FDA Calendar Updates: ABII, BMRN, JNJ, OSIP, Roche Print E-mail
Monday, 13 July 2009 13:29

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 254 entries as of 7/13/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/13/09, BioMarin Pharma (NASDAQ:BMRN) announced that patient enrollment has been completed for its Phase I/II clinical trial for BMN-110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The Company expects to report initial results during 1H10. BMRN stated that the enrollment of 20 patients is a critical milestone for the MPS IVA program and the data generated from this study will be valuable in demonstrating safety and could be instrumental in designing a successful Phase 3 trial, including assessments from the Phase I/II study such as plasma and urine keratan sulfate levels, pulmonary function and walk tests to establish optimal Phase 3 endpoints. During the dose escalation phase of the study, subjects will receive weekly intravenous infusions of BMN-110 in three consecutive 12-week dosing intervals. The objectives of the Phase I/II study will be to evaluate safety, pharmacokinetics, pharmacodynamics and to identify the optimal dose of GALNS for future studies.

On 7/13/09, OSI Pharma (NASDAQ:OSIP) announced that SATURN, a pivotal Phase 3 study of Tarceva (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population. The new data will be presented during the 13th World Conference on Lung Cancer to be held July 31 to August 4, 2009 in San Francisco. The overall survival data will be submitted to the FDA to support the supplemental New Drug Application (sNDA) for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC that was submitted on 3/17/09 with an expected PDUFA action date of 1/18/10.

Also, Roche (OTC:RHHBY) (VTX:ROG), OSI's international collaborator for Tarceva, will submit the overall survival data to the European Medicines Agency (EMEA) to support the application for use of Tarceva as a first-line maintenance treatment submitted in March 2009. The U.S. and EU submissions were based on positive data from SATURN that were presented at ASCO on 5/31/09. SATURN met its primary endpoint and showed patients with advanced NSCLC who received Tarceva as a first-line maintenance treatment had a 41% improvement in the time they lived without the disease advancing (progression-free survival or PFS) compared to placebo.

On 7/13/09, Abraxis BioScience (NASDAQ:ABII) announced that it has completed patient enrollment of a pivotal, phase 3 clinical study comparing the Company's chemotherapy agent ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) with Taxol (paclitaxel) injection, both in combination with carboplatin, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). The study is being conducted at 111 global sites and includes 1,050 patients. ABII expects to file a supplemental new drug application (sNDA) with the FDA during 1H10 for what would be a second indication for ABRAXANE, which is currently approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

On 7/15/09, the Oncologic Drugs Advisory Committee will review Johnson & Johnson's (NYSE:JNJ) Yondelis (trabectedin) NDA, which seeks approval in combination with Doxil (doxorubicin) for the treatment of relapsed ovarian cancer in women. Briefing documents posted online 7/13/09 questioned whether interpretations of imaging scans designed to show a halt in progression of the patients' cancer status were reliably assessed in the main study of the drug. Patients taking Yondelis and Doxil together lived an average of 7.3 months without disease progression versus 5.8 months for patients taking Doxil alone. FDA staff said they would ask the Advisory Panel if the results are reliable, clinically significant, and associated with an acceptable benefit/risk ratio. A final FDA decision is expected during late 3Q09 for the Yondelis NDA.

Disclosure: No positions.

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