NBIX.....thieworst thing i could do is sell NBIX and then news comes out.....what the heck i will hold for the long haul and hope for the best i guess i will just keep on waiting -------------------------------------------------------------------------------- Quote from gimp570: Neurocrine Biosciences Inc. (NBIX)- I have been waiting for big news Good or Bad for a long time now....something big has to come out sooonnn At this point i just want big news..... Anyone know of anytime frames for these drug trials to be complete?? --------------------------------------------------------------------------------
well this is taken much longer than i thought. Looks like the new time frame is years away. Neurocrine Still Looks Significantly Underrated September 18, 2012 by: Stephen Simpson | about: NBIX, includes: ABT, ISRG, LLY, NVS Disclosure: I am long NBIX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...) I've written positively on Neurocrine Biosciences (NBIX) twice already this year, and I finally took the plunge and bought it for my own account. Although there's ample risk with this company's clinical programs, the pipeline addresses some major unmet clinical needs and could support a price target roughly double today's price. Pivotal Phase 3 Underway At Last For Elagolix The development of Elagolix, an oral gonadotropin-releasing hormone (GnRH) agonist, has had a long and sometimes convoluted history. There have been 18 Phase I and Phase II studies conducted to date, due in part to wrangling with the FDA over the measurement of endpoints like dysmenorrhea and non-menstrual pelvic pain. Although the drug has consistently shown a strong safety profile and good efficacy through laparoscopic follow-up, it has taken some work to get the pain assessment dialed in. The most recent studies have shown solid improvements in pain, though, and Elagolix does look like a potential winner. Development timelines have slipped a bit with Elagolix, due in large part to the need for Neurocrine and partner Abbott Labs (ABT) to meet with the FDA and get a special protocol assessment (SPA) hammered out for the Phase 3 pivotal study. The pivotal study is now underway, though - a study that will enroll 875 patients in the U.S., Canada, and Puerto Rico and should deliver top-line data in early 2014. This study will measure non-menstrual pelvic pain and dysmenorrhea after three months to a baseline as the primary endpoint, but will also include secondary measures like persistence of efficacy, analgesic use, and dyspareunia. Assuming that the data is good, a filing with the FDA should occur in 2016. Abbott and Neurocrine are also developing Elagolix for uterine fibroids, with a Phase 2 study on track to deliver results later this year. The Potential Is Well Worth It All of the fuss and hassle for Elagolix should be well worth the trouble if the data holds up in Phase 3 studies. Although the number of women in the U.S. actively receiving treatment for endometriosis is measured in the hundreds of thousands, it is believed that 6 million women have the condition and a meaningful percentage (20%+) could be eligible patients for Elagolix, especially considering the clean side-effect profile seen to date. Looking at it another way, of the roughly 600,000 annual hysterectomies performed in the U.S., about one-sixth have endometriosis as the stated cause. Uterine fibroids could be an even larger opportunity, as fully 40% of hysterectomies are performed due to uterine fibroids, as well as many more less-invasive ablation, embolization, and fibroid removal procedures. If Abbott and Neurocrine can charge roughly $3,500 for this drug, just the hysterectomy patients alone would be worth $1.2 billion in annual sales. Now it's all but impossible that this drug will capture 100% of surgical patients (particularly as Intuitive Surgical (ISRG) offers a safer, less painful alternative approach to hysterectomy), but that figure also exclude ex-US markets and less severe patients. All in all, I think Elagolix is a billion-dollar drug with some upside beyond that. NBI-98854 - Still Unpartnered And Still Unproven Neurocrine's unpartnered VMAT2 inhibitor NBI-98854 could possibly hold almost as much value as Elagolix, though it has a lot more left to prove to capture similar value in today's stock price. About six months ago, Neurocrine reported what initially looked like disappointing data from a small (32-patient) Phase II crossover study. Because one of the trial sites seriously screwed up the process of evaluating the drug's efficacy, the trial looked like a failure. A company-run post-hoc analysis suggested that highest dose of the drug showed the same 40% improvement seen in earlier studies (a result that would be statistically and clinically significant). Since then, the company had Dr. Paul Ramirez, a leader in the Abnormal Involuntary Movement Scaling (AIMS) scoring system used in these studies and a developer of AIMS training videos, conduct his own review. Encouragingly, Dr. Ramirez's analysis showed a similar result, with a p-value of 0.008. The company has pushed on with further clinical development, with the drug going into a Phase II-B study assessing the drug in tardive dyskinesia patients with schizophrenia and bipolar disorder. This study (120 patients) should deliver results in the first quarter of 2013, and solid results would clearly support Phase III development. Importantly, Dr. Ramirez will be training each site as to how to evaluate the patients and that should reduce the risk of a repeat occurrence of the response evaluation kerfuffle. I'm optimistic about NBI-98854, and believe tardive dyskinesia is a major under-served market. Anti-psychotic medication frequently leads to TD in long-term users, and while TD rates for more modern drugs like Bristol-Myers' (BMY) Abilify, Lilly's (LLY) Zyprexa, and Johnson & Johnson's (JNJ) Risperdal are lower than in the past (where 50-60% of patients would ultimately develop TD), a long-term incidence rate of 35-40% still points to significant opportunity. Neurocrine is careful with its cash, but I nevertheless expect further development of NBI-98854 in Tourette's, tardive dystonia, and possibly Huntington's disease if this Phase II-B TD data looks strong. The TD market is probably worth north of $1 billion, with Tourette's possibly tripling that and Huntington's supporting another $1 billion in revenue. Keep in mind that no drug gets 100% of its market and the odds of success in Huntington's are low, but there's enough potential here to follow the drug carefully. Other Pipeline Efforts Will Take Longer Back in May of this year, Neurocrine released encouraging Phase II data on its heart failure candidate urocortin-2. This 53-patient trial studied the use of urocortin-2 in acute decompensated heart failure, and showed an encouraging 50% improvement in cardiac output and unspecified improvements in peripheral vascular resistance and dyspenea. While there are about 1 million hospitalizations every year in the U.S. for ADHF, Neurocrine is not likely going to advance this drug without a partner. Novartis (NVS) did pay $120 million upfront (and up to $620 million total) for Corthera and its heart failure drug relaxin, but Corthera had more data at the time - particularly dyspnea data from a 200-patient Phase 2/3 study. Consequently, I'm not sure what sort of deal Neurocrine could get at this point without further self-funded clinical data. Other drugs in Neurocrine's pipeline include pre-clinical compounds for schizophrenia, tremor/epilepsy, oncology (partnered with Abbott), and diabetes (partnered with Boehringer Ingelheim). The Bottom Line I'm moving down my price target on Neurocrine from my initial March estimates due to a longer timeline and slightly higher risk weighting on Elagolix. A sales estimate of $1.2 billion supports nearly $13 per share in value for this drug, but I could see this being a multi-billion dollar drug if the endometriosis and fibroid studies both show strong efficacy. For NBI-98854, which is still unpartnered, I use a $400 million estimate which leads to a $3 per share value, but acknowledge the possibility of upwards of $1 billion to $1.5 billion in sales if the follow-on indications succeed. Assigning no value to urocortin-2 and the rest of the pipeline, that suggests Neurocrine is worth about $16 per share against a current price near $8. Remember, though, that these are conservative numbers (to the extent that assuming success for any unapproved drug can be conservative), and simply the time value of money between 2021 (the year I'm using for base case revenue estimates) and 2020 is worth $3 per share for Elagolix alone. I own these shares and I believe Neurocrine remains a significantly undervalued biotech with multiple data releases coming over the next six months
finally some good news.....it been a long time Neurocrine Announces Start Of Phase IIb Study Of VMAT2 Inhibitor NBI-98854 For Treatment Of Tardive Dyskinesia Kinect Study to Evaluate Twelve Weeks of Continuous Dosing Press Release: Neurocrine Biosciences, Inc. â Mon, Oct 1, 2012 4:05 PM EDTEmailShare0PrintCompanies:Neurocrine Biosciences Inc.RELATED QUOTESSymbol Price Change NBIX 8.30 +0.23 SAN DIEGO, Oct. 1, 2012 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX) announced today that it has initiated a Phase IIb clinical trial (Kinect Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The design of this twelve-week Phase IIb study is a randomized, parallel, double-blind, placebo-controlled, trial of 120 subjects with moderate to severe tardive dyskinesia and underlying schizophrenia or schizoaffective disorder. Topline data is expected in the second quarter of 2013. "We are pleased that NBI-98854 is taking the next step in development with this Phase IIb clinical trial," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences. "The Kinect Study incorporates key refinements to improve the appropriateness of tardive dyskinesia subjects, reduce the variability in AIMS assessments, and expand our dose response database. This study will provide us with the data necessary to develop the Phase III program for NBI-98854." Kinect Study Design The Kinect Study is a randomized, parallel, double-blind, placebo-controlled, Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia or schizoaffective disorder. This 120 subject study will assess two doses of once-daily NBI-98854 over a six-week placebo-controlled dosing period. Half of the randomized subjects will receive placebo and half will receive one of two doses of NBI-98854. The two NBI-98854 dosing groups will consist of a 50mg group for six weeks and a group that will begin at 100mg for the initial two weeks then convert to a 50mg for the final four weeks of placebo-controlled dosing period. Subsequent to the placebo-controlled dosing, all subjects will enter a six-week open label safety extension of 50 mg of NBI-98854 administered once daily with additional AIMS assessments. The primary endpoint of the study is a comparison of placebo vs. active scores utilizing the Abnormal Involuntary Movement Scale (AIMS) at the end of week six. The Company has designated a small panel of independent, blinded AIMS assessors to determine subject eligibility for the Kinect Study. Prior to the randomization of any subject, a video of each potential subject's initial screening AIMS evaluation will be reviewed by a member of this panel to determine whether the individual has moderate to severe tardive dyskinesia. The independent panel is the sole determiner as to whether or not the subject meets the AIMS severity criteria to be eligible for the Kinect Study. Additionally, this central panel will continue to serve as independent quality control monitors of the AIMS assessments during the entire course of the trial. The Company has also enhanced the training and certification of the site specific, non-treating investigator to administer the AIMS assessments. About the Abnormal Involuntary Movement Scale (AIMS) The AIMS is a structured neurological examination that was developed in 1976 and has been used extensively in movement disorder assessments. It consists of ten distinct ratings of regional involuntary body movements that are scored on a zero to four scale with zero being rated as none and four being rated as severe. The primary endpoint is assessed on items one through seven which rate facial, extremity and trunk movements, the AIMS total dyskinesia score. Next Steps for NBI-98854 Another randomized, parallel, placebo-controlled, double-blind, Phase IIb study is planned to assess six-week dosing of NBI-98854 against placebo. This study will assess moderate to severe tardive dyskinesia sufferers with underlying mood disorders, schizophrenia and schizoaffective disorders, and gastrointestinal disorders. About Tardive Dyskinesia 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. About NBI-98854 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. The Company has completed three-month in vivo toxicology studies to support longer dosing regimens. NBI-98854 may also be useful in other disorders such as Huntington's chorea, schizophrenia, Tourette's syndrome, and tardive dystonia. About Neurocrine Biosciences Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world, including endometriosis, stress-related disorders, pain, tardive dyskinesia, uterine fibroids, diabetes, insomnia, and other neurological and endocrine-related diseases and disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at http://www.neurocrine.com. In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general, as well as risks and uncertainties associated with the Company's VMAT2 program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company's VMAT2 program include, but are not limited to; risk that NBI-98854 will not proceed to later stage clinical trials and risk that the Company's clinical trials will fail to demonstrate that NBI-98854 is safe and effective. With respect to its pipeline overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company's dependence on contract manufacturers for clinical drug supply; risks associated with the Company's dependence on corporate partners for development, commercial manufacturing and marketing and sales activities for the Company's partnered programs; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2011 and on Form 10-Q for the quarter ended June 30 , 2012. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
NBIX is finally making a move. Its been a long long hold. It shoook off a bad Seekingalpha article a few days ago, but they did write that The experts I spoke with, and I, believe the compound has a very good chance of meeting its endpoints and receiving FDA approval i guess thats a good sign