FDA, Clinical Trial Calendar Updates: SOMX, EPIX, HLUKY, ARKTF

 |  Includes: ARKTF, EPIX, HLUKY, SOMX
by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com database of 239 entries included in the FDA and Clinical Trial Calendars.

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 113 entries through 4/7/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.

The Clinical Trial Calendar includes 126 entries through 4/7/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
On 4/7/09, SOMX provided an update on its NDA (a complete response letter was received on 2/25/09) for insomnia drug Silenor (doxepin) following a meeting with the FDA Division of Neurology Products on the previous day. The FDA stated that to obtain approval of a chronic insomnia treatment, objective and subjective efficacy must be established in adult and elderly patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, defined as at least one month.
Based on the feedback it received at the meeting, Somaxon plans to conduct additional analyses of its clinical data focused on the durability of subjective sleep maintenance efficacy in adults with primary insomnia. SOMX will complete these analyses as soon as possible and include this data in a resubmission to the FDA only if the Company believes the data can meet the criteria for approval. The FDA provided guidance for a six-month review timeline from the date of resubmission.
SOMX will no longer seek approval of a 1 mg dose of Silenor and will not request labeling that indicates clinical trials of the drug have demonstrated improvement in sleep onset. The FDA acknowledged receipt of the Company's previous submission of ECG data and no additional safety issues were raised. SOMX continues to plan to submit the results of its standard two-year carcinogenicity study as a post-approval commitment, with data from the study expected 1Q10.
The NDA was filed under the 505(b) pathway as a new indication for an approved drug. Somaxon's new formulation of doxepin is at lower doses (3, 6 mg) compared to existing generic products on the market at doses of 10mg-150mg to reduce the incidence of side effects.
A drug from H. Lundbeck (Denmark: LUN.CO) (US ADR: HLUKY.PK) is safe enough to win approval for some patients with schizophrenia, a U.S. FDA Advisory Panel said on Tuesday.The panel voted 8-2 (three panelists abstained from the vote) in favor of FDA approval for Serdolect (sertindole) among certain patients (such as those who do not respond to other treatments) despite concerns about heart-related risks.
The Company proposed that Serdolect reduced suicide attempts, which is a major risk for patients with schizophrenia. However, the panel rejected this notion in a 12-1 vote based on a lack of convincing evidence to support the claim. The PDUFA decision date for an expected FDA decision on Serdolect is 5/15/09.
EPIX Pharma (NASDAQ:EPIX) announced today that it has sold the U.S. (including Puerto Rico), Canadian, and Australian rights for MS-325 (formerly marketed as Vasovist, gadofosveset trisodium) to Lantheus Medical Imaging, Inc. for aggregate gross cash proceeds of $28M. In December 2008, EPIX received FDA approval for MS-325 as a first-in-class blood specific MRA contrast agent under the trade name Vasovist to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD).
EPIX is a component in the ETF Innovators Emerging Diagnostics Index.
Ark Therapeutics (UK: AKT.L) (US ADR: ARKTF.PK) announced today that it has completed the first update of results for its Cerepro Phase 3 clinical trial as a novel gene-based medicine for the treatment of operable malignant glioma. The study is being conducted to confirm the safety and efficacy of Cerepro in patients with operable high grade glioma (brain cancer) against current standard treatment options, including (1) surgery and radiotherapy or (2) surgery and radiotherapy followed approximately 40 days post-op by temozolomide.
Results of the Phase 3 trial were first reported on 7/30/08 when 53 patients had yet to reach a primary endpoint and the latest updata analysis today includes median survival and adverse event profile results that are consistent with those previously reported. On the primary endpoint of death or re-intervention, Kaplan Meier curves have improved to show a clear sustained separation from around four months post-surgery in favour of Cerepro treatment.
Significance levels associated with the main data have improved in the update analyses and 29 patients have yet to reach a primary endpoint event (versus 53 previously), of which 18 have been treated with Cerepro and 11 received standard of care treatment. Data suggests improved overall survival in patients receiving Cerepro after about 500 days with 56 patients in the trial still alive.
A marketing approval application (MAA) in Europe for Cerepro was filed with the EMEA in 4Q08 and an opinion from the CHMP is expected during 4Q09.

Disclosure: No positions.