SAN DIEGO, April 11, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has
completed its acquisition of SynthRx, Inc., now a wholly owned
subsidiary of ADVENTRX. SynthRx's lead product candidate is a
novel, proprietary, rheologic and antithrombotic compound,
poloxamer 188, that ADVENTRX will develop as ANX-188.
"With ANX-188, we add to our pipeline another late-stage asset
with multiple exciting development opportunities. We plan to
meet with FDA this year to reach agreement on a protocol for a
pivotal phase 3 study for treatment of sickle cell crisis in a
pediatric population, an orphan indication," said Brian M. Culley, Chief Executive Officer of
ADVENTRX. "Because sickle cell crisis is a severe and painful
condition often with life-threatening complications and for which
existing drugs provide only limited symptomatic relief, there is a
significant need to improve treatment options. Beyond sickle
cell, ANX-188 may have clinical utility in other acute events
related to microvascular-flow abnormalities, such as heart attack,
stroke and hemorrhagic shock."
As previously announced, ADVENTRX and SynthRx entered into a
definitive merger agreement in February
2011, which was completed on April 8,
2011. In connection with the closing, ADVENTRX issued
approximately 2.8 million shares of its common stock, of which
862,078 shares (or an approximately 3.3% ownership stake) are
vested and approximately 1.9 million are unvested. The
unvested shares will vest upon dosing of the first patient in a
phase 3 clinical study meeting certain criteria, subject to
reductions based on the timing of dosing of the first patient and
the anticipated size of the study. SynthRx stockholders also are
entitled to receive additional shares of common stock upon
successful achievement of development milestones consisting of
dosing of the first patient in a phase 3 clinical study meeting
certain criteria (subject to reduction as described above),
acceptance by the U.S. Food and Drug Administration (FDA) of a New
Drug Application (NDA) and approval by the FDA of an NDA. Of
the total shares issuable in connection with the acquisition, more
than 75% are contingent upon the FDA accepting and approving an NDA
covering ANX-188 to treat sickle cell crisis in children.
Should ADVENTRX's stockholders not approve the issuance of the
milestone-related shares as required by NYSE Amex listing
standards, ADVENTRX would pay SynthRx's stockholders 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 ANX-188 and all milestone payments payable in quarterly
installments.
The investment banking firm Canaccord Genuity Inc. advised
ADVENTRX and its Board of Directors in connection with the
transaction. Beal Advisors advised SynthRx.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company
focused on acquiring, developing and commercializing proprietary
product candidates. 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 development
opportunities and plans for ANX-188 and their timing, ANX-188's
ability to demonstrate clinical benefits for patients suffering
from sickle cell crisis and other microvascular-flow abnormalities
and the form of consideration payable to SynthRx's stockholders.
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: delays associated with the
development of ANX-188, including identifying and qualifying
contract manufacturers and contract research organizations and
developing and reaching agreement with FDA regarding a pivotal
phase 3 clinical study, including the potential for FDA to require
additional nonclinical or clinical work prior to initiating the
currently contemplated phase 3 clinical trial of ANX-188; the
potential that the cost and time required to develop ANX-188 are
greater than ADVENTRX's current expectations; the risk that
clinical study results do not support the safety and efficacy or
the commercial viability of ANX-188; 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 risk that the
neither the FDA nor any other regulatory agency approves a product
based on ANX-188 or any other product candidate developed using
technology acquired from SynthRx on a timely basis, or at all; the
potential that ADVENTRX may require substantial additional funding
to develop and commercialize ANX-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.