0001062993-15-003934.txt : 20150720 0001062993-15-003934.hdr.sgml : 20150720 20150720082743 ACCESSION NUMBER: 0001062993-15-003934 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150720 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150720 DATE AS OF CHANGE: 20150720 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: 15995130 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, DC 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): July 20, 2015

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

Delaware 001-34236 11-3054851
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)

35 Wilbur Street 11563
Lynbrook, NY  
   
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: 516.593.7000

N/A

(Former name or former address, if changed since last report)

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 (see General Instruction A.2. below):

[   ] 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 July 20, 2015, the Company announced that Asahi Kasei Pharma Corporation had received approval for its regulatory application to the Japanese Pharmaceutical and Medical Device Agency to manufacture and sell XIAFLEX® (collagenase clostridium histolyticum) for the treatment of patients with Dupuytren’s contracture in Japan.

A press release regarding the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01.

Financial Statements and Exhibits


(d)

Exhibits.


Exhibit

Description

99.1

Press Release dated July 20, 2015



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 hereunto duly authorized.

Dated: July 20, 2015

BioSpecifics Technologies Corp.

By: /s/ Thomas L. Wegman
Name: Thomas L. Wegman
Title: President


EXHIBIT INDEX

Exhibit No.

Description

99.1

Press Release dated July 20, 2015



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

BioSpecifics Announces Approval of XIAFLEX® in Japan for the
Treatment of Dupuytren’s Contracture

LYNBROOK, NY – July 20, 2015 - BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products, announced that Asahi Kasei Pharma Corporation (Asahi Kasei) has received approval for its regulatory application to the Japanese Pharmaceutical and Medical Device Agency (PMDA) for XIAFLEX® (collagenase clostridium histolyticum) for the treatment of patients with Dupuytren’s contracture in Japan. Asahi has the rights to develop and market XIAFLEX in Japan through an agreement with BioSpecifics’ partner Endo International plc (Endo). BioSpecifics will receive a milestone payment upon commercial launch in Japan.

"This approval in Japan marks another milestone in our globalization strategy for XIAFLEX and we look forward to the upcoming commercial launch. We believe Asahi Kasei’s strong development and commercialization organizations will greatly enhance the sales potential of XIAFLEX in this region," commented Thomas L. Wegman, President of BioSpecifics. “We are very happy that these patients now have a minimally-invasive non-surgical treatment option available to them.”

About Dupuytren's Contracture

Dupuytren's contracture is caused by an abnormal accumulation of collagen in the palm of the hand 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 to date. Injectable collagenase is approved for marketing as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. for the treatment of adult Dupuytren's contracture patients with up to two palpable cords in the same palm and for Peyronie's disease in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy. XIAFLEX is marketed in the U.S. by BioSpecifics' partner, Endo International plc (Endo), following the acquisition of Auxilium Pharmaceuticals, Inc. by Endo. Endo has the following partnerships outside the U.S. for XIAFLEX in Dupuytren's contracture and Peyronie's disease: Swedish Orphan Biovitrum AB has marketing rights for XIAPEX® (the EU tradename for CCH) in 71 Eurasian and African countries, Actelion Pharmaceuticals Ltd. has rights in Canada, Australia, Mexico and Brazil, and Asahi Kasei Pharma Corporation in Japan. CCH is in clinical development for the treatment of several additional promising indications. Endo is managing the clinical development of CCH for frozen shoulder syndrome and cellulite as well as development in canine lipoma. BioSpecifics is currently managing the clinical development of CCH for the treatment of human lipoma and preclinical development for uterine fibroids. For more information, please visit www.biospecifics.com.


Forward-Looking Statements

This release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are "forward-looking statements." The forward-looking statements include statements concerning, among other things, whether BioSpecifics will receive a milestone payment upon commercial launch in Japan and whether and to what extent Asahi Kasei’s development and commercialization organizations will enhance the sales potential of XIAFLEX in Japan. In some cases, these statements can be identified by forward-looking words such as "believe, and whether BioSpecifics "expect," "anticipate," "plan," "estimate," "likely," "may," "will," "could," "continue," "project," "predict," "goal," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on BioSpecifics' current expectations and its projections about future events. There are a number of important factors that could cause BioSpecifics' actual results to differ materially from those indicated by such forward-looking statements including, among other things, the ability of Endo and its partners, Asahi Kasei Pharma Corporation, Actelion Pharmaceuticals Ltd. and Swedish Orphan Biovitrum AB, to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and timing, initiation and outcome of clinical trials for, additional indications including frozen shoulder, cellulite, human lipoma, canine lipoma and uterine fibroids; the potential of CCH to be used in additional indications; Endo modifying their objectives or allocating resources other than to CCH; and other risk factors identified in BioSpecifics' Quarterly Report on Form 10-Q for the first quarter ended March 31, 2015, its Annual Report on Form 10-K for the year ended December 31, 2014, and its Current Reports on Form 8-K filed with the Securities and Exchange Commission. All forward-looking statements included in this Report are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this Report and, except as may be required by law, the Company assumes no obligation to update these forward-looking statements.

Contact:

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


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