-- All-stock transaction (assuming stockholder approval)
-- Over 95% of merger consideration based on milestone
achievement
-- Over 75% of merger consideration based on NDA
acceptance/approval
-- Conference call to discuss pending acquisition today at
8:30 am ET
SAN DIEGO, Feb. 14, 2011 /PRNewswire via COMTEX/ --
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.