-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Op+pwnvO7K1c7vXXnCspBZV3eL6cF8z3J5zX1qVqHIYHVXuBMrjFSzIWG3qmCD8o DarjmdP+/V2feWelW3O4jg== 0000921530-99-000092.txt : 19990514 0000921530-99-000092.hdr.sgml : 19990514 ACCESSION NUMBER: 0000921530-99-000092 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990510 ITEM INFORMATION: FILED AS OF DATE: 19990513 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOSPECIFICS TECHNOLOGIES CORP CENTRAL INDEX KEY: 0000875622 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 113054851 STATE OF INCORPORATION: DE FISCAL YEAR END: 0131 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-19879 FILM NUMBER: 99619291 BUSINESS ADDRESS: STREET 1: 35 WILBUR ST CITY: LYNBROOK STATE: NY ZIP: 11563 BUSINESS PHONE: 5165937000 MAIL ADDRESS: STREET 1: 35 WILBUR STREET CITY: LYNBROOK STATE: NY ZIP: 11563 8-K 1 FORM 8-K RE BIOSPECIFICS TECHNOLOGIES CORP. ________________________________________________________________________________ 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. ________________________________________________________________________________ (Exact Name of Registrant as Specified in Charter) Delaware 0-19879 11-3054851 ________________________________________________________________________________ (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 35 Wilbur Street Lynbrook, New York 11563 ________________________________________________________________________________ (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (516) 593-7000 ----------------------------- Not applicable ________________________________________________________________________________ (Former Name or Former Address, if Changes Since Last Report) Item 5. Other Events - ---------------------- 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 - ------------------------------------------- (c) Exhibits EXHIBIT NUMBER DESCRIPTION -------------- ----------- 99.1 Press Release dated May 12, 1999. 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 ------------------------------------------------- Albert Horcher Secretary, Treasurer and Chief Accounting Officer Date: May 13, 1999. EXHIBIT INDEX Exhibit Number Description - ------ ----------- 99.1 Press Release dated May 12, 1999. EX-99 2 EXHIBIT 99.1 - PRESS RELEASE 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 -----END PRIVACY-ENHANCED MESSAGE-----