Dendreon Corporation (Nasdaq: DNDN) today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline. The Company will host a conference call at 9:00 a.m. ET to review additional details.
"Last year was foundational for Dendreon with the successful introduction of PROVENGE as the world's first autologous cellular immunotherapy," said Mitchell H. Gold, MD, president and chief executive officer. "As we look to 2011 and beyond, we are positioned for significant growth with our increased capacity in the U.S., our European strategy for filing now set, and our progress in advancing our ACI pipeline in bladder cancer. Most importantly, we are proud to deliver on our commitment to transform the lives of patients with cancer by making PROVENGE more broadly available in the U.S. and abroad."
- In 2010, Dendreon achieved revenues from PROVENGE of approximately $48 million.
- In anticipation of a ten-fold increase in capacity from its facilities in New Jersey, Los Angeles, and Atlanta coming on line this year, Dendreon has increased its sales force to approximately 100 reps to service approximately 450 centers by the end of 2011.
- In 2011, Dendreon plans to increase marketing and awareness efforts to educate physicians and patients and to maximize the additional capacity.
- Following a number of pre-submission meetings with European Union (E.U.) National Agencies, the company expects that data from the IMPACT study, supported by data from D9901 and D9902A, will be sufficient to seek regulatory approval in the E.U.
- Dendreon plans to use the clinical data described in its U.S. Biologics License to file its marketing authorization application (MAA) to the European Medicines Agency (EMA) in late 2011/early 2012.
- To accelerate the regulatory timeline, initially PROVENGE will be manufactured through a Contract Manufacturing Organization (CMO) while Dendreon concurrently builds an immunotherapy manufacturing facility in Europe.
- The company anticipates a regulatory decision in the first half of 2013.
DN24-02 IND Filing
- Dendreon filed an Investigational New Drug (IND) application in December 2010 with the U.S. Food and Drug Administration (FDA) for DN24-02 for the treatment of invasive bladder cancer.
- The randomized Phase 2 study will evaluate the safety and efficacy of DN24-02 in patients with HER2+ invasive transitional cell carcinoma (TCC) of the bladder following cystectomy.
- The primary endpoint is to evaluate overall survival. Approximately 180 patients will be enrolled at clinical sites throughout the U.S.