ADVENTRX Pharmaceuticals Inc. Announces Manufacturing Agreement With Patheon Inc. to Manufacture ANX-188 Drug Product
Published: Jun 26, 2012
SAN DIEGO, June 26, 2012 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that is has entered into a multi-year agreement with Patheon Inc. under which Patheon will formulate, fill and finish ANX-188 drug product for use in clinical trials, including the phase 3 study of ANX-188 that ADVENTRX plans to initiate this year.
"This agreement is another step toward initiating the phase 3 study of ANX-188 in patients with sickle cell disease," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "Patheon is a global contract manufacturer that serves more than 300 customers, including many of the world's largest pharmaceutical and biotechnology companies. I am confident in their manufacturing expertise, experienced staff and world-class facilities and pleased to partner with them for the manufacture of ANX-188 clinical trial material."
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on developing proprietary product candidates. The Company's lead product candidate is ANX-188, a rheologic, antithrombotic and cytoprotective agent that improves microvascular blood flow and has potential application in treating a wide range of diseases and conditions, such as complications arising from sickle cell disease. More information can be found on the Company's web site at www.adventrx.com.
Patheon is a leading global provider of contract dosage form development and manufacturing services to the pharmaceutical and biotechnology industries. Patheon provides fully integrated contract manufacturing and development solutions to its customers, from early development through to high-volume commercial manufacturing and packaging.
Patheon's development and manufacturing capabilities cover prescription (Rx) products in solid, softgel and liquid dosage forms, as well as specialized capabilities in high-potency, cephalosporin, controlled/sustained release and sterile manufacturing, including aseptic filling and lyophilization.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding ADVENTRX's development plans for ANX-188, including the nature and timing of future clinical studies, and Patheon's manufacturing capabilities with regard to ANX-188. Among the factors that could cause or contribute to material differences between ADVENTRX's actual results and those indicated from the forward-looking statements are risks and uncertainties inherent in ADVENTRX's business, including, but not limited to: the potential for ADVENTRX to delay, reduce or discontinue current and/or planned development activities, partner its product candidates at inopportune times or pursue less expensive but higher-risk development paths if it is unable to raise sufficient additional capital as needed; ADVENTRX's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for delays in the commencement or completion of its planned clinical studies including as a result of difficulties or delays in completing manufacturing process development activities and manufacturing clinical trial material; the risk of suspension or termination of a clinical study including due to lack of adequate funding; the risk that planned clinical studies of ADVENTRX's product candidates, including ANX-188, are not successful and, even if they are successful, that the FDA could determine they are not sufficient to support an NDA for the product candidate; the risk that the FDA does not grant market approval of ADVENTRX's product candidates, including ANX-188, on a timely basis, or at all; ADVENTRX's reliance on third parties to assist in the conduct of important aspects of its product candidates' development programs, including the manufacture of clinical trial material, the conduct of clinical studies and regulatory submissions related to product approval, and that such third parties may fail to perform as expected; the risk that intellectual property protection ADVENTRX obtains with respect to its product candidates, including ANX-188, is insufficient to provide a competitive advantage; 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 www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
SOURCE ADVENTRX Pharmaceuticals, Inc.