Market potential over $6.00 Billions? Is this real?
Hobbs during recent CC; Post by allneatstuff.
C of 6/15/10 answered questions regarding potential market size. It still seems to be a main weapon of the naysayers. Mr. Hobbs did a good job so here it is again.
Eamonn P. Hobbs:
Thank you, Kris, and other esteemed doctors. At this point, let me briefly address the key remaining questions we've received during the past ten days.
First, is progression free survival primary endpoint enough for potential FDA approval? The answer to this question is yes. First, the FDA provided input in the development of our SPA, with hepatic progression free survival being the primary endpoint. Second, in the same 2005 to 2007 retrospective analysis that Kris mentioned previously, progression free survival was the primary endpoint for 11 of 53 oncology drugs approved during this time frame.
A second question concerns what indication will the FDA potentially approve? At our March 9th pre-NDA meeting with the FDA, Phase 3 and other data was presented and deemed acceptable by the FDA for our NDA application for the indication of metastatic melanoma to the liver, ocular or cutaneous. It is important to note that there are no treatment result differences between ocular and cutaneous melanoma in the study and there is no requirement under our SPA for an enrollment minimum of either ocular or cutaneous melanoma. As Dr. Kandarpa mentioned during his comments, both tumor types when present in the liver responded in the same manner when treated with Melphalan and this scenario is consistent with historical literature
Another question is the market opportunity for chemosaturation therapy via PHP. We are pursuing labeling for both cutaneous melanoma and ocular melanoma that have metastasized to the liver. According to a 2009 report of the American Cancer Society, in the United States, cutaneous melanoma is reported in approximately 68,720 patients, and ocular melanoma is reported in approximately 2,350 patients. Literature suggest that liver metastasis predominate in about 20% of the cutaneous patients and about 75% of the ocular patients. Although patients in the treatment arm of the Phase 3 trial received an average of three chemosaturation via PHP treatments, we have elected to use in our potential market modeling a more conservative forecast of 2.5 treatments per patient. Assuming an average selling price to Delcath of approximately $20,000, the annual on-label market opportunity in the US alone would be approximately $775 million. In addition, it is important to note that less than 10% of the global liver cases are here in the United States. Based on conversations with physicians, we believe that chemosaturation via PHP will be used off-label for certain patients with a variety of liver cancers, including HCC Neuroendocrine Mets and colorectal metastasis. Based on the $20,000 per procedure average selling price and the 2.5 average number of procedures per patient, we believe that this could result in an overall and off-label US market opportunity of approximately $6.8 billion. Next week, as part of our strategic planning process, we'll be focusing our attention on the development of trials for some of these other indications based on the strong data that was presented at ASCO.
AI
