SAN DIEGO, Oct. 26 /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 screening of patients for a dose-targeting
study for Budesonide Spiros(TM). The clinical study is designed to establish
target dosages by comparing budesonide delivered in the Spiros(R) pulmonary
drug delivery system to a commercially available dry powder inhaler form of
budesonide. Patient dosing with budesonide is scheduled to begin later this
week.
Budesonide, currently marketed by another pharmaceutical company as
Pulmicort(R), is a steroid drug prescribed as a maintenance therapy for the
treatment of asthma. Budesonide is currently the leading steroid in Europe
for the maintenance treatment of asthma. Corticosteroids, such as budesonide
and beclomethasone, are the mainstay in treating the underlying inflammatory
condition associated with asthma. The National Institutes of Health consider
corticosteroids to be effective long-term therapy for persistent asthma
(Guidelines for the Diagnosis and Management of Asthma).
"We are very pleased with the continuing progress in the development of
Budesonide Spiros," stated David S. Kabakoff, Ph.D., President of Dura
Technologies and President and CEO of Spiros Corp. II. "Our budesonide team
has effectively leveraged the knowledge gained from the Beclomethasone
Spiros(TM) and Albuterol Spiros(TM) development programs and have
expeditiously moved the program into clinical studies."
Dura, on behalf of Spiros Corp. II, plans to begin a pivotal clinical
program for Budesonide Spiros in mid-2000.
Budesonide Spiros is one of three drugs currently in development by Dura
on behalf of Spiros Corp. II. On October 14, 1999, the two companies announced
the commencement of the pivotal clinical program for Beclomethasone Spiros.
Dura is continuing to address chemistry, manufacturing and control (CMC)
issues for Albuterol Spiros with the goal of initiating clinical studies by
year-end 1999. The Spiros 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 the 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(R), a pulmonary drug delivery
system for both topical and systemic delivery of medications.
Spiros Development Corporation II, is a public company formed primarily
for 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, 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.
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.
 back to top
Related links:
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 of Dura
Technologies and Dura Pharmaceuticals, Inc., 858-457-2553
|
