(By Balaseshan) Dendreon Corp. (NASDAQ: DNDN) said it has sold its immunotherapy manufacturing facility (IMF) based in Morris Plains, New Jersey to Novartis Pharmaceuticals Corp., the U.S. pharmaceuticals unit of Swiss drug giant Novartis AG (NYSE: NVS), for $43 million in cash.
Dendreon's Morris Plains, New Jersey, facility is a 173,100 square foot IMF, featuring capabilities to manufacture Provenge (sipuleucel-T).
Provenge is the first autologous cellular immunotherapy to receive U.S. Food and Drug Administration approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.
"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," said John Johnson, chairman, president and chief executive officer of Dendreon.
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.
"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," said Johnson.
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.
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 about 1500 patients to further evaluate a small potential safety signal of cerebrovascular event.
DNDN is trading up 0.75% at $5.38 on Thursday. The stock has been trading between $3.69 and $17.04 for the past 52 weeks.