AEterna Zentaris Receives Regulatory Approval for Impavido(R) in Germany
December 06 2004 - 7:30AM
PR Newswire (US)
AEterna Zentaris Receives Regulatory Approval for Impavido(R) in
Germany QUEBEC CITY, Dec. 6 /PRNewswire-FirstCall/ -- AEterna
Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced that it has
received German Food and Drug Agency (BfarM) approval for
miltefosine (Impavido(R)), the first-ever orally- administered,
breakthrough therapy for visceral and cutaneous leishmaniasis, a
parasitic disease estimated to affect millions of people worldwide.
The approval enables AEterna Zentaris to market Impavido(R) in
Germany, as well as to distribute it to military personnel who have
become infected with leishmaniasis while serving in Afghanistan and
Iraq. In addition, the German regulatory approval enables AEterna
Zentaris to receive a Free Sales Certificate (FSC), which can
provide the basis for registration in countries where leishmaniasis
is endemic, such as Colombia and Pakistan. Impavido(R), or
miltefosine, is an alkylphospholipid that has been marketed in
India since 2003 through cooperation with German Remedies (a member
of Zydus Cadila). It is the first orally administered therapy for
visceral and cutaneous leishmaniasis, a parasitic infection, also
known as black fever, which affects millions of people and is,
according to WHO, endemic in 88 countries in the world with nearly
350 million people at risk. It is estimated that 12 million people
currently suffer from this disease with 1-1.5 million new cases
reported annually. Leishmaniasis is a very virulent tropical
disease, second only to malaria. The cure rate of Impavido(R) is
95%, even in patients resistant to antimony-based standard therapy.
Leishmaniasis is transmitted by sand flies. The symptoms of
visceral leishmaniasis include fever, spleen and liver enlargement,
blood deficiencies, bleeding of mucous membranes, and severe weight
loss. If left untreated, visceral leishmaniasis can lead to death
within 0.5-2 years. The cutaneous form of leishmaniasis, although
not deadly, is a chronic, severely disfiguring condition. In
Europe, leishmaniasis is a growing problem, especially in the
southern regions where, until recently, it was not considered
endemic. Immunocompromised HIV patients, in particular those with
AIDS, are at an increased risk for this life-threatening disease
with approximately 25%-70% of leishmaniasis cases in Southern
Europe being associated with HIV infection. HIV patients are also
particularly susceptible to repeated recurrences of leishmaniasis
due to their immune system's inability to fight off the infection.
Recently, in November 2004, AEterna Zentaris announced a
publication in the peer-reviewed Clinical Infectious Diseases
Journal, demonstrating the therapeutic utility and favourable
tolerability of oral miltefosine (Impavido(R)) as an initial and
maintenance treatment of recurrent visceral leishmaniasis in
immunocompromised HIV-infected patients. "In addition to providing
an orally-effective new medication with the potential to alleviate
some human suffering from this horrible disease which unfortunately
affects mostly the poorest people on earth, this approval
represents the culmination of twenty years of Research and
Development work conducted by Dr. Jurgen Engel and his colleagues
from the World Health Organization, the Max Planck Institute and
the University of Goettingen in Germany", said Gilles Gagnon,
President and Chief Executive Officer at AEterna Zentaris. "Dr.
Engel, our Executive Vice President, Global R&D and Chief
Operating Officer, won the Galien Prize in 1995 in Germany for the
discovery and development of this alkylphospholipid-based product,
today recognized as an innovative medicine that can cure this
potentially lethal disease which has now spread even to some parts
of Southern Europe." About AEterna Zentaris Inc. AEterna Zentaris
Inc. is a biopharmaceutical company focused in oncology and
endocrine therapy. Its extensive portfolio, from drug discovery to
marketed products, includes cetrorelix and perifosine. Cetrorelix,
an LHRH antagonist already marketed for in vitro fertilization
under the brand name Cetrotide(R), is also in advanced clinical
development for the treatment of uterine myoma, endometriosis and
benign prostatic hyperplasia (BPH). Perifosine, an orally-active
AKT inhibitor, is in several Phase II trials for multiple cancers.
AEterna Zentaris also owns 60% of Atrium Biotechnologies Inc.,
which develops, manufactures and markets active ingredients,
specialty fine chemicals, cosmetic and nutritional products for the
cosmetics, chemical, pharmaceutical and nutritional industries.
News releases and additional information about AEterna Zentaris are
available on its new Web site http://www.aeternazentaris.com/ .
Forward-Looking Statements This press release contains
forward-looking statements made pursuant to the safe harbor
provisions of the U.S. Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks and
uncertainties, which could cause the Company's actual results to
differ materially from those in the forward-looking statements.
Such risks and uncertainties include, among others, the
availability of funds and resources to pursue R&D projects, the
successful and timely completion of clinical studies, the ability
of the Company to take advantage of business opportunities in the
pharmaceutical industry, uncertainties related to the regulatory
process and general changes in economic conditions. Investors
should consult the Company's quarterly and annual filings with the
Canadian and U.S. securities commissions for additional information
on risks and uncertainties relating to the forward-looking
statements. Investors are cautioned not to rely on these
forward-looking statements. The Company does not undertake to
update these forward- looking statements. DATASOURCE: AETERNA
ZENTARIS INC. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
CONTACT: Media Relations: Paul Burroughs, (418) 652-8525, ext. 406,
; Investor Relations: Jacques Raymond, (418) 652-8525, ext. 360, ;
U.S. Investor Relations: Lippert/Heilshorn & Associates, Kim
Golodetz, (212) 838-3777, ; Europe: Dr. Mathias Pietras, +49 69
42602 3423, To request a free copy of this organization's annual
report, please go to http://www.newswire.ca/ and click on
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