SAN DIEGO, Oct. 19 /PRNewswire/ -- Spiros Development Corporation II, Inc.
(Spiros Corp. II) (Nasdaq: SDCOZ), a developer of respiratory drugs for
delivery in Spiros(R), a proprietary new pulmonary drug delivery system, today
reported a net loss of $11.7 million, or $1.86 per share, for the third
quarter of 1998 and $32.3 million, or $5.10 per share, for the first nine
months of 1998.  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.
    "During the third quarter we have advanced the development of Albuterol
Spiros(TM) and Beclomethasone Spiros(TM), the first two asthma drugs under
development in the Spiros(R) pulmonary drug delivery technology," stated David
Kabakoff, Ph.D., Chairman, President and CEO of Spiros Corp. II.  "In July,
pivotal clinical trial patient dosing was completed for Beclomethasone
Spiros(TM), an inhaled steroid used for the treatment of asthma.  Presently
data from the trial are being analyzed and the new drug application (NDA) is
being compiled."
    In September, Dura, on behalf of Spiros Corp. II, submitted additional
information to the U.S. Food and Drug Administration (FDA) to support the
pending NDA for Albuterol Spiros(TM).  "We are pleased that the on-going
dialogue with the FDA has included early requests for information throughout
the review process," commented Dr. Kabakoff.  "We expect FDA action on this
first Spiros(R) product reasonably soon, as the twelve-month anniversary of
the NDA submission is in early November.  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.  Meanwhile, the Dura manufacturing and
marketing organizations continue to prepare for Albuterol Spiros(TM) scale-up
and commercialization."
    "Of interest to Spiros Corp. II shareholders is the recently announced
agreement between Dura and Eli Lilly & Company (NYSE: LLY) to develop inhaled
insulin products for delivery with Spiros(R)," noted Dr. Kabakoff.  "The
collaboration to develop inhaled insulin with the leader in U.S. diabetes care
serves to validate our Spiros(R) pulmonary drug delivery technology and
development programs."
    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, 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 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.

    STATEMENT OF OPERATIONS DATA
    In Thousands, Except Per Share Data
                                                  (Unaudited)
                                    Three Months Ended     Nine Months Ended
                                    September 30, 1998    September 30, 1998
    REVENUES:
      Interest                              $1,995               $6,434

    EXPENSES:
      Research and Development              13,443               37,788
      General and Administrative               239                  781
        Total Expenses                      13,682               38,569

    OPERATING LOSS BEFORE
     INCOME TAXES                          (11,687)             (32,135)
    PROVISION FOR INCOME TAXES                  60                  146
    NET LOSS                              $(11,747)            $(32,281)
    NET LOSS PER BASIC
     AND DILUTED SHARE                      $(1.86)              $(5.10)
    WEIGHTED AVERAGE NUMBER OF COMMON
     AND COMMON EQUIVALENT SHARES            6,325                6,325


    BALANCE SHEET DATA
                                                              (unaudited)
                                    December 31, 1997     September 30, 1998

    Cash and Short-term Investments       $170,506             $135,232
    Other Current Assets                        --                  216
      TOTAL ASSETS                        $170,506             $135,448
    Current Liabilities                     $8,425               $5,175
    Shareholders' Equity                   162,081              130,273
      TOTAL LIABILITIES AND
       SHAREHOLDERS' EQUITY               $170,506             $135,448

Link to this page: