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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
Date of Report (Date of earliest event reported): JULY 26, 1999
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MAGAININ PHARMACEUTICALS INC.
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(Exact name of registrant as specified in its charter)
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DELAWARE 0-19651 13-3445668
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<S> <C> <C>
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
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5110 CAMPUS DRIVE, PLYMOUTH MEETING, PA 19462
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(Address of principal executive offices) (Zip Code)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (610) 941-4020
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(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS.
On July 26, 1999, Magainin Pharmaceuticals Inc. (the "Company") announced
that it had received notification from the U.S. Food and Drug Administration
that its New Drug Application for LOCILEX CREAM (pexiganan acetate cream 1%)
had been deemed not approvable. For more information regarding this
announcement, please see the Company's press release, dated July 26, 1999, which
is filed herewith as Exhibit 99.1 and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Financial Statements of Business Acquired: None
(b) Pro Forma Financial Information: None
(c) Exhibits:
99.1 Press release, dated July 26, 1999.
2
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SIGNATURES
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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.
By: /s/ Michael R. Dougherty
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Michael R. Dougherty
President and Chief Executive Officer
Dated: July 26, 1999
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EXHIBIT INDEX
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Exhibit
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99.1 Press release, dated July 26, 1999.
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EXHIBIT 99.1
NEWS RELEASE
FOR IMMEDIATE RELEASE
CONTACT:
Magainin Pharmaceuticals Inc. Burns McClellan, Inc.
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Dennis Molnar Miriam Weber (media)
(610) 941-4020 John Nugent (investors)
(212) 213-0006
MAGAININ PHARMACEUTICALS RECEIVES REGULATORY NOTIFICATION
THAT LOCILEX CREAM IS NOT APPROVABLE
Plymouth Meeting, PA, July 26, 1999 -- Magainin Pharmaceuticals Inc. (NASDAQ:
MAGN) today announced that the Company has received notification from the U.S.
Food and Drug Administration (FDA) that their New Drug Application (NDA) for
LOCILEX(TM) CREAM (pexiganan acetate cream 1%) has been deemed not approvable.
"We are very disappointed in the outcome of our submission for LOCILEX(TM)
CREAM, however, we continue to believe in the need for a non-systemic antibiotic
for this indication," said Michael R. Dougherty, President and Chief Executive
Officer of Magainin Pharmaceuticals Inc. "We expect to consult with SmithKline
Beecham, our marketing partner, as to the further development of this product.
Beyond LOCILEX(TM) CREAM, we believe there is substantial value in other
programs at Magainin, including squalamine, our anti-angiogenic agent in Phase
II clinical testing in solid tumors, and our respiratory program, focused on the
role of IL9 in asthma. We expect to intensify our efforts in the business
development arena, and also evaluate other strategic alternatives."
Magainin Pharmaceuticals Inc. is a biopharmaceutical company engaged in the
development of medicines for serious diseases. The Company's development efforts
are focused on anti-infectives, oncology, and pulmonary and allergic disorders.
For company information, visit Magainin Pharmaceuticals on the World Wide Web at
http://www.magainin.com.
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This announcement contains statements by the Company that involve risks and
uncertainties and may constitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. 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
in this announcement as well as those discussed under "Risk Factors" set forth
in Item 1 of the Company's Annual Report on Form 10K for the year ended December
31, 1998, as filed with the Securities and Exchange Commission. Given these
uncertainties, current or prospective investors are cautioned not to place undue
reliance on any such forward-looking statements. Furthermore, the Company
disclaims any obligation or intent to update any such factors or forward-looking
statements to reflect future events or developments.
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