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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): March 4, 1999
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 (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
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 March 4, 1999, Magainin Pharmaceuticals Inc. announced that the FDA
Anti-Infectives Drug Advisory Committee, by a vote of 7 to 4, declined to
recommend approval of LOCILEX(TM) (pexiganan acetate) Cream 1% for the treatment
of infected diabetic foot ulcers. For more information regarding this
announcement, please see the Company's press release, dated March 4, 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 March 4, 1999.
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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: March 12, 1999
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EXHIBIT INDEX
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Exhibit
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99.1 Press release, dated March 4, 1999.
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EXHIBIT 99.1
Magainin Pharmaceuticals' Statement on FDA Advisory Committee Meeting
Plymouth Meeting, Pa., March 4, 1999 - Magainin Pharmaceuticals Inc. (NASDAQ:
MAGN) said that it expects to meet with officials of the U.S. Food and Drug
Administation (FDA) to review the outcome of the meeting today of the
Anti-Infectives Drug Advisory Committee.
The Committee, by a vote of 7 to 4, declined to recommend approval of
LOCILEX(TM) (pexiganan acetate) Cream 1% for the treatment of infected diabetic
foot ulcers. The Committee's advice will be considered by the FDA in its final
review of the New Drug Application submitted by Magainin Pharmaceuticals.
"We will continue to work with the FDA to resolve issues discussed by the
Advisory Committee," said Michael R. Dougherty, President and Chief Executive
Officer of Magainin. "After discussions with the FDA, and consultations with
SmithKline Beecham, our marketing partner in North America, we expect to be able
to speak more specifically about our plans for LOCILEX(TM)."
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.
This announcement contains statements by Magainin 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 Magainin's Annual Report on Form 10-K 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, Magainin disclaims
any obligation or intent to update any such factors or forward-looking
statements to reflect future events or developments.
