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): November 21, 2014
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) |
Registrants 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 November 21, 2014, the Company announced new data on XIAFLEX for the treatment of Peyronies disease from the Phase 2 and the pivotal Phase 3 IMPRESS (The Investigation for Maximal Peyronies Reduction Efficacy and Safety Studies) trials, presented by BioSpecifics licensee, Auxilium Pharmaceuticals, Inc. at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America held in Miami, FL from November 20-23, 2014.
A press release regarding the announcement is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits (d) Exhibits
Exhibit No. | Description |
99.1 | Press Release of the Company, dated November 21, 2014 |
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.
Biospecifics Technologies Corp. | ||
Date: November 21, 2014 | By: | /s/ Thomas L. Wegman |
Thomas L. Wegman | ||
President |
EXHIBIT INDEX
Exhibit No. | Description |
99.1 | Press Release of the Company, dated November 21, 2014 |
Exhibit 99.1
BioSpecifics Technologies Corp. Announces New
Data on
XIAFLEX®for Peyronies Disease
Presented at SMSNA
Scientific Meeting
LYNBROOK, NY November 21, 2014 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced new data on XIAFLEX for the treatment of Peyronies disease from the Phase 2 and the pivotal Phase 3 IMPRESS (The Investigation for Maximal Peyronies Reduction Efficacy and Safety Studies) trials, presented by BioSpecifics licensee, Auxilium Pharmaceuticals, Inc. (Auxilium) at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) held in Miami, FL from November 20-23, 2014.
The clinical data presented today further demonstrate the crucial therapeutic benefits that XIAFLEX can offer to Peyronies disease patients. These data show improvement in objective measurements related to penile curvature deformity. In addition, the data also show effectiveness in other clinical measurements including patient bother, quality of life and the impact on patients sexual partners, stated Thomas L. Wegman, President of BioSpecifics. While we have previously discussed the severe stress that Peyronies disease may cause on a relationship or to the partner of the patient, we are pleased to be able to present data related to our minimally-invasive treatment, that we believe can improve associated bother and quality of life measures of the patient as well as those of their sexual partners.
XIAFLEX is the first and only FDA-approved biologic therapy indicated for the treatment of Peyronies disease in men with a palpable plaque and a penile curvature deformity of 30 degrees or greater at the start of therapy.
New data were presented at SMSNA assessing the impact on female sexual partners of men treated for Peyronies disease, suggesting that female bother by their partners symptoms improved after their partners treatment with XIAFLEX. To assess female bother, female sexual partners completed the Female Sexual Function Index (FSFI) and the Peyronies disease Questionnaire (PDQ), a 12-item, investigational questionnaire adapted from the mens PDQ.
A post-hoc analysis of data from the IMPRESS studies suggests that improvements in Peyronies disease bother correlates with improvements in Peyronies disease penile curvature deformity, further reinforcing the previously demonstrated conclusion that Peyronies disease bother is a valid clinical assessment.
The post-hoc analysis of the IMPRESS studies in patients with Peyronies disease for 6-12 months also suggest that further study of XIAFLEX treatment in the early months of Peyronies disease should be considered.
IMPORTANT SAFETY INFORMATION
A full Prescribing Information and Medication Guide are available at www.XIAFLEX.com.
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 by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium). Auxilium has the following partnerships outside the U.S. for XIAFLEX in Dupuytrens contracture and Peyronies 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. Auxilium is managing studies of CCH for frozen shoulder syndrome in a Phase 2b study, and also for cellulite. BioSpecifics is currently managing the development of CCH for the treatment of human and canine lipomas. 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, including statements
regarding our strategy, future operations, future financial position, future
revenues, projected costs, prospects, plans and objectives of management,
expected revenue growth, and the assumptions underlying or relating to such
statements, are forward-looking statements. The forward-looking statements in
this release include statements concerning, among other things, the impact of
data from the Phase 2 and Phase 3 IMPRESS trials, the improvement in objective
measurement related to penile curvature deformity, and the potential for
improvements in bother, quality of life and sexual function for patients and
partners. In some cases, these statements can be identified by forward-looking
words such as believe, 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 our current expectations and our projections
about future events and various assumptions. There can be no assurance that we
will realize our expectations or that our beliefs will prove correct. 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 the timing of regulatory filings and action; the ability of Auxilium
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 and canine lipoma and uterine fibroids, all of
which will determine the amount of milestone, royalty, mark-up on cost of goods
sold and sublicense income BioSpecifics may receive; the potential of CCH to be
used in additional indications; the Auxilium acquisition by Endo International
Plc; and other risk factors identified in BioSpecifics Annual Report on Form
10-K for the year ended December 31, 2013, its Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2014,June 30, 2014 and
September 30, 2014 and its Current Reports on Form 8-K filed with the Securities
and Exchange Commission. All forward-looking statements included in this release
are made as of the date hereof, are expressly qualified in their entirety by the
cautionary statements included in this release and, except as may be required by
law, we assume no obligation to update these forward-looking statements.
Contact:
BioSpecifics Technologies Corp.
Thomas L. Wegman,
President
(516) 593-7000
thomas_wegman@biospecifics.com