Positive Data on BioSpecifics/ Auxilium's Xiaflex - Analyst Blog


BioSpecifics Technologies Corp . ( BSTC ) recently announced encouraging top-line data on Xiaflex from a phase II dose escalation clinical trial for the treatment of human lipoma.

The phase II open label single-center dose escalation study (n=14) assessed the safety and efficacy of Xiaflex in patients with lipoma, divided into four dose cohorts. The data from the trial showed reduction of lipoma size in patients following its treatment with Xiaflex.

Xiaflex, developed in collaboration with Auxilium Pharmaceuticals, Inc . ( AUXL ), is approved in the U.S. and EU (EU trade name: Xiapex) for Dupuytren's Contracture (DC) and Peyronie's disease (PD).

We note that Xiaflex has been granted Orphan Drug Designation in the U.S. by the Food and Drug Administration (FDA) for DC and PD.

Based on encouraging data from the phase I and phase II trials for the indication of human lipoma, BioSpecifics plans to initiate a placebo-controlled study to further assess the efficacy and safety of Xiaflex for the treatment of human lipoma in the first half of 2014.

Meanwhile, Auxilium Pharma has the option to exclusively license development and marketing rights for the human lipoma indication following the completion of a new trial. The completion of the new trial will trigger an opt-in payment and potential future milestone and royalty payments from Auxilium Pharma.

Auxilium Pharma recently announced that interim data from its phase IV retreatment study evaluating Xiaflex in adult patients with DC and a recurrent contracture with a palpable cord will be presented at the American Association for Hand Surgery (AASH) 2014 Annual Meeting.

The open label phase IV study is evaluating patients (n=51) who had recurrence of a contracture in a joint that was previously effectively treated with Xiaflex. The interim analysis was conducted after all patients had completed their 30-day follow up assessments.

Auxilium Pharma aims to evaluate the efficacy of Xiaflex following a recurrence in DC that was initially treated with this modality.

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 space are Forest Laboratories ( FRX ) and Sucampo Pharmaceuticals Inc . ( SCMP ). Both stocks carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: AUXL , BSTC , FRX , SCMP



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