sb, The number of CTCL patients is small (I think that it's something like 10,000 current patients with about 2000 new patients per year in the US. However, I believe that LGND plans to charge about $40,000 for a treatment course. For KS, there are about 25,000 patients in the US and and equal number in Europe. I think that a treatment course for topical Panretin is closer to $5,000.
As far as off label prescription are concerned, once a drug is approved, any MD can prescribe it for anything that would benefit the patient. Restrictions are on the company's promotion. I think that the FDA modernization act allows for off label promotion after two peer reviewed publications for the off label indication. However, a recent federal court ruling indicated that off label promotion was covered by free speech, and companies could promote without meeting FDA off label requirements:
paradise-web.com
As far as combinations with Targretin and SERMs or TZDs are concerned, oral Targretin approval is projected for next year as is Avandia and Actos. SERMs that are already available include Tamoxifen and Evista, while Rezulin is an approved TZD.
Peer reviewed off label applications for diabetes could happen next year if the European data is publishable. Similarly, Targretin for cancers other than CTCL could also be published next year. I haven't heard anything new about a Targretn breast cancer trial, but initial data on Panretin combined with tamoxifen for breast cancer could also be published next year.
Of course abstracts on initial data could be published sooner than peer reviewed papers.
Of interest, the British Medical journal just came out with an editorial on breast cancer prevention using COX-2 inhibitors:
paradise-web.com
which would also suggest use of TZD's for breast cancer in addition to diabetes. |
