Investors Show Confidence in Dendreon
by: EP Vantage March 07, 2010 | about: DNDN EP Vantage 85
Followers 2
Following FollowArticles (97)
Instablogs (6)
Profile
Send Message You are currently following EP Vantage
Stop FollowingYou are no longer following EP Vantage
About this author:
Profile & More Articles
Visit: EP Vantage
Submit
an article to Font Size: PrintEmail TweetThis It has been a good week for Dendreon (DNDN). First, the FDA, prodded by rumours to the contrary, announced that it had not scheduled another advisory committee to review the application for cancer vaccine Provenge, leaving only a May 1 PDUFA date standing in the way of a product launch (Event - Dendreon's Provenge PDUFA clouded by adcom worry, February 2, 2010). Then the company announced follow-up data from a pivotal study affirming that the vaccine significantly increased three-year survival and overall survival in patients with metastatic castrate-resistant prostate cancer when compared to placebo.
Continuing a trend of volatility, Dendreon shares have gained 14% over the week on the back of the two news items, hitting a record high of $35.68 in morning trade Friday, valuing the company at a staggering $4.78bn. Investors were buoyed by hope that the FDA had dispensed with a second adcom – the drug was already backed by the Cellular, Tissue and Gene Therapies Advisory Committee in 2007 - and clearly the positive follow-up data only served to raise spirits further.
Fear of the unknown
Therapeutic cancer vaccines remain a largely unproven technology, with numerous candidates landing in the R&D dustbin, and as Provenge would be the first such product approved in a major market, volatility is to be expected around Dendreon (The Dendreon roller coaster continues, April 29, 2009). Removing the risk of a negative adcom vote surely makes investors feel more comfortable spending their money on Dendreon shares.
Meanwhile, the positive follow-up data from the phase III IMPACT study, presented Friday at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium in San Francisco, did nothing to make the drug look better than it did when the trial data first were disclosed. The data affirmed Provenge’s efficacy in its primary endpoint, extending survival by a median of 4.1 months to 25.8 months, when compared to 21.7 months of patients in a placebo arm. But most importantly for investors, the new data did not show any signs that previously demonstrated superiority was unsustainable.
As a sign that investors are confident of approval, not only have the shares been hitting record highs, only 7.6% of the company’s shares are held in short positions.
Likely blockbuster
With projected sales in 2014 of $1.07bn, Provenge is valued at $4.87bn according to EvaluatePharma's NPV Analyzer, just above the Seattle company’s market capitalisation. Dendreon has no products on the market and behind Provenge only two products in phase I trials, the anti-HER2 cancer vaccine Neuvenge and D-3263, a Trp-p8 agonist it is co-developing with Roche (RHHBY.PK) for cancer and benign prostatic hyperplasia.
Approval and successful commercialisation of Provenge would transform the company and give it the funds it needs to develop the candidates in its pipeline or purchase new assets. While nothing is a given at the FDA – and its surprise initial rejection of Provenge in May 2007 after the original positive adcom vote is a prime example – the signs are growing that the cancer vaccine will get a thumbs-up.
Disclosure: No positions
About the author: EP Vantage
by: EP Vantage March 07, 2010 | about: DNDN EP Vantage 85
Followers 2
Following FollowArticles (97)
Instablogs (6)
Profile
Send Message You are currently following EP Vantage
Stop FollowingYou are no longer following EP Vantage
About this author:
Profile & More Articles
Visit: EP Vantage
Submit
an article to Font Size: PrintEmail TweetThis It has been a good week for Dendreon (DNDN). First, the FDA, prodded by rumours to the contrary, announced that it had not scheduled another advisory committee to review the application for cancer vaccine Provenge, leaving only a May 1 PDUFA date standing in the way of a product launch (Event - Dendreon's Provenge PDUFA clouded by adcom worry, February 2, 2010). Then the company announced follow-up data from a pivotal study affirming that the vaccine significantly increased three-year survival and overall survival in patients with metastatic castrate-resistant prostate cancer when compared to placebo.
Continuing a trend of volatility, Dendreon shares have gained 14% over the week on the back of the two news items, hitting a record high of $35.68 in morning trade Friday, valuing the company at a staggering $4.78bn. Investors were buoyed by hope that the FDA had dispensed with a second adcom – the drug was already backed by the Cellular, Tissue and Gene Therapies Advisory Committee in 2007 - and clearly the positive follow-up data only served to raise spirits further.
Fear of the unknown
Therapeutic cancer vaccines remain a largely unproven technology, with numerous candidates landing in the R&D dustbin, and as Provenge would be the first such product approved in a major market, volatility is to be expected around Dendreon (The Dendreon roller coaster continues, April 29, 2009). Removing the risk of a negative adcom vote surely makes investors feel more comfortable spending their money on Dendreon shares.
Meanwhile, the positive follow-up data from the phase III IMPACT study, presented Friday at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium in San Francisco, did nothing to make the drug look better than it did when the trial data first were disclosed. The data affirmed Provenge’s efficacy in its primary endpoint, extending survival by a median of 4.1 months to 25.8 months, when compared to 21.7 months of patients in a placebo arm. But most importantly for investors, the new data did not show any signs that previously demonstrated superiority was unsustainable.
As a sign that investors are confident of approval, not only have the shares been hitting record highs, only 7.6% of the company’s shares are held in short positions.
Likely blockbuster
With projected sales in 2014 of $1.07bn, Provenge is valued at $4.87bn according to EvaluatePharma's NPV Analyzer, just above the Seattle company’s market capitalisation. Dendreon has no products on the market and behind Provenge only two products in phase I trials, the anti-HER2 cancer vaccine Neuvenge and D-3263, a Trp-p8 agonist it is co-developing with Roche (RHHBY.PK) for cancer and benign prostatic hyperplasia.
Approval and successful commercialisation of Provenge would transform the company and give it the funds it needs to develop the candidates in its pipeline or purchase new assets. While nothing is a given at the FDA – and its surprise initial rejection of Provenge in May 2007 after the original positive adcom vote is a prime example – the signs are growing that the cancer vaccine will get a thumbs-up.
Disclosure: No positions
About the author: EP Vantage
