|Updated: Neurocrine granted Fast Track designation; Continues creating value for investors|
|Wednesday, 25 January 2012 09:10|
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is currently no known treatment.
Neurocrine's research and development efforts are focused on neurological and endocrine diseases and disorders. Its product candidates address the pharmaceutical markets including endometriosis, stress-related disorders, pain, diabetes, insomnia, and other neurological and endocrine-related diseases and disorders.
"The FDA's Fast Track designation recognizes the significant need for an effective treatment for tardive dyskinesia," said Christopher F. O'Brien, M.D., Chief Medical Officer of Neurocrine Biosciences. "We look forward to continuing to collaborate with the FDA on the development of NBI-98854, and welcome the opportunity for increased interactions with the Agency."
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) among nerve cells. NBI-98854, developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines thereby reducing the likelihood of "off target" side effects. NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive dopamine depletion.
NBI-98854 may be useful in other disorders such as Huntington's chorea, schizophrenia, Tourette's syndrome, and tardive dystonia.
Las October, Neurocrine announced that it had achieved its second milestone in its collaboration with Abbott for elagolix and next-generation Gonadotropin Releasing Hormone (GnRH) Receptor Antagonists. The Company and Abbott held a pre- phase III meeting with the FDA, the outcome of which generated a $20 million milestone payment from Abbott to the Company. This milestone event brings the total milestones achieved by the Company in the third quarter of 2011 to $30 million.
Interestingly, when the stock was trading at $6.42, we told readers that a substantial insider buy had been placed by Mark N. Lampert of the BioTechnology Value Fund, LP and that his buying activity put shares on the higher end of a tight trading range that had been in play for NBIX shares since August.
From a technical standpoint, it may be worth noting the flag which has formed on the chart. Flags and pennants are among the most reliable of continuation patterns and only rarely produce a trend reversal. Keep an eye on the trade action here for a possible break-out or continuation. The important thing to remember is that a flag formation like this one is characterized by diminishing trade volume (also seen here). If you can catch the potential breakout early, you may see a substantial move to the upside.
Neurocrine's product pipeline includes: GnRH Antagonist - a peptide that stimulates the secretion of the pituitary hormones that are responsible for sex steroid production and normal reproductive function; NBI-98854 - a potent, highly selective, VMAT2 inhibitor that is effective in regulating the levels of dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines; Urocortin 2 - selectively stimulates the CRF2 receptor and can improve cardiac output with minimal increase in heart rate; GPR119 - a novel target for the treatment of Type II diabetes; CRF antagonists for psychiatric, neurological and gastrointestinal diseases; etc.
Neurocrine has collaborations with Abbott Laboratories, GlaxoSmithKline plc, Boehringer Ingelheim GmbH, Dainippon Sumitomo Pharma Co Ltd, GeneData AG, The Michael J. Fox Foundation for Parkinson's Research, The Hebrew University of Jerusalem, Protox Therapeutics Inc, Xceleron Inc, Entelos Inc, Iconix Biosciences Inc, and others.