Alle Storys
Keine Story von Vasogen Inc. mehr verpassen.

Vasogen Inc.

Vasogen and Grupo Ferrer Announce Initial Roll-out of Celacade - New Therapy for Chronic Heart Failure

Mississauga, Canada (ots/PRNewswire)

Vasogen Inc. (NASDAQ:VSGN;
TSX:VAS) and Grupo Ferrer Internacional, S.A.  ("Ferrer"), a leading
European  pharmaceutical and medical devices company,  today
announced the receipt of initial orders for Vasogen's Celacade(TM)
System in Germany. Celacade, a first-in-class therapy, is the only CE
Mark  approved product that specifically targets the destructive
chronic  inflammation underlying the development and progression of
chronic heart  failure. Under the CE Mark, Celacade can be marketed
in the 27 countries that  comprise the European Union and is
indicated in the EU for the treatment of  New York Heart Association
(NYHA) Class II patients and NYHA Class II, III, &  IV heart failure
patients who do not have a prior history of heart attack.
In the international ACCLAIM trial, Celacade was shown to
significantly  reduce the risk of death or cardiovascular
hospitalizations in large  pre-specified subgroups of patients with
chronic heart failure, including  NYHA Class II patients, where risk
was reduced by 39%, and NYHA Class II to  IV patients with no prior
heart attack, where risk was reduced by 26%. The  commercial
introduction of Celacade in the European Union provides physicians
and patients with a novel approach for the treatment of heart failure
that is  safe and well tolerated and can be used in combination with
currently  approved therapies for this condition.
"The initial orders for the Celacade System are a major milestone
for  Vasogen," commented Chris Waddick, President and CEO of Vasogen.
"We are  extremely pleased that Ferrer has secured these orders so
quickly after  completing key pre-marketing activities. We look
forward to continuing our  close collaboration with Ferrer as we work
to rapidly expand the use of  Celacade within the European Union."
"We are firmly committed to the success of Celacade in Europe,"
commented Dr. Carlos de Lecea, Vice President International and
Business  Development at Ferrer. "We are very pleased that the
initial orders are from  sites who participated in the ACCLAIM study,
which we believe reflects the  clinical benefits of Celacade and the
feedback the physicians received from  patients."
About Celacade:
The Celacade System targets the inflammation underlying chronic
heart  failure and other cardiovascular diseases. Inflammation is a
normal response  of the immune system to cellular injury caused by
infection, trauma, or other  stimuli. During the inflammatory
process, immune cells release a number of  factors, including
cytokines - potent chemical messengers that modulate  inflammation
and facilitate the healing process. While this inflammatory  process
is usually self-limiting, it can persist, become chronic, and lead to
a number of serious medical conditions.
During a brief outpatient procedure, a small sample of a patient's
blood is drawn into Vasogen's Celacade single-use disposable
cartridge and  exposed to controlled oxidative stress utilizing
Vasogen's proprietary  Celacade medical device technology. Oxidative
stress is a factor known to  initiate apoptosis, a physiologic
process that is inherently  anti-inflammatory. The treated blood is
then administered to the same patient  intramuscularly. An initial
course of treatment comprising three consecutive  outpatient
procedures is administered over a two-week period, and treatments
are continued once per month thereafter.
About Grupo Ferrer Internacional, S.A.:
Vasogen has entered into a collaboration with Grupo Ferrer
Internacional, a privately held European research and commercial
development  based pharmacochemical and medical devices company
headquartered in  Barcelona, Spain. Ferrer operates today in over 60
countries with the overall  aim to improve people's health and
quality of life. Based on its policy of  continuous expansion
throughout the world, Ferrer has established strong  industrial and
commercial operations in Europe and has extensive commercial
experience in Latin America, Africa, and in the Middle and Far East.
Ferrer  has licensing, distribution, and marketing agreements with
large  multinational pharmaceutical companies, as well as mid-size
firms, including  AstraZeneca, Astellas, Johnson & Johnson, Merck
Sharp & Dohme, Novartis,  Roche, Sanofi-Aventis, Solvay, Cephalon,
United Therapeutics, and The  Medicines Co., among others. In
addition to its commercial operations, Ferrer  operates
pharmaceutical research and development facilities in Barcelona,
Spain and Alsdorf, Germany. The research facilities in Barcelona
manage all  aspects of drug development from concept through to
clinical development and  product registration. The Alsdorf facility
is specialized in new applications  of pharmaceutical technology.
Ferrer also has established research  collaborations with a large
number of pharmaceutical companies and  universities throughout the
About Vasogen:
Vasogen is a biotechnology company engaged in the research and
commercial development of therapies designed to target the
destructive  inflammatory process associated with the development and
progression of  cardiovascular and neurodegenerative disorders. The
Company's lead product,  the Celacade System, is designed to activate
the immune response to  apoptosis - an important physiological
process that regulates inflammation.  Celacade is in late-stage
development for the treatment of chronic heart  failure and has
received European regulatory approval under the CE Mark for  this
indication. Vasogen is also developing a new class of drugs for the
treatment of certain neuro-inflammatory disorders. VP025 is the lead
drug  candidate from this new class.
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 Celacade(TM) or
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,  2006, 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.


For further information: Glenn Neumann, Investor Relations, 2505
Meadowvale Blvd., Mississauga, ON, Canada L5N 5S2; Tel:
+1-905-817-2004; Fax: +1-905-569-9231;

Weitere Storys: Vasogen Inc.
Weitere Storys: Vasogen Inc.
  • 18.04.2007 – 15:01

    Vasogen and Grupo Ferrer Form Collaboration to Commercialize Celacade(TM) in the European Union

    Toronto, Canada (ots/PRNewswire) - - Vasogen to Host Conference Call Today at 9:00 a.m. (ET) Vasogen Inc. (NASDAQ:VSGND; TSX:VAS) today announced a collaboration with Grupo Ferrer Internacional, S.A. ("Ferrer"), a leading European pharmaceutical and medical devices company, to commercialize Vasogen's Celacade(TM) technology for the treatment of chronic ...