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). A FDA Advisory Panel was conducted on 9/23/09 for Exalgo, which had an original PDUFA action date of 11/22/09 that was extended today by three months until 2/22/10.
On 11/20/09, Pozen (NASDAQ: POZN) announced the start of enrollment for the Phase 3 studies evaluating PA32540, which is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole that is being studied for the potential use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. POZN is conducting two pivotal Phase 3 studies and one long-term safety study.
The two Phase 3 pivotal trials will be conducted under a Special Protocol Assessment (SPA) agreed upon with the FDA. These studies will involve over 100 sites, enrolling approximately 500 patients per study. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term safety study will be enrolling approximately 400 subjects and will assess the safety of PA32540 over one year.
Key elements of this Phase 3 development program include: (1) bio-equivalency proven to enteric coated aspirin (ECASA); (2) SPA agreement with FDA for 2 replicate 6-month Phase 3 studies to demonstrate that PA32540 is associated with a significant reduction in gastric ulcers compared to ECASA 325 mg in patients requiring aspirin therapy for secondary CV prevention who are at risk for ASA-associated gastric ulcers; and (3) safety of PA32540 based on at least 100 patients with 12 months exposure.
On 6/30/09, Photocure (OSL: PHO) (OTC: PHCUF.PK) announced that a New Drug Application (NDA) was submitted to the FDA seeking approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence cystoscopy. The NDA includes clinical data from 1838 patients, comprising two recently completed clinical studies, one Phase 3 pivotal study in 789 patients from EU/US and a Phase 3 study performed in Denmark in 233 patients. All studies in the documentation demonstrate that fluorescence cystoscopy using Hexvix significantly improves detection of papillary bladder cancer compared to standard white light cystoscopy.
Photocure, in collaboration with GE Healthcare (NYSE: GE) has had several meetings with the FDA, leading up to this submission and the results of the pivotal Phase 3 study have been presented to the FDA. On 8/31/09, Photocure announced the FDA granted a priority (6-month) review for the NDA with an expected PDUFA decision date of 12/30/09. On 12/17/09, this NDA will be discussed at a meeting of the FDA Oncologic Drugs Advisory Committee.
The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
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