Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 243 entries as of 7/7/09. 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 7/7/09, King Pharma (NYSE:KG) and Pain Therapeutics (NASDAQ:PTIE) announced that KG met with the FDA on 7/2/09 to discuss the Complete Response Letter (CRL) for the Remoxy NDA.KG expects the resubmission of the NDA to occur mid-year 2010 and believes that the rate limiting step is the generation of six-month stability data, and no new clinical trials are required.
Remoxy is based on Durect's (NASDAQ:DRRX) Oradur technology as a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for Remoxy was accepted by the FDA and granted Priority Review. In December 2008, PTIE received a CRL from the FDA, and subsequently, KG assumed full control of all activities related to the development of Remoxy.
On 7/7/09, Allos Therapeutics (NASDAQ:ALTH) announced the completion of patient enrollment in the Company's randomized Phase 2b clinical trial comparing pralatrexate to erlotinib (Tarceva) in patients with Stage IIIB/IV non-small cell lung cancer (NSCLC) who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen. This randomized, open-label, international, multi-center Phase 2b trial was initiated in January 2008 and enrolled 201 patients.
The objective of the trial is to compare the efficacy of pralatrexate to that of erlotinib in patients with Stage IIIB/IV NSCLC who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen, including subsets of light and heavy smokers, as well as current and former smokers. Per the protocol, the primary endpoint is overall survival. Response rate, progression-free survival and the safety and tolerability of pralatrexate will also be assessed. Patients were randomized 1:1 to receive either pralatrexate or erlotinib. The primary survival analysis will be performed when a pre-specified number of events have occurred in all randomized patients.
On 7/7/09, Trinity Biotech (NASDAQ:TRIB) announced the FDA approval and U.S. launch of its high throughput haemostasis (blood clot) analyzer, the Destiny Max. On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.
On 7/6/09, Cubist Pharma (NASDAQ:CBST) announced that it began dosing in the CONSERV-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate ecallantide’s effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects. Ecallantide is a potent inhibitor of plasma kallikrein, and CONSERV-2 will evaluate the effects of plasma kallikrein inhibition in the trial population. Surgical environments, such as those involving the trial population, are associated with the activation of plasma kallikrein and subsequent activation of coagulation, fibrinolytic, and inflammatory cascades, which likely contribute to blood loss and blood transfusion requirements in the perioperative setting.
CBST stated that it remains on track for a mid-2010 end-of-phase 2 meeting with the FDA and anticipates that the results of this trial and the ongoing CONSERV-1 trial will provide meaningful insights into the optimal design of subsequent Phase 3 trials. In April 2008, Cubist announced an exclusive North American and European license and collaboration agreement with Dyax Corp. (NASDAQ: DYAX) for the development and commercialization of the intravenous formulation of ecallantide for surgical indications. The first indication being sought by Cubist for ecallantide is the reduction of blood loss during on-pump cardiac surgery.
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