SAN DIEGO, June 2 /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 completed patient dosing of the one-year open-label clinical trial for
Albuterol Spiros(TM) and has, as part of the review process, completed a Food
and Drug Administration (FDA) GMP pre-approval inspection of Dura's
manufacturing facility for this first Spiros(R) product. Additionally, full
enrollment in the Beclomethasone Spiros(TM) pivotal clinical trial has been
reached.
"The completion of the Albuterol Spiros(TM) open-label trial concludes our
planned pre-approval clinical trial program, and we expect to submit data from
this trial to the FDA early in the third quarter," stated David S. Kabakoff,
Dura's Executive Vice President and Chairman, President and CEO of Spiros
Corp. II. "Based on the favorable results of the pre-approval inspection of
our manufacturing facility by field investigators, it is still reasonable to
anticipate an FDA decision on Albuterol Spiros(TM) by the end of the year, and
pending approval, to launch the product in the first quarter of 1999." Prior
to marketing, Dura must complete the validation of its manufacturing processes
at full commercial scale.
"We are pleased with the continuing progress in the development of
Beclomethasone Spiros(TM), as we had achieved full enrollment of over 400
patients for the 12-week, 30-center pivotal clinical trial at the end of
April," said Dr. Kabakoff. "We expect to conclude patient dosing in late
July, and to submit an NDA for Beclomethasone Spiros(TM) in the fourth quarter
of this year or in the first quarter of 1999." The Companies expect a twelve-
month FDA review period for the second Spiros(R) product.
"The Spiros(R) technology represents an extraordinary opportunity to
improve the approach to pulmonary drug delivery in the U.S.," noted Cam L.
Garner, Dura's Chairman, President and CEO. "Our strategy is designed to
first benefit patients with asthma and chronic obstructive pulmonary disease
(COPD), as we are developing, on behalf of Spiros Corp. II, formulations of
five of the leading therapies for these respiratory diseases for delivery in
Spiros(R). We expect to commercialize these drugs over the next four to five
years, pending FDA approval, which will provide physicians and patients with
an alternative form, designed to be efficient and easy-to-use, of some the
most commonly prescribed respiratory medications."
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 advantages 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,
however, 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 or factual information contain herein, the
matters discussed in this press release may contain forward-looking statements
which involve risks and uncertainties, including the timely development of the
Spiros(R) system, government regulation and dependency on FDA approval,
competitive products, Dura's and Spiros Development Corporation II, Inc.'s
limited manufacturing experience, dependency on third parties and their
successful development efforts, and other risks detailed from time to time in
the companies' filings with the Securities and Exchange Commission. Actual
results may differ materially from those projected. Forward-looking
statements represent the companies' judgments as of the date of this release.
Each of Dura and Spiros Development Corporation II, Inc. disclaims, however,
any intent or obligation to update any forward-looking statements.
SOURCE Dura Pharmaceuticals
 back to top
Related links:
http://www.durapharm.com
Company News On-Call: http://www.prnewswire.com or
fax, 800-758-5804, ext. 197051
CONTACT:
Karen Lundstedt, Director, Investor Relations
of Dura Pharmaceuticals, Inc., 619-457-2553
|
