CRA Celera Corp. (MM)

Celera Corporation (NASDAQ:CRA) today provided an update on recent scientific findings pertaining to the KIF6 gene variant and its pre-market approval application (PMA) with the United States Food and Drug Administration (FDA) for its KIF6 Genotyping Assay. In nine previously published peer-reviewed articles on genetic studies of KIF6, including 4 prospective randomized clinical trials of statin therapy (CARE, WOSCOPS, PROSPER, and PROVE IT), KIF6 carriers had greater risk for coronary heart disease (CHD) and received greater benefit from pravastatin therapy (or from high-dose atorvastatin compared with pravastatin in the PROVE IT trial) than did noncarriers. Two recent papers in peer-reviewed publications, and two posters presented at the annual meeting of the American College of Cardiology earlier this month, provided new information relative to KIF6 that differed in several important respects from the above-mentioned genetic studies.

One poster was on the results of genotyping KIF6 in the JUPITER clinical trial (Justification for use of Statins in Primary Prevention, An Intervention Trial Evaluating Rosuvastatin), and the second poster was on the TNT (Treating to New Targets) and the IDEAL (Incremental Decrease in Endpoints Through Aggressive Lipid lowering) studies. JUPITER was a study of rosuvastatin versus placebo in patients with low LDL-C but high C-reactive protein levels. KIF6 carriers benefited from statin therapy in JUPITER; however, unlike the 4 previous trials of high risk subjects noted above, KIF6 noncarriers also benefited from rosuvastatin in JUPITER. Because the trial was stopped early, there were not enough events in JUPITER to accurately assess the association between KIF6 719Arg and risk for cardiovascular disease (the statistical power was only 18%). Since the differential statin benefit between carriers and noncarriers previously observed in clinical trials of pravastatin or atorvastatin was not observed in JUPITER, the differential benefit in KIF6 carriers may not apply to all statins as a class. This study was published1 online in Circulation Cardiovascular Genetics, on April 14, 2011.

TNT was a study of high- versus low-dose atorvastatin in patients with stable coronary heart disease. In TNT, carriers of two copies of the KIF6 719Arg variant received significant event reduction (56% relative risk reduction) and noncarriers did not receive significant event reduction. However, unlike the previous statin trials, carriers of one copy of the KIF6 variant did not receive significant event reduction, possibly because the treatments compared in TNT were with the same statin and differed only in dose, a difference that may be less significant than differences between statins. Also, the previous PROVE IT trial had enrolled acute coronary syndrome patients who may benefit more from a KIF6-related pleiotropic effect of high-dose statin therapy than would the stable CHD patients in TNT. Since there was no placebo arm in TNT, an association of KIF6 genotypes with risk for CHD could not be assessed.

IDEAL was a study of high dose atorvastatin versus standard dose simvastatin in patients with stable CHD. As in the original IDEAL trial, in which a significantly better reduction of primary endpoint events from intensive statin therapy was not achieved, in the genetic study of IDEAL significant reduction of primary endpoint events was also not achieved in either KIF6 carriers or noncarriers. Since there was no placebo arm in IDEAL, an association of KIF6 genotypes with risk for CHD could not be assessed.

On March 30, 2011, the Journal of the American College of Cardiology published2 a study of KIF6 in the Heart Protection Study (HPS) that compared simvastatin versus placebo in patients with prior cardiovascular disease, noncoronary vascular disease, diabetes, or hypertension. In HPS, KIF6 carriers received a significant reduction of both major coronary and stroke events from simvastatin therapy and noncarriers did not receive a significant reduction in stroke events. However, in contrast to previous genetic studies, KIF6 noncarriers treated with simvastatin had significantly reduced cardiovascular events. Like the JUPITER results, the HPS results suggest that KIF6 carriers do not receive preferential cardiovascular event reduction from treatment with every statin. The HPS authors also found that KIF6 carriers were not at greater risk of CHD in the placebo group. However, all patients in the HPS placebo group received simvastatin therapy during a 4 to 6 week run-in period, and by the end of the study 33 percent of those in the placebo group were using a non-study statin, factors which could have confounded the results.

Celera believes that differences in study design and patients’ clinical phenotypes could explain the contradictory results described above and that research in progress on the biological function of KIF6 could add support for the association with risk for CHD and statin benefit.

Citing, among other things, preliminary reports on some of these studies, the FDA sent a decision letter to Celera on April 7, 2011 stating that the PMA application the company submitted for its KIF6 Genotyping Assay was not approvable without major amendment. The letter states that the clinical data and peer-reviewed publications submitted in support of the PMA are insufficient to demonstrate the safety and effectiveness of the device for its proposed intended use. Further, the FDA stated that it believes that the approach to demonstrate the safety and effectiveness of the KIF6 Genotyping Assay for the intended indications would be to collect additional data on clinical utility, which could include conducting a prospective, randomized, controlled clinical trial. Celera has requested a meeting with the agency to discuss the deficiencies cited in the letter as well as next steps toward seeking approval of the KIF6 Genotyping Assay.

References

1. Ridker et al., Circ Cardiovasc Genet (Published online April 14, 2011).

2. Hopewell et al., J Am Coll Cardiol, doi:10.1016/j.jacc.2011.02.015 (Published online 30 March 2011).

About Celera

Celera is a healthcare business focusing on the integration of genetic testing into routine clinical care through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management. Celera also commercializes a wide range of molecular diagnostic products through Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer. Information about Celera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.celera.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "could," among others. These forward-looking statements are based on Celera Corporation'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, Celera 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. These factors include but are not limited to: (1) the risks that Celera may not receive required regulatory approvals to commercialize a diagnostic product for KIF6; (2) Celera is using novel and unproven methods to discover markers for the development of new diagnostic products, which may not be successful; (3) Celera's scientific discoveries may not be replicated in studies by other investigators, which may negatively impact the acceptance of, or reimbursement for, its diagnostic products; (4) the diagnostic industry is very competitive, and new diagnostic products may not be accepted and adopted by the market; (5) demand for diagnostic products may be adversely affected if users of these products cannot receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (6) potential product liability or other claims against Celera as a result of the testing or use of its products; and (7) uncertainty of the availability to Celera of intellectual property protection, limitations on its ability to protect trade secrets, the risk to it of infringement claims, and the possibility that it may need to license intellectual property from third parties to avoid or settle such claims. The foregoing list sets forth some, but not all, of the factors that could affect Celera's ability to achieve results described in any forward-looking statements. For additional information about the risks and uncertainties that Celera faces and a discussion of its financial statements and footnotes, see documents filed by Celera with the SEC, including its Annual Report on Form 10-K and all subsequent periodic reports. All information in this press release is as of the date of the release, and Celera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Copyright© 2011. Celera Corporation. All Rights Reserved. Celera is a registered trademark of Celera Corporation or its subsidiaries in the U. S. and/or certain other countries.

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