Conference call was very upbeat on near term approval. Chemistry issue relates to expiration date. Different FDA sections review the application, and its hard for them all to meet the 6 month deadline.
The marketing force is in place and has been building a contact base for the past 60 days. The compound can be supplied within days of approval (unless packaging insert needs to be tweaked, which could take a few more days). The "at risk" material has also been printed.
There are 20 sales reps in the US and 18 of the 20 territories have been filled. They are currently targeting 150 centers. Next year the # of territories is expected to expand to 26. In addition there are 4 regional managers and 3 accountants.
Since Panretin is an orphan drug, it will enjoy the associated reimbursement privleges. Some distribution may require 30-90 days to get through buyers.
Systemic treatments currently cost between $8,500 and $12,000 per course. Panretin will be less (in the $5,000 to $7,000 range) and exact pricing will depend on dose, duration, and continue to treat recommendations.
Qustions were asked by BBRS (Mike King) and Farallon (David ?).
US KS population estimated to be about 12,000 (between 9,000 and 15,000). New KS patients declined by over 50%, but not due to anti-retroviral therapy (decline began before new drugs were introduced).
In the past, patient dies 12-14 months after diagnosed with KS. Now patients lives 3-5 years or more. KS not being cured by HAART therapy. 80% of patients in Panretin trial had been on HAART for some time. Chemo also not curing disease. Panretin redness and pain only for initial treatments.
Western Europe more robust. NAA filing in Jan'Feb anticipated, but going through reimbursement procedure takes longer there. Estimate 15,000 to 20,000 patients in EEC.
Classical KS also responds to Panretin. US patient population in the 1,000 to 2,000 range.
Panretin also can be use to treat problems associated with opportunistic infections in transplant patients.
Off label uses include Muluscum Contagious (in HIV and non-HIV patients) as well as conoulomata (sp?) patients.
LGND plans to start testing next year in basal and squamous cell carcinoimas as well as safety trials using Panretin with systemic treatment of KS. |
