Drug Pipeline Series: Phase III, Nov 13 - Nov 20, 2006

DVANCED MAGNETICS REPORTS POSITIVE RESULTS FROM IRON-REPLACEMENT STUDY
Advanced Magnetics presented positive results from a Phase III clinical trial of ferumoxytol as an intravenous iron replacement therapeutic at the American Society of Nephrology's annual meeting.
The study enrolled 304 non-dialysis-dependent chronic kidney disease patients who were randomized to receive either two 510-mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The study demonstrated a statistically significant achievement of all the primary and secondary endpoints. Additionally, all endpoints were statistically significant in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.
Efficacy results in the intent-to-treat and efficacy-evaluable populations were similar. In the intent-to-treat population, ferumoxytol significantly outperformed oral iron for the primary endpoint of change in hemoglobin at day 35.
The results from the efficacy-evaluable population analysis showed that at day 35 patients receiving ferumoxytol had a significantly greater mean increase in hemoglobin compared with patients in the oral iron group. Ferumoxytol was more likely to increase baseline hemoglobin by greater than or equal to 1 g/dL compared with oral iron. Also, an increase in serum ferritin was significantly greater in the ferumoxytol group compared with the oral iron group at day 21. Stratifying by ESP use, there was a significant difference in hemoglobin increase for ferumoxytol compared with oral iron in both patients who were on ESP and those who were not.
Ferumoxytol was well-tolerated with repeated dosing. Adverse events occurred in 52.0 percent of oral iron patients compared with 35.5 percent of ferumoxytol patients. Similarly, drug-related adverse events occurred in 24.0 percent of oral iron patients compared to 10.6 percent of ferumoxytol patients.


Medicure Announces Initiation Of Enrollment In Pivotal Phase III MEND-CABG II Study
Medicure Inc. announced it has commenced enrollment in the MEND-CABG II study. This single confirmatory Phase III study for registration will evaluate the cardioprotective effects of the Company's FDA Fast Tracked product, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery.
MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that will enroll up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. The study design was reviewed with the United States Food and Drug Administration (FDA). Study patients will be randomized to receive placebo or MC-1 250mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis.


Auxilium Pharmaceuticals, Inc. Initiates Phase III Trials for AA4500 in Dupuytren's Contracture
Auxilium Pharmaceuticals, Inc. announced that the first patients have been dosed in the Company's second U.S. Phase III pivotal trial and the first Phase III study outside the U.S. for AA4500 for the treatment of Dupuytren's contracture, a disabling and recurring condition in which the joints in the hand contract, impairing patients' ability to straighten and move their fingers.
The U.S. study is a double-blind, randomized, placebo controlled study of AA4500 involving more than 200 patients at up to 15 sites throughout the U.S. Patients in the study will be randomized on a 2:1 basis in favor of AA4500 treatment. To qualify for the study, patients must have at least 20 degrees of contracture. The primary endpoint of the study is to determine if AA4500 can reduce the contracture angle to within 0 to 5 degrees of normal as measured by digital goniometry.


Vanda Pharmaceuticals' VEC-162 Demonstrates Positive Results in a Phase III Transient Insomnia Clinical Trial
Vanda Pharmaceuticals Inc. announced positive top-line results from the company's Phase III clinical trial evaluating VEC-162, a balanced melatonin receptor agonist, in transient insomnia. VEC-162 demonstrated statistically significant improvements at all three tested doses compared to placebo (p<0.001) in the primary endpoint of the trial, Latency to Persistent Sleep (LPS), a measure of sleep onset. VEC-162 also produced statistically significant improvements relative to placebo in Latency to Non-Awake (LNA), another measure of sleep onset, Wake After Sleep Onset (WASO), a measure of sleep maintenance, and Total Sleep Time (TST). VEC-162 was also demonstrated to be safe and well-tolerated.
The Phase III trial was a randomized, double-blind, placebo-controlled, multi-center study that enrolled 412 adults in a sleep laboratory setting using a phase-advance, first-night assessment model of induced transient insomnia. The trial examined VEC-162 dosed 30 minutes before bedtime at 20, 50 and 100 mg versus placebo.


MEDICINOVA BEGINS TRIAL PROGRAM FOR ASTHMA TREATMENT
MediciNova has initiated a Phase III clinical program to determine the safety and efficacy of its novel oral treatment for bronchial asthma, MN-001.
The first Phase III trial in this program will involve approximately 705 asthma patients enrolled at 75 to 90 clinical sites in the U.S. Mild-to-moderate asthma patients will receive placebo or MN-001 for 12 weeks in this randomized, placebo-controlled, double-blind study. The primary endpoint of the trial will be the change from baseline in mean FEV1 (forced expiratory volume in one second) after 12 weeks of treatment. Secondary outcome measures will include a self-administered asthma quality-of-life questionnaire, the change from baseline in morning and evening peak flow rates, rescue beta-agonist use, serial spirometry parameters including assessment of acute effects following first dose on day one, daytime asthma symptom scores, nighttime awakenings from asthma, physician's global assessment, number of asthma exacerbations, discontinuations due to asthma, clinical global impression evaluations and change in urinary LTE4 levels. Additional Phase III trials are planned. Development of a continuous-release formulation of MN-001 will parallel the initial Phase III trials.
MN-001 is a novel, orally bioavailable compound that has been shown to block a number of the inflammatory mechanisms activated by mast-cell degranulation (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2) that are important in the pathogenesis of inflammatory disorders including asthma.
MN-001 is also under development by MediciNova for the treatment of interstitial cystitis. MN-001 is currently being evaluated in a pivotal-design Phase II/III clinical trial in 305 patients with moderate-to-severe interstitial cystitis at 39 clinical sites in the U.S. MediciNova anticipates having results from this trial by the beginning of 2007.