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 Endo’s 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 Endo’s 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
Dupuytren’s disease, Peyronie’s 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 Endo’s exercise of an early opt-in right for CCH to include two new
potential indications, lateral thigh fat and plantar fibromatosis; Endo’s
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 Company’s 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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