W. Thomas Amick, CEO
Increased utilization of the autologous cellular immunotherapy sipuleucel-T (Provenge) led to a $20.1 million improvement in total revenue in 2014 for the manufacturer Dendreon, when compared with 2013.
Total revenue in 2014 came to $303.8 million compared with $283.7 million in 2013, representing the first time that the company has ever exceeded its revenue goal. In the fourth quarter of 2014, Dendreon reported $79.8 million in revenue, as compared with $74.8 million in the fourth quarter of 2013. This milestone arrived despite the announcement that Dendreon was undertaking financial restructuring under Chapter 11 of the Bankruptcy Code in November.
“Dendreon is moving in the right direction, and we are delivering on our commitment to expand access to Provenge for advanced prostate cancer patients worldwide,” W. Thomas Amick, president and chief executive officer of Dendreon, said in a statement.
Under the restructuring, the company noted that it would continue to make sipuleucel-T available and that any transactions under the various shareholder agreements would be focused on retaining access to the therapy. At the time of this decision, Dendreon held approximately $100 million in cash and investments, which increased to $122 million by the end of 2014.
The company is optimistic that Europe will hold the key to future revenue growth. In early January 2015, the first patient in Europe was treated with sipuleucel-T.
“Achieving these three major milestones—delivering four consecutive quarters of year-over-year growth, exceeding our target revenue, and commercializing Provenge in Europe—starts 2015 on a positive note,” Amick said.
Germany was the first company to utilize sipuleucel-T at the Klinik for Urologie in Aachen, Germany. The treating physician at this institution, Axel Heidenreich, MD, called the use of the immunotherapy a “privilege.”
“The availability of Provenge in Europe gives physicians a brand-new way to fight this difficult-to-treat disease and may extend the lives of patients, who currently have limited effective therapies available,” Heidenreich added.
The European Commission granted marketing authorization for sipuleucel-T as a treatment for chemotherapy ineligible men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) in September 2013. Approximately 6 months after this, Dendreon announced plans to make sipuleucel-T available in Germany and the United Kingdom through the manufacturer PharmaCell.
In the United States, sipuleucel-T has been approved since April 2010 as a treatment for men with asymptomatic or minimally symptomatic mCRPC. This approval was based on a 4.1-month extension in overall survival (OS) in men treated with the immunotherapy compared with placebo.
In the pivotal IMPACT study, 512 men with mCRPC were randomized in a 2:1 ratio to receive sipuleucel-T (n = 341) or placebo (n = 171). In the study, 82% of patients enrolled had received prior androgen blockade, 54% had received radiotherapy, 35% radical prostatectomy, and 18% chemotherapy. The median age was 71 years.
The median OS with sipuleucel-T was 25.8 versus 21.7 months with placebo (HR = 0.78; 95% CI, 0.61-0.98; P
= .032). Following disease progression, 57% of patients in the sipuleucel-T arm receive docetaxel compared with 50.3% in the placebo arm. Time to progression was similar in both arms.
Following its approval in the United States, sipuleucel-T gained recommendations across several guidelines, including those created by NCCN and AUA. Additionally, the immunotherapy is covered by Medicare, resulting in approximately 75% of patients accruing no out-of-pocket expenses, according to the company.
Neal D. Shore, MD, of Atlantic Urology Clinics in Myrtle Beach, South Carolina, told OncLive
that he did not see any reason why the financial restructuring would impact the ongoing manufacturing process. Furthermore, he added that he did not see any reason why the NCCN or AUA guidelines would be impacted.
“The NCCN and AUA guidelines offer the highest level of evidence that sipuleucel-T is a very appropriate therapy to discuss with patients who have asymptomatic or minimally symptomatic mCRPC,” Shore said. “I don’t think that discussion should change for any patient or clinician at the current time.”