Novacea Announces Preliminary Findings From Data Analysis of Ascent-2 Phase 3 Trial

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 06/04/08 -- Novacea, Inc. (NASDAQ: NOVC) announced today preliminary findings from its ASCENT-2 Phase 3 clinical trial, which compared Asentar(TM) in combination with Taxotere(R) (docetaxel) chemotherapy to Taxotere alone in patients with androgen-independent prostate cancer (AIPC). The ASCENT-2 trial was terminated by Novacea in November 2007 due to an unexplained imbalance of deaths between the treatment and control arms of the trial.

As of the termination date of ASCENT-2, Novacea had enrolled over 950 of the planned total enrollment of 1,200 AIPC patients in the trial at multiple centers in various countries, including the United States, Canada, Germany, and Central Europe. Novacea's preliminary evaluation of the ASCENT-2 data reflects median survival of 16.7 months in the treatment arm, which included Asentar in combination with once-weekly Taxotere, as compared to median survival of 18.5 months in the control arm of the study, in which Taxotere was administered every three weeks.

In the treatment arm of ASCENT-2, 11.5% of AIPC patients completed their planned treatment, as compared to 21.0% of AIPC patients who completed their planned treatment in the control arm of the study. The overall incidence of grade 3 (severe) and grade 4 (life-threatening or disabling) adverse events was 51.4% in the treatment arm, as compared to 50.0% in the control arm.

"While the asymmetric design of our ASCENT-2 Phase 3 trial increased the difficulty of our data analysis and interpretation, we presently have two observations: First, the overall incidence of grade 3 and grade 4 adverse events between the treatment arm and the control arm of ASCENT-2 appears to be comparable; and second, median survival data from the treatment arm of ASCENT-2 appears to be similar to median survival data observed in AIPC patients not receiving Asentar who were treated with once-weekly Taxotere in each of the control arm of our earlier ASCENT Phase 2 trial, and in one of the comparator arms of the TAX327 trial, as reported by Sanofi-Aventis in 2004," said Edward F. Schnipper, M.D., Novacea's executive vice president and chief medical officer. "We are in the process of updating our data analyses and preparing a complete response to the U.S. Food and Drug Administration (FDA) regarding releasing the clinical hold on the Asentar Investigational New Drug (IND) application."

John P. Walker, Novacea's chief executive officer and chairman of the board commented, "If the IND is released from clinical hold by the FDA, we intend to evaluate the potential for new development activities for Asentar, including in disease areas outside of oncology, which could include inflammation and immune disorders. However, despite our solid financial position, we intend to evaluate any plans to initiate clinical studies of Asentar in the context of our ongoing evaluation of strategic alternatives for Novacea."

About ASCENT-2

The ASCENT-2 Phase 3 trial was terminated by Novacea in November 2007 due to an unexplained imbalance of deaths between the treatment and control arms of the trial. At that time, Novacea also suspended enrollment in its Phase 2 clinical trial of Asentar for the treatment of advanced pancreatic cancer and in each of the other ongoing investigator-sponsored trials involving the use of Asentar. Since that time, the Company has been reviewing and analyzing the data from ASCENT-2 in an attempt to determine the reason for the higher number of deaths in the treatment arm.

ASCENT-2 was an open-label trial that randomized patients to either combination therapy with Asentar and Taxotere or Taxotere alone. The basic trial design compared the treatment arm of the ASCENT Phase 2 trial (Asentar in combination with once-weekly Taxotere) to the current standard of care for AIPC (Taxotere every three weeks) and aimed to measure the overall survival benefit of Asentar plus Taxotere versus the standard of care. The trial design specified 30 weeks of treatment, with the primary endpoint of overall survival.

In May 2007, Novacea had entered into a collaboration agreement for the development and commercialization of Asentar with Schering Corporation (Schering). As previously announced, Schering terminated the agreement and returned all rights in Asentar to Novacea in April 2008.

Except for the historical information contained herein, the matters set forth in this press release, including statements as to financial guidance, development, clinical studies, regulatory review and approval, and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events. You should not put undue reliance on any forward-looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements made by Novacea include: early stage of development; the focus, conduct, enrollment and timing of Novacea's clinical trials; the Company's ability to identify and complete one or more strategic transactions, particularly in light of the termination of its ASCENT-2 trial in November 2007 and its decision to place the Phase 2a portion of its AQ4N trial on hold; the Company's ability to acquire and develop other products or product candidates at all or on commercially reasonable terms; the Company's ability to retain key employees required to maintain its operations; regulatory review and approval of product candidates; success or failure of Novacea's future collaboration agreements, if any; commercialization of products; developments relating to Novacea's licensing and collaboration agreements; market acceptance of products; funding requirements; intellectual property protection for Novacea's product candidates; competing products; and other risks detailed from time to time under the heading "Risk Factors" in Novacea's most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K, as may be updated from time to time by Novacea's future filings under the Securities Exchange Act. If one or more of these risks or uncertainties materialize, or if any underlying assumptions prove incorrect, Novacea's actual performance or results may vary materially from any future performance or results expressed or implied by these forward-looking statements. We assume no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws.

Novacea is a registered trademark of Novacea, Inc., and Asentar(TM) is a trademark of Novacea, Inc. All other trademarks are property of their respective owners.

Novacea Contact: Ed Albini Tel: 650-228-1825 E-mail: albini@novacea.com

2008-06-04 07:31:50 0376958 MARKETWIRE