AEterna Zentaris Receives First Regulatory Approval for Impavido(R) for Parasitic Skin Disease
March 23 2005 - 7:31AM
PR Newswire (US)
AEterna Zentaris Receives First Regulatory Approval for Impavido(R)
for Parasitic Skin Disease QUEBEC CITY, March 23
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) today announced it has received Colombian Food and Drug
Agency approval for Impavido(R) (miltefosine), to treat the
cutaneous form of leishmaniasis, a severe parasitic skin disease
estimated to affect millions of people worldwide. This is the
first-ever approval of Impavido(R) for this form of leishmaniasis.
The approval also applies for the visceral form (black fever) of
leishmaniasis for which Impavido(R) had already received approval
by the Indian and German Regulatory Authorities. Impavido(R) thus
becomes the first orally-administered, breakthrough therapy for
both visceral and cutaneous leishmaniasis. Impavido(R), or
miltefosine, is an alkylphospholipid that has been marketed in
India since 2003 through cooperation with the Zydus Cadila Group
and is available in Germany via AEterna Zentaris' partner Paesel +
Lorei. In order to optimize Latin American distribution of
Impavido(R) following the approval, AEterna Zentaris has granted
distribution rights for Colombia to Tecnofarma, a leading Latin
American pharmaceutical company. Tecnofarma thus holds rights to
the drug for the entire Latin American territory excluding only
Brazil, where Roche has been granted marketing rights. Tecnofarma
is currently preparing the filing of Impavido(R) in several other
Latin American countries. "Everything is in place for a first
delivery of Impavido(R) to Colombia very shortly", said Prof.
Jurgen Engel, Executive Vice President Gobal R&D and Chief
Operation Officer at AEterna Zentaris and added, "We were hoping
that German approval of Impavido(R), received only in December last
year, could form the basis for registration in other countries
where leishmaniasis is endemic, such as Colombia. Only three months
later, we are proud to deliver on that expectation. It is our goal
to place Impavido(R) as a worldwide standard therapy for both
cutaneous and visceral leishmaniasis." According to Gilles Gagnon,
President and Chief Executive Officer at AEterna Zentaris, the
impact of the approval is at least twofold. "We are excited about
the progress of our efforts to make this innovative drug available
to patients. The approval and the subsequent roll-out of the
product also has a strategic dimension in that we can further
diversify the business risk of our pharmaceutical activities while
optimizing return for investors. With two products on the market
generating revenues, Cetrotide(R) and Impavido(R), we are further
establishing a solid financial basis to support the development of
our promising earlier pipeline projects." About Leishmaniasis
Leishmaniasis is a severe tropical disease, second only to malaria.
Transmitted by sand flies, leishmaniasis affects millions of people
and is, according to the World Health Organisation, endemic in 88
countries throughout 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. The
cure rate of Impavido(R) is 95%, even in patients resistant to
antimony-based standard therapy. Symptoms of the visceral form of
the disease 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. About
Tecnofarma Technofarma is a leading Latin American company engaged
in the production, promotion and marketing of pharmaceutical
products. Founded in 1971, it has established branch companies in
fourteen countries, including Mexico and Central America, with over
1 200 pharmaceutical sales representatives. In 2004, its annual
sales were US$159 million. About AEterna Zentaris Inc. AEterna
Zentaris Inc. is an oncology and endocrine therapy focused
biopharmaceutical company with proven expertise in drug discovery,
development and commercialization. The Company's broad 20 product
pipeline leverages five different therapeutic approaches, including
LHRH antagonists and signal transduction inhibitors. The lead LHRH
antagonist compound, cetrorelix, is currently marketed for in vitro
fertilization under the brand name Cetrotide(R). Cetrorelix is also
in late-stage clinical development for endometriosis and benign
prostatic hyperplasia (BPH). The lead signal transduction inhibitor
compound, perifosine, is an orally-active AKT inhibitor in several
Phase II trials for multiple cancers. AEterna Zentaris owns 61.1%
of Atrium Biotechnologies Inc., a leading developer, manufacturer
and marketer of value-added products for the cosmetics,
pharmaceutical, chemical and nutritional industries. News releases
and additional information about AEterna Zentaris are available on
its 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: Ginette Vallieres, (418) 652-8525, ext. 265,
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