Investors eagerly wait for updates on the pipelines of
biopharma/biotech companies. Such updates including label
expansions of marketed products help them to decide whether or
not to invest in a particular company. Pipeline updates provide
information on experimental drugs and also provide an insight
into the commercial potential of the candidate once it is
successfully developed and commercialized.
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BioSpecifics Technologies Corp.
) which has been actively developing its pipeline announced mixed
top-line data from a phase II study (Chien-804) which is
evaluating the efficacy of Xiaflex (collagenase clostridium
histolyticum) in 37 canines with benign subcutaneous lipomas.
We note Xiaflex has been in-licensed by
Auxilium Pharmaceuticals, Inc.
) from BioSpecifics Technologies and is approved in the U.S. and
EU (EU trade name: Xiapex) for Dupuytren's Contracture (DC).
Xiaflex is also approved for treating Peyronie's disease (PD) in
men with a palpable plaque and a curvature deformity of 30
degrees or greater at the start of therapy.
BioSpecifics Technologies said in its press release that the
placebo-controlled, double-blind, randomized trial failed to meet
its primary endpoint of a statistically significant difference
(post-treatment) in the mean percentage change in lipoma volume
measured by CT scan.
Data from the study however revealed a statistically significant
reduction in lipoma surface area in responder analysis (measured
by caliper). BioSpecifics Technologies intends to submit a final
report on the study to Auxilium by Mar 31, 2014. The submission
will trigger the 120-day opt-in period as Auxilium has the option
to exclusively license development and marketing rights to the
canine lipoma indication. The rights will go back to BioSpecifics
Technologies in the event of Auxilium not opting-in.
BioSpecifics Technologies was also in the news recently when
Auxilium dosed its first patient for the phase II study on
Xiaflex for the treatment of frozen shoulder syndrome (FSS or
adhesive capsulitis). We believe investor focus will remain on
the efforts to expand Xiaflex's label.
BioSpecifics Technologies, a biopharmaceutical company, carries a
Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma
Vanda Pharmaceuticals Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).