Wachovia Upgraded Dendreon (DNDN) to Outperform, Expects PROVENGE Approval
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Price: $0.13 --0%
Rating Summary:
2 Buy, 15 Hold, 9 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 7 | Down: 16 | New: 37
Rating Summary:
2 Buy, 15 Hold, 9 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 7 | Down: 16 | New: 37
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Wachovia upgraded Dendreon (Nasdaq: DNDN) from Market Perform to Outperform, citing the impressive survival results from the PROVENGE IMPACT study released yesterday. The firm expects FDA approval and set a $29-$32 valuation range on Dendreon, based on 2014 Provenge revenue estimate of $707 million capitalized at 9-10x.
On the data the firm said, "This absolute survival improvement offers a favorable risk/benefit profile given that the safety profile was consistent with prior studies. Importantly, the placebo arm demonstrated a median survival of 21.7 months indicating that the benefit was from drug effect versus poor performance in the control arm. Additionally, after adjustment for docetaxel use following Provenge, the Hazard Ratio maintained its robustness (HR=0.763; p-value=0.036). Overall, we view these data as clinically meaningful. This is clearly a positive outcome for the company and given that Provenge is the first immunotherapy (cancer vaccine) to extend survival in a randomized Phase III trial, we view this as a positive outcome for the entire biotech group."
The firm said the data should support FDA approval of the drug. Commenting, the firm said, "We recognize that there will be numerous debatable issues with the data such as the vehicle, the fact that Provenge did not significantly delay the time to progression in the trial (consistent with prior trials)
and the cross-over design of the trial; however this is trumped by positive survival data, in our opinion. Provenge extends survival in an unmet cancer indication backed by significant patient advocacy for the drug, a positive panel meeting and an Approvable Letter, all of which favor approval."
The firm said they conservatively model 13,500 AIPC patients of a total 60,000 available patients on therapy by 2014 generating ~$700 mm in revenues.
On the data the firm said, "This absolute survival improvement offers a favorable risk/benefit profile given that the safety profile was consistent with prior studies. Importantly, the placebo arm demonstrated a median survival of 21.7 months indicating that the benefit was from drug effect versus poor performance in the control arm. Additionally, after adjustment for docetaxel use following Provenge, the Hazard Ratio maintained its robustness (HR=0.763; p-value=0.036). Overall, we view these data as clinically meaningful. This is clearly a positive outcome for the company and given that Provenge is the first immunotherapy (cancer vaccine) to extend survival in a randomized Phase III trial, we view this as a positive outcome for the entire biotech group."
The firm said the data should support FDA approval of the drug. Commenting, the firm said, "We recognize that there will be numerous debatable issues with the data such as the vehicle, the fact that Provenge did not significantly delay the time to progression in the trial (consistent with prior trials)
and the cross-over design of the trial; however this is trumped by positive survival data, in our opinion. Provenge extends survival in an unmet cancer indication backed by significant patient advocacy for the drug, a positive panel meeting and an Approvable Letter, all of which favor approval."
The firm said they conservatively model 13,500 AIPC patients of a total 60,000 available patients on therapy by 2014 generating ~$700 mm in revenues.
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