On 11/2/09, Dendreon (NASDAQ:
DNDN) announced that it has completed the submission of its amended Biologics License Application (BLA) for PROVENGE (sipuleucel-T), seeking approval for men with metastatic castrate-resistant prostate cancer (CRPC). The amended BLA includes data from the IMPACT trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.
PROVENGE is currently available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT, and NeoACT. On 4/28/09, DNDN announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011.
On 11/20/09, the FDA accepted Dendreon's amended BLA as a complete response and set a PDUFA action date of 5/1/10 for an expected FDA decision, seeking approval for PROVENGE in men with metastatic castrate-resistant prostate cancer (CRPC). The FDA considers the amended BLA to be a complete, Class 2 Resubmission following the action letter the company received in 2007.
On 11/16/09, CombinatoRx (NASDAQ: CRXX) announced that on 11/13/09, representatives of Neuromed discussed the pending Exalgo NDA with staff from the FDA. In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo. Based on these discussions with the FDA, Neuromed is working with Mallinckrodt, who owns the commercial rights to Exalgo, to determine the appropriate actions to be taken based on the discussions with the staff of the FDA, which actions may include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2), which utilizes different criteria to determine the basis for approval of a new drug candidate.
On 7/1/09, CRXX and Neuromed Pharma (privately held) announced a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Final merger terms will be adjusted based upon the outcome of a pending FDA decision for Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone) seeking approval for the treatment of moderate to severe pain in opioid tolerant patients. The rights to Exalgo have been acquired by a subsidiary (Mallinckrodt) of Covidien (NYSE: COV).
