Product

Xiaflex

Approval Date

February 3, 2010

Release Date

March 8, 2010

Company

Auxilium Pharmaceuticals, Inc.

Class

Collagenase

Indication

Treatment of adult Dupuytren’s contracture patients with a palpable cord.

Active Ingredient

Collagenase clostridium histolyticum

Agency Roster

Medicus Life Brands/ BioSpecifics Technologies

Marketing Strategy/Execution

Auxilium launched Xiaflex about a month after US approval through a team of about 100 field sales managers and reps, reimbursement specialists and managed market account directors, plus 11 MSLs providing medical support. Work continues in marketing, sales, reimbursement and managed care. Auxilium is planning to train hand, orthopedic, plastic and general surgeons and rheumatologists who are very familiar with the diagnosis and treatment of Dupuytren’s contracture (DC), a condition that keeps bent fingers from straightening. Xiaflex is injected into the hand to dissolve excess collagen. A day later, the doctor tries to straighten the finger, and several shots might be needed. Physicians may not receive Xiaflex until they attest to having completed a program on how to administer the drug. Clinicians can download educational materials, or attend physician speaker meetings or training sessions held during medical society meetings. A week after launch, analyst Salveen Kochnover, of Collins Stewart, said about 550 physicians had completed Xiaflex training (out of the 7,000 targeted physicians), suggesting they plan to use the drug on patients. In addition, several physicians, including hand and plastic surgeons who have administered Xiaflex, had reported positive clinical and reimbursement feedback. However, the drug’s price may be off-putting to some doctors—Xiaflex will be priced around $3,250 per injection, and Auxilium estimates the average cost per patient will be about $5,400. Government reimbursement for doctors could pose another “headwind,” according to Auxilium. Joseph Schwartz, an analyst from Leerink Swann, said doctors will be reluctant to use Xiaflex until reimbursement rates increase.

Also in the Pipeline (courtesy of Adis R&D Insight)

No competitor compounds in phase III or pre-registration, US.

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Pharmacology

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Clinical Trials

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adverse Reactions

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adults

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Children

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Contraindications

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Precautions

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Interactions

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.