1. XIAFLEX Driving Stock, Dupuytren Indication
Armando Anido, CEO of Auxilium Pharmaceuticals (AUXL) is interviewed by Salveen Kochnover of Collins Stewart. Salveen asks about the enzyme know as XIAFLEX that breaks down the collagen causing Dupuytren’s disease. Armando explains Dupuytren’s disease is present in 3-6% of adult caucasian males. Salveen and Armando discuss the clinical data, which has been favorably reviewed by the FDA for safety and efficacy. The results of the XIAFLEX treatment seem to be comparable to those of surgery.
2. The CEO’s Strategy to Bring XIAFLEX to the Dupuytren Market
With upcoming Phase 3 results, Armando Anido, CEO has ramped up Auxilium Pharmaceuticals’ commercial infrastructure. The interaction FDA has been positive although they missed their PDUFA date last August. Salveen Kochnover of Collins Stewart inquires about the physician training program and the 5year, 50% recurrence of Dupuytren’s disease.
3. Collagenese XIAFLEX Could be a Pipeline in a Product, Treat Multiple Indications
XIAFLEX attacks the collagen deposits that cause Dupuytren’s contracture (a fixed flexion contracture of the hand where the fingers bend towards the palm and cannot be fully extended), Peyronie’s disease (abnormal curvature of the penis), cellulite, keloidal scar, and frozen shoulder (restricting motion and causing chronic pain). Results are expected in Peyronie’s in December, with a breaking of the blind and release of top line data. Armando Anido, CEO of Auxilium Pharma is planning an FDA Phase 3 proposal in early 2010. Salveen asks Armando about access to treating physicians for Peyronie’s disease (since they are not the same as those treating Dupuytren). Armando explains that Auxilium is well implanted in the urology community with TESTIM, a product that has been treating men with hypogonadism, or low testosterone since Feb 2003. With a Phase 3 approval in Dupuytren, Auxilium will launch new programs, in new indications.
4. Pfizer Deal, Financials, Business Development, and Upcoming Milestones
$75M upfront, with a total of $500M in milestones, and double digit royalties. Those are the terms of Auxilium Pharmaceutical’s deal with Pfizer. The synergy has increased with Pfizer’s recent aquisition of Wyeth. Salveen Kochnover of Collins Stewart and Armando Andio of Auxilium discuss the commercial rights, with an outlook on geography, indications, and other partnership opportunities. Salveen and Armando also review the expected TESTIM revenues for 2009, and the upcoming milestones (Dec 09, data in Dupuytren’s; early 2010, submission of XIAFLEX in EU by Pfizer). 5 years from now, Armando expects XIAFLEX will be blockbuster drug.
This interview was conducted at the NASDAQ Marketsite, on November 4th, 2009, in New York City.
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