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
Date of report (Date of earliest event reported) July 23, 2003
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CollaGenex Pharmaceuticals, Inc.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-28308 52-1758016
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(State or Other Jurisdiction (Commission File Number) (IRS Employer
of Incorporation) Identification No.)
41 University Drive, Newtown, Pennsylvania 18940
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(Address of Principal Executive Offices) (Zip Code)
(215) 579-7388
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(Registrant's telephone number,
including area code)
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(Former Name or Former Address, if Changed Since Last Report)
ITEM 5. OTHER EVENTS.
On July, 23, 2003, CollaGenex Pharmaceuticals, Inc., a Delaware corporation (the
"Company"), issued a press release announcing that the United States District
Court of the District of Columbia has granted a preliminary injunction
temporarily restraining the FDA from approving any abbreviated new drug
applications ("ANDAs") submitted for a capsule or tablet generic dosage form of
Periostat(R) (doxycycline hyclate) 20mg.
In addition, the Company announced that until the Court has made a final ruling
on the regulatory status of Periostat, specifically whether or not the drug
should be classified as an antibiotic, the FDA cannot approve the ANDAs on file
for West-ward Pharmaceutical Corporation's 20 mg doxycycline hyclate capsule,
Mutual Pharmaceutical Company's 20 mg doxycycline hyclate tablet or any other
ANDA for a generic version of Periostat.
As a result of the ruling in the District Court of the District of Columbia, the
Company has withdrawn its motion for a temporary restraining order and
preliminary injunction in its patent infringement suit against Mutual
Pharmaceutical Company, which was previously filed in the District Court of the
Eastern District of New York, although its complaint remains outstanding. In
addition, the Company is considering its alternatives regarding its motion for
preliminary injunction in its patent infringement suit filed against West-ward
Pharmaceutical Corporation in the same jurisdiction.
The foregoing statements are qualified in their entirety by the Company's press
release, a complete copy of which is filed herewith as Exhibit 99.1 and is
incorporated herein by reference.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) Exhibits.
Exhibit No. Description
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99.1 Press release of CollaGenex Pharmaceuticals, Inc., dated July
23, 2003.
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.
COLLAGENEX PHARMACEUTICALS, INC.
By: /s/ Nancy C. Broadbent
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Nancy C. Broadbent
Chief Financial Officer
(Principal Financial Officer)
Date: July 23, 2003