TORONTO, April 11 /PRNewswire-FirstCall/ - Predictive medicine companyPreMD Inc. (TSX: PMD; Amex: PME) today announced that the U.S. Food and DrugAdministration ("FDA") has upheld their decision regarding the company'sappeal of the not substantially equivalent (NSE) letter it received in January2008 in connection with a premarket submission to expand indication for itsskin cholesterol test. In the ruling, the FDA agreed with the company on twoof the three issues on appeal, but concluded that the clinical trial data wasnot sufficient to determine that the product is substantially equivalent toother markers of cardiovascular risk. PreMD submitted the 510(k) notificationin 2007 with the data from a clinical study that was based on guidancereceived from the FDA in 2004.
"Our situation now is strictly in the area of a scientific disagreement.There is a well defined process for a scientific dispute resolution, one ofthe paths we will be exploring immediately," said Brent Norton, president andCEO of PreMD. "While the agency has agreed with two of the three issues,including the use of CIMT as a clinical endpoint, we are very disappointedwith the decision. We continue to believe that our skin cholesterol test is abeneficial product for healthcare providers and patients, as the test adds toour understanding of those at cardiovascular risk."
The Company disagreed with the original decision as expressed in the NSEdetermination letter and, in response, appealed the decision via a review withFDA officials. A written appeal was submitted to the FDA and a meeting washeld on March 21, 2008 between PreMD, several medical experts, regulatoryconsultants, executives from AstraZeneca Pharmaceuticals LP, and various FDApersonnel involved in the review process. PreMD presented expert analysis ofthe data gathered during clinical trials, in particular that data relating tothe use of carotid intima wall thickness (CIMT) is a determinant for those atrisk of cardiovascular disease. In addition, PreMD argued the appropriatenessof a reversal of the FDA's decision.
Additional information regarding the status of FDA clearance efforts andother business updates will be provided as information becomes available.
About PreMD Inc.
PreMD Inc. is a leader in predictive medicine, dedicated to developingrapid, non-invasive tests for the early detection of life-threateningdiseases. PreMD's cardiovascular products include a line of non-invasive skincholesterol tests. PreMD's other skin cholesterol products include PREVU(x)LT, a skin cholesterol test designed for use in the life insurance industry.The Company's cancer tests include ColorectAlert(TM), LungAlert(TM) and abreast cancer test. PreMD's head office is located in Toronto, Ontario and itsresearch and product development facility is at McMaster University inHamilton, Ontario. For more information about PreMD, please visitwww.premdinc.com.
This press release contains forward-looking statements. These statementsinvolve known and unknown risks and uncertainties, which could cause theCompany's actual results to differ materially from those in theforward-looking statements. Such risks and uncertainties include, amongothers, the successful development or marketing of the Company's products, thecompetitiveness of the Company's products if successfully commercialized, thelack of operating profit and availability of funds and resources to pursue R&Dprojects, the successful and timely completion of clinical studies, productliability, reliance on third-party manufacturers, the ability of the Companyto take advantage of business opportunities, uncertainties related to theregulatory process, and general changes in economic conditions. In addition,while the Company routinely obtains patents for its products and technology,the protection offered by the Company's patents and patent applications may bechallenged, invalidate