-----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, NqoJp1ixpAqw2EwLUUc7Ngsb1l2/S2t5sgxy7WJ2z/xFT7jaLBVEi5ZqfVN0R5e3 E+G5QKoc2RnZOvJ+1KLCSQ== 0001204459-11-000557.txt : 20110301 0001204459-11-000557.hdr.sgml : 20110301 20110301163350 ACCESSION NUMBER: 0001204459-11-000557 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20110301 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110301 DATE AS OF CHANGE: 20110301 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: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34236 FILM NUMBER: 11652147 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 form8k.htm FORM 8-K BioSpecifics Technologies Corp.: Form 8-K - Filed by newsfilecorp.com

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 Report (Date of Earliest Event Reported): March 1, 2011

BIOSPECIFICS TECHNOLOGIES CORP.
(Exact name of registrant as specified in its charter)

Delaware 001-34236 11-3054851
(State or Other Jurisdiction (Commission File Number) (I.R.S. Employer
Of Incorporation)   Identification No.)

35 Wilbur Street
Lynbrook, NY 11563
(Address of Principal Executive Office) (Zip Code)

516.593.7000
(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[   ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[   ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)

[   ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))

[   ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))


INTRODUCTORY COMMENT

Throughout this Current Report on Form 8-K, the terms “we,” “us,” “our” and “Company” refer to BioSpecifics Technologies Corp.

ITEM 8.01 OTHER EVENTS

On March 1, 2011, the Company announced that Pfizer Inc. received approval from the European Medicines Agency to market XIAPEX® (collagenase clostridium histolyticum) in Europe for the treatment of Dupuytren’s contracture.

A press release regarding the announcement is attached hereto as Exhibit 99.1.

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS

  (d) Exhibits

99.1 Press release dated March 1, 2011


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.

Date: March 1, 2011 BIOSPECIFICS TECHNOLOGIES CORP.
  ——————————————————
  (Registrant)
   
   
  /s/ Thomas L. Wegman
  ——————————————————
  Thomas L. Wegman
  President


EX-99.1 2 exhibit99-1.htm EXHIBIT 99.1 BioSpecifics Technologies Corp.: Exhibit 99.1 - Filed by newsfilecorp.com

Exhibit 99.1

BioSpecifics Technologies Corp. Announces Approval of XIAPEX®for
Treatment of Dupuytren’s Contracture in Europe

LYNBROOK, NY – March 1, 2011 - BioSpecifics Technologies Corp. (NASDAQ: BSTC; “BioSpecifics”), a biopharmaceutical company developing first in class collagenase-based products, today announced that Pfizer Inc. (“Pfizer”) received approval from the European Medicines Agency (“EMA”) to market XIAPEX (collagenase clostridium histolyticum) in Europe for the treatment of Dupuytren’s contracture, a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers, and is expected to be available for use in some European markets later this year.

“This approval is a significant milestone for XIAPEX, and we look forward to its commercial success in this important market,” commented Thomas L. Wegman, President of BioSpecifics.

BioSpecifics’ strategic partner, Auxilium Pharmaceuticals, Inc. (“Auxilium”), markets collagenase clostridium histolyticum as XIAFLEX® for Dupuytren’s contracture in the United States, and sub-licensed Pfizer the rights to market XIAPEX for Dupuytren's contracture and Peyronie's disease in 27 member countries of the European Union and 19 other European and Eurasian countries.

Under the terms of the strategic alliance agreement between Pfizer and Auxilium, BioSpecifics receives 8.5% of any milestone payments received by Auxilium from Pfizer, in addition to milestone payments due to BioSpecifics under its separate agreement with Auxilium. A milestone payment from Auxilium is due to BioSpecifics based on the first commercial sale in the UK, France, Germany, and Spain. BioSpecifics will also continue to receive low double-digit royalties on sales, independent of indication, territory, sales volume and whether Auxilium or Pfizer sells the product. In addition, BioSpecifics will receive a markup on the cost of goods sold.

About Dupuytren’s Contracture

Dupuytren’s contracture is caused by an abnormal accumulation of collagen in the palm characterized by the formation of nodules or lumps in the early stages. As the disease progresses, a cord is formed and the fingers may become progressively contracted.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications, three of which include: Dupuytren's contracture, Peyronie's disease, and frozen shoulder (adhesive capsulitis). Auxilium markets XIAFLEX in the U.S. for the treatment of Dupuytren's contracture. Pfizer is responsible for marketing XIAPEX in Europe. More information about BioSpecifics may be found on its website at www.biospecifics.com.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statements regarding BioSpecifics’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, its expected revenue growth, and any other statements containing the words “believes,” “expects,” “anticipates,” “plans,” “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause its actual results to differ materially from those indicated by such forward-looking statements, including the statements made by BioSpecifics regarding the success of the commercialization of XIAPEX in Europe by Pfizer; the timing and amount of milestone and royalty payments due to BioSpecifics from Auxilium resulting from the commercialization of XIAPEX in Europe by Pfizer; and other risk factors identified in BioSpecifics’ Form 10-K for the year ended December 31, 2009 and its reports on Form 8-K filed with the SEC. All forward-looking statements included in this press release are made as of the date hereof, and BioSpecifics assumes no obligation to update these forward-looking statements.

Contact:
BioSpecifics Technologies Corp.
Thomas L. Wegman, President
(516) 593-7000
thomas_wegman@biospecifics.com


-----END PRIVACY-ENHANCED MESSAGE-----