SAN DIEGO, Feb. 22 /PRNewswire/ -- Dura Pharmaceuticals, Inc. (Dura)
(Nasdaq: DURA) and Spiros Development Corporation II, Inc. (Spiros Corp. II)
(Nasdaq: SDCOZ) jointly provided an update today on the ongoing development of
the respiratory products using Dura's proprietary Spiros(R) pulmonary delivery
technology. As result of a series of meetings since November 1998 with the
U.S. Food and Drug Administration (FDA), Dura and Spiros Corp. II have
determined the requirements for the Albuterol Spiros(TM) clinical trial
program and defined the major outstanding chemistry, manufacturing and control
(CMC) issues to be addressed to support the resubmission of the new drug
application (NDA) for the product. On behalf of Spiros Corp. II, Dura plans
to initiate an open-label clinical trial involving 6-month patient dosing, as
well as supporting clinical studies, to demonstrate reliability and efficacy
of the to-be-marketed inhaler in patients and to strengthen the support for
desired labeling claims.
Additionally, Dura and Spiros Corp. II have decided to enhance the
development priority of the Spiros(R) inhaled steroid products. "Based on our
on-going analysis of the opportunity for the Spiros(R) system in the
respiratory market, we see an advantage in placing beclomethasone and
albuterol on independent, nearly parallel regulatory tracks," stated David
Kabakoff, Dura's President, Dura Technologies and Chairman, President and CEO,
Spiros Development Corp. II. "For Beclomethasone Spiros(TM), we plan to
initiate an independent open-label study and supporting clinical trials to
complete our NDA submission. The details of these studies will be determined
in future discussions with the FDA. Our goal is to begin clinical programs
for both beclomethasone and albuterol in the fourth quarter of this year and,
pending FDA review and approvals, to commercialize both products in 2001."
"As previously announced, our objective for the second inhaled steroid
product in development, budesonide, is to initiate clinical studies this
year," Dr. Kabakoff continued. "We will be focusing resources principally on
the development of the inhaled steroid products and albuterol, so we will
temporarily suspend work on the ipratropium and albuterol/ipratropium
combination products and will review the opportunity for these products at a
later date. We are committed to resolving the technical challenges at hand
and we remain very enthusiastic about the market potential of the Spiros(R)
respiratory product line, as these products, pending approval, will be
significant potential additions to Dura's product portfolio."
The Spiros(R) line of respiratory products, including Albuterol
Spiros(TM), Beclomethasone Spiros(TM), and Budesonide Spiros(TM), is being
developed by Dura on behalf of Spiros Corp. II as a novel means of delivering
medication to the lungs. The Spiros(R) delivery system is comprised of two
components, an inhaler that aerosolizes powdered drug, and a powder storage
system, such as a cassette, that stores pre-measured doses of drug. The
Spiros(R) products, pending approval, are expected to compete in the U.S.
market for inhaled asthma medications, which totaled approximately $2 billion
in 1998. Metered dose inhalers (MDIs) currently represent the most common
method of respiratory drug delivery to the lungs. Most MDIs contain
chlorofluorocarbon (CFC) propellants, which deplete the ozone layer and are
subject to worldwide regulations aimed at eliminating their use. MDIs also
generally require press-and-breathe coordination that many patients are unable
to properly perform.
Dura Pharmaceuticals, Inc. is a San Diego based developer and marketer of
prescription pharmaceutical products for the treatment of allergies, asthma,
pneumonia and related respiratory conditions. Dura has focused on the U.S.
respiratory market because of its size and growth opportunities through two
major strategies: (1) acquiring prescription pharmaceuticals and/or
businesses developing or marketing such pharmaceuticals to support its
marketing presence in high-prescribing respiratory physicians' offices and/or
the hospital market, and (2) developing Spiros(R), a pulmonary drug delivery
system for both topical and systemic delivery of medications.
Spiros Development Corporation II, Inc. is a public company formed
primarily to fund the continued development of Spiros(R), a proprietary
pulmonary drug delivery system of Dura Pharmaceuticals, Inc., and to conduct
formulation work, clinical trials and commercialization for defined
respiratory drugs in Dura's Spiros(R) inhalation system.
Except for the historical and factual information contained herein, the
matters discussed in this press release may contain forward-looking statements
which involve risks and uncertainties, including market conditions,
competitive products and pricing, the timely development of the Spiros(R)
system, the timely receipt of FDA approval of Spiros(R) products, if at all,
Dura's limited manufacturing experience, Spiros Corp. II's limited supply and
availability of future funding, Dura's exercise, if at all, of options to
acquire products or capital stock of Spiros Corp. II, dependency upon third
parties and their successful development efforts and other risks detailed from
time to time in each of the companies' filings with the Securities and
Exchange Commission. Actual results may differ materially from those
projected. Any forward-looking statements represent the companies' judgment
as of the date of this release. Each of Dura Pharmaceuticals, Inc. and Spiros
Development Corporation II, Inc. disclaims, however, any intent or obligation
to update these forward-looking statements.
SOURCE Dura Pharmaceuticals, Inc.; Spiros Development
Corporation II, Inc.
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Company News On-Call:
http://www.prnewswire.com/comp/197051.html or fax,
800-758-5804, ext. 197051
CONTACT:
David Kabakoff, Ph.D., President, Dura
Technologies, Dura Pharmaceuticals, Inc., Chairman, President and
Chief Executive Officer, Spiros Development Corporation II, Inc.,
619-457-2553
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