Dendreon Announces Presentation of PROVENGE® (sipuleucel-T) Data at the 2013 ASCO Annual Meeting

Fri May 31, 2013 8:00am EDT

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Dendreon Announces Presentation of PROVENGE® (sipuleucel-T) Data at the 2013 ASCO Annual Meeting

  • Data Evaluate Sequencing of PROVENGE® (sipuleucel-T) in Treatment of Advanced Prostate Cancer and Demonstrate Immune Responses in Patients Retreated With PROVENGE®
  • Preliminary Phase II Data for DN24-02 for High-Risk Urothelial Carcinoma Demonstrate Positive Immune Response

May 31, 2013 – Dendreon Corporation (NASDAQ: DNDN) announced today that four abstracts featuring PROVENGE® (sipuleucel-T) data from ongoing Phase II sequencing studies and the PROCEED registry, and two abstracts highlighting preliminary Phase II data of DN24-02, an investigational active cellular immunotherapy in patients with surgically resected HER2+ urothelial cancer, will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) from May 31-June 4, 2013 in Chicago, IL.

Data from an open-label study demonstrate the presence of existing immunological memory in advanced prostate cancer patients retreated with PROVENGE several years after initial treatment for androgen dependent prostate cancer (ADPC) in the Phase III PROTECT study. In addition, the retreatment appeared to boost product potency compared with prior treatment. Separately, data from two Phase II studies indicate that PROVENGE can be combined with androgen deprivation therapy (ADT) or abiraterone acetate plus prednisone.

“These studies help us understand how PROVENGE may be combined or sequenced with other advanced prostate cancer treatments,” said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer at Dendreon. “We are also pleased with the preliminary data demonstrating that the antigen-presenting cell activity of DN24-02 for HER2+ urothelial cancer is similar to that of PROVENGE. The data highlight the promise of our active cellular immunotherapy platform and furthers Dendreon’s position as a leader in personalized cancer therapies.”

Studies evaluating PROVENGE and DN24-02 data at ASCO include:

PROVENGE:

Poster discussion session: Genitourinary Cancer, Saturday, June 1, 12:00 PM – 1:00 PM CDT., E Arie Crown Theater Lead Author: Emmanuel Stylianos Antonarakis, M.D., Sidney Kimmel Comprehensive Cancer Center at John Hopkins University, Baltimore, MD

General poster session: Genitourinary Cancer, Monday, June 3, 8:00 AM – 11:45 AM CDT., S Hall A2 Lead Author: Eric J. Small, M.D., Department of Medicine, University of California San Francisco, San Francisco, CA

General poster session: Genitourinary Cancer, Monday, June 3, 8:00 AM – 11:45 AM CDT., S Hall A2 Lead Author: Celestia S. Higano, M.D., FACP Seattle Cancer Care Alliance, Seattle, WA

General poster session: Genitourinary Cancer, Monday, June 3, 8:00 AM – 11:45 AM CDT., S Hall A2 Lead Author: Tomasz M Beer, M.D., Oregon Health & Science University Knight Cancer Institute, Portland, OR

DN24-02:

General poster session: Genitourinary (Nonprostate) Cancer, Monday, June 3, 8:00 AM – 11:45 AM CDT., S Hall A2 Lead Author: Dean F. Bajorin, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY

Poster discussion session: Genitourinary (Nonprostate) Cancer, Tuesday, June 4, 11:30 AM – 12:30 PM CDT., E354a Lead Author: Michael Press, M.D., University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA

“Data from the PROTECT study suggest the presence of existing immunological memory to PROVENGE years following initial treatment and after patients progressed to mCRPC, and retreatment produced a boost in product potency compared with prior treatment,” said Tomasz M. Beer, M.D., Grover C. Bagby Endowed Chair for Prostate Cancer Research, professor of medicine, hematology & medical oncology and Director of the Prostate Cancer Research Program, Oregon Health & Science University. “These data suggest that the immune response from PROVENGE continues well beyond the date of infusion and supports our understanding of how PROVENGE works over time.”

About PROVENGE

Indication and Important Safety Information

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For the FDA approved full prescribing information, please visit http://www.provenge.com.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements regarding the Company's expectations concerning the settlement of the pending securities litigation against the Company and three of its current or former officers, the expected benefits of the restructuring, the timing and elements of the restructuring, the timing and form of related charges, the expected annual operating expense reduction, expectations and beliefs regarding Dendreon's financial position, profitability and Dendreon's ability to break even and achieve improved performance as a result of the restructuring, expectations regarding reductions of cost of goods sold, expectations regarding regulatory approval of PROVENGE® in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon's U.S. and global business and prospects and potential revenue and earnings from product sales, expectations regarding market size and market opportunity, beliefs regarding the impact of our direct to consumer advertising, expectations with respect to our sales force execution, and progress generally on commercialization efforts for PROVENGE. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our ability to complete documentation of the settlement among the parties to the litigation and with Dendreon's insurers and to obtain court approval of the settlement, neither of which can be assured; our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer due to competing therapies, instability in our sales force, including the risk that we cannot replace vacant sales positions on a prompt basis, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our operations to support the commercial launch of PROVENGE; the impact of competing therapies on sales of PROVENGE, and other factors discussed in the "Risk Factors" section of Dendreon's Annual Report on Form 10-K for the year ended December 31, 2012. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Dendreon Corporation
Corporate Communications
Lindsay Rocco, 862-596-1304
media@dendreon.com
or
Investor Relations
Nicole Soley, 206-455-2220
ir@dendreon.com

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