BioSpecifics Technologies Corp. Announces First Commercial Sale of XIAFLEX® for the Treatment of Dupuytren’s Contracture in Japan
LYNBROOK, NY – September 21, 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, announced today that the first commercial sale of XIAFLEX by Asahi Kasei Pharma Corporation for the treatment of Dupuytren’s contracture in Japan has triggered a $1.0 million milestone payment to BioSpecifics. Asahi Kasei Pharma has the rights to develop and market XIAFLEX in Japan for Dupuytren’s contracture and Peyronie’s disease through an agreement with BioSpecifics' partner Endo International plc (Endo).
“We recognize the importance of expanding XIAFLEX's reach to new patients around the globe and the first commercial sale of XIAFLEX in Japan is an important milestone for this effort,” commented Thomas L. Wegman, President of BioSpecifics. “We are very happy that there is now a non-surgical treatment option available to patients suffering from the debilitating effects of Dupuytren's contracture in this territory.”
Under the terms of BioSpecifics’ agreement with Endo, in addition to receiving a $1.0 million milestone payment related to the first commercial sale of XIAFLEX in Japan, BioSpecifics will receive royalties on net sales, mark-up on cost of goods sold and sales-based milestone payments.
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. Once the Dupuytren's collagen cord can be felt, it is
referred to as a "palpable cord."
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.
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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, whether
BioSpecifics will receive a milestone payment for the first commercial sale of
XIAFLEX in Japan and the amount of any such milestone payment, and whether
BioSpecifics will receive royalties on net sales and mark-up on cost of goods
sold payments. In some cases, these statements can be identified by
forward-looking words such as "expect," "believe," "likely," "continue,"
"estimates," "may," "will," "currently," and "potential," the negative or plural
of these words, and other similar expressions. These forward-looking statements
are the Company's predictions based on its current expectations and its
projections about future events. There are a number of important factors that
could cause the Company's 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 BioSpecifics'
Quarterly Report on Form 10-Q for the quarter ended June 30, 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 presentation are made as of the date hereof, and BioSpecifics assumes 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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