SAN DIEGO, Oct. 10 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. , a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, announced today that it has completed patient enrollment in its marketing-enabling clinical study of ANX-530 (vinorelbine emulsion), a novel, emulsion formulation of vinorelbine tartrate. Vinorelbine tartrate, marketed under the brand name Navelbine(R), is an anti-cancer agent that is approved to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin. Worldwide annual sales of Navelbine and generic vinorelbine in 2006 were approximately $200 million.
“Completing enrollment keeps us on schedule to announce results from this study next month and, if the results are succesful, to submit an NDA as early as next year,” said Evan M. Levine, chief executive officer of ADVENTRX. “Advancing ANX-530 is a key value-driver for this company and we are taking the steps to help ensure its success. We are preparing for a meeting with the FDA later this year and plan to provide an update regarding our NDA timeline for ANX-530 following that meeting.”
ANX-530 is currently being tested in a 28-patient bioequivalence study. The study is a crossover comparison of ANX-530 and Navelbine, also available as generic vinorelbine, with a primary endpoint of pharmacokinetic equivalence of ANX-530 and Navelbine. The safety of a single dose of ANX-530 is being evaluated as a secondary endpoint. The FDA has indicated that this single clinical study, should it demonstrate bioequivalence between ANX-530 and Navelbine, would provide sufficient clinical data to support the submission of an NDA.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of vinorelbine tartrate, a generic chemotherapy agent. ANX-530 is designed to reduce the incidence and severity of vein irritation from IV-delivery of vinorelbine tartrate. Vinorelbine tartrate works by disrupting microtubule formation and is a member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer and has also shown activity in breast, ovarian, and other cancers.
About Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows the Food and Drug Administration (FDA) to approve a follow-on drug on the basis of data in the scientific literature or conclusions regarding safety or effectiveness made by the FDA in the approval of other drugs. This regulatory pathway potentially makes it easier for drug manufacturers to obtain rapid approval of new forms of drugs based on the FDA’s approval of the original drug. Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration, formulation or indication. Upon approval, a drug may be marketed only for the FDA-approved indications in the approved dosage forms. Further clinical trials are necessary to gain approval for the use of the product for any additional indications or dosage forms. To the extent a Section 505(b)(2) applicant is relying on the FDA’s findings for an already-approved drug, the applicant is required to certify to the FDA concerning any patents listed for the approved drug in the FDA’s Orange Book publication, which may include a certification that listed patents are invalid or will not be infringed by the manufacture, use or sale of the new drug.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems such as drug metabolism, bioavailability, excessive toxicity and treatment resistance. More information can be found on the Company’s web site at http://www.adventrx.com.
Forward Looking Statement
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause ADVENTRX’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that results from ADVENTRX’s on-going marketing-enabling study will not indicate bioequivalence of ANX-530 and Navelbine; the FDA’s views on the appropriateness of seeking marketing approval of ANX-530 under Section 505(b)(2); difficulties or delays in manufacturing, marketing and obtaining regulatory approval for ANX-530, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-530 and other challenges by patent holders during the Section 505(b)(2) process; uncertainty under Section 505(b)(2) resulting from legal action against the FDA and the potential that future interpretations of Section 505(b)(2) could delay or prevent the FDA from approving any Section 505(b)(2) NDA; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; patent and non-patent exclusivity covering Navelbine; ADVENTRX’s lack of long-term agreements with suppliers of ANX-530 components and contract manufacturers of ANX-530, including its inability to timely secure commercial quantities of ANX-530 or its components on commercially reasonable terms, or at all; the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones, including funding the continued development of ANX-530; and other risks and uncertainties more fully described in ADVENTRX’s press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX’s public filings with the Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made.
CONTACT: Ioana C. Hone of ADVENTRX Pharmaceuticals, +1-858-552-0866
Web site: http://www.adventrx.com/
