Neurocrine Biosciences Inc. (NYSE: NBIX) announced Monday its phase II drug candidate to treat endometriosis achieved main and secondary goals.
Endometriosis is diagnosed in women mostly between the ages of 25 and 35 who experience varying levels of pelvic pain associated with the uterine lining growing outside the womb, a condition with no cure and the primary cause of infertility.
Estimates of the portion of women suffering from endometriosis range from a low of 3% to as high as 18% of the U.S. population.
The company’s lead antagonist drug for the treatment of endometriosis, called elagolix, demonstrated a statistically significant reduction in pelvic pain during menstruation and during intercourse among patients who took the drug, compared with patients who receive placebos.
The Daisy PETAL phase II study included 137 endometriosis sufferers, who received one 150 mg dosage of elagolix for two months.
The drug is safe and well-tolerated, said the company, with nausea as the lead complaint reported by patients.
To date, the company has completed 17 phase I and II clinical trials of elagolix.
The company expects phase III clinical trials to begin later this year, but will not initiate elagolix phase III prior to partnering with one of the big pharmas.
EARNINGS
Late last month, the company posted a first-quarter net loss of $8.6 million, or a loss of 19 cents per share, compared with a net loss of $19.7 million, or a loss of 51 cents per share, for the first quarter of fiscal 2009.
Revenue reached $0.8 million, up from $0.7 million for the equivalent quarter last year. Revenue is derived primarily from amortized licensing fees from its collaboration agreement with Japanese drug maker Dainippon Sumitomo Pharma Ltd.
As of March 31, the company reported total assets of $79.9 million, including cash and cash equivalents of $69.2 million, down from the quarter ending December 31 of $70.8 million and $59.9 million, respectively. The nearly $10 million increase in cash/cash equivalents was due to proceeds from a stock offering completed during the quarter.
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