FREMONT, Calif., April 2 /PRNewswire-FirstCall/ -- Vermillion, Inc. today announced that it has filed a voluntary petition for reorganization relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware ("Bankruptcy Court") in Wilmington, Delaware. The company plans to continue operating without interruption as it focuses on obtaining regulatory clearance respecting the company's ovarian tumor triage test ("OVA1") 510(k) pre-market notification to the United States Food and Drug Administration ("FDA"). That submission is currently pending and the company continues to work diligently to provide information and data in response to FDA inquiries. Upon receipt of FDA regulatory clearance, the company would then seek to move forward, including with a strategic alliance partner, to bring the OVA1 test to market.
In conjunction with the filing, the company is seeking customary authority from the Bankruptcy Court that will enable it to continue operating its business in the ordinary course. To address its financial condition and deteriorating liquidity position, as a cost-saving measure, the company reduced its workforce.
In connection with the filing, directors Kenneth Conway, Rajen Dalal, James Rathmann and John Young resigned from the Board of Directors, effective immediately. Gail Page has been elected as the Executive Chair of the Board of Directors of the company, also effective immediately. The board will continue to operate with a reduced number of directors as a cost-saving measure.
The board now consists of Gail Page, John Hamilton and James Burns, all of whom have indicated their intention to continue their role as directors of the company for the time being.
For purposes of conserving company resources, on March 27, 2009, Vermillion requested the resignation of several of its executive officers. The officers who have resigned following this request are Gail Page, President and Chief Executive Officer, Qun Zhou, Interim Chief Financial Officer, and Simon Shorter, Vice President of Corporate Business Development. The sole reason for these resignations was to conserve company resources and was not the result of any disagreement with the company on any matter relating to the company's operations, policies or practices or in any way for cause. The resigning personnel will continue to act as consultants to Vermillion. They will accrue severance and other rights as a result of the termination to the extent funds for such payments are available in the bankruptcy reorganization.
Vermillion has multiple ovarian cancer diagnostic tests in development. The most advanced of Vermillion's programs is the OVA1 test, which is designed to utilize a panel of biomarkers to help identify women with a higher likelihood of malignancy so they can be referred to a gynecologic oncologist for their initial surgery. Vermillion filed a 510(k) Application with the U.S. Food and Drug Administration for its OVA1(TM) Test in June 2008.
On February 10, 2009, the company presented data from its prospective OVA1 clinical trial at the Society of Gynecologic Oncologists' (SGO) 40th Annual Meeting on Women's Cancer in San Antonio, TX. The primary aim of the study was to determine the ability of its proprietary OvaCalc algorithm to estimate the risk of malignancy in pre and postmenopausal women who were scheduled for surgery with an ovarian mass. The data demonstrated that the OvaCalc algorithm can effectively identify women with a higher likelihood of malignancy. Within the study population, the OvaCalc algorithm also detected 90% of Stage I epithelial ovarian cancer cases and 100% of stage 2-4 cancers while maintaining a greater than 90% negative predictive value among both premenopausal and postmenopausal patients.
About Ovarian Cancer
Commonly known as the "silent killer," ovarian cancer leads to approximately 15,000 deaths each year in the United States, according to the American Cancer Society. Approximately 20,000 new cases are diagnosed each year, with the majority in patients diagnosed with late stage disease where the cancer has spread beyond the ovary. The prognosis is poor in these patients, leading to the high mortality from this disease. A diagnostic test is needed that can provide adequate predictive value to stratify patients with a pelvic mass into high risk of invasive ovarian cancer versus those with low risk, as well as a screening test for the diagnosis of early-stage ovarian cancer, which is essential for improving overall survival in patients. Ovarian cancer has up to a 90% cure rate following surgery and/or chemotherapy if detected in stage 1.
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in oncology, hematology, cardiology and women's health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at http://www.vermillion.com.
This news release contains forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion's plans, objectives, expectations and intentions. These forward-looking statements are based on Vermillion's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. There are no guarantees that Vermillion will succeed in its efforts to commercialize ovarian cancer or OVA1 diagnostics products in 2009 or during any other period of time. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty in obtaining intellectual property protection for inventions made by Vermillion; (2) unproven ability of Vermillion to discover, develop, and commercialize ovarian cancer or OVA1 diagnostic products based on findings from its disease association studies; (3) unproven ability of Vermillion to discover or identify new protein biomarkers and use such information to develop ovarian cancer or OVA1 diagnostic products; (4) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its ovarian cancer or OVA1 diagnostic products; (5) uncertainty of market acceptance of its ovarian cancer or OVA1 diagnostic products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third party payors such as private insurance companies and government insurance plans; (6) uncertainty that Vermillion will successfully license or otherwise successfully partner its products; (7) uncertainty that Vermillion will have the resources to successfully execute the contemplated reorganization; (8) uncertainty as to whether a long period operating under Chapter 11 may harm our business; (9) uncertainty regarding whether we will be able to obtain confirmation of our Chapter 11 plan; (10) uncertainty as to whether we will be able to emerge from bankruptcy without being liquidated; (11) uncertainty whether a plan of reorganization may result in holders of our common stock receiving no distribution on account of their interests and cancellation of their common stock; (12) uncertainty whether operating under the U.S. Bankruptcy Code may restrict our ability to pursue our business strategies; (13) uncertainty whether loss of our listing on the Nasdaq Capital Market has made our stock significantly less liquid or has significantly reduced its value; and (14) other factors that might be described from time to time in Vermillion's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion's expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.
CONTACT: Investors, Gail Page, Vermillion, Inc., +1-512-587-8070
Web site: http://www.vermillion.com/