SAN DIEGO, Sept. 23 /PRNewswire/ -- Dura Pharmaceuticals, Inc.
(Nasdaq: DURA) and Spiros Development Corporation II, Inc. (Nasdaq: SDCOZ)
(Spiros Corp. II) jointly announced that Dura, on behalf of Spiros Corp. II,
has recently submitted additional information to the U.S. Food and Drug
Administration (FDA) to support the pending new drug application (NDA) for
Albuterol Spiros(TM). In response to questions from the Agency, Dura has
provided chemistry and manufacturing control data on behalf of Spiros Corp. II
that were not available at the time of the original submission.
Dura has been in discussions with the FDA concerning the Albuterol
Spiros(TM) NDA over the last several months on behalf of Spiros Corp. II. "We
are pleased that we have received early requests for information during our
on-going dialogue with FDA, which has allowed us to supply additional
information throughout the review process," said David Kabakoff, Ph.D.,
President of Dura Technologies and Chairman, President and CEO of Spiros Corp.
II. "We do not yet know how the FDA will respond to the NDA. The Agency may
have additional questions on the recently submitted data or on other topics.
We anticipate FDA action on this product before the end of the year, as the
12-month anniversary of the submission is in November. Internally, the
organization is actively preparing for Albuterol Spiros(TM) launch in the
second quarter of 1999, which allows adequate time to build commercial
inventories for launch if product approval is obtained before year-end."
In July, pivotal clinical trial patient dosing was completed for the
second Spiros(R) product in development, Beclomethasone Spiros(TM), an inhaled
steroid for the treatment of asthma. Data from the trial are being analyzed
and the NDA is being compiled. The submission of this second NDA will be
scheduled following the receipt of FDA's review of Albuterol Spiros(TM).
"We are extremely pleased with the progress to date in the development of
the Spiros(R) products," said Cam L. Garner, Dura's Chairman and CEO. "We
believe the clinical data supporting the Albuterol Spiros(TM) NDA are very
solid. We have successfully completed the FDA's pre-approval inspection of
our manufacturing facility, and we are providing information to the Agency as
questions arise. With the completion of the planned clinical trial program
for Beclomethasone Spiros(TM) and anticipation of initiation of Ipratropium
Spiros(TM) and Budesonide Spiros(TM) clinical trials by early 1999, we are
excited about the momentum of the development program. Significantly adding
to that momentum is the announcement made today in a separate release of
Dura's collaboration with Eli Lilly and Company to develop inhaled insulin for
delivery in our Spiros(R) technology. We believe that this partnership
further validates the Spiros(R) technology platform and its application to the
systemic delivery of macromolecules, which represents a vast market
opportunity for Dura."
Dura is making significant investments in preparation for the launch of
the Spiros(R) platform. These investments include the expansion of Dura's
national sales force, the strengthening of its scientific organization, and
the completed installation of the fully automated cassette filling equipment
in its dedicated GMP manufacturing facility.
The Spiros(R) inhaler uses a unique, breath-activated technology and is
designed to deliver a consistent dose of drug to the lung, independent of a
patient's ability to inhale forcefully. Additionally, Spiros(R) requires no
chlorofluorocarbon (CFC) propellants. These design attributes address the
limitations of other inhalation delivery systems, such as metered dose
inhalers (MDIs) and other dry powder inhalers. In 1997, the U.S. market for
inhaled asthma medications totaled nearly $2 billion, with MDIs representing
the most common method of delivery. Most MDIs contain 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. Albuterol
Spiros(TM) is expected to be the first multi-dose non-CFC albuterol powder
inhaler product in the U.S. and will compete in the established $700 million
U.S. market for inhaled albuterol, the most frequently prescribed asthma
medication worldwide.
Dura Pharmaceuticals, Inc. is a San Diego based developer and marketer of
prescription pharmaceutical products for the treatment of allergies, asthma,
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 respiratory prescription pharmaceuticals and/or
businesses developing or marketing such pharmaceuticals targeted at
high-prescribing respiratory physicians, and (2) developing Spiros(R), a
pulmonary drug delivery system.
Spiros Development Corporation II, Inc. is a separate public company
formed primarily to fund the continued development of Spiros(R), a proprietary
pulmonary drug delivery system, and to conduct formulation work, clinical
trials and commercialization for defined asthma drugs in the 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, seasonality, Dura's ability to add
additional people to support activities, the timely development of the
Spiros(R) system, the timely receipt of FDA approval, if at all, Dura's
limited manufacturing experience, dependency upon third parties and their
successful development efforts and other risks detailed from time to time in
the Companies' filings with the SEC. Actual results may differ materially
from those projected. Forward-looking statements represent the Companies'
judgment as of the date of this release. Each of Dura and Spiros Development
Corp. II disclaim, however, any intent or obligation to update any forward-
looking statements.
SOURCE Dura Pharmaceuticals
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Company News On-Call: http://www.prnewswire.com or
fax, 800-758-5804, ext. 197051
CONTACT:
David Kabakoff, Ph.D., President of Dura
Technologies and Dura Pharmaceuticals, Inc. and Chairman,
President and CEO of Spiros Development Corporation, II,
619-457-2553
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