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 5, 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) |
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 BioSpecifics, we, us, our and Company refer to BioSpecifics Technologies Corp.
Item 8.01. | Other Events |
On November 5, 2015, BioSpecifics announced that its partner Endo International plc (Endo) had exercised, with BioSpecifics consent, an early opt-in right for CCH to include two new potential indications, plantar fibromatosis and lateral thigh fat. In light of the early opt-in, Endo will pay BioSpecifics an opt-in fee of $500,000 for each indication. BioSpecifics has been relieved of the requirement to do further clinical development for these two indications. These two indications otherwise remain subject to the terms of the Second Amended and Restated Development and Licensing Agreement. This early opt-in does not affect any other Stage I development activities of BioSpecifics.
A press release regarding the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K. The notice of early opt-in is attached as Exhibit 99.2 to this Current Report on Form 8-K.
Item 9.01. | Financial Statements and Exhibits |
(d) |
Exhibits. |
Exhibit | Description |
99.1 | Press Release dated November 5, 2015 |
99.2 | Notice of early opt-in, dated as of November 3, 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: November 6, 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 November 5, 2015 |
99.2 | Notice of early opt-in, dated as of November 3, 2015 |
BioSpecifics Technologies Corp. Announces Partner Endo
International
Exercises Early Opt-In for XIAFLEX for Two New
Indications
- Company to receive opt-in fee of $0.5M for each new indication; lateral thigh fat and plantar fibromatosis
LYNBROOK, NY November 5, 2015 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase based-therapies with a first in class collagenase-based product marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and Xiapex® in Europe, today announced that its partner Endo International plc (Endo) has exercised an early opt-in for CCH to include two new potential indications, lateral thigh fat and plantar fibromatosis. The Company will receive a $0.5 million opt-in fee for each indication.
"Our partner Endo shares our belief in the vast potential of CCH as an effective treatment for many important conditions and diseases, said Thomas L. Wegman, President of BioSpecifics. We are very excited to report that they have chosen to opt-in early for the development of these two promising indications.
As a result of Endos early opt-in for these two indications, Endo is now responsible for all costs for future clinical development. All other terms and conditions of the agreement remain the same, however, including Endos obligations with respect to developmental milestone payments and royalties and mark-up on cost of goods sold payments. BioSpecifics agreed to this early opt-in which does not affect any of the other Stage I development activities of BioSpecifics including human lipomas and uterine fibroids.
In addition to these two new indications announced today, Endo's current licensed rights also include Dupuytren's contracture, Peyronie's disease, adhesive capsulitis, cellulite and canine lipoma.
About Lateral Thigh Fat
Lateral thigh (trochanteric) fat accumulation is common among
woman particularly as they age and it is often very difficult to improve its
appearance through exercise and diet alone. Patients frequently avoid exercise
and are unable to restrict their caloric intake. In some cases, cyrolipolysis
and liposuction are performed to remove the unsightly fat deposits in the
lateral thigh. There are no pharmaceutical products that are labeled for use on
lateral thigh fat in the U.S.
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About Plantar Fibromatosis
Plantar fibromatosis or Ledderhose disease is a medical
condition characterized by pain and disability caused by the thickening of the
feet's deep connective tissue resulting in the formation of nodules or cords
along tendons of the foot. Patients with plantar fibromatosis often have
Dupuytrens disease, Peyronies disease and adhesive capsulitis. Treatment may
include orthothotics and anti-inflammatory drugs in the early stages of the
disease, steroid injections and surgery in advanced cases. There are no
pharmaceutical products that are Food and Drug Administration approved for use
in this indication in the U.S.
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 marketing rights in Canada and
Australia and Asahi Kasei Pharma Corporation has marketing rights 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, including statements regarding the Company's 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 Report include statements
concerning, among other things, the receipt of two $0.5 million opt-in fees from
Endo for Endos exercise of an early opt-in right for CCH to include two new
potential indications, lateral thigh fat and plantar fibromatosis; Endos
commitment to further develop the two new potential indications that it
exercised its early-opt in right for; the future receipt of payments from Endo,
including milestone and royalty payments, in connection with the Auxilium
Agreement; whether Endo will exercise its right to opt-in early for other
additional indications. In some cases, these statements can be identified by
forward-looking words such as "expect," "continue," "may," "will, "currently,"
and "potential," the negative or plural of these words, and other similar
expressions. These forward-looking statements are our predictions based on our
current expectations and our projections about future events. There are a number
of important factors that could cause our actual results to differ materially
from those indicated by such forward-looking statements, including the ability
of Endo and its partners to achieve their respective objectives for CCH in their
applicable territories; the uncertainties inherent in the initiation of future
clinical trials; Endo or any of its partners modifying their respective
objectives and/or allocating resources other than to CCH; the potential market
for CCH in a given indication being smaller than anticipated; the potential of
CCH to be used in additional indications and the initiation, timing
and outcome of clinical trials of CCH for additional indications; the protection
of the Companys intellectual property portfolio; the timing of regulatory
filings and action; the receipt of any payments from Endo; and other risk
factors identified in our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2015, our Annual Report on Form 10-K for the year ended December 31,
2014 and our Current Reports on Form 8-K filed with the Securities and Exchange
Commission. All forward-looking statements included in this presentation are
made as of the date hereof, and we assume no obligation to update these
forward-looking statements.
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Contact:
BioSpecifics Technologies Corp.
Thomas L. Wegman, President
(516) 593-7000
thomas_wegman@biospecifics.com
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Endo | ||||||||
1400 Atwater Drive | ||||||||
Malvern, PA 19355 | ||||||||
484 216 0000 | ||||||||
endo.com | ||||||||
endo | ||||||||
Sent via electronic mail and overnight courier |
November 3, 2015
Mr. Tom Wegman
President
BioSpecifics Technologies Corp.
35 Wilbur Street
Lynbrook, NY 11563
RE: | Exercise of Option Pursuant to Section 2.2 of the Second Amended and Restated Development and License Agreement, dated August 31, 2011, as amended. |
Dear Tom:
Endo Global Ventures provides this notice pursuant to Section 2.2 of the Second Amended and Restated Development and License Agreement, dated as of August 31, 2011, as amended, (the Agreement) by and between BioSpecifics Technologies Corp. (BTC) and Auxilium Pharmaceuticals, Inc. (Auxilium). An Affiliate of Endo International plc acquired Auxilium in January 2015 and the Agreement has been assigned to Endo International plc Affiliate, Auxilium Bermuda ULC, currently known as Endo Global Ventures (hereinafter referred to as Endo).
Endo hereby provides to BTC written notice of exercise of its Additional Indication Option (as defined in the Agreement) with regard to the Additional Indications for the Product (as defined in the Agreement) of plantar fibromatosis and lateral thigh fat.
Endo hereby waives the requirement set forth in Section 2.2(c) that BTC complete Stage I Development and submit to Endo a completed Phase II Clinical Trial report. Except as set forth herein, all other terms, provisions, conditions and covenants of the Agreement remain in full force and effect.
The Exercised Indication Date (as defined in the Agreement) shall be the date hereof, and pursuant to Section 2.2(e), the definition of Field in the Agreement shall be expanded to include both plantar fibromatosis and lateral thigh fat.
By mutual agreement of the parties, Endo shall pay to BTC the amount of $500,000 for each Additional Indication for the Product within thirty (30) days of the date hereof.
Mr. Tom Wegman | endo |
November 3, 2015 | |
Page 2 of 2 | |
Please countersign below and return a copy to Endo. As stated in the Agreement, BTC and Endo agree that this exercise notice shall be appended to the Agreement upon signature by BTC and incorporated by reference into the Agreement effective November 3, 2015.
We look forward to our continuing collaborations.
Sincerely,
/s/ Sue Hall
Sue Hall
Chief Scientific Officer & Global Head of
Research and Development, Endo International plc
Director, Endo Global
Ventures
/s/ Thomas Wegman | |
BioSpecifics Technologies Corp. | |
Name: Thomas Wegman | |
Title: President |
cc to: | Attn: Carl A. Valenstein, Esq. |
Bingham McCutchen LLP | |
2020 K Street NW | |
Washington, DC 20006 |