SAN DIEGO, Feb. 14, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has
entered into a definitive agreement to acquire SynthRx, Inc.
(SynthRx), a private biotechnology company developing a purified
form of a rheologic and antithrombotic agent, poloxamer 188
(188).
"The acquisition of SynthRx will be a transformative event for
ADVENTRX, adding another late-stage asset to our pipeline," stated
Brian M. Culley, Chief Executive
Officer of ADVENTRX. "The all-stock, milestone-based deal structure
is a win for ADVENTRX and its stockholders in that it allows us to
retain our cash for development activities and, other than a modest
upfront equity payment, ensures we pay only as the 188 program
achieves success. I'm pleased that we would have the data
from the planned phase 3 study in-hand while having paid less than
25% of the total deal consideration."
"The 188 program will fit well with our existing assets and
provide several exciting development opportunities. We would plan
to meet with the FDA later this year to reach agreement on a
protocol for a pivotal phase 3 study for the treatment of sickle
cell crisis in a pediatric population, for which 188 has orphan
drug designation. Sickle cell patients are an under-served
population suffering from an excruciatingly painful condition with
limited palliative options. Beyond sickle cell, we believe 188 has
clinical benefits in other acute events related to
microvascular-flow abnormalities, such as heart attack, stroke and
hemorrhagic shock," Mr. Culley continued.
Under the terms of the all-stock transaction, SynthRx would
become a wholly-owned subsidiary of ADVENTRX in exchange for shares
of ADVENTRX common stock representing, in the aggregate, an
approximately 4% ownership stake in ADVENTRX. SynthRx
stakeholders also would be entitled to receive additional shares of
common stock upon successful achievement of development milestones
consisting of dosing the first patient in a phase 3 clinical study,
acceptance by the U.S. Food and Drug Administration (FDA) of a New
Drug Application (NDA) and approval by the FDA of an NDA. If
all milestones are achieved without reduction, the number of shares
issued in connection with the acquisition would, in the aggregate,
represent an approximately 40% ownership stake in ADVENTRX (based
on currently outstanding shares plus shares issued in connection
with the acquisition). Of the total number of shares issuable, more
than 75% are based on NDA acceptance and approval.
If ADVENTRX's stockholders do not approve the issuance of the
milestone-related shares as required by NYSE Amex listing
standards, ADVENTRX expects to pay SynthRx's stakeholders in cash
the value of the shares it otherwise would have issued, with the
NDA acceptance and NDA approval milestone payments payable based on
net sales of 188 and all milestone payments payable in quarterly
installments.
About Poloxamer 188
Poloxamer 188 is a nonionic block copolymer surfactant that is
believed to adhere to hydrophobic surfaces that develop when cells
are damaged. It has been shown to restore hydration lattices and
minimize the cascade of adhesive, inflammatory and coagulation
responses that cause adhesion of cells, impaired blood flow and
tissue ischemia. Improving blood flow in the microvasculature may
benefit patients with sickle cell disease in acute crisis, which is
associated with microvascular occlusion. Formulations of 188 have
been extensively studied in numerous clinical trials, including a
2,950-patient, randomized, controlled study in acute myocardial
infarction.
SynthRx's lead product candidate, a purified form of poloxamer
188, is an investigational product intended to treat micro-vascular
disorders. Purified poloxamer 188 has been evaluated in multiple
clinical studies, including a 255-patient, randomized,
double-blind, placebo-controlled phase 3 study in patients with
sickle cell disease in acute vaso-occlusive crisis. The FDA
has granted orphan drug designation for poloxamer 188 for the
treatment of sickle cell crisis.
About Sickle Cell Disease and Sickle Cell Crisis
Sickle cell disease (SCD) or sickle cell anemia (SCA) is a
genetic, autosomal, recessive blood disorder characterized by red
blood cells that assume an abnormal, rigid, sickle shape. This
sickling is caused by an abnormality in the hemoglobin molecule
found in red blood cells which carry oxygen throughout the body.
Sickled red blood cells cannot pass through capillaries and may
occlude capillaries and small blood vessels. This blockage can
cause a wide range of serious and life-threatening conditions,
including chronic hemolytic anemia, chronic pain and acute painful
crisis, stroke, acute chest syndrome, as well as cumulative damage
to tissues and organs.
Patients with SCD experience an average life expectancy of
approximately 40 years. According to the National Institutes of
Health (NIH) and the Sickle Cell Disease Association of America
(SCDAA), it is estimated that over 70,000 people have sickle cell
disease and about 1,000 babies are born with the disease each year
in the United States.
Vaso-occlusive crisis is caused by sickle-shaped red blood cells
that obstruct capillaries and restrict blood flow to an organ,
resulting in ischemia (restriction of blood supply), pain,
necrosis, and often organ damage. The frequency, severity, and
duration of these crises can vary considerably.
Conference Call Information
ADVENTRX will hold a conference call today at 8:30 am ET to discuss the potential acquisition.
Interested parties may access the conference call by dialing (800)
860-2442 from the U.S. and (412) 858-4600 from outside the U.S. and
requesting the ADVENTRX Pharmaceuticals Corporate Update Call. The
webcast will be available live via the Internet by accessing the
Investors section of ADVENTRX's website at http://ir.adventrx.com.
Replays of the webcast will be available on the Company's website
for 30 days and a phone replay will be available through
February 19, 2011 by dialing (877)
344-7529 from the U.S. and (412) 317-0088 from outside the U.S. and
entering conference reference number 448547.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company
focused on acquiring, developing and commercializing proprietary
product candidates principally for the treatment of cancer.
More information can be found on the Company's web site at
www.adventrx.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 the form of
consideration payable to SynthRx's stakeholders, development plans
for 188, and 188's ability to demonstrate clinical benefits for
patients suffering from sickle cell crisis and other
microvascular-flow abnormalities. Actual events or results
may differ materially from those expressed or implied by the
forward-looking statements in this press release due to a number of
risks and uncertainties, including, without limitation: the risk
that ADVENTRX does not consummate its acquisition of SynthRx on a
timely basis, or at all; the potential that ADVENTRX's stockholders
do not approve the issuance of the milestone-related shares and
ADVENTRX must pay the cash value of those shares, to the extent the
milestones are achieved; the risk that ADVENTRX may not be able to
integrate SynthRx's assets successfully into its operations or that
it may incur unexpected costs and disruptions to its business as a
result of such integration; the potential for the FDA to require
ADVENTRX to perform additional nonclinical or clinical studies
prior to initiating or following completion of the currently
contemplated phase 3 clinical trial of 188 for the treatment of
sickle cell crisis; the risk that subsequent nonclinical or
clinical study results do not support the safety and efficacy or
the commercial viability of 188 or any other product candidate
developed using technology acquired from SynthRx; the risk that the
neither the FDA nor any other regulatory agency approves a product
based on 188 or any other product candidate developed using
technology acquired from SynthRx on a timely basis, or at all; the
potential for the out-of-pocket cost to ADVENTRX and the time
required for development of 188 necessary to support an NDA
submission are greater than ADVENTRX's current expectations; the
risk that 188 loses its orphan drug designation for the treatment
of sickle cell crisis or that a third party's product candidate is
shown to be clinically superior and is approved by the FDA during
188's market exclusivity period; the risk that individuals
previously involved in the development of 188 will not assist
ADVENTRX in further development of 188 and that ADVENTRX may be
unable to retain the services of other qualified individuals on a
timely basis, or at all; ADVENTRX's planned reliance on third
parties to assist with its nonclinical and clinical studies,
regulatory submissions, manufacturing and other important aspects
of the 188 development program, if it consummates its acquisition
of SynthRx, and the risk that FDA approval may be delayed if their
performance is found to be substandard; the potential that ADVENTRX
may require substantial additional funding in order to obtain FDA
approval for and commercialize 188, and the risk that ADVENTRX may
not be able to raise sufficient capital when needed, or at all; 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.