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.
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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 ANX‑188, 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.