SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------------------------
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
December 19, 2002
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
On December 19, 2002, Registrant issued a press release to announce an
interruption in the supply of its Surfaxin(R) drug product for Part B of
Registrant's ongoing Phase 2 clinical trial for Acute Respiratory Distress
Syndrome (ARDS) in adults. Registrant presently anticipates that the completion
of this part of the ARDS Phase 2 trial will now occur in the second quarter of
2003, a delay of approximately three months. The interruption in supply is not
expected to have an effect on Registrant's other ongoing Phase 3 clinical trials
for Surfaxin, including the two pivotal, landmark multinational Phase 3 trials
for Respiratory Distress Syndrome (RDS) in premature infants and the Phase 3
clinical trial for Meconium Aspiration Syndrome (MAS) in full-term infants.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.1 Press Release dated December 19, 2002.
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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
----------------------------------------
Name: Robert J. Capetola, Ph.D.
Title: President and Chief Executive Officer
Date: December 20, 2002
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Exhibit 99.1
Discovery Laboratories Announces Interruption in Supply of Surfaxin(R)for ARDS
Phase 2 Trial - Completion Anticipated in Q2 2003
Conference call scheduled for Friday, December 20th at 8:45 AM EST
Doylestown, PA - December 19, 2002 - Discovery Laboratories, Inc. (Nasdaq:
DSCO), a late-stage specialty pharmaceutical company leveraging its technology
in humanized lung surfactants to develop novel respiratory therapies and
pulmonary drug delivery products, announced today that it anticipates a delay in
the supply of Surfaxin for Part B of its Phase 2 clinical trial for Acute
Respiratory Distress Syndrome (ARDS) in adults. It is now anticipated that this
trial will be completed in the second quarter of 2003, a delay of approximately
three months. This delay is due to operational difficulties experienced by
Akorn, Inc., Discovery's contract manufacturer. The difficulties being
experienced by Akorn, are in no way expected to have an effect on Discovery's
ongoing Phase 3 clinical trials for Surfaxin for Respiratory Distress Syndrome
(RDS) in premature infants.
In a recent press release, Akorn reported that they were experiencing operating
difficulties in a production room primarily used for the filling of its
customers' sterile pharmaceutical products. Akorn previously expected that this
general purpose sterile production room would be operational in mid-November,
however, it has not yet returned to full operational status. Akorn believes it
has identified the problem and is in the process of returning this sterile
production room to full operational status as soon as possible. It is important
to note that the difficulties being experienced by Akorn do not involve
Discovery's dedicated equipment, raw materials or process to formulate Surfaxin.
Christopher J. Schaber, Executive Vice President and Chief Operating Officer of
Discovery commented, "We are in frequent contact with Akorn to effectively
manage the impact on our ARDS Phase 2 study. Based on our discussions, we
anticipate having our personnel back in their facility in February 2003 when the
manufacture of Surfaxin for our ARDS clinical trial is expected to recommence.
As for our ongoing Phase 3 clinical trials for RDS, we have an ample supply of
Surfaxin to satisfy our needs."
Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery
commented, "Surfaxin for the treatment of ARDS holds great promise for
respiratory medicine and we remain encouraged by the results of Part A of our
Phase 2 ARDS trial. Of course, we are disappointed by this interruption. You
should know that we have conducted a thorough analysis of our alternatives and
considered several clinical drug supply strategies that would possibly have
allowed us to optimize patient enrollment while this issue is being resolved.
However, conducting our trials in accordance with the highest quality clinical
standards is of paramount importance and we rejected all strategies that we
believed might jeopardize the successful outcome of our trial."
Surfaxin is manufactured using Discovery-owned specialized equipment under the
direct supervision of Discovery's manufacturing and quality control personnel.
The drug is formulated and filled in a sterile production room. Discovery
presently uses the sterile room facility and filling equipment of its contract
pharmaceutical manufacturer, Akorn, Inc. Given the late stage development status
of Surfaxin and in line with Discovery's strategy for potential
commercialization, the Company's Board of Directors recently approved plans to
invest approximately $1.5 million in 2003 for certain manufacturing scale-up and
enhancements, including additional equipment for scale-up at the Akorn facility
and establishing alternative manufacturing capabilities with an additional
contract manufacturer. This investment was a planned use of the approximately
$12.8 million gross proceeds from the recent November 2002 private financing.
The Company has scheduled a conference call and live audio Web cast for Friday,
December 20, 2002 at 8:45 AM EST that is available to shareholders and
interested parties on the Internet through http://audioevent.mshow.com/77862 and
at www.discoverylabs.com. It is recommended that participants log onto one of
these sites at least 15 minutes prior to the call. The Internet broadcast will
be available for up to 30 days after the call on both Website addresses.
About Discovery Laboratories, Inc.
Discovery Laboratories, Inc. is a specialty pharmaceutical company leveraging
its platform technology in humanized lung surfactants to develop a number of
potential novel respiratory therapies and pulmonary drug delivery products.
Surfactants are produced naturally in the lungs and are essential to the lungs'
ability to absorb oxygen. Discovery's technology is being developed initially
for critical care patients with life-threatening respiratory disorders where
there are few or no approved therapies available. Surfaxin(R), Discovery's lead
product, is currently in Phase 3 clinical trials for Respiratory Distress
Syndrome (RDS) in premature infants, a Phase 3 clinical trial for Meconium
Aspiration Syndrome (MAS) in full-term infants, and a Phase 2 clinical trial for
Acute Respiratory Distress Syndrome (ARDS) in adults. Aerosol formulations are
being developed in an effort to treat other respiratory conditions such as
asthma, chronic obstructive pulmonary disease, and acute lung injury, and as a
novel pulmonary drug delivery vehicle to render drugs more effective when
delivered to or via the respiratory tract. Discovery is developing a dedicated
sales and marketing capability through a collaboration with Quintiles for the
United States, and has a strategic alliance with Esteve for Europe and Latin
America.
To the extent that statements in this press release are not strictly historical,
including statements as to the Company's business strategy, outlook, objectives,
future milestones, plans, intentions, goals, future financial conditions, future
collaboration agreements, the success of the Company's product development, or
otherwise as to future events, such statements are forward-looking, and are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The forward-looking statements contained in this release are
subject to certain risks and uncertainties that could cause actual results to
differ materially from the statements made including, without limitation, risks
associated with the fact that we have presently validated only a single
manufacturing facility for our drug product. There can be no assurance that the
Company can produce sufficient quantities of drug product under current Good
Manufacturing Practice conditions. Should a lack of sufficient drug product
delay the completion of any of the Company's clinical studies including, without
limitation, further delay of its Phase 2 clinical trial for ARDS, the Company
may experience
additional costs that cannot be accurately estimated. Among other factors which
could affect the Company's actual results and could cause results to differ from
those contained in the forward-looking statements contained herein are the risk
that financial conditions may change, the risk that the Company will not be able
to raise additional capital or enter into additional collaboration agreements,
risks relating to the progress of the Company's research and development and the
development of competing therapies and/or technologies by other companies. Those
associated risks and others are further described in the Company's periodic
filings with the Securities and Exchange Commission including the most recent
reports on Forms 10-KSB, 8-K, 10-QSB and 10-Q, and amendments thereto.