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BioSpecifics Technologies Is Focused On The
Development Of Collagenase For Injection Products To Be Used In The
Treatment Of Dupuytren’s Disease, Peyronie’s Disease And Frozen Shoulder
Healthcare
Biotechnology
(BSTC-OTC: BB)
BioSpecifics Technologies Corp.
35 Wilbur Street
Lynbrook, NY 11563
Phone: 516-593-7000
Thomas L. Wegman
President and CEO
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published – March 21, 2008
BIO:
THOMAS L. WEGMAN.
Mr. Wegman, has served as an officer of BioSpecifics the Company for more
than 15 years. He is the current President Of BioSpecifics and has served in
this capacity since October 17, 2005. Prior to such appointment he served as
the Executive Vice President of the Company. Effective in 1994, Mr. Wegman
became a director on the Board of the Company and has served as such since
that time. He has over 30 years of experience in the bio-pharmaceutical
industry that encompasses managing company operations and drug development,
clinical trials, licensing, and registration. From 1978 thru 1983, Mr.
Wegman managed the production, marketing and foreign registration activities
related to an avian vaccine business. Mr. Wegman has been instrumental in
licensing technologies from universities for use by BioSpecifics. Mr. Wegman
managed the successful renovation of BioSpecifics’ manufacturing facility
which received approval from FDA in 2003. He is the author of a number of
U.S. and foreign patents in the life sciences field. Mr. Wegman received his
B.A. from Boston University.
Company Profile:
BioSpecifics Technologies Corp. is a
biopharmaceutical company that has developed and licensed injectable
collagenase for three clinical indications. We have a development and
licensing agreement with Auxilium Pharmaceuticals for clinical indications
in Dupuytren's disease, Peyronie's disease and frozen shoulder (adhesive
capsulitis).
Prior to March 2006, our primary focus was on the manufacture of the FDA
licensed product collagenase ointment for use in debridement of dermal
ulcers and severely burned areas. Following the sale of our collagenase
topical business to DFB BioTech, we reorganized and concentrated all
activities on the future development and commercialization of our injectable
collagenase products.
CEOCFO: Mr. Wegman, what is your vision for
BioSpecifics?
Mr. Wegman: “The short-term vision for
BioSpecifics relates to the technology that is involved with our collagenase
for injection products. Collagenase for injection is a therapy that has the
possibility to help treat multiple disease conditions. The one that is
furthest along in our pipeline is collagenase for the use in Dupuytren’s
disease, which is a contracture of the fingers and what it involved is an
injection of collagenase, which could substitute or serve as an adjunct to
surgery. That product is in Phase III and the studies are ongoing currently
and it is anticipated that the top line results will be announced in the 2nd
Quarter of 2008. In addition, there are two other indications for
collagenase for injection for Peyronie’s disease, which is a corresponding
disease with Dupuytren’s, where the penis can be bent at an angle upwards of
90 degrees. The other one is collagenase for use in frozen shoulder, which
is a disease which involves scarring around the shoulder capsule in which
range of motion can be severely limited and it is normally accompanied by
considerable pain. Patients with Dupuytren’s disease, Peyronie’s disease and
frozen shoulder currently have limited options and we believe that
collagenase injection will provide a significant therapeutic benefits in the
future.”
CEOCFO:
What is collagenase?
Mr. Wegman: “Collagenase is an enzyme
that hydrolyzes or breaks down collagen. Collagen is generally thought to be
a good thing, which is because it is the major component of connective
tissue, it also provides a structure for keeping all of your organs in
place, and it is one third of all the protein in the mammalian kingdom. It
is very much a vital protein and in fact the most prevalent protein in the
mammalian kingdom. However, there are situations where collagen is produced
in an out-of-control fashion. For example, scar tissue is primarily collagen
but there are a lot of diseases that are associated with excess scar tissue,
so then there may be a role for collagenase, which would be a minimally
invasive type of therapy which could reduce scar tissue and help cure
various diseases.”
CEOCFO:
Other than surgery are there any treatments now for these particular
targets?
Mr. Wegman: “The only technique that is
proven for Dupuytren’s disease is surgery. There has been the use of what
they call a needle procedure where the needle is used to stab the cord and
perhaps be less invasive than normal surgery. However, that procedure has
not been considered orthodox by the mainstream hand surgeons. In the case of
Peyronie’s disease the only proven therapy is surgery and surgery has a
number of downsides. In addition, all of the surgical procedures involve the
use of general anesthesia and since most people who have Dupuytren’s disease
are older, there may be resistance to general anesthesia. In terms of the
Dupuytren’s procedure, any time you perform surgery you have the chance of
creating more scarring.In addition, Dupuytren’s surgery has a significant
recurrence rate. In the case of Peyronie’s disease, typical surgical post
operative side-effects are shortening of the penis and many cases just
creating more scarring.”
CEOCFO: Are
you getting a good reception?
Mr. Wegman: “We are getting a very good
reception in terms of surveys in the medical community. Auxilium
Pharmaceuticals, with whom we have a development and licensing agreement,
has done surveys in the US and they believe they could use it on 76% of
patients who are considered surgical candidates for Dupuytren’s disease.
That is very similar to a survey that had been conducted by Biospecifics a
few years back where we found that hand surgeons would use it on 80% of the
patients who are considered candidates for Dupuytren’s surgery today.”
CEOCFO:
Would you tell us about your arrangement with Auxilium Pharmaceuticals?
Mr. Wegman: “Auxilium Pharmaceuticals is
our licensee so they have complete responsibility for the development in
marketing of the product. To date they have given us $8.5 billion in
milestone payments. In terms of royalty payments, they would pay net royalty
on worldwide sales. The royalty has been described by both Biospecifics and
Auxilium Pharmaceuticals as low double-digit royalty so that is on worldwide
sales and it is the same throughout any indication.”
CEOCFO: Are there other indications and
potential uses?
Mr. Wegman: “Yes there are. We have
licensed Auxilium Pharmaceuticals three uses so far. The ones I have
mentioned were Dupuytren’s disease, Peyronie’s disease and frozen shoulder,
In terms of Dupuytren’s disease, thirteen to 27 million people worldwide
have Dupuytren’s disease including early stage. It is estimated by Auxilium
that there are 240,000 patients annually in the US and Europe for
Dupuytren’s disease. With Peyronie’s disease for the US and Europe combined
it will be 210,000 patients per year that are candidates. It is also noted
that frozen shoulder has a much higher prevalence strain, so worldwide
people with frozen shoulder range between 20 and 50 million people.”
CEOCFO:
Down the road, there is also cellulite and some other uses?
Mr. Wegman: “Exactly, so further on down
the road we have announced that in the first half of 2008 we will initiate a
trial for Lipoma and in the second half of 2008 we are planning on
initiating a trial for cellulite. Lipomas are encapsulated fat deposits that
can appear in the skin or other parts of your body. It is estimated that
575,000 Americans present to physicians with Lipoma, as a primary diagnosis
annually. In terms of cellulite up to 95% of all women have cellulite and it
gets worse as you get older, and it is a well-known phenomenon.”
CEOCFO: How
well are you funded development?
Mr. Wegman: “We are adequately funded I
would say for now. The short-term goals are to perform I would call a
proof-of-concept trials for Lipoma as well as cellulite. Since we have an
exclusive arrangement with Auxilium they have an opt-in right after we
complete the trials so we do the trials, we may sell them to Auxilium, they
have a choice of whether they want to opt-in or not, if they don’t want to
opt-in we can pursue with other parties.”
CEOCFO: How
is Biospecifics ready for the commercialization phase?
Mr. Wegman: “Those responsibilities are
in the hands of Auxilium primarily after we signed our agreement with them
in June of 2004. Therefore, Auxilium has been able by virtue of the
technology that we licensed to them to get a great support from the capital
markets. Based on the licensed technology their market cap is $1.5 billion
today, so they can have the tools to finance the development and
commercialization.”
CEOCFO:
Biospecifics is in a very good position nowadays!
Mr. Wegman: “I think we are!”
CEOCFO: Why
should potential investors be interested in Biospecifics, what sets you
apart?
Mr. Wegman: “Essentially, if you believe
in the potential of collagenase we are a bargain at the current stock price.
Auxilium has described the collagenase therapy as a billion dollar
opportunity.”
CEOCFO:
What should people remember most about Biospecifics?
Mr. Wegman:
“They should take away the fact that collagenase for injection has the
potential to serve as a minimally invasive approach for diseases that have
limited treatment options today. The clinical results for its use in
Dupuytren’s disease have been compelling.”
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