Neurochem Inc. (NRMX-$14.54) is a Canadian biopharmaceutical company focusing on the development and commercialization of therapeutics for a variety of neurological disorders.
Though high risk, we purchased 800 shares of Neurochem common stock. We believe two important milestones coming in the second quarter of 2007 will be the driving catalyst(s) for any upward price move:
- Alzhemed Phase 3 clinical data for the treatment of mild-to-moderate Alzheimer's disease (AD) patients.
- FDA six-month review of NDA amendment (updated efficacy data) of eprodisate (KIACTA) for AA Amyloidosis,, a disease associated with chronic inflammatory diseases, including rheumatoid arthritis and Crohn's disease. The goal date for a decision on eprodisate (KIACTA™) is April 16, 2007.
Investment Risks & Considerations
- Tramiprosate (Alzhemed) is a small, orally-administered molecule known as an amyloid (B) antagonist that crosses the blood-brain-barrier, binds to soluble A(B) peptide and is thought to offer therapeutic utility by interfering with the amyloid cascade, inhibiting A(B) protein deposition in the brain (amyloid plaques), and provides protection against A(B)-induced neurotoxicity.
Alzhemed holds blockbuster potential, if successful, but we cautiously note that the drug’s probability of success in showing disease modification carries above average risk, for (similar to drug development for ischemic stroke) the complex pathological process of Alzheimer's disease is not well understood and likely involves several neuronal cascade failures occurring simultaneously, which skews risk/reward profile.
- In 2003 Neurochem successfully completed a randomized, multi-centre, double-blind, placebo-controlled Phase II clinical trial for Alzhemed. However, the sample size was small, with only a total of 58 patients with mild-to-moderate AD enrolled in this trial for three months. [Ed. note. It is difficult to accurately assess the efficacy of a drug being given for a debilitating, progressive disease after only 12-weeks!]
At the end of the 90 days, all patients, including those previously on placebo, were invited to participate in an open-label, single-arm extension study using the 300 mg dose. Efficacy, defined as a change in cognitive function, was assessed again at various time intervals. Again, this trial extension gives us little clue as to what to expect from the Phase 3 trial— The patient numbers only got smaller; only 24 patients remained in the study at 20 months (at the three-year mark, only nine patients were still being followed).
- According to Chris Schumacher, a short trader, now is not the ideal time to do speculative buying, for Nerochem’s stock chart revealed a bearish technical formation of a head-and-shoulders pattern. The share price recently closed below initial support of $15.00 per share.