UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
August 12, 2003
Date of Report (Date of earliest event reported)
Discovery Laboratories, Inc.
(Exact name of Registrant as specified in its charter)
Delaware 000-26422 94-3171943
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification Number)
350 Main Street, Suite 307
Doylestown, Pennsylvania 18901
(Address of principal executive offices)
(215) 340-4699
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
Item 5. Other Events and Regulation FD Disclosure
On August 12, 2003, Discovery Laboratories, Inc. (the "Company"),
issued a news release announcing financial results for the second quarter ended
June 30, 2003, and providing selected updates on the Registrant's progress since
the end of the first quarter (the "2003 Second Quarter Financial Results and
Trial Update News Release"). Such updates included the transferring of the
Company's Surfaxin(R) manufacturing capabilities to a new contract facility in
connection with implementing the initial phase of its long-term manufacturing
strategy. No delay is expected regarding the planned completion of the Company's
ongoing pivotal Phase 3 clinical trial for Respiratory Distress Syndrome (RDS)
in premature infants, however, as a result, the timeline for the completion of
the Company's Phase 2 clinical trial for Acute Respiratory Distress Syndrome in
adults is being adjusted from the fourth quarter of 2003 to the second quarter
of 2004.
In order to implement its long-term manufacturing strategy, the
Company is currently negotiating the final terms and conditions of an agreement
pursuant to which Laureate Pharma, L.P. ("Laureate Pharma"), would become the
Company's contract manufacturer for Surfaxin(R). Until the execution of said
agreement, Laureate Pharma is not obligated to manufacture any drug products for
the Company. There can be no assurance that the Company and Laureate Pharma will
ultimately execute such agreement nor that such agreement ultimately will be on
terms favorable to the Company. If the agreement is not executed, the Company
may pursue alternative manufacturing arrangements, which may delay or impair its
ability to obtain regulatory approval for its products or be available only on
terms that are not favorable to the Company.
The full text of the 2003 Second Quarter Financial Results and Trial
Update News Release is set forth in Exhibit 99.1 hereto and except for the
reference to the Company's website is incorporated in this Report as if fully
set forth herein.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.1 The 2003 Second Quarter Financial Results and Trial Update News
Release (as defined in Item 5 above).
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Discovery Laboratories, Inc.
By: /s/ Robert J. Capetola
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Name: Robert J. Capetola, Ph.D.
Title: President and Chief Executive
Officer
Date: August 12, 2003
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