Vasogen Announces Implementation of Strategic Restructuring Plan
14 Aprile 2008 - 4:31PM
PR Newswire (US)
MISSISSAUGA, ON, April 14 /PRNewswire-FirstCall/ -- Vasogen Inc.
(NASDAQ:VSGN; TSX:VAS), today announced that it has implemented a
strategic restructuring plan to significantly reduce its cash burn
rate and focus its efforts on opportunities that the Board and
management believe are most likely to provide long-term shareholder
value. This plan re-focuses Vasogen's resources on the development
of its VP series of drugs while the Company seeks alternatives to
fund further development of the Celacade(TM) System, the Company's
technology for the treatment of chronic heart failure. As a result
of this restructuring, which reduces Vasogen's work force by
approximately 85%, the Company expects to have approximately two
years of cash resources. As previously reported, Vasogen has
encountered significant delays with the FDA regarding the design of
ACCAIM II, a clinical trial to support an application for U.S.
market approval of Celacade for the treatment of patients with NYHA
Class II heart failure. Given these delays, Vasogen's current lack
of access to capital, and the uncertainty surrounding the FDA's
continued opposition to a relatively small trial utilizing a
Bayesian statistical design, the Company has placed on hold plans
to fund ACCLAIM II. The Company will, however, continue to work
with the FDA towards finalizing the design of ACCLAIM II, and will
evaluate potential strategic alternatives to fund such a study. In
addition, subsequent to the recent receipt of a much lower than
anticipated revenue forecast for Celacade from its European
marketing partner, Grupo Ferrer, Vasogen plans to discontinue
operational and financial support for European commercialization
and is exploring alternative strategies with Ferrer. Ferrer's sales
forecast was impacted by the uncertainty surrounding ACCLAIM II.
"We cannot financially justify maintaining our existing
infrastructure in light of the regulatory challenges facing ACCLAIM
II and the revenue forecast received from Ferrer. That said, the
science underlying Celacade remains strong and we continue to
believe that the rationale for its therapeutic use in the treatment
of certain heart failure patients was evident in the subgroup
analysis from the ACCLAIM trial. For these reasons, we plan to
explore opportunities to support the further development of
Celacade in the US and continue working with Ferrer to evaluate
alternative strategies to support the commercialization of Celacade
in Europe," commented Chris Waddick, President and CEO of Vasogen.
"This has been a challenging process, but through the measures
announced today we believe that we have a plan that allows us to
conserve our financial resources, while executing a strategy
focused on rebuilding shareholder value. We are deeply grateful for
the contributions of the many talented and dedicated employees
whose positions are impacted by this restructuring, and thank them
for all their hard work." "We have developed significant expertise
and intellectual property in the area of immune system modulation
to treat inflammatory disorders, with data acquired from numerous
preclinical models of human disease. I continue to be very excited
by the potential of our VP series of drugs including VP015 and
VP025," commented Dr. Anthony Bolton, Chief Scientific Officer of
Vasogen. "Extensive preclinical research has been conducted with
both of these drug candidates and we are impressed with their
ability to reduce markers of inflammation and improve outcome
measures across a number of experimental models. The understanding
of the role of inflammation in a wide range of human diseases
continues to grow and treatments that regulate different aspects of
inflammation have become a key focus for researchers
internationally." The Company will incur cash expenditures of
approximately $2.6 million during the second quarter related to the
restructuring. Vasogen has also retained JMP Securities to assist
it in exploring other potential strategic alternatives with the
goal of enhancing shareholder value. About the VP Series of Drugs
Vasogen's VP series of drug assets are based on synthetic
three-dimensional phospholipid-based structures with specific
groups of surface molecules, and are designed to modulate cytokine
levels and control inflammation. VP025, the lead product candidate
from this new class of drugs, is currently being developed for the
treatment of neuro-inflammatory disorders. VP015 is an additional
product candidate from this new class of drugs, with the potential
to treat other inflammatory conditions. Many neurological
conditions, including Alzheimer's disease, Parkinson's disease, and
amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's
disease), are associated with an inflammatory response in the
nervous system. The Company has completed a considerable amount of
preclinical work that has demonstrated the ability of VP025 to
reduce inflammation in models of certain neurodegenerative
disorders, including Parkinson's disease, memory loss models, ALS,
and retinal inflammation in a model of diabetes. About Vasogen
Vasogen is a biotechnology company engaged in the research and
development of therapies designed to target the destructive
inflammatory process associated with the development and
progression of cardiovascular and neurodegenerative disorders.
Certain statements contained in this press release, or elsewhere in
our public documents constitute "forward-looking statements" within
the meaning of the United States Private Securities Litigation
Reform Act of 1995 and/or "forward-looking information" under the
Securities Act (Ontario). These statements may include, without
limitation, plans to advance the development of the Celacade(TM)
System or our VP Series of drugs including VP015 and VP025, plans
to fund our current activities, statements concerning our
partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future revenues and
projected costs. In some cases, you can identify forward-looking
statements by terminology such as "may", "will", "should",
"expects", "plans", "anticipates", "believes", "estimated",
"predicts", "potential", "continue", "intends", "could", or the
negative of such terms or other comparable terminology. We made a
number of assumptions in the preparation of these forward-looking
statements, including assumptions about the nature, size, and
accessibility of the market for Celacade in the treatment of
chronic heart failure, particularly in Europe, the regulatory
approval process leading to commercialization and the availability
of capital on acceptable terms to pursue the development of
Celacade, and the feasibility of additional trials. You should not
place undue reliance on our forward-looking statements which are
subject to a multitude of risks and uncertainties that could cause
actual results, future circumstances or events to differ materially
from those projected. These risks include, but are not limited to,
the outcome of further ongoing analysis of the ACCLAIM trial
results, the requirement or election to conduct additional clinical
trials and the size and design of any such trials, delays or
setbacks in the regulatory approval process, difficulties in the
maintenance of existing regulatory approvals, securing and
maintaining corporate alliances, the need for additional capital
and the effect of capital market conditions and other factors on
capital availability, the potential dilutive effects of any
financing, risks associated with the outcomes of our preclinical
and clinical research and development programs, the adequacy,
timing, and results of our clinical trials, competition, market
acceptance of our products, the availability of government and
insurance reimbursements for our products, the strength of
intellectual property, reliance on partners, subcontractors, and
key personnel, losses due to fluctuations in the U.S.-Canadian
exchange rate, and other risks detailed from time to time in our
public disclosure documents or other filings with the Canadian and
U.S. securities commissions or other securities regulatory bodies.
Additional risks and uncertainties relating to our Company and our
business can be found in the "Risk Factors" section of our Annual
Information Form and Form 20-F for the year ended November 30,
2007, as well as in our later public filings. The forward-looking
statements are made as of the date hereof, and we disclaim any
intention and have no obligation or responsibility, except as
required by law, to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise. DATASOURCE: Vasogen Inc. CONTACT: Glenn Neumann,
Investor Relations, 2505 Meadowvale Blvd, Mississauga, ON, Canada,
L5N 5S2, tel: (905) 817-2004, fax: (905) 569-9231,
http://www.vasogen.com/,
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