Dendreon Corporation (DNDN) has sold its immunotherapy manufacturing facility (IMF) based in Morris Plains, New Jersey, to Novartis Pharmaceuticals Corporation for $43 million in cash. The facility is a state-of-the-art IMF and is spread across 173,100 square foot featuring revolutionary capabilities to manufacture PROVENGE (sipuleucel-T).
“This agreement represents a positive outcome for Dendreon, our shareholders and New Jersey,” said John H Johnson, chairman, president and chief executive officer of Dendreon. “Dendreon continues to make progress in improving our financial strength, and this transaction is aligned with that goal as we work to build value for our shareholders. We are also pleased that approximately 100 of the existing employees at the facility will have the opportunity to retain their jobs and work for Novartis as the company builds out its immunotherapy operations and develops new treatments for patients.”
Dendreon’s New Jersey, facility is the first autologous cellular immunotherapy to receive US Food and Drug Administration (FDA) approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. Earlier this year, Dendreon announced its intent to wind down the manufacturing of PROVENGE at the Morris Plains facility in conjunction with a strategic restructuring plan designed to accelerate the Company’s path to profitability and future growth.
“Activated Cellular Immunotherapy offers the potential to treat a variety of diseases in a revolutionary way. We are pleased that Novartis has selected our facility to advance and accelerate their work in this exciting and emerging field,” said Christine Mikail, executive vice president, corporate development at Dendreon.
PROVENGE 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 per cent) 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 per cent 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.
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.