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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?


To: Torben Noerup Nielsen who wrote (571)4/6/2000 2:26:00 AM
From: Spekulatius  Respond to of 1834
 
CRF antagonist R121919 news
I would not buy this one too early. It is my understanding that R121919 was a major drug for NBIX and its dead now.
Even worse, some people have known before, before the result of this study became public.
This reminds me of the GLIA Adcon debacle where also some pigs were more equal than the others.
Tomorrow will be a very bleak day for NBIX and I do not think it will come back very quickly.

Good luck!



To: Torben Noerup Nielsen who wrote (571)4/6/2000 8:36:00 AM
From: tom pope  Read Replies (1) | Respond to of 1834
 
Just to demonstrate in public my total naivete, is the incidence of reversible liver damage in two subjects in a population of 250 sufficient to halt clinical development of an otherwise promising drug?

Seems to me that the average package insert for FDA approved drugs contains more threatening potential side effects.



To: Torben Noerup Nielsen who wrote (571)4/7/2000 12:19:00 AM
From: Asymmetric  Respond to of 1834
 
Neurocrine Biosciences Ends Devt Of Lead CRF Antagonist

Dow Jones Newswires/April 5, 2000

SAN DIEGO -- Neurocrine Biosciences Inc. (NBIX) said a back-up compound that resulted from a collaboration with Johnson & Johnson's (JNJ) Janssen Pharmaceutica Inc. unit will be substituted for Janssen's lead CRF antagonist R121919.

In a press release Wednesday, Neurocrine said a decision has been made to discontinue further development of R121919, based on observations of reversible increases in liver enzymes in two volunteers in an expanded safety trial in the U.K. About 250 subjects to date have been treated in various clinical trials with no other observed safety issues, Neurocrine said.

Separately, Neurocrine said Phase I clinical trials are scheduled to begin in the second half of 2000 for its unpartnered CRF antagonist compound for anxiety/depression. This proprietary compound is from a novel chemical series which is distinct from R121919.

Based on pre-clinical studies, Neurocrine said the proprietary compound has demonstrated "improved specificity and greater potency together with excellent pharmacokinetic properties."

CRF was first identified and cloned by Neurocrine co-founder Wylie Vale and his colleagues at the Salk Institute, Neurocrine said.

Neurocrine holds the patent rights to the CRF family of receptors and has developed multiple series of selective, potent, small molecule antagonists for these receptors.

CRF functions as a neurotransmitter in the brain and plays a critical role in coordinating the body's responses to stress.

In pre-clinical models, selective CRF1 receptor antagonists block stress responses - evidence that this novel mechanism may result in improved anti-anxiety and anti-depressant drugs, Neurocrine said.