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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
SEPTEMBER 25, 1996
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(DATE OF REPORT)
MAGAININ PHARMACEUTICALS INC.
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(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 0-19651 13-3445668
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(STATE OR OTHER JURISDICTION OF (COMMISSION (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) FILE NUMBER) ID NO.)
5110 CAMPUS DRIVE
PLYMOUTH MEETING, PENNSYLVANIA 19462
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(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)
(610) 941-4020
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(REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE)
NOT APPLICABLE
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(FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR,
IF CHANGED SINCE LAST REPORT)
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ITEM 5. OTHER EVENTS.
On September 25, 1996, the Registrant announced by press
release (the "Press Release") the successful results of its initial, pivotal
phase III clinical trial of MSI-78, a topical anti-infective for the
treatment of infection in diabetic foot ulcers.
The Registrant hereby incorporates by reference the Press
Release, which is attached hereto as Exhibit 99.1 and made a part hereof, into
this Item 5.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) Financial Statements of Businesses Acquired: None
(b) Pro Forma Financial Information: None
(c) Exhibits:
99.1 Press Release, dated September 25, 1996.
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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 thereunto duly authorized.
MAGAININ PHARMACEUTICALS INC.
Date: September 25, 1996 By:/s/ Michael R. Dougherty
--------------------------------
Michael R. Dougherty
Executive Vice President and
Chief Financial Officer
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EXHIBIT INDEX
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Exhibit Page
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99.1 Press Release dated September 25, 1996
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EXHIBIT 99.1
Magainin Pharmaceuticals Inc.
NEWS RELEASE
FOR IMMEDIATE RELEASE
Contact:
Michael R. Dougherty Kathryn Corbett
Magainin Pharmaceuticals Inc. Dewe Rogerson
(610) 941-4020 (212) 688-6840
MAGAININ ANNOUNCES SUCCESSFUL MSI-78 PHASE III TRIAL RESULTS
(September 25, 1996, Plymouth Meeting, PA) - Magainin Pharmaceuticals Inc.
(NASDAQ:MAGN) today announced the successful results of its initial, pivotal
Phase III clinical trial of MSI-78 1% topical cream (Cytolex(TM)) for the
treatment of infection in diabetic foot ulcers. The Company's analysis of the
study showed statistical equivalence between MSI-78 and orally administered
ofloxacin, with respect to the study's primary endpoint of clinical response of
infection at day 10 of treatment, and at subsequent time points through day 28,
and at follow-up. Floxin (R) (ofloxacin) is a quinolone antibiotic indicated
for the treatment of skin and soft tissue infections. The study enrolled 584
patients.
As a secondary endpoint, MSI-78 and ofloxacin were comparable with respect to
overall assessments of microbiological improvements.
Preliminary analyses of adverse events in the study suggest a favorable profile
for MSI-78. Both drugs were well tolerated; however, treatment with ofloxacin
was associated with a significant excess of complaints of insomnia in
comparison with MSI-78. Additional study data also suggest a lower frequency
of occurrence of certain other adverse events for patients receiving MSI-78.
Jay Moorin, Magainin's chairman, president and chief executive officer, along
with Paul Litka, M.D., senior vice president clinical research and regulatory
affairs, will make a Company presentation at the Cowen & Company Eleventh
Annual Biotechnology Conference in San Francisco on Thursday, September 26,
1996.
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The Company is currently conducting a second Phase III clinical trial of MSI-78
in the treatment of infection in diabetic foot ulcers. Results from this
second trial are expected in the first quarter of 1997. The Company is also
engaged in significant manufacturing scale-up efforts with its contract
manufacturer. Success in both pivotal trials, as well as the completion of
manufacturing scale-up efforts and stability studies, is required for the
submission of a New Drug Application for MSI-78 to the U.S. Food and Drug
Administration.
Magainin Pharmaceuticals Inc. is a biopharmaceutical company engaged in the
development of breakthrough medicines for serious diseases. The Company
isolates and develops compounds from the host-defense systems of animals and
uses molecular techniques such as gene identification to understand the
pathogenesis of disease. The Company's development efforts are focused on
anti-infectious, oncology and, pulmonary and allergic disorders.
###
This announcement contains certain forward looking statements that are subject
to risks and uncertainties. Such statements reflect management's current views
and are based on certain assumptions. Actual results could differ materially
from those currently anticipated as a result of a number of factors, including,
but not limited to, the risks and uncertainties discussed under Management's
Discussion and Analysis of Financial Condition and Results of Operations in the
Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 1996 as
filed with the Securities and Exchange Commission and the following sections of
Item 1 of the Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 1995 as filed with the Securities and Exchange Commission:
"Synthesis Technology; Manufacturing;" "Product Development and Research
Programs;" "Government Regulation;" "Additional Regulatory Issues;" "Patents
and Proprietary Rights; Licensed Technology;" "Competition" and "Product
Liability and Insurance." The Company disclaims any intent or obligation to
update these forward looking statements.
Upon applicable regulatory approvals, if any, Magainin plans to market MSI-78
under the trade name Cytolex(TM).
