SAN DIEGO, July 21 /PRNewswire/ -- Spiros Development Corporation II, Inc.
(Spiros Corp. II) (Nasdaq: SDCOZ) today reported a net loss of $11.6 million,
or $1.83 per share, for the second quarter of 1998 and $20.5 million, or $3.25
per share, for the first six months of 1998. Spiros Corp. II is a developer
of respiratory drugs for delivery in Spiros(R), a proprietary new pulmonary
drug delivery technology. The Company also reported on research and
development progress made by Dura Pharmaceuticals, Inc. (Dura) (Nasdaq: DURA)
on Spiros Corp. II's behalf under the various contractual agreements between
the two companies.
"Our second quarter marks another period of solid accomplishment as we
proceed with the development and commercialization of several asthma drugs in
Spiros(R)," commented David S. Kabakoff, Chairman, President and Chief
Executive Officer of Spiros Corp. II. "Patient dosing of the one-year open-
label clinical trial for Albuterol Spiros(TM) has been successfully completed.
A further step towards commercialization of Albuterol Spiros(TM) includes the
successful completion of a Food and Drug Administration (FDA) GMP pre-approval
field inspection of the manufacturing facility for this first Spiros(R)
product. We anticipate an FDA decision on Albuterol Spiros(TM) by the end of
the year and, pending approval, product launch in first quarter 1999."
"Progress on several other Spiros(R) development projects continues,"
added Dr. Kabakoff. "Full enrollment in the Beclomethasone Spiros(TM) pivotal
clinical trial was reached in April and patient dosing will be completed this
month. Meanwhile, development work on the budesonide and ipratropium
Spiros(R) products continues. We are extremely pleased with the pace of our
multiple development efforts presently underway."
Spiros(R) is Dura's proprietary pulmonary drug delivery technology. The
Spiros(R) inhalation system is uniquely designed to deliver a consistent dose
of medication to a patient's lungs efficiently, independent of a patient's
inspiratory effort and requiring no special coordination by the patient. This
easy-to-use, propellant-free system is designed to overcome the inherent
weaknesses of currently marketed delivery systems such as metered dose
inhalers, nebulizers and other dry powder inhalers. Dura, on behalf of Spiros
Corp. II, is developing five Spiros(R) products for the prescription inhaled
asthma and COPD (chronic obstructive pulmonary disease) pharmaceuticals
market, which totaled $2 billion in the U.S. in 1997. Dura is also applying
its Spiros(R) technology to other novel respiratory and non-respiratory
prescription market opportunities, including proteins and peptides, in
conjunction with corporate partners.
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, and to conduct formulation work, clinical
trials and commercialization for defined respiratory drugs in Dura's
proprietary Spiros(R) inhalation system.
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, and is developing a pulmonary drug
delivery system. Dura's mission is to be the leading pharmaceutical company
with a focus in the high-growth U.S. respiratory market. Dura is pursuing
that goal through two major strategies: (1) acquiring late-stage prescription
pharmaceuticals and/or companies with rights to such pharmaceuticals for
marketing to high-prescribing respiratory physicians and (2) developing
Spiros(R), a proprietary dry powder pulmonary drug delivery 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 the timely development of
Spiros(R) products, uncertainties in the regulatory process, government
regulation, the dependency on FDA approval, competitive products, Dura
Pharmaceuticals, Inc.'s and Spiros Development Corporation II Inc.'s limited
manufacturing experience, dependency on Dura and other 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. These forward-looking
statements represent the Companies' judgments 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.
STATEMENT OF OPERATIONS DATA
In Thousands, Except Per Share Data
(Unaudited)
Three Months Ended Six Months Ended
June 30, 1998 June 30, 1998
REVENUES:
Interest Income $2,106 $4,439
EXPENSES:
Research and Development 13,360 24,345
General and Administrative 278 542
Total Expenses 13,638 24,887
OPERATING LOSS BEFORE
INCOME TAXES (11,532) (20,448)
PROVISION FOR INCOME TAXES 60 86
NET LOSS $(11,592) $(20,534)
NET LOSS PER BASIC
AND DILUTED SHARE $(1.83) $(3.25)
WEIGHTED AVERAGE NUMBER
OF COMMON AND
COMMON EQUIVALENT SHARES 6,325 6,325
BALANCE SHEET DATA
(unaudited)
December 31, 1997 June 30, 1998
CASH AND SHORT-TERM
INVESTMENTS $170,506 $146,543
OTHER CURRENT ASSETS 157
TOTAL ASSETS $170,506 $146,700
CURRENT LIABILITIES $ 8,425 $ 5,262
SHAREHOLDERS' EQUITY 162,081 141,438
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY $170,506 $146,700
SOURCE Spiros Development Corporation II, Inc.
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fax, 800-758-5804, ext. 197051
CONTACT:
Erle Mast, Vice President and Chief Financial
Officer of Spiros Development Corporation II, Inc., 619-457-2553
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