Press ReleaseNeurocrine Biosciences Reports First Quarter 2009 Results
Revenues for the first quarter of 2009 were
Research and development expenses decreased to
General and administrative expenses were
The Company incurred
The Company's balance sheet on
"We continue to move our GnRH program forward with the most recent twelve
month data from our 603 study showing that elagolix had no deleterious impact
on bone mineral density. To date we have successfully treated approximately
700 subjects with elagolix, and continue to build value in this franchise
through our ongoing development efforts," said
GnRH Antagonists in Phase II Clinical Trials for Endometriosis
Elagolix for Endometriosis
Petal Study (NBI-56418-0603)
The Company has recently completed the entire twelve months of the Petal study, which included the post-treatment reviews to determine the impact, if any, of elagolix on bone mineral density (BMD) six months after stopping treatment. The dual energy X-ray absorptiometry (DXA) data were consistent with the six-month end of treatment results showing a negligible change from baseline in the elagolix treatment arms. In particular, the elagolix 150 mg once daily mean percent change in BMD at twelve months in the spine was 0.19% and in the femur was -0.28%. Analysis of the pain data, collected utilizing the Visual Analog Scale (VAS) and the Composite Pelvic Sign and Symptoms Scale (CPSSS), revealed that the subjects report a sustained improvement of endometriosis symptoms while off medication. While there is a modest increase in scores during the six months after discontinuation of treatment, the mean scores did not return to baseline severity. This would be consistent with a disease modification effect but such a conclusion requires additional clinical study for confirmation.
Lilac Petal Study (NBI-56418-0702)
The Company recently reported the top-line study results from the
three-month, double-blind placebo controlled portion of the Lilac Petal Study.
These data confirmed the efficacy and safety of elagolix at 150 mg and 250 mg
once daily. All subjects have completed the six months of treatment and final
study results are expected during the summer. The Company found that for two
exploratory scales, daily assessment of non-menstrual pelvic pain was
associated with a statistical "floor effect" given the overall mild nature of
this symptom in many subjects as assessed utilizing these scales. Analysis of
these scores for the sub-set of subjects with moderate or severe non-menstrual
pelvic pain at baseline revealed statistically significant separation of
elagolix from placebo. The Company is meeting with consultants to discuss
methods for addressing this "floor effect" with the
Tulip Petal Study (NBI-56418-0703)
The Phase IIb trial in central
The Company continues to investigate the potential of certain GnRH antagonists in treating other hormone-dependent diseases in men's and women's health.
Corticotropin Releasing Factor (CRF1) Receptor Antagonists for Anxiety/Depression and IBS
The CRF collaboration between Neurocrine and GSK has identified multiple unique high affinity and selective antagonists for the CRF1 receptor that are currently in clinical development for mood disorders.
GSK has advanced a novel lead CRF1 receptor antagonist compound, 561679, into a Phase II trial. This six week randomized, double-blind, placebo-controlled trial is designed to assess the safety and efficacy of this compound in approximately 150 subjects with Major Depressive Disorder. Results from this study are expected in the second half of 2010.
In addition to this compound, GSK has also successfully completed a Phase I single dose-escalating clinical trial with an additional CRF1 compound, 586529, for the treatment of anxiety and depression.
Neurocrine continues to collaborate with our basic and clinical research
colleagues on urocortin 2 (UCN2) for cardiovascular indications.
Vesicular Monoamine Transporter 2 Inhibitor (VMAT2)
VMAT2 is a protein concentrated in the human brain that is essential for the transmission of nerve impulses between neurons. Neurocrine identified a 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 thereby reducing the likelihood of "off target" side effects. This clinical candidate should be effective in the management of hyperkinetic movement disorders characterized by involuntary bodily movements as seen in patients suffering from tardive dyskinesia, and Huntington's disease. Additionally, the modulation of dopamine pathways may also be useful for patients suffering from schizophrenia.
The pre-clinical IND enabling studies have been completed and the Company expects to move this compound into the clinic during the summer of 2009.
The Company continues to wait for the final FDA meeting minutes from the
end-of-review meeting held in
Conference Call and Webcast
Neurocrine will hold a live conference call and webcast tomorrow morning,
If you are unable to attend the Webcast and would like further information
on this announcement please contact the
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 GnRH program, R & D
pipeline and Company overall. Specifically, the risks and uncertainties the
Company faces with respect to the Company's GnRH program include risk that the
elagolix clinical trials will fail to demonstrate that elagolix is safe and
effective; risk that elagolix will not proceed to later stage clinical trials;
risks associated with the Company's dependence on corporate collaborators for
development, commercial manufacturing and marketing and sales activities. In
addition, the Company faces risks and uncertainties with respect to the
Company's R & D pipeline including risk that the Company's urocortin 2, CRF1
receptor antagonist, and VMAT2 clinical candidates will not proceed to later
stage clinical trials, and risk that the Company's research programs will not
identify pre-clinical candidates for further development. The Company also
faces risk that the Company may be unable to obtain FDA approval for indiplon
commercialization in the near future or at all. 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 collaborators for commercial manufacturing and marketing and sales
activities; 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
NEUROCRINE BIOSCIENCES, INC. Condensed Consolidated Statements of Operations (in thousands, except for loss per share data) Three Months Ended March 31, 2009 2008 (unaudited) (unaudited) Revenues: Sponsored research and development $17 $12 License fees and milestones 730 1,730 Grant revenue - 9 Total revenues 747 1,751 Operating expenses: Research and development 10,848 14,227 General and administrative 4,195 8,286 Cease-use expense 4,828 - Total operating expenses 19,871 22,513 Loss from operations (19,124) (20,762) Other income and (expenses): Interest income and other income (expense) (541) 1,606 Interest expense - (1,921) Total other expense (541) (315) Net loss $(19,665) $(21,077) Net loss per common share: Basic and Diluted $(0.51) $(0.55) Shares used in the calculation of net loss per common share: Basic and Diluted 38,669 38,330 NEUROCRINE BIOSCIENCES, INC. Condensed Consolidated Balance Sheets (in thousands) March 31, December 31, 2009 2008 (unaudited) Cash, cash equivalents and marketable securities $66,375 $80,473 Other current assets 829 950 Total current assets 67,204 81,423 Property and equipment, net 5,075 6,191 Long-term investments 19,609 21,057 Restricted cash 6,404 6,409 Other non-current assets 2,736 3,102 Total assets $101,028 $118,182 Current liabilities $32,536 $26,094 Long-term liabilities 49,381 55,314 Stockholders' equity 19,111 36,774 Total liabilities and stockholders' equity $101,028 $118,182
Web Site: http://www.neurocrine.com