IRVINE, Calif., July 15, 2014 (GLOBE NEWSWIRE) -- AtheroNova Inc. (OTCBB:AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that it has filed pre-Investigational New Drug (pre-IND) documents with the US Food and Drug Administration (the "FDA") under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (the "Act") using a patented bile acid, in combination with a statin for the treatment of patients who fail to reach their LDL cholesterol target with statin treatment alone. The Company has received its initial pre-IND file number from the FDA indicating the initiation of the review process. Section 505(b)(2) of the Act specifically allows the FDA to rely on data not developed by the applicant company for approval of a New Drug Application ("NDA") for their intent to use previously approved active ingredient(s) in a combination product or for a new indication not previously approved.
The 505(b)(2) process is often an accelerated pathway through the regulatory system. An applicant may not be required to generate the amount of pre-clinical and clinical data normally required with a new chemical entity. Rather, the applicant proposes to utilize the existing data generated for the original clinical development and FDA approval of the compound for its original indication. The Hatch-Waxman Act specifically includes these guidelines to encourage cost effective innovation by companies with the intent of reducing the cost of developing listed drug compounds or expanding their therapeutic areas.
"This is an important opportunity for the Company and will expand our product portfolio for our platform of systemically delivered bile acids for the treatment of cardiovascular and metabolic diseases. Our initial pre-clinical work with this target compound, our second bile acid, has yielded positive cardiovascular results and we have very good indications of the potential synergy of this combination product that we plan to launch following completion of the 505(b)(2) protocol that emerges from our interaction with the FDA," said Tom Gardner, CEO of AtheroNova. "The number of cardiovascular patients who can't reach their LDL target on statins, and can't tolerate high doses of statins, is significant. The goal for this product is to help patients reach their LDL target without significantly increasing their side effect profile. This program was initiated after the issuance of the patent for this additional component of our bile acid platform."
AtheroNova will work with its clinical and regulatory teams to prepare for the coming dialogue with the FDA regarding this application and the proposed plan for the 505(b)(2) clinical development pathway. If the FDA concurs with the Company's proposed plan, AtheroNova could accelerate into the clinical development phase in 2015.
The Company also remains committed to the clinical development plan for lead compound AHRO-001 for regression and stabilization of soft vulnerable plaque, which is currently entering the next phase of clinical development.
AtheroNova Inc. is a biotechnology company focused on the discovery, research, development and licensing of novel compounds to safely reduce or regress atherosclerotic plaque deposits and improve lipid profiles in humans. AtheroNova's lead compound, AHRO-001, directly targets atherosclerosis. In addition to its lead compound AHRO-001, AtheroNova plans to develop multiple applications for its patented and patents-pending therapies in market sectors that include: Cardiovascular Disease, Stroke and Peripheral Artery Disease, all of which have been linked to atherosclerosis. Atherosclerosis and its related pharmaceutical expenses for these indications cost consumers more than $41 billion annually in the United States alone. For more information, please visit www.AtheroNova.com.
This news release includes "forward-looking statements". These statements are based upon the current beliefs and expectations of AtheroNova's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the FDA, general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; AtheroNova's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of AtheroNova's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Examples of forward-looking statements in this release include statements regarding reduced data production in connection with accelerated regulatory review, the Company's expanded product portfolio, synergies and benefits from proposed products and accelerated clinical development.
AtheroNova undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in AtheroNova's 2013 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov). CONTACT: Company Contact: Thomas Gardner, CEO Tel: (949) 476-1100 or Mark Selawski, CFO Tel: (949) 476-1100 Investor Contact: Michael Rice LifeSci Advisors LLC Tel: (646) 597-6979
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