The Biotech Indices have shot up about 10% over the last six weeks, which is a clear indicator that investors are anxiously anticipating something big. One potential outcome is a round of buyouts in the drug discovery business, with Pfizer as the hunter looking for its prey; an attractive biotech with promising technology and near ripe pipeline. Depending on the target(s), a host of Big Pharma companies are expected to weigh in on the bidding. So, let the games begin.
Then, there is GTx/NASDAQ: GTXI which has fallen of late, despite the potential to file an NDA in the U.S. for its lead compound, Acapodene.
Acapodene is a selective estrogen receptor modulator (SERM) that is the subject of two pivotal Phase III trials being conducted under SPAs, for the amelioration of side effects of androgen deprivation therapy (ADT) in men with prostate cancer and for the prevention of prostate cancer. The standard-of-care for men with locally advanced or metastatic prostate cancer or more recently high-risk patients is ADT, which carries with it severe side-effects such as bone loss. At present there are over 1 million men on ADT in the U.S. Positive interim analyses provide confidence that top-level results from the pivotal Phase III trial evaluating 80 mg Acapodene for the treatment of side-effects associated with ADT will be positive. The results are expected in the first quarter of 2008.
The odds of trial success and ultimate approval in this $600 million indication are high. The lipid lowering benefit demonstrated by Acapodene is clinically meaningful and a significant differentiator from competitors. Further confidence in the trial outcome is gained from the broad safety database that has been compiled for toremifene, the active ingredient in Acapodene, is backed by 350,000+ patient years of safety data and is already approved for the treatment of metastatic breast cancer.
An interim analysis of the Phase III trial evaluating 20 mg Acapodene for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia is expected to occur in the first quarter of 2008, assuming 281 clinical events have occurred. Overall, we are optimistic about Acapodene’s ability to prevent prostate cancer given the intriguing Phase II results demonstrating that participants treated for a full year with 20 mg toremifene had a 48% reduction in the incidence of prostate cancer versus placebo. Positive prostate prevention data could mean blockbuster status for Acapodene.
Over the next 6-9 months, GTx should announce a deal out-licensing the rights for use of Acapodene in Japan. At its current share price we consider GTx a buying opportunity.
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 FITNESSFOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE ARE MADE WITH RESPECT TO THIS INFORMATION OR TO ANY EXPRESSED VIEWS PRESENTED IN THIS INFORMATION.