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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (9638)	12/2/2003 7:44:28 PM
From: Icebrg	Respond to of 52153

>>Trisenox for myelodysplastic syndromes (MDS) is something of a wild card. There are some abstracts on this at ASH that I haven't looked at yet.>> The key with Trisenox is the IP position. If they can get the patent issued, this may well become a "real drug". At the latest conference Bianco had the following to say with regard to Trisenox. [CTIC deserves some credit for filing their conference transcripts with SEC]. Note that only 15 % of product sales is on-label. Erik Let’s talk a little bit about TRISENOX®. The initial label indication, relatively narrow, acute promyelocytic leukemia. The interesting aspect about this product with that disease — now with three years of follow-up data — we can claim that we cure about 50 percent of the patients who’ve had relapsed/refractory APL. We’re now moving this into a variety of other indications, including front-line APL. And very nice data being presented at ASH from MD Anderson that you can replace chemotherapy in the front-line treatment and cause molecular emissions in 80 percent of those patients. They’re long-term and durable and obviously that has some significant growth implications for this product and that disease. We’re also investigating the product in both MDS — specifically the high risk population — and in myeloma and several solid tumors. If you look at our performance over the three years since we launched this product, we’re putting up as we said — we made $24 million this year. This is our net sales guidance, that we’ll make this a profitable operating business. That was our goal three years out to have this pay for itself, for a commercial organization. And going forward, you look at the estimates in ‘04 — as I mentioned on our conference call — we typically will do that at the Q4 financial release. But just giving a sense of where the street’s numbers are, they can be a low of $27. Obviously we’re going to be well over that run rate just coming into the fourth quarter of this year, versus a high of $43 million. So we think that this continues to be a very attractive opportunity for us as our first commercial product and provides us some discretionary cash flow back to the development organization to help fund our other products in our pipeline. Look at where the majority of those are being generated. This was the first nine months last year versus the same period in ‘03. And you could see that MDS now makes up the majority of our sales. About 15 percent are so-called on label sales. We did see a little softening in the myeloma usage. This was really reflected by the launch of Velcade. I can tell you that that has now plateaued off and we’re starting to see again a healthy up-surgence in the use of TRISENOX® in multiple myeloma. Our label expansion strategy is pretty straightforward. This drug does not have traditional chemotherapy-like side effects. In fact, it’s not additive when given with other agents. And it is clearly synergistic when you put it together with chemotherapy or radiation therapy. So, no overlapping toxicities, but enhances the signal of the underlying agent. And the diseases that we’re targeting for label expansion, you’ll see some data at ASH in two large studies, about a hundred patients each. Looking at the so-called high-risk population. We think that the response rate of durable responses of about 30 percent is probably a good hurdle to get in. Along with obviously transfusion independence across multiple blood cell types — meaning platelets and white cells. And probably the most important kind of progression in ultimate leukemic transformation appears to have been impacted in those studies. And we look forward to presenting that data at the upcoming hematology meeting. This is data from an abstract from Jim Berenson’s group in myeloma. You can see that even in patients who fail melphalan, thalidomide, and Velcade, if you add low doses of chemotherapy together with arsenic and (arsenic trioxide) TRISENOX®, you get a very high rate of response. These responses are very durable. And in this population of patients that typically are very poor-risk — meaning they have renal failure at the time that they are treated — they had a hundred percent improvement in their renal functions in the five of the five patients who had significant renal dysfunction. We’re also investigating based upon the Stanford study the utility of radiation in combination with TRISENOX® in glioblastoma. There are studies that are ongoing with Taxotere® in prostate cancer. And lastly, as I mentioned, we’ll highlight this at ASH — a study from Dr. Estey and his colleagues being able to replace chemotherapy in the front-line treatment of APL.