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SECURITIES AND EXCHANGE COMMISSION
450 Fifth Street, N.W.
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: October 11, 1995
Atrix Laboratories, Inc.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-18231 84-1043826
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(State of (Commission (IRS Employer
incorporation) File Number) Identification No.)
2579 Midpoint Drive, Fort Collins, Colorado 80525
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (970) 482-5868
Not Applicable
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(Former Name or Former Address, if Change Since Last Report)
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Item 5. Other Events.
See the Press Release attached hereto as Exhibit 20.
Item 7. Financial Statements and Exhibits.
(c) Exhibits
20 Press Release dated October 11, 1995 regarding the results
of a one year pivotal study on Atrix Laboratories, Inc.'s
ATRISORB(TM) Guided Tissue Regeneration (GTR) product.
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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.
ATRIX LABORATORIES, INC.
Date: October 20, 1995 By: /s/ Kimberly A. Marks
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Kimberly A. Marks, Corporate Controller
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EXHIBIT INDEX
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<CAPTION>
Exhibit No. Exhibit Description Page
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20 Press Release dated October 11, 1995 regarding
the results of a one year pivotal study on Atrix
Laboratories, Inc.'s ATRISORB(TM) Guided
Tissue Regeneration (GTR) product.
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Exhibit 20
FOR IMMEDIATE RELEASE: CONTACT: Kimberly A. Marks
October 11, 1995 Atrix Laboratories, Inc.
(970) 482-5868
OR: Melissa Wilmoth
Cameron Associates, Inc.
(212) 644-9560
ATRIX LABORATORIES ANNOUNCES
POSITIVE CLINICAL STUDY RESULTS
AND PLANS FOR COMMERCIALIZATION
FORT COLLINS, CO--OCTOBER 11, 1995--Atrix Laboratories, Inc. (NASDAQ: ATRX)
today announced it has completed the statistical analysis of the one year
pivotal study completed in July of the ATRISORB(TM) Guided Tissue Regeneration
(GTR) product. The results were positive and therefore pave the way for the
filing of a 510(k) medical device application with the Food and Drug
Administration in the fourth quarter of this year. The ATRISORB(TM) GTR Barrier
is a medical device designed to aid periodontal tissue healing following gum
surgery.
Unlike some products currently used to perform this procedure, the Atrix
product is biodegradable, avoiding the need for a second surgical procedure for
removal. The pivotal study just completed compared the performance of the
ATRISORB(TM) Barrier with the leading product on the market in an effort to
determine substantial equivalency.
Dr. Steven Garrett, Vice President of Dental Clinical Research for Atrix, said,
"The conduct and results of this study were gratifying. If the FDA agrees with
our analysis of the performance data and determines that the product is
substantially equivalent, I believe periodontists will find the ATRISORB(TM) GTR
Barrier very user friendly with distinct advantages over products currently
being used."
Based upon the favorable outcome of the study, the Company is proceeding with
plans to begin marketing the barrier in five European countries during the
first quarter of next year. In preparation for commercialization, the Company
also announced the appointment of Mr. Michael R. Duncan to the newly-created
position of Vice President of Manufacturing. Mr. Duncan comes to Atrix from
Geneva Pharmaceuticals, Inc., a division of Ciba-Geigy Corp., where he was the
Director of Production Operations. Duncan has twelve years of experience in
the manufacturing and packaging of a variety of pharmaceutical products. His
immediate duties will be to support the launch of the ATRISORB(TM) GTR Barrier
in Europe, but he is also responsible for the long term sourcing aspects of the
Company's strategic plan.
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John Urheim, Vice Chairman and CEO said, "We are pleased to have Mike joining
us at this important time. His role is a critical one in our overall plan of
building a state-of-the-art manufacturing infrastructure appropriate to support
the Company's commercial efforts worldwide."
Atrix Laboratories, Inc., is a drug delivery and medical device company whose
platform technology is comprised of the ATRIGEL(TM) biodegradable polymeric
system, which can be used for a broad range of applications, including drug
delivery, medical devices and the treatment of periodontal disease.
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