Unappreciated -- Dendreon
At the first of the year, Dendreon (NASDAQ: DNDN) took it in the chin over an announcement that Provenge, the company's novel dendritic cell-based treatment for prostate cancer, did not inhibit time to disease progression compared to standard treatment alone. However, the company did note that patients receiving Provenge did have an increase in survival time.
At this year's meeting, Dendreon and their clinical collaborators reported that the Phase III clinical results indicated that Provenge was associated with an increase in survival from 21.4 to 25.9 months. These results are nothing to sneeze at, as an increase in survival is an important and relevant marker for cancer treatment.
The Street's reaction or lack of makes us think that there are still lingering questions regarding the statistical analysis. That is, if the results were truly real, as the number of patients enrolled in the study was not large. There was also concern that the increase in survival might be due to other factors, such as age, weight and diet of the patient population, which would be unrelated to Provenge.
Armed with this clinical data, Dendreon intends to pool clinical data from two ongoing Phase III clinical trials with the existing data to ensure the reproducibility of the results. Although it is difficult to predict the outcome of the ongoing studies, we think there is strong scientific and clinical evidence to support Provenge.
Despite this news, the market did not fully embrace Provenge's clinical data and Dendreon's share price did not show much change in valuation, positive or negative. We think that the market is off base here, as Provenge was being evaluated in men with advanced prostate cancer. If the patient population were different, as is in the current Phase II clinical trial, which includes men with early- stage disease, Provenge would probably have been shown to be more efficacious. Advanced cancers of any kind are extremely difficult to treat.
Regardless, if all goes well with the Phase III clinical trials, which we believe will happen, Dendreon should be able to submit a market application with the FDA in 2006. We think Dendreon will prevail with Provenge along with Dendreon's ability to identify a partner to help market Provenge. We predict an increase in share price for the company.
DISCLAIMER
Information transmitted via BioSpace.com has been provided by publisher, Nadine Wong, of the "Biotech Sage Report" Investment Newsletter and all comments and opinions are solely those of Nadine Wong. Information provided is not guaranteed as to completeness or accuracy by Nadine Wong (the "Biotech Sage Report" publisher), BioSpace, Inc., or any person. Such Information is neither an offer to sell nor a solicitation to buy the securities of any company. The security portfolio of the editor of this newsletter, our employees, principals or affiliated companies may, in some instances, include securities and/or options on securities mentioned in each issue. Additional information is available upon request. Information in this publication has been obtained from sources believed to be reliable, but the accuracy, completeness and interpretation are not guaranteed. Opinions expressed are subject to change without notice. The Information and views provided by the "Biotech Sage Report" Newsletter are prepared by Nadine Wong, and in no way reflect the views or efforts of BioSpace, Inc., any of BioSpace's employees or officers. BioSpace, and BioSpace's employees and officers, as well as (www.biotechnav.com) Wong & Wong, Inc, and Wong & Wong Inc.'s employees and officers, in no way accept responsibility for any of the Newsletter's content.
While all reasonable care has been taken to ensure that the Information contained herein is presented in good faith, and is not untrue or misleading at the time of publication, BioSpace, Inc. and Nadine Wong make no representation as to its accuracy or completeness and it should not be relied upon as such. The Information is supplied on the condition that the reader or any other person receiving the Information will make his or her own determination as to its suitability for any purpose prior to any use of the Information. From time to time, BioSpace, Inc. and any officers or employees of BioSpace, Inc., as well as Nadine Wong and or (www.biotechnav.com) Wong & Wong, Inc., and any officers or employees of Wong & Wong, Inc., may, to the extent permitted by law, have a position or otherwise be interested in any transactions, in any investments (including derivatives) directly or indirectly in the subject of this report. Also BioSpace, Inc. and (www.biotechnav.com) Wong & Wong, Inc., may, from time to time solicit business from any company mentioned in this report. This report is provided solely for the information of viewers of BioSpace.com and/or viewers and subscribers of the Newsletters, who are expected to make their own investment decisions without reliance on this report. Neither BioSpace, Inc. nor any officer or employee of BioSpace, Inc., nor Nadine Wong or (www.biotechnav.com) Wong & Wong, Inc., or any officer or employee of Wong & Wong, Inc., accepts any liability whatsoever for any direct, indirect, special or consequential damages or loss arising from any use of this report or their contents. This report may not be reproduced, distributed or published by any recipient for any purpose without the prior express consent of the publishers. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark or copyright of BioSpace.com, Nadine Wong or (www.biotechnav.com) Wong & Wong, Inc., or any third party.
The value of the investment(s) to which this report relates and their income yield(s) may go up or down. The investment(s) referred to in this report may not be suitable for private investors: if you are in any doubt you should seek advice from your investment advisor. Changes in rates of currency exchange may have an adverse effect on the value, price or income of investments. Statements as to past performance of any investment are not a guide to future performance. The levels and bases of taxation can change, and if you are in doubt you should seek independent professional advice. In some cases it may be difficult for you to sell or realize your investment or to obtain reliable information about its value or the extent of the risks to which you are exposed.
THIS INFORMATION IS PROVIDED "AS IS" AND NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED OF ACCURACY, MERCHANTIBILITY FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE ARE MADE WITH RESPECT TO THIS INFORMATION OR TO ANY EXPRESSED VIEWS PRESENTED IN THIS INFORMATION.