LYNBROOK, N.Y., Sept. 5 /PRNewswire-FirstCall/ -- BioSpecifics
Technologies Corp. (OTC Bulletin Board: BSTC), a biopharmaceutical company
developing first in class collagenase based products, announced today that it
has signed an agreement to significantly improve the deal terms related to its
future royalty obligations for Peyronie's disease by buying down its future
royalty obligations with a one-time cash payment.
BioSpecifics has modified its previously announced agreement to lower
future royalties payable on net sales of its injectable collagenase,
XIAFLEX(TM), for Peyronie's disease. The Company has taken this strategic step
because of the imminent initiation of the Phase 2b clinical trial, lack of
currently available desirable therapeutic options for Peyronie's patients, the
strong commitment of the Company's partner Auxilium Pharmaceuticals to pursue
the development for this clinical indication and the results of the three
separate positive clinical trials published to date.
BioSpecifics has previously announced that its third party royalty
obligations for Dupuytren's disease are 0.5% of net sales.
Auxilium is obligated to pay low double digit royalties at a flat rate as
a percentage of future worldwide net sales for all clinical indications,
irrespective of territory, and independent of sales volume. BioSpecifics will
also receive a percentage of non royalty payments (upfront, milestones, etc.)
if Auxilium sub-licenses the marketing rights to a third party. In addition,
BioSpecifics will receive a certain percentage mark up on cost of goods based
on Auxilium's manufacturing costs.
About Peyronie's Disease
Peyronie's disease is characterized by the presence of a collagen plaque
on the shaft of the penis, which can distort an erection and make intercourse
difficult or impossible in advanced cases. The plaque is not elastic and it
does not stretch during erection. In some mild cases, the plaque can resolve
spontaneously without medical intervention. The most common plaque forms on
the top of the penis causing the penis to arc upward. In severe cases, the
penis can be bent at a 90-degree angle during erection. Significant
psychological distress has been noted in patients with Peyronie's disease who
are sexually active. Frequent patient complaints include increased pain,
painful erections, palpable plaque, penile deformity, and erectile
dysfunction. Patients with Peyronie's disease have been reported to have an
increased likelihood of having Dupuytren's disease, frozen shoulder, plantar
fibromatosis, knuckle pads, hypertension and diabetes. Peyronie's disease
typically affects males in the range of 40-70 years. The cause of Peyronie's
disease is unknown, although some investigators have proposed that it may be
due to trauma or an autoimmune component. A number of researchers have
suggested that the incidence of Peyronie's disease has increased due to the
use of erectile dysfunction drugs.
Auxilium Pharmaceuticals has estimated that there are 210,000 potential
candidates in the US and Europe for XIAFLEX treatment on an annual basis.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has
developed and licensed injectable collagenase for three clinical indications:
Dupuytren's disease, Peyronie's disease and frozen shoulder (adhesive
capsulitis). The positive top line results for the Phase 3 trials on
Dupuytren's disease have been previously announced. BioSpecifics has a
development and licensing agreement with Auxilium Pharmaceuticals, Inc. More
information about the Company may be found on its website at
www.biospecifics.com.
SOURCE BioSpecifics Technologies Corp.
