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UNITED STATES
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 Earliest Event Reported: May 10, 1999
BIOSPECIFICS TECHNOLOGIES CORP.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-19879 11-3054851
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
35 Wilbur Street
Lynbrook, New York 11563
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (516) 593-7000
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Not applicable
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(Former Name or Former Address, if Changes Since Last Report)
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Item 5. Other Events
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Attached hereto as Exhibit 99.1, and incorporated herein by reference,
is the text of a May 12, 1999 press release of BioSpecifics Technologies Corp.
(the "Company") announcing that on May 10, 1999, the Food and Drug
Administration (the "FDA") stated that it will institute action to revoke the
Company's license to manufacture its product Collagenase Santyl Ointment, if the
Company fails to submit to the FDA a detailed, comprehensive plan of corrective
action within 30 days.
Item 7. Financial Statements and Exhibits
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(c) Exhibits
EXHIBIT NUMBER DESCRIPTION
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99.1 Press Release dated May 12, 1999.
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SIGNATURE
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.
BIOSPECIFICS TECHNOLGIES CORP.
/S/ ALBERT HORCHER
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Albert Horcher
Secretary, Treasurer and Chief Accounting Officer
Date: May 13, 1999.
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EXHIBIT INDEX
Exhibit
Number Description
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99.1 Press Release dated May 12, 1999.
EXHIBIT 99.1
FOR IMMEDIATE RELEASE
BIOSPECIFICS ANNOUNCES UPDATE OF FDA SITUATION
LYNBROOK, NY, May 12, 1999 - As previously announced by BioSpecifics
Technologies Corp. (Nasdaq/NMS:BSTC) on April 23, 1999 and May 7, 1999, the U.S.
Food and Drug Administration (FDA) noted inspectional observations in its latest
inspection of the Company's facilities.
On May 10, 1999, the FDA advised the Company that the Company must submit to the
FDA a detailed, comprehensive plan of corrective action within 30 days. If the
Company fails to do so, the FDA stated that it will institute action to revoke
the Company's license to manufacture its product, Collagenase Santyl Ointment.
The Company intends to comply with the FDA demands and is preparing a
comprehensive corrective action plan to address the deficiencies and FDA's
concerns. The Company does not believe that any of the deficiencies are
uncorrectable and stated that it has the financial resources and the necessary
professional expertise available to it in order to achieve compliance.
BioSpecifics Technologies Corp. is a pharmaceutical company with a focus on
wound healing and tissue remodeling. It has pioneered the application of
collagenase for several disease conditions, notably dermal ulcers, pressure
sores (bedsores), and second and third degree burns. BioSpecifics produces
Collagenase ABC, the essential ingredient in the prescription drug Collagenase
Santyl sold in the United States, and under other trademarks abroad.
Forward looking statements in this release involve a number of risks and
uncertainties including, but not limited to, health authority regulations,
product demand, pricing, market acceptance, changing economic conditions, risks
in product and technology development, the effect of the Company's accounting
policies, and other risk factors detailed in the Company's filings with the
Securities and Exchange Commission.
Contact: BioSpecifics Technologies Corp. Thomas L. Wegman (516) 593-7000
William Dunk Partners, Inc. Deborah Passik (919) 929-4100
