Below is a summary of updates to the
<font> BioMedReports.com </font> database of over 200 entries included in the
<font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar 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.
Genzyme (NASDAQ:GENZ) and Isis Pharma (NASDAQ:ISIS) announced on 5/20/09 that the Phase 3 clinical trial of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25% reduction in LDL cholesterol after 26 weeks of treatment compared to a 3% placebo reduction (p<0.001). This study also met each of its three secondary endpoints of reduction in levels of apolipoprotein B, total cholesterol, and non-HDL cholesterol (all p<0.001). Data from this phase 3 study of mipomersen in patients with hoFH will form the basis of Genzyme’s initial regulatory filing for marketing approval, which is expected to occur during 2H10.
Although the patients were on maximally tolerated statins and other lipid-lowering therapies, their average LDL-C at baseline was greater than 400 mg/dL. The reductions observed in the study were in addition to those achieved with the patients’ existing therapeutic regimen. Full data from the study will be presented at a future medical meeting. Consistent with previous studies evaluating mipomersen, the most commonly observed adverse events were injection site reactions, flu-like symptoms, and elevations in liver enzymes. Of the 34 patients treated with mipomersen, 28 completed the study. One patient discontinued due to elevations in liver enzymes.
On 5/20/09, Dainippon Sumitomo Pharma (TYO:4506) (PINK:DNPUF) announced positive results from its first Phase 3 clinical trial for lurasidone, which is under global clinical development for the treatment of patients with schizophrenia. In this six-week, double-blind, placebo-controlled trial, lurasidone 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. In addition, lurasidone was well-tolerated and had a relatively low discontinuation rate. The Company intends to file a New Drug Application (NDA) for FDA approval upon completion of its Phase 3 clinical development program.
Lurasidone has been studied in three double-blind, placebo-controlled, six-week trials involving more than 650 patients with schizophrenia, of which 392 patients received lurasidone. Two of the three studies demonstrated that lurasidone had superior efficacy compared to placebo at doses ranging between 40 mg and 120 mg/day. A third study, which examined three fixed doses of lurasidone (20 mg, 40 mg, and 80 mg/day) did not show statistical differences vs. placebo. This trial is regarded as "failed," or inconclusive, as haloperidol (10 mg/day), which was included for purposes of assay sensitivity, also failed to distinguish from placebo. These data showed that lurasidone was well tolerated with a low propensity for EPS, QTc interval changes and weight, lipid and glucose adverse effects. Adverse events seen in the three trials were generally mild.
On 5/19/09, NicOx (EPA:COX (PINK:NICXF) announced that quality of life and utility results from its first Phase 3 clinical trial for naproxcinod were presented at the International Society For Pharmacoeconomics and Outcomes Research Annual International Meeting in Orlando, FL. Naproxcinod is a novel type of anti-inflammatory agent, which completed a Phase 3 clinical program last year in patients with osteoarthritis.
The drug is designed to have an improved side effect profile (including a neutral effect on blood pressure) as compared to a standard dose of the widely used NSAID drug naproxen. Naproxcinod has completed three pivotal Phase 3 studies with positive results and NicOx expects to submit a NDA by mid-2009 for FDA approval, in addition to presenting the utility and quality of life data from the full Phase 3 program before year-end.
Johnson & Johnson (NYSE:JNJ) : On 5/20/09, JNJ announced new clinical trial results which demonstrated that the NEVO Sirolimus-eluting Coronary Stent was superior to Boston Scientific's (NYSE:BSX) Taxus Liberte Stent in reducing tissue growth within the stent that can potentially lead to repeat procedures. In addition, no reports of stent thrombosis were reported in patients treated with NEVO through six months. The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
NEVO is the first drug-eluting stent utilizing RES Technology, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75% bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100% of their surfaces coated with drug and polymer; and the polymer is never fully bio-absorbed.
The NEVO Sirolimus-eluting Coronary Stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64% in the NEVO arm as compared to the Taxus Liberte arm (0.13 mm compared to 0.36 mm, p<0.001). In-stent late lumen loss, which is tissue growth within a stent, reduces the diameter of the lumen thus restricting blood flow through the stent and can potentially lead to major adverse coronary events.
Data from this trial will support a regulatory filing for a CE mark in countries outside the U.S. while results from the pending NEVO II clinical trial will provide long-term data in support of a Pre-Market Approval (PMA) application with the FDA to market the stent domestically.
Disclosure: No positions.
$55.87 (05/20/09)
