towards its ambitious goal of becoming a major global biotech firm.