Date: 2014-04-24
Type of information: Licensing agreement
Compound: septin9
Company: Epigenomics (Germany - USA) BioChain (USA - CA - China)
Therapeutic area: Diagnostic - Cancer - Oncology
Type agreement: licensing
collaboration
Action mechanism:
Disease: colorectal cancer
Details: * On October 27, 2013, Epigenomics has signed an agreement with BioChain regarding a broad strategic collaboration of both companies. BioChain is a leading clinical diagnostics company in cancer and genetic tests in China and the US. As part of the agreed collaboration, which significantly expands the license agreement for a laboratory developed test, BioChain will acquire an exclusive license to develop and commercialize Septin9 in vitro diagnostic (IVD) tests for colorectal cancer (CRC) screening in the Chinese market. Under the terms of the agreement, Epigenomics will receive undisclosed upfront and minimum annual payments as well as mid single-digit royalty payments once the product is approved by the Chinese Food and Drug Administration (CFDA). Until then, Epigenomics will continue selling laboratory developed test (LDT) components to BioChain.At its own expense, BioChain will initiate a major clinical trial to validate the Septin9 CRC screening assay with the goal to gain market approval for the blood-based test by the CFDA. In order to execute the clinical trial, BioChain has placed an order for 5,000 Epi proColon® tests with Epigenomics. The trial will start in Q4 2013 and is expected to be completed in the second half of 2014. This is the first clinical study to demonstrate the clinical utility of the Septin9 assay in China, where, in accordance with internationally accepted guidelines, nearly 290 million people are currently eligible for CRC screening. In China CRC is a rapidly growing medical problem demanding for better, simple to use and affordable screening methods.The parties also agreed to work together on the validation of other methylation biomarkers in the cancer field. Should the companies develop any future products, BioChain shall have the option to acquire commercialization rights for the Chinese market, while Epigenomics will retain rights for the rest of the World.BioChain and certain of its shareholders will also invest US$ 1.3 million (€ 0.94 million) into Epigenomics by subscribing 217,935 newly issued shares (http://biopharmanalyses.fr/fundraising-and-ipo/?pageid=561)
Financial terms:
Latest news: * On April 24, 2014, Epigenomics and BioChain Institute have announced that BioChain has completed its major clinical validation study to validate Epigenomics' blood-based Septin9 screening assay Epi proColon® for the early detection of colorectal cancer with the goal to gain market approval for the test in China. In addition, BioChain has officially submitted an application to China Food and Drug Administration (CFDA) in April for the approval of Epi proColon®. Both companies expect commercialization of the test in China to start in 2015.
The clinical validation study was designed to evaluate the clinical performance of Epi proColon® for the detection of colorectal cancer and is part of the required data package to seek regulatory approval in China. From November 2013 to March 2014, a total of 1,074 patients at three top ranking hospitals in China were tested by using Epigenomics' Epi proColon® 2.0 CE assay. Epi proColon® detected 74.8% of the cancer cases (sensitivity) and correctly identified 97.4% of the patients free of disease (specificity). The tested study cohort included 300 cancer cases in stages I to IV. The results were marked as positive when at least two out of three samples of the test triplicate were evaluated as positive.
The results were in line with those achieved in Epigenomics' European CE marking study reported in 2011, which followed the same principle of data interpretation (80% sensitivity and 99% specificity).
