ADVENTRX Pharmaceuticals Inc. and Pierre Fabre Announce Manufacturing Agreement for ANX-188 Drug Substance
Published: Jun 12, 2012
SAN DIEGO and CASTRES, France, June 12, 2012 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) and Pierre Fabre Medicament today announced they have entered into a multi-year agreement under which Pierre Fabre, as contract manufacturer, will produce the active ingredient in ANX-188 (purified poloxamer 188) for use in clinical trials, including the Phase 3 study of ANX-188 that ADVENTRX plans to initiate this year.
For 10 years, Pierre Fabre has successfully developed highly technical manufacturing processes at its FDA-inspected facilities in Pau and Gaillac as a contract manufacturer for international pharmaceutical companies.
"We are delighted that the two companies have signed this multi-year agreement," said Frederic Duchesne, President Pharmaceuticals Division of Pierre Fabre. "Such a partnership is very exciting for the whole Pierre Fabre team. We are convinced of the high potential of ANX188, and our dedicated Supercritical Fluids unit, chosen by ADVENTRX to manufacture the ANX-188 active ingredient, will have the opportunity to put its cutting-edge expertise at the service of a unique manufacturing process."
"We continue to make progress in the development of ANX-188 and the Phase 3 study we plan to begin later this year. Pierre Fabre is an experienced manufacturer with an impeccable reputation for quality that manufactures a number of products for commercial sale," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "Working with Pierre Fabre will enhance our proprietary position in the unique manufacturing process we have developed for ANX-188 and the long-term commercial value of ANX-188."
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.
About Pierre Fabre
Pierre Fabre, the second largest independent pharmaceutical group in France, achieved a turnover of 1.9 billion Euros in 2011, with international sales accounting for 52%. Pierre Fabre has branches in 42 countries and markets its products in over 130 countries. Their activities cover all aspects of healthcare, from prescription drugs and family health products to dermo-cosmetics. The Pierre Fabre Laboratories employ some 10,000 people worldwide, 1,300 of whom are dedicated to R&D. In 2011, the group allocated 20% of its Pharmaceuticals business revenues to R&D, focusing on four main areas: oncology, dermatology, women's health and neuro-psychiatry. Pierre Fabre has made the choice to manufacture its own products to guarantee their quality through total control of the entire supply chain. Among its 9 production units, a dedicated unit of Pierre Fabre located in Gaillac (Tarn, South West of France) specialises in supercritical fluids.
Created in 2004, the Supercritical Fluids Division has developed proprietary knowledge in supercritical fluids technology for pharmaceutical applications and commercializes its cutting-edge expertise to external partners. Specialized in the purification of molecules using supercritical fluids, this Division has also developed different green patented processes (Formulplex®, Formuldisp® and Formulcoat®) for pre-formulation of Active Pharmaceutical Ingredients. Its facilities are composed of 2 units (development and production). It can handle quantities from a few grams up to several tons, and has a specific area for toxic and cytotoxic molecules. Supercritical fluid technology presents real opportunity for increasing bioavailability and/or solubility of poorly soluble drugs or taste-masking of bad-taste molecules. The Supercritical Fluids Division's facilities, development and production procedures are ICHQ7A-, GMP- and BPF (Bonnes Pratiques de Fabrication)-compliant, and it is certified as a Pharmaceutical establishment by French Health Authorities. To learn more about Pierre Fabre: www.pierre-fabre.com. To learn more about Pierre Fabre supercritical fluids: www.supercritical-solutions.com.
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 and progress for ANX-188, including the nature and timing of future clinical studies, intellectual property protection for ANX-188, ANX-188's potential as an effective treatment for sickle cell disease patients and the potential commercial value of 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 are 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.