Biotech / Medical | Neurocrine Biosciences (NBIX)


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To: Biotech Jim who wrote (802)9/26/2001 12:48:50 AM
From: mopgcw   of 1826
 
"I hope the stock does well, though, since I still hold half my shares from the days at 5-6, before the first solid run. This is a first rate company in a tough business."

If you are referring to NBIX, i completely agree and am a happy camper with an unbelievable basis. Long-term quite bullish. If you are referring to medichem..

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To: Biotech Jim who wrote (802)9/26/2001 1:35:15 AM
From: Miljenko Zuanic   of 1826
 
BJ<

<<My bet is that the binding domains of the BP and the receptor are totally different molecular recognition events, like ACh at the nicotinic and muscarinic receptor families. I am not sure any current or near future Medichem results will facilitate CRF small molecule clinical PK attributes, or efficacy, either. >>

If NBIX-GSK continue clinical trials with NBI 34041 (after completion of the multiple doses safety trials) I will go with your explanation.
Oposite, I will believe that MediChem collaboration is for reason(s). Actually, they enter into collaboration with MediChem few weeks before GSK deal. What a coincidence?

BTW, wasn't NBIX-LLY collaboration on CRF-BP antagonist.

Miljenko

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To: Miljenko Zuanic who wrote (804)9/26/2001 7:03:19 AM
From: Biotech Jim   of 1826
 
MOPGCW-

I was referring to NBIX.

Miljenko-

I think the GSK discussions were initiated much before the Medichem discussions, since this is a more complex deal with much more $ involved. Yes, LLY did have the CRF-BP antagonist collaboration with NBIX, it has been over for some time now, due to ... biological efficacy?

BJ

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To: Biotech Jim who wrote (805)10/1/2001 6:20:35 AM
From: smh   of 1826
 
Monday October 1, 5:50 am Eastern Time
Press Release
SOURCE: Neurocrine Biosciences, Inc.
Neurocrine Biosciences Announces Additional Positive Phase II Results With NBI-34060 in 331 Subjects With Transient Insomnia
NBI-34060 Demonstrates Statistical Significance in Sleep Initiation In Primary and Secondary Endpoints; Doses Selected for Pivotal Phase III Program to Begin Q4 2001
SAN DIEGO, Oct. 1 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - news) today announced positive results with NBI-34060 in achieving both primary and secondary endpoints of sleep initiation in a Phase II clinical trial in subjects with transient insomnia. The study was a randomized, multi-center, multi-national, double blind, placebo-controlled, dose response study in 331 subjects with Transient Insomnia. The objective of this study was to assist in the selection of doses for pivotal Phase III clinical trials. The efficacy endpoints of this study were Latency to Persistent Sleep (LPS) as measured objectively by polysomnography and Time to Sleep Onset (TSO), the endpoints for approval of currently marketed sedative hypnotics. In this study NBI-34060 demonstrated a statistically significant effect on the primary endpoint of LPS relative to placebo (p<0.004) with up to a 40% improvement. The secondary efficacy endpoint of TSO also demonstrated improvements in the drug treated group as compared to the placebo group (p<0.001), indicating that the NBI-34060 subjects fell asleep more rapidly. There were no differences in residual sedation or in the incidence of adverse events as compared to placebo. This Phase II study demonstrated that NBI-34060 was safe, well tolerated and effective in these subjects with transient insomnia and achieved rapid sleep induction without next day residual effects associated with many currently marketed sedative hypnotics. These results are consistent with the safety and efficacy results seen in previous Phase II studies. Based upon the results of multiple successful Phase I and Phase II trials with NBI-34060 in Chronic (Primary) and Transient Insomnia administered in the beginning and middle of the night, Neurocrine has selected doses for the pivotal Phase III clinical program planned for initiation in the fourth quarter of 2001.

Commenting on the clinical results, James Walsh, Ph.D., a clinical investigator in the Phase II clinical trial and Executive Director, Sleep Medicine and Research Center St. Luke's Hospital, St. Louis, Missouri said, ``These are encouraging results showing that NBI-34060 has demonstrated robust effects on sleep initiation and has demonstrated an excellent safety profile with no next day residual effects. This compound may offer important new benefits to those who suffer with insomnia.''

``NBI-34060 has been administered to more than 900 adult and elderly male and female subjects. We have compiled a large database that confirms that this compound is well tolerated and is an active sedative hypnotic. We are proceeding with multiple Phase III safety and efficacy trials to support our registration. Based on recent discussions with the Food and Drug Administration (FDA) at our end of Phase II meeting, we will initiate our pivotal Phase III clinical programs this quarter,'' said Bruce Campbell, Ph.D., Senior Vice President of Development for Neurocrine Biosciences.

Background on NBI-34060 for Insomnia

NBI-34060 is a non-benzodiazepine that acts on a specific site of the GABA-A receptor. It is through this mechanism that the currently marketed non-benzodiazepine therapeutic also produce their sleep-promoting effects.

Insomnia is a term used to describe conditions related to the perception of inadequate or non-restful sleep. It encompasses a heterogeneous set of complaints reflecting difficulties initiating and/or maintaining sleep. Insomnia is one of the most prevalent neurological disorders in the United States, with up to 58% of the adult population reporting one or more symptoms of insomnia each year, according to the National Sleep Foundation (NSF).

Clinical Status Update on Neurocrine's Other Product Candidates:

Separately, Neurocrine reported on the status of its other clinical programs in development. One of the pivotal Phase IIb clinical trials for NBI-6024 is scheduled to begin early in the fourth quarter of 2001. This clinical trial is a randomized, double blind, placebo-controlled, multi- center, multinational study, in adolescent and adult patients. The study will involve at least 30 study centers and approximately 400 patients.

Neurocrine continues enrollment of its Phase I/II clinical trial with NBI-3001 for glioblastoma. The Company is on track to complete this study and initiate the pivotal program later this year. Neurocrine also expects to initiate Phase I studies with NBI-3001 for renal, breast and non-small lung cancer shortly.

In addition, an orally active GnRH antagonist development candidate has been selected for the treatment of endometriosis, uterine fibroids and prostrate cancer. This program is expected to enter Phase I studies by the fourth quarter of 2001.

Neurocrine is also working with partner GlaxoSmithKline to complete a multi-dose Phase I clinical trial with NBI-34041 in development for anxiety and depression and irritable bowel syndrome (IBS).

<snip>

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To: smh who wrote (806)10/1/2001 12:03:49 PM
From: Icebrg   of 1826
 
Neurocrine Biosciences [NASDAQ: NBIX $32.02]
12-Month Price Target: $57.00
F2001E EPS: $(1.63)
F2002E EPS: $(1.36)
Strong Buy
Michael King, Biopharmaceuticals (Robertson Stephens)

"Neurocrine is successfully completing a robust Phase II program for its insomnia compound, which was highly effective in treating transient insomnia in the most recent trial," said King. "The company plans to initiate Phase III trials by year end. With Neurocrine to join the ranks of top biotech companies with compounds in Phase III trials, we reiterate our Strong Buy rating and 12-month target price of $57."

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To: NeuroInvestment who wrote (673)10/10/2001 10:51:36 PM
From: scaram(o)uche   of 1826
 
You know, Harry, biotech investors everywhere owe you one big "thanks".

You work hard, and the effort to find good science is always sincere. Sure would be great if there were other editors around like you.

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To: scaram(o)uche who wrote (808)10/11/2001 8:54:42 PM
From: Miljenko Zuanic   of 1826
 
I second your view.

Few note from NBIX UBS presentation.

Insomnia:
-They are expanding PIII programs, five PIII trials (three PIII with IR: safety, transient and chronic insomnia, and middle of night, and two PIII with MR: chronic), total of ~3000 pts. Up to date ~1200 pts in trials completed.
-Will ask FDA for STRONG label (Long term…. and middle of night).
-IF they are successful with all this 5 trials (we still do not know will tolerance play rule here), they can ask partner for some or similar terms like IMCL

SKB CRF contract:
Few additional details on this:
-6 milestone streams (different indications), EACH with ~$100 millions in milestones,
-all development cost pay SKB,
-STRONG double-digit royalty, with co-promotion right in US (at SKB expense),
-20-30 FTE for 5 years, pay by SKB.
-Back-up ~6 months behind, with follow-up from different class and binding property (X-ray study?)

Miljenko

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To: Miljenko Zuanic who wrote (809)10/12/2001 9:26:34 AM
From: scaram(o)uche   of 1826
 
Thanks!! (eom)

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To: Billy Dunn who started this subject10/22/2001 8:42:30 PM
From: Miljenko Zuanic   of 1826
 
Monday October 22, 7:32 am Eastern Time
Press Release
SOURCE: Neurocrine Biosciences, Inc.
Neurocrine Biosciences Announces Appointment of Executive Vice President of Clinical Development
SAN DIEGO, Oct. 22 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - news) announced today the appointment of Henry Y. Pan, M.D., Ph.D., F.A.C.C. to the position of Executive Vice President of Clinical Development and Chief Medical Officer. Dr. Pan has gained worldwide recognition as a senior executive with major pharmaceutical, healthcare, and technology companies. He brings to Neurocrine over 20 years of experience in the pharmacological, medical, clinical pharmacological, and drug development.

Dr. Pan joins Neurocrine from VennWorks LLC, an operating company that creates, builds, and operates high value companies in different technology areas. At VennWorks, he was a Managing Director of the operating company, and CEO of VennWorks RTP, an incubator company that focused in Life Sciences. Prior to joining VennWorks, Dr. Pan was the President, CEO and Managing Partner of Pharmacologics LLC, and was President & CEO of the Pharmaceutical Services division of MDS Inc., a fully integrated Contract Research Organization that included MDS Harris, MDS Panlabs, MDS Clinical Trial Laboratories, among others. Dr. Pan also served as Executive Vice President, Drug Development and Medical Affairs with DuPont Merck Pharmaceutical Company, now a Bristol-Myers Squibb Company. There, he was responsible for the success of the Coumadin, Cardiolite, Neurolite, ReVia, and Sustiva programs. In addition to his tenure at DuPont Merck, Dr. Pan was Vice President of Clinical Research and Development at Bristol-Myers Squibb where he was instrumental in the development of Pravachol taking the compound from preclinical development to drug approval and launch in over 90 countries around the world. Dr. Pan was also directly involved with numerous FDA Advisory Committee meetings at both Bristol-Myers Squibb and DuPont Merck and he was the recipient of numerous company and state awards.

Dr. Pan is a Fellow of the American College of Clinical Cardiology, the American College of Clinical Pharmacology, the American Heart Association, the Institute of Biological and Clinical Investigation, and the Academy of Medicine of New Jersey.

``We are pleased to have Dr. Pan as a member of our senior management team at Neurocrine. His vast knowledge and expertise in both the clinical and scientific arena will significantly accelerate Neurocrine's development and commercialization efforts. With six products in advanced clinical development, it is an asset to have Dr. Pan join Neurocrine at this time of major progress,'' said Gary Lyons, President and Chief Executive Officer of Neurocrine Biosciences.

Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, malignant brain tumors and peripheral cancers, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, stroke, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at neurocrine.com  .

In addition to historical facts, this press release contains 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 development programs and business and finances including, but not limited to, risk that Neurocrine's development programs will not successfully proceed through Phase I clinical trials or that in later stage clinical trials will not show that it is effective in treating humans; determinations by regulatory and governmental authorities; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K for the year ended December 31, 2000 and the current form 10Q each of which should be read before making any investment in Neurocrine common stock. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

SOURCE: Neurocrine Biosciences, Inc.

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To: Miljenko Zuanic who wrote (811)10/22/2001 11:43:55 PM
From: scaram(o)uche   of 1826
 
Two months left, but someone is really going to have to do tricks to beat out Lyons as biotech's CEO of the year.

Two year charts.........

quote.yahoo.com 

here's my fave........

quote.yahoo.com 

As we were saying, March 2000...... most biotechs hit ridiculous valuations in the bubble, but NBIX was only getting to where it belonged.

**NEW YORK**

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