• Conclusion(s) — This morning, we hosted a breakfast meeting with a leading oncologist from NY to discuss the emerging therapies in prostate cancer. Below are the highlights from our conversation.
  
• Provenge Opportunity — According to our expert, about 60% of the 30K pts who become hormone-refractory each yr present when they are asymptomatic, which translates to about 18K pts. In addition, of those pts who present w/ bone pain, about 5K-6K of those pts can fall into the minimally symptomatic population after Taxotere treatment. Therefore, b/c of Provenge’s broad label, he ests the U.S. mkt opportunity to be about 23K-24K pts who fall into the asymptomatic or minimally symptomatic HRPC population. He does not anticipate that Provenge will move into in earlier stages of the disease as, a 7-10 yr trial may be required.
  
• Logistics on Provenge — Our expert notes that pts are prescreened by Dendreon to confirm that they are covered by insurance prior to initiation of therapy. Additionally, if the pt does not receive the infusion for any reason (eg, product did not meet specifications, or the pt is unable to come into the office), the pt will not be charged for the drug. Physician offices have 120 days to pay for the drug.
  
• AMGN's Dmab — Our expert was positive on Dmab due to the recent ph 3 trial that demonstrated it was superior to Zometa at preventing SRE in prostate cancer pts and due to its more convenient SC dosing vs. Zometa’s 15 min IV infusion. He stated that Zometa’s administration is a barrier for use for urologists as most cannot conduct infusions or do not have the proper sterile setting to dilute the drug. He also highlighted Dmab is not associated w/ renal toxicity (like Zometa) and that Dmab and Zometa have similar rates of ONJ. Based on this, he stated that he would use it for SRE. Finally, he expects that Dmab's prostate cancer prevention study will work since Dmab can shut down the bone resorption process that is essential for cancer mets to the bone.
  
• JNJ’s Abiraterone — Our expert believes abiraterone will not compete with Provenge since both can be theoretically used together. He was optimistic about abirateron’s use initially in chemo refractory pts. JNJ has completed enrollment of both of its ph 3 trial for abiraterone w/ top-line results from both in mid-2011. The 1st trial is in castrate resistant, metastatic prostate cancer pts (post-Taxotere). The 2nd trial is in the less advanced, pre-Taxotere pts.
  
• CELG's Revlimid — Our expert was bullish on Revlimid’s potential in prostate cancer due to its dual mechanism of T-cell stimulatory and anti-angiogenic effect. He viewed the ph 1/2 positively based on PSA and TTP and stated that the myelosuppression was manageable w/ growth factors. He is very optimistic that the ongoing ph 3 trial, which is powered to show a 30% OS improvement, will be successful but admits that ph 3 trials in prostate cancer are notoriously difficult.
  
• Beyond — MDV3100, an oral anti-androgen being developed by Medivation, is currently in ph 3. He is constructive on this drug. Our expert noted that in the ph 1 trials, there were some seizures at higher doses of MDV3100 (500 mg QD); however, a lower dose (240 mg QD) is used in the ph 3 trial. PROSTVAC, a cancer vaccine being developed by Bavarian Nordic, is set to move into ph 3 later this year.  Our expert believes the design will be similar to that of the ph 2 trial.

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https://www.citigroupgeo.com/pdf/SNA56861.pdf