FDA requests further data for approval of Epigenomics' blood based colorectal cancer screening test

Epigenomics adjusts 2015 outlook after FDA response letter.

In its letter, the FDA provided guidance and recommendations on how to amend the PMA to make it approvable. The agency requested additional data demonstrating that the blood-based Epi proColon test will increase compliance to CRC screening in the intended use population; i.e., in those patients with a history of noncompliance to recommended CRC screening programs.

The management of Epigenomics is taking immediate steps to address the FDA's requests. This includes a meeting with the FDA in the near term to discuss how to best address the outstanding questions. It is expected that an additional study to demonstrate increased compliance and adherence of patients to blood-based CRC testing will be needed. Details of the study will be determined in dialogue with the FDA.

Epigenomics says it is committed to provide information about the regulatory way forward to its shareholders and to the public in a timely and comprehensive manner.

Together with its strategic commercialization partner Polymedco, Epigenomics will continue to diligently prepare for commercializing Epi proColon in the US.

In the previous ADMIT (Adherence to Minimally Invasive Testing) study, Epigenomics aimed to demonstrate that Epi proColon will increase CRC participation in patients being offered this convenient blood-based test as compared to those being offered a fecal immunochemical test (FIT). While the adherence to Epi proColon was nearly 100%, the participation rate to the FIT-test of 88% by far exceeded the levels seen in many studies. The FDA's request for additional data suggests that the studied population in the ADMIT trial was not fully suitable for Epi proColon.

"While disappointed by the FDA's decision, we will make every effort to address the outstanding questions as soon as possible", said Dr Thomas Taapken, CEO/CFO of Epigenomics AG. "We remain highly committed to providing an innovative and convenient option to those many Americans who do not undergo colorectal cancer screening. Colorectal cancer is still the second-leading cause of cancer death in the US."

Epigenomics has announced that it has adjusted its financial outlook for fiscal year 2015 following the FDA response letter on the company's lead product Epi proColon. Such a decision has a significant impact on the achievement of certain projected financial parameters for 2015.

The company's financial outlook for 2015 changes as follows:

Revenue is projected to exceed last year's figure of EUR 1.5 million, which is significantly less than the projected EUR 3–4 million. In the first 9 months 2015, Epigenomics recorded revenue of EUR 1.3 million* (9M 2014: EUR 1.1 million).

EBIT is now projected at the lower end, or may slightly fall short, of the previous outlook range of EUR -10.0 to -11.0 million. Cash consumption is projected at the upper end of, or may slightly exceed, the previous outlook range of EUR 9.5 to 10.5 million.

*preliminary; final report on first nine months of 2015 will be published on 18 November 2015