FDA Calendar Updates: Amgen, Bayer, Biogen, Noveko, Peplin, Transdel

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Includes: AMGN, BAYRY, BIIB, NKOFF, TDLP
by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 246 entries as of 7/8/09. I originally created this calendar 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 (NYSE:CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/8/09, Bayer (OTCPK:BAYRY) announced the submission of a New Drug Application (NDA) to the FDA for a new estradiol-based oral contraceptive (estradiol valerate/dienogest). It seeks approval for the indications oral contraception and treatment of heavy and/or prolonged menstrual bleeding. The new product with an estradiol valerate/dienogest combination is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. It is marketed in Europe under the tradename Qlaira. The estimated PDUFA action date for a standard, 10-month review by the FDA for this NDA is 5/8/10.
Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen’s experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.
On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.
On 7/8/09, Biogen Idec (NASDAQ:BIIB) announced that the FDA granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). BIIB is currently enrolling patients in a global Phase 3 study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population. BIIB plans to enroll more than 1,200 patients in the Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS. The global trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS at one year.
On 7/8/09, Peplin [ASX:PLI] announced the completion of enrolment of its two Phase 3 clinical trials for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on head treatment areas, which include the face and scalp. These Phase 3 clinical trials are referred to as REGION-IIa and REGION-IIb and enrolled approximately 250 patients each. Peplin plans to announce the REGION-II trial results during 4Q09. In addition to the REGION-II trials on head locations, Peplin recently completed its REGION-Ia trial for non-head locations, which included the trunk and extremities, and plans to initiate the REGION-Ib trial during 3Q09 to corroborate the results of the previously completed trial and expects to file a New Drug Application in mid-2010.
On 7/8/09, Transdel Pharma (OTC:TDLP) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
On 7/8/09, Noveko (OTC:NKOFF) announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.
Disclosure: No positions.