APRIL 27, 05

Eye On

NEUROCHEM  (NRMX) got a green light from  Independent Safety Review Board (ISRB) to continue its  North American Phase 3 clinical trial for Alzhemed™ for the treatment of Alzheimer's Disease (AD).

Neurochem's ISRB for Alzhemed™ is made up of independent medical experts who monitor and evaluate the safety of patients taking part in the Alzhemed(TM) Phase 3 clinical trial in North America. The recommendation by the ISRB members was based on their recent review of the safety data from 562 patients who have been monitored in the trial for at least 12 weeks so far. After reviewing the safety information, the ISRB concluded that there were no significant safety concerns to report in the study and that the trial should continue as planned.

Alzhemed™ is an orally administered, small organic molecule that has an anti-amyloid activity. As part of a "disease modifying" novel class of product candidates, Alzhemed™ is expected to act at two levels: in preventing and stopping the formation and the deposition of amyloid fibrils in the brain and in binding to soluble A(B) protein to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells associated with amyloid build-up in AD.

In a 2000 report, the Biotechnology Industry Organization estimated that in the United States the total cost of AD has been estimated at US$100 billion per year.

Neurochem develops therapeutics for neurological disorders. The Company's pipeline of proprietary, disease-modifying oral products addresses critical unmet medical needs. 1,3-propanedisulfonate (1,3PDS; Fibrillex™ is designated as an orphan drug and a Fast Track Product candidate and is also part of an FDA Continuous Marketing Applications Pilot 2 program. The Phase 2/3 clinical trial of Fibrillex™ for the treatment of AA Amyloidosis was recently concluded and preliminary results have been issued in April 2005. 3-amino-1-propanesulfonic acid (3APS; Alzhemed™, for the treatment of Alzheimer's Disease, is in a Phase 3 clinical trial and 3APS (Cerebril™, for the prevention of hemorrhagic stroke caused by Cerebral Amyloid Angiopathy, has completed a Phase 2a clinical trial.

AMGEN (AMGN) AND ABGENIX (ABGX): initiated of a Phase 3 clinical study to evaluate the potential benefits of adding panitumumab, an experimental fully human monoclonal antibody, administered every other week to Avastin™ and either oxaliplatin- (Eloxatin®, sanofi-aventis) or Camptosar®, chemotherapy for the first-line treatment of metastatic colorectal cancer. The clinical trial, called the PACCE (Panitumumab Advanced Colorectal Cancer Evaluation) study, is a randomized, multi-center, open-label study, with endpoints of progression-free survival, overall survival and response rate. Enrollment in the study of approximately 1,000 patients is already underway.

Targeting multiple pathways that aid in tumor survival and growth at the same time or in succession theoretically has advantages over targeting one pathway alone," said Willard Dere, M.D., chief medical officer and senior vice president of global development at Amgen. "In clinical studies to date, panitumumab appears to be well-tolerated, and interim Phase 2 data demonstrate that objective tumor responses in metastatic colon cancer patients occurred following panitumumab treatment."

Panitumumab inhibits the epidermal growth factor receptor (EGFr), while bevacizumab targets the vascular endothelial growth factor involved in angiogenesis. Although EGFr normally helps regulate the growth of many different cells in the body, EGFr can also stimulate cancer cells to grow. In fact, many cancer cells actually require signals mediated by EGFr for their survival. Residing on the surface of these tumor cells, EGFr is activated when naturally occurring proteins in the body, epidermal growth factor (EGF) or transforming growth factor alpha (TGF-alpha), bind to it. This binding changes the shape of EGFr, which, in turn, triggers internal cellular signals that stimulate tumor cell growth.

Panitumumab binds to EGFr, preventing EGF and TGF-alpha from binding to the receptor and interfering with the signals that would otherwise stimulate growth of the cancer cell and allow it to survive.

Co-developed by Amgen and Abgenix, panitumumab is an investigational product in a novel class of targeted cancer treatments called epidermal growth factor receptor (EGFr) inhibitors. Panitumumab (formerly ABX-EGF) is the first fully human monoclonal antibody directed against EGFr and is being evaluated as both a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung and kidney. Panitumumab is generated with Abgenix's XenoMouse® technology, which creates a fully human monoclonal antibody that contains no murine (mouse) protein. The fully human nature of panitumumab may result in a favorable safety profile with a low incidence of infusion reactions, antigenicity and allergic response. These are attributes currently being investigated in clinical trials. Pivotal clinical studies evaluating panitumumab as a third-line monotherapy in colorectal cancer patients are ongoing with an every-other-week dosing regimen.

GILEAD (GILD) failed in a first attempt to create a new HIV pill with Bristol-Myers Squibb (BMY). Gilead said it would reformulate the pill, which combines its Truvada HIV pill with Bristol-Myers Squibb's Sustiva HIV medication. Assuming the reformulation works, Gilead said it believed it could submit on application for the once-a-day combination drug to the Food and Drug Administration by year-end.

The companies established a U.S. joint venture last December to develop a Truvada-Sustiva pill. Gilead said the first formulation failed because the Sustiva levels measured in patients' blood were too low.

 The stock will lose momentum, for a very short while. When the normal reaction fades, an opportunity to buy the stock at a lower price presents.

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