Auxilium says AA4500 study confirms efficacy in treating Dupuytren's disease

By E. Janene Geiss

Philadelphia, June 21 - Auxilium Pharmaceuticals, Inc. reported Wednesday top-line results from a pivotal efficacy study of AA4500, its injectable enzyme product, in patients with Dupuytren's disease.

The company also said it will pursue additional sources of commercial supply for AA4500 and has revised financial guidance with respect to research and development costs and full-year loss for 2006, according to a company news release.

The primary endpoint was met, and the study showed that a local injection of AA4500 was highly effective in treating Dupuytren's disease, also known as Dupuytren's Contracture.

BioSpecifics Technologies Corp., licensor of AA4500, sponsored and monitored the study, and Auxilium conducted follow-up and data analyses, officials said.

In the double-blind, randomized pivotal efficacy trial, 23 of 35 patients were randomized to receive AA4500 for up to three injections and 12 patients were randomized to receive a placebo, with the goal of reaching therapeutic success.

Therapeutic success was defined as reaching a reduction of the contracture of the affected joint to less than five degrees, essentially allowing the hand to be flat when placed on a table, officials said.

AA4500 achieved a 91% success rate for the primary endpoint of less than five degrees of contracture in treated joints, both Proximal Intra-Phalangeal, or PIP, joint and Metacarpal Phalangeal, or MP, joint, after up to three injections, compared to a 0% response rate in the placebo group, officials said.

The mean number of injections per joint was 1.4. These results were consistent with those from a phase 2 study published in The Journal of Hand Surgery.

The results observed after a single injection of AA4500 showed that 70% of subjects achieved therapeutic success; no patients responded to the placebo.

After finishing the study, patients from both AA4500 and placebo groups were permitted to receive additional AA4500 injections to either unsuccessfully treated joints or untreated joints in an open follow-up study, officials said.

A total of 19 patients enrolled in the follow-up study and received up to five injections of AA4500.

This follow-up study provided further support for the safety and tolerability of AA4500 injections in the treatment of Dupuytren's Contracture.

The company said it continues to plan for the start of a second phase 3 pivotal trial in Dupuytren's Contracture, sponsored and monitored by Auxilium, during the second half of 2006.

As the company said it believes it is now in the final stages of development for AA4500 in Dupuytren's Contracture, Auxilium's board of directors has approved the acceleration of the search for further commercial scale manufacturing capacity for AA4500 in addition to the existing drug supply from Auxilium's current contract manufacturer.

As a result of the higher 2006 manufacturing expense with the company's current supplier, Auxilium said it expects 2006 research and development expenditure to be $33 million to $37 million, rather than its previously disclosed range of $27 million to $30 million.

In light of the anticipated increase in research and development costs, the company said it estimates that its full-year 2006 loss will range from $40 million to $43 million, as compared to its former guidance of less than $38 million. Other estimates previously provided by the company, including revenues of $64 million to $68 million, remain the same, officials said.

Dupuytren's disease is a condition that involves contracture of joints in the hand that impairs patients' ability to straighten and move their joints due to a thickening and shortening of the normal ligaments of the palm and digits.

Auxilium is a Malvern, Pa., specialty pharmaceutical company.

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