SAN DIEGO, Feb. 9 /PRNewswire/ -- Spiros Development Corporation II, Inc.
(Spiros Corp. II) (Nasdaq: SDCOZ), a developer of respiratory drugs for
delivery in Spiros(R), a novel proprietary pulmonary drug delivery system,
today reported a net loss of $11.5 million, or $1.82 per share, for the fourth
quarter of 1998 and $43.8 million, or $6.92 per share, for the full year 1998.
The Company commenced operations in December 1997 and reported a net loss of
$6.9 million, or $1.09 per share, for both the fourth quarter and year of
1997.  The Company also reported on research and development progress made by
Dura Pharmaceuticals, Inc. (Dura) (Nasdaq: DURA) on behalf of Spiros Corp. II,
under the various contractual agreements between the two companies.
    "Although Albuterol Spiros(TM), the first asthma drug under development in
the Spiros(R) pulmonary drug delivery technology, was not approved during
1998, we remain confident of the commercial potential for the Spiros(R)
technology," said David S. Kabakoff, Ph.D., Chairman, President and Chief
Executive Officer of Spiros Corp. II.  "We have advanced discussions with the
U.S. Food and Drug Administration (FDA) on our new drug application filed for
Albuterol Spiros(TM) to define the requirements for gaining product approval.
We expect to be in a position to provide details on the timeline for
completion of the Albuterol Spiros(TM) development program, including required
additional clinical data and chemistry, manufacturing and control information,
later this month."
    "In 1998, Dura achieved a number of key milestones in the Spiros(R)
programs undertaken on behalf of Spiros Corp. II," Dr. Kabakoff continued.
"Dura significantly enlarged its technical organization and management team in
order to complete the ongoing development programs as rapidly as possible and
to expand our development opportunities.  In the second quarter Dura completed
a successful pre-approval inspection of its San Diego manufacturing facility
by FDA.  In July 1998, a 12-week, 30-center pivotal clinical trial for
Beclomethasone was completed.  We look forward to presenting the
Beclomethasone data at a major scientific conference later this year.  We also
anticipate providing an update on the status of the Beclomethasone Spiros(TM)
development program later this month."
    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, relatively 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
many of 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 currently 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 of Dura Pharmaceuticals, Inc., and to conduct
formulation work, clinical trials and commercialization for defined
respiratory drugs in Dura's 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,
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.

    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 timely receipt of FDA approval, if at all, 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.

    STATEMENTS OF OPERATIONS DATA
    (In thousands, except per share data)             (unaudited)
                                       Three Months Ended       Year Ended
                                           December 31,        December 31,
                                         1997        1998      1997    1998
    REVENUES:
     Interest                             $222     $1,805      $222   $8,239

    EXPENSES:
     Research and Development            7,040     13,011     7,040   50,799
     General and Administrative            106        245       106    1,026
       Total Expenses                    7,146     13,256     7,146   51,825

    OPERATING LOSS BEFORE INCOME TAXES  (6,924)   (11,451)   (6,924) (43,586)

    PROVISION FOR INCOME TAXES                         61                207

    NET LOSS                           $(6,924)  $(11,512)  $(6,924)$(43,793)

    NET LOSS PER BASIC AND
     DILUTED SHARE                     $(1.09)     $(1.82)   $(1.09) $(6.92)

    WEIGHTED AVERAGE NUMBER OF COMMON
     AND COMMON EQUIVALENT SHARES        6,325      6,325     6,325    6,325

    BALANCE SHEET DATA                                        (unaudited)
                                             December 31,      December 31,
                                                 1997              1998

    CASH AND SHORT-TERM INVESTMENTS            $170,506         $123,604
    OTHER CURRENT ASSETS                                             192

       TOTAL ASSETS                            $170,506         $123,796

    CURRENT LIABILITIES                          $8,425           $4,878
    SHAREHOLDERS' EQUITY                        162,081          118,918

       TOTAL LIABILITIES AND
       SHAREHOLDERS' EQUITY                    $170,506         $123,796

Link to this page: