BOSTON ( TheStreet) -- To prep healthcare investors for 2015, I've compiled a list of crucial clinical trial read-outs and FDA events such as approval decisions and advisory panels that are likely to effect stock prices in the first half of 2015.
Biogen's (BIIB) anti-LINGO-1 antibody is a potential therapeutic game changer for chronic neuro-degenerative diseases like multiple sclerosis. The drug is designed to block the production of a protein known as LINGO-1, which when expressed in the central nervous system, leads to the degradation of the protective myelin sheath around nerve fibers. The breakdown or "demyelination" of nerve fibers interferes with the transmission of nerve impulses, leading to physical and cognitive disability.
If anti-LINGO-1 antibody can prevent the destructive LINGO-1 protein from being produced, nerve fibers in multiple sclerosis patients might be "remyelinated" and the damage caused by the disease reversed or eradicated altogether. No wonder anti-LINGO-1 is considered a crucial, if not the most important, compound in Biogen's research pipeline.
Biogen is running two phase II studies of anti-LINGO-1. Top-line results from the first study in patients with optic neuritis will be announced in January. These optic neuritis data are highly anticipated by investors as substantial proof of concept for the entire remyelination thesis and as a signal for what may come from the second, more important phase II study of anti-LINGO-1 in multiple sclerosis patients. Results from that study are also expected next year.
Neurocrine Biosciences and Abbvie
Neurocrine (NBIX) has a busy schedule of clinical data in 2015, starting in early January with the expected announcement of top-line results from the phase III "Violet Petal" study of Elagolix in endometriosis.
Elagolix is a daily pill designed to rapidly suppress the production of hormones believed to cause endometriosis, a gynecological disease in which cells from a woman's uterus grow in other parts of the body, causing pain and other reproductive complications. Current therapies for endometriosis require injections which can be painful, slower acting and harder to "turn off" if complications arise.
The "Violet Petal" study is the first of two phase III studies of Elagolix required for a regulatory submission. Neurocrine is developing Elagolix in partnership with Abbvie (ABBV) . The drug is also being studied as a treatment for uterine fibroids. Endometriosis represents a $500 million to $1 billion worldwide commercial market opportunity for the companies, depending on pricing and market share penetration.
Bristol-Myers Squibb and Merck
The cancer immunotherapies known as checkpoint inhibitors will remain a big story for healthcare investors in 2015, just like they were this year.
In the early part of the year, Bristol (BMY) is expected to release top-line results from the Checkmate-017 study of nivolumab (Opdivo) in second-line, squamous non-small cell lung cancer patients. Checkpoint inhibitors have demonstrated profound efficacy in melanoma, but Checkmate-017 will be the first chance to see results from a randomized phase III study in lung cancer, a much larger commercial opportunity.
Later in the year, Bristol will have results from Checkmate-057, a similar, randomized phase III study looking at Opdivo in previously treated, non-squamous non-small cell lung cancer patients.
For Merck (MRK) , in early 2015, investors should look forward to results from the phase III "Keynote-006" study comparing Keytruda to Bristol's Yervoy in melanoma patients.
More 2015 biotech events on the next page...
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