Dendreon Corp fka DNDNQ

[rancherho]

1. Trp-p8 mRNA is overexpressed in ADPC and may be down regulated as hormone therapy gradually causes pc cells to become androgen independent. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_...

2. On 4/18/05 DNDN reported: “The data presented show that these potent agonists of Trp-p8 significantly inhibited the growth of Trp-p8 positive tumors in mice by as much as 77 percent over controls (p=<0.0001). The lead compounds presented selectively killed Trp-p8 expressing cells at a physiologically relevant temperature and at well tolerated doses” http://investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=160508&Header=IR

3. DNA reportedly did not give DNDN the reasons that it chose to drop out of the Trp-p8 development program. However, if its utility as a pc target is limited to the ADPC stage of the disease, there could be several potential reasons for their decision: (a) hormone therapy is relatively inexpensive with competitive products already on the market; (b) the median duration of ADPC before transition to AIPC is only about 18 months; (c) ODAC and the FDA have not agreed upon any surrogate markers that could shorten the long periods required to establish statistical significance for clinical benefits in ADPC such as survival and metastases; (d) if a Trp-p8 agonist works against the same pathological channel as anti-androgen therapy it might not prove any more effective than hormone therapy, and even worse, might speed the transition to the AIPC stage. OTOH, when the FDA approves Provenge for use in AIPC, its earlier use in ADPC would be a logical expansion where its benefits against AIPC cells would start even before the number of those cells became the dominant pc cell type and ADPC cells were reduced in relative numbers.

4. Genentech’s forte is in monoclonal antibodies where there are certainly many additional unexploited targets, and where they are transitioning some of their best sellers from “naked” mabs that attract immunity attacks to kill cancer cells to conjugated mabs that bring their own cytotoxins to the cancer cells.

5. Adding to all of the above, the division of profits with DNDN in the event of the development of a successful Trp-p8 therapy would further reduce the desire to commit time and resources to development.

6. It would have taken many years to bring any Trp-p8 therapy through clinical trials and FDA approval. One may argue that its perhaps temporary elimination from DNDN’s pipeline is somehow material. However, it is becoming increasingly obvious that WS views investing in early stage biotech candidates as akin to hoping for success in wildcat oil and gas drilling. DNDN has a blockbuster in Provenge tantalizingly close to FDA approval and commercialization with the ability to generate one billion in annual sales just out of their NJ facility. CELG is just approaching the annual billion dollar sales figures now and has a $15 billion market cap. DNDN’s sole focus on bringing Provenge through FDA approval is just economic common sense.

Good luck to all DNDN longs.