Research Update
September 02 2003 - 8:08AM
UK Regulatory
BW20030902002026 20030902T120839Z UTC
( BW)(IVAX-CORPORATION)(IVX) Research Update
Business Editors
UK REGULATORY NEWS
MIAMI--(BUSINESS WIRE)--Sept. 2, 2003--
IVAX Submits First NDA for Easi-Breathe in U.S.
IVAX Corporation (AMEX:IVX)(LSE:IVX.L) has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for
approval to market a CFC-free formulation of albuterol in IVAX'
patented Easi-Breathe(R) inhaler. Already marketed successfully in
several countries around the world, the Easi-Breathe inhaler
eliminates the need to coordinate the release of the medication and
its inhalation. Such coordination, required by standard metered dose
inhalers, can be a troublesome for some patients, particularly the
young and elderly. Easi-Breathe is the best selling breath-activated
aerosol inhaler in the United Kingdom, the world's second largest
asthma market. Albuterol is the most widely used "rescue" medicine
taken by asthma sufferers for acute attacks. Easi-Breathe CFC-free
albuterol is the first submission of an NDA on an IVAX Easi-Breathe
product in the United States. In January 2003, IVAX submitted an NDA
for CFC-free albuterol in a standard metered dose inhaler and that
application is pending.
"This NDA submission is an important milestone for IVAX," said Neil
Flanzraich, vice chairman and president of IVAX Corporation. "We have
been selling our Easi-Breathe inhalers abroad for years, and now we
are bringing this important product to the U.S., the largest asthma
market in the world, by far. We believe that our CFC-free Easi-Breathe
product will be used by a substantial number of asthma patients and
will achieve a significant market share."
IVAX has had a long-standing commitment to provide CFC-free inhalers
for the treatment of asthma. In 1997, IVAX became the first company in
the world to receive approval to market CFC-free beclomethasone.
Today, IVAX markets CFC-free beclomethasone and CFC-free albuterol
abroad in both MDI and Easi-Breathe inhalers. Over 40 million
albuterol inhalers were sold in the U.S. last year; more than 90%
employed CFC propellants and these are expected to be removed from the
market due to concerns that CFC's contribute to the depletion of the
ozone layer.
In the U.S., IVAX currently markets QVAR(R), a CFC-free formulation of
beclomethasone dipropionate, the only CFC-free aerosol corticosteroid
sold in the United States to treat asthma. While albuterol is a
"rescue" medication used to treat asthma attacks, beclomethasone is a
"maintenance" medicine used to prevent them.
IVAX Corporation, headquartered in Miami, Florida, discovers,
develops, manufactures, and markets branded and brand equivalent
(generic) pharmaceuticals and veterinary products in the U.S. and
internationally.
Copies of this and other news releases may be obtained free of charge
from IVAX' website at http://www.ivax.com.
This press release contains certain forward-looking statements
regarding product development efforts and product performance and
other non-historical facts which are being made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of
1995. These statements involve risks and uncertainties that cannot be
predicted or quantified and, consequentially, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
among others, that the FDA may not accept IVAX' NDA or approve this
product; that the FDA may not approve IVAX' pending NDA for its
standard metered dose inhaler product; the difficulty of predicting
the timeliness or outcome of product development efforts and the
filing of regulatory applications; FDA and other requisite regulatory
authorizations may be achieved later than anticipated or not at all;
market share and demand for IVAX' Easi-Breathe inhaler may not be as
anticipated; that CFC propellants may not be removed from the market;
and the impact of competitive products and pricing and successful
compliance with extensive, costly, complex and evolving governmental
regulations and restrictions. In addition to the risk factors set
forth above, IVAX' forward looking statements may also be adversely
affected by general market factors, competitive product development,
product availability, federal and state regulations and legislation,
the regulatory process for new products and indications, manufacturing
issues that may arise, trade buying patterns, patent positions and
litigation, among other things. For further details and discussion of
these and other risks and uncertainties, see IVAX' Annual Report on
Form 10-K and other filings with the Securities and Exchange
Commission.
Short Name: IVAX Corporation
Category Code: RES
Sequence Number: 00009150
Time of Receipt (offset from UTC): 20030829T223814+0100
--30--EG/mi* FLB/ny
CONTACT: IVAX Corporation, Miami
David Malina, 305-575-6043
KEYWORD: FLORIDA UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL PRODUCT
SOURCE: IVAX Corporation
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