SAN DIEGO, Oct. 14 /PRNewswire/ -- Dura Pharmaceuticals, Inc. (Dura)
(Nasdaq: DURA) and Spiros Development Corporation II, Inc. (Spiros Corp. II)
(Nasdaq: SDCOZ) today announced that Dura, on behalf of Spiros Corp. II, has
initiated the run-in period for the first in a series of pivotal clinical
studies for Beclomethasone Spiros(TM). The first clinical study is designed
to determine safety and reliability of the Beclomethasone Spiros inhaler.
Patient dosing with beclomethasone is scheduled to begin next week. Spiros(R)
is a new pulmonary drug delivery system in development designed to improve
delivery of medication to the lung. Beclomethasone, currently marketed by
other pharmaceutical companies as Vanceril(R) and Beclovent(R), is a steroid
drug prescribed as a maintenance therapy for the treatment of asthma.
"Beclomethasone is the first steroid we are developing in the Spiros
pulmonary drug delivery system," stated David S. Kabakoff, Ph.D., President of
Dura Technologies and President and CEO of Spiros Corp. II. "The goal of the
Beclomethasone Spiros clinical program is to demonstrate the safety, efficacy
and potential patient benefits of the Spiros system compared to a currently
marketed form of beclomethasone delivered by metered dose inhaler."
Corticosteroids, such as beclomethasone and budesonide, are the mainstay
in treating the underlying inflammatory condition that can lead to the
development of asthma. The National Institutes of Health considers
corticosteroids to be the most potent and most effective long-term therapy for
persistent asthma (Guidelines for the Diagnosis and Management of Asthma).
Beclomethasone Spiros is one of three drugs currently in development by
Dura on behalf of Spiros Corp. II. Dura plans to initiate a dose-targeting
clinical program for Budesonide Spiros(TM) during the fourth quarter of 1999
and is continuing to address chemistry, manufacturing and control (CMC) issues
for Albuterol Spiros(TM). Dura's goal remains to initiate the clinical
program for Albuterol Spiros by year-end 1999. The clinical programs and
regulatory reviews, if successful, should allow for three product launches in
the 2001-2002 time frame, if each product is approved by the U.S. Food and
Drug Administration (FDA).
The Spiros line of respiratory products is being developed by Dura, on
behalf of Spiros Corp. II, as a novel means of delivering medication to the
lung. The Spiros delivery system is comprised of two components, an inhaler
that aerosolizes powdered drug and a powder storage cassette that stores pre-
measured doses of drug. The Spiros products, if approved by the FDA, are
expected to compete in the U.S. market for inhaled asthma medications, which
totaled approximately $2 billion in 1998. The Spiros system is designed to
address the limitations of other inhalation delivery systems currently on the
market, such as metered dose inhalers and other dry powder inhalers. The
Spiros system is designed to deliver a consistent drug dose to the lung over a
wide range of inspiratory flow rates, to minimize need for patient
coordination, and is free of chlorofluorocarbon (CFC) propellants.
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, a proprietary pulmonary drug
delivery system for both topical and systemic delivery of medications.
Spiros Development Corporation II is a public company formed primarily to fund
the continued development of Spiros, a proprietary pulmonary drug delivery
system for selected respiratory medications.
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 the timely initiation and
successful completion of the clinical trial programs for the Spiros products,
the ability to obtain adequate funding to complete the clinical trial programs
for the Spiros products, the timely FDA approval of the Spiros products, if at
all, our dependence on third parties for marketing, manufacturing and
development, the competitiveness of the pharmaceutical industry, and other
risks detailed from time to time in Dura's and Spiros Corp. II's filings with
the Securities and Exchange Commission. Actual results may differ materially
from those projected. Any forward-looking statements represent Dura's and
Spiros Corp. II's judgment as of the date of this release. Dura and Spiros
Corp. II disclaim, however, any intent or obligation to update these forward-
looking statements. Further information about Dura Pharmaceuticals, Inc. can
be found at http://www.durapharm.com.
News releases from Dura Pharmaceuticals are available at no charge on
Dura's web site at http://www.durapharm.com and through PR Newswire's On-Call fax
service by calling (800) 758-5804, extension 197051.
SOURCE Dura Pharmaceuticals, Inc.
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http://www.durapharm.com
Company News On-Call:
http://www.prnewswire.com/comp/197051.html or fax,
800-758-5804, ext. 197051
CONTACT:
David S. Kabakoff, President, Dura
Technologies of Dura Pharmaceuticals, Inc., 858-457-2553
NOTE TO EDITORS: A separate press release was issued today
entitled "Dura Pharmaceuticals Reports Third Quarter 1999
Results".
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