8-K

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): September 16, 2009

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

Delaware	0-19879	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:

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

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

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

o     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 September 16, 2009, the Arthritis Advisory Committee appointed by the Division of Anesthesia, Analgesia and Rheumatology Products of the U.S. Food and Drug Administration (the "FDA") recommended by a unanimous vote of 12 to 0 that XIAFLEX™ be granted marketing approval by the U.S. Food and Drug Administration for the treatment of Dupuytren’s disease. The Arthritis Advisory Committee’s recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application submitted for XIAFLEX™ by the Company’s partner, Auxilium Pharmaceuticals, Inc.

NASDAQ halted trading of the Company’s common stock on the morning of September 16, 2009, because the Arthritis Advisory Committee appointed by the FDA was scheduled to meet on the afternoon of September 16, 2009 to review and discuss the Biologics License Application for XIAFLEX™ for the treatment of Dupuytren’s disease.

Press releases announcing these development are attached hereto as Exhibit 99.1 and Exhibit 99.2.

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS

(d)	Exhibits
99.1	Press release dated September 16, 2009
99.2	Press release dated September 16, 2009

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, each registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: September 16, 2009	BIOSPECIFICS TECHNOLOGIES CORP.
	——————————————————
	(Registrant)
	/s/ Thomas L. Wegman
	——————————————————
	Thomas L. Wegman
	President

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release dated September 16, 2009
99.2	Press release dated September 16, 2009

EX-99.1

Exhibit 99.1

FDA Advisory Committee Unanimously Recommends
Approval of XIAFLEX™ for Treatment of Dupuytren’s
Disease

LYNBROOK, NY – September 16, 2009 - BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first-in-class collagenase-based products, today announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration’s (FDA) unanimously recommended by a vote of 12 to 0 that XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's disease, a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers.

"We believe that the Advisory Committee’s very supportive vote today for XIAFLEX represents a major advance for both the patients suffering from Dupuytren’s disease, as well as for BioSpecifics and its shareholders," stated Thomas L. Wegman, President of BioSpecifics. "We congratulate our partner Auxilium on its thorough and thoughtful presentation today and look forward to the FDA’s decision regarding the approval of XIAFLEX."

The Advisory Committee’s recommendations are not binding, but will be considered by the FDA in its review of the XIAFLEX BLA. Auxilium Pharmaceuticals, Inc. has licensed the rights to XIAFLEX from BioSpecifics for three clinical indications: Dupuytren's disease; Peyronie's disease; and frozen shoulder (adhesive capsulitis). Auxilium filed its BLA for XIAFLEX for the treatment of Dupuytren's disease on February 27, 2009 and received a target date under the Prescription Drug User Fee Act (PDUFA) date of August 28, 2009, which has not been updated.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for three clinical indications: Dupuytren's disease; Peyronie's disease; and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium Pharmaceuticals, Inc. has announced the acceptance of the Biologic License Application (BLA) and Priority Review by the U.S. Food and Drug Administration for injectable collagenase XIAFLEX™ in the treatment of Dupuytren's disease. Pfizer, Inc. is responsible for marketing XIAFLEX™ product in Europe.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the company’s 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 ability of its partner Auxilium to obtain regulatory approval of XIAFLEX™ in the United States for Dupuytren's disease and Peyronie's disease and the ability of Pfizer to obtain regulatory approval of XIAFLEX™ in its territory for these same indications, which will determine the amount of milestone, royalty and sublicense income payments it may receive; the amount of earn out payments it may receive from DFB Biotech Inc. and its affiliates; whether Auxilium exercises its option under the companies’ license agreement for additional indications; the potential benefits of its existing license and development agreements; its estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company’s Form 10-K for the year ended December 31, 2008 and the Form 10-Q for the quarter ended June 30, 2009 and any subsequent reports filed with the SEC. The Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Contact:

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

EX-99.2

Exhibit 99.2

BioSpecifics Technologies Corp. Stock Trading Halted Today

- FDA Advisory Committee to Review XIAFLEX™ BLA for Dupuytren’s Disease -

LYNBROOK, NY – September 16, 2009 – BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that NASDAQ has halted trading of the Company’s common stock this morning. The Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration’s (FDA) Division of Anesthesia, Analgesia and Rheumatology Products will be meeting today to review and discuss the Biologics License Application (BLA) for XIAFLEX™ for the treatment of Dupuytren's disease, a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers. Auxilium Pharmaceuticals, Inc. has licensed the rights to XIAFLEX from BioSpecifics for this indication.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for three clinical indications: Dupuytren's disease; Peyronie's disease; and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium Pharmaceuticals, Inc. has announced the acceptance of the Biologic License Application (BLA) and Priority Review by the U.S. Food and Drug Administration for injectable collagenase XIAFLEX™ in the treatment of Dupuytren's disease. Pfizer, Inc. is responsible for marketing XIAFLEX™ product in Europe.

Contact:

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