Shares of Neurocrine Biosciences Inc. (NBIX) have been up 60 percent since hitting a low for the year in early October, and trade around $8.60. This biopharmaceutical company, which is developing drugs for neurological and endocrine diseases and disorders, has a number of milestones coming up this year.
For readers who are new to Neurocrine, here's what to expect in the coming months...
The company has a portfolio of pipeline candidates to address endometriosis, stress-related disorders, pain, tardive dyskinesia, uterine fibroids, diabetes, and other neurological and endocrine-related diseases and disorders.
The lead product candidate of Neurocrine is Elagolix, which is being investigated for the treatment of endometriosis and uterine fibroids.
Elagolix is an oral GnRH (gonadotropin-releasing hormone) antagonist that is being developed by Neurocrine and Abbott under a deal worth $575 million signed in June 2010.
Researchers have found that chronic administration of GnRH agonists is clinically useful in treating hormone-dependent diseases such as endometriosis and uterine fibroids.
Endometriosis is a female health disorder in which the tissue that forms the lining of the uterus grows in places in the body other than the uterus, like ovaries, fallopian tubes, bladder or rectum. Some of the symptoms associated with endometriosis are chronic pelvic pain throughout the menstrual cycle, infertility, and menorrhagia.
It is estimated that there are over 170 million women worldwide and more than 7 million women in the U.S. suffering from endometriosis. Pain killers, oral contraceptives, progestins/progesterone and injectable GnRH-drugs like Decapeptyl SR, Gonapeptyl, Lucrin Depot, Prostap SR, Zoladex and Suprefact are used to treat endometriosis.
Elagolix has successfully completed phase II studies in the indication of endometriosis.
Abbott is currently pursuing a Special Protocol Assessment with the FDA to decide on the design of the pivotal phase III program for Elagolix in endometriosis. Subject to finalizing the SPA, Elagolix is expected to enter phase III trials for endometriosis in the first half of 2012.
Another indication for which Elagolix is being evaluated is uterine fibroids.
Uterine fibroids are benign tumors that are formed in the uterus, and these tumors occur in up to 50% of all women. Uterine fibroids are associated with abnormal uterine bleeding, pelvic pain and pressure on the bladder and rectum. It is estimated that about 25 million women in the U.S. suffer from uterine fibroids. Depending on the symptoms, treatment sometimes requires surgery, including the total removal of the uterus.
A phase II clinical trial to evaluate Elagolix in the treatment of uterine fibroids was started by Abbott last September. This clinical trial is a randomized, double-blind, placebo controlled study designed to enroll 300 women. The primary endpoint is an assessment of blood loss after three months of treatment with Elagolix. The trial is expected to be completed by November of 2012.
Yet another partnered clinical program of Neurocrine is 561679, a Corticotropin-Releasing Factor, or CRF, Receptor 1 antagonist, being developed in partnership with GlaxoSmithKline, for stress-related disorders.
A phase II clinical trial evaluating 561679 in women with post-traumatic stress disorder was started in late 2009 by Emory University of Atlanta and Mt. Sinai Medical Center in New York, in conjunction with GlaxoSmithKline. This study is expected to take several years to complete, according to Neurocrine.
Additionally, the National Institute on Alcohol Abuse and Alcoholism, in conjunction with GlaxoSmithKline , is planning to initiate a phase II clinical trial evaluating 561679 in stress-induced craving in alcoholic women with high anxiety. This randomized, double-blind, placebo-controlled trial is expected to enroll 50 patients for a four-week treatment period. This study is also expected to take several years to complete, according to Neurocrine.
In 2010, 561679 failed to meet the primary end point in a phase II depression study.
Neurocrine entered into a worldwide collaboration with GlaxoSmithKline to develop and commercialize CRF antagonists for psychiatric, neurological and gastrointestinal diseases in July 2001. The research portion of the collaboration was completed in 2005.
Another product candidate of Neurocrine under phase II testing is NBI-98854, a highly selective Vesicular Monoamine Transporter 2 inhibitor, for the treatment of tardive dyskinesia.
Tardive dyskinesias are involuntary movements of the tongue, lips, face, trunk, and extremities that occur after months or years of treatment with dopamine receptor antagonist therapeutics like antipsychotics for schizophrenia, bipolar disorder, and depression, and metoclopramide for nausea and vomiting and gastric emptying in patients with *gastroparesis (*a disorder in which the stomach takes too long to empty its contents).
In September 2011, Neurocrine started a phase II study to evaluate the efficacy and safety of NBI-98854 for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder. The results from this study are scheduled to be released in March , which will be used to guide the dosing selection for larger phase IIb studies in tardive dyskinesia patients that are expected to begin this year.
Urocortin 2, which is a CRF 2 peptide agonist is also a phase II product candidate, and it is being evaluated for congestive heart failure. A pilot study of Urocortin 2 in at least 50 patients with acute decompensated heart failure is currently underway. The results of this study are expected in the first quarter of 2012.
The pilot study is being conducted by Christchurch Cardioendocrine Research Group at University of Otago and Christchurch School of Medicine and Health Sciences, New Zealand through a grant from the Health Research Council of New Zealand.
The American Heart Association estimates that more than 6 million people experience congestive heart failure and about 670,000 new cases are diagnosed each year in the United States.
Neurocrine's preclinical programs include GnRH antagonists for women's and men's health indications; GPR119 agonist for type II diabetes; VMAT2 for schizophrenia; Antiepileptic drugs and G Protein-Coupled Receptors.
GnRH antagonists for women's and men's health indications, and GPR119 agonist for type II diabetes are the company's partnered preclinical programs. Neurocrine has a partnership with Abbott for developing GnRH antagonists for women's and men's health indications while GPR119 agonist is being developed in partnership with Boehringer Ingelheim International GmBH.
The company has also tried its hand in developing a drug for insomnia. However, after two failed attempts to win FDA approval for the drug candidate -Indiplon, in 2006 and 2007, the company ceased all clinical development activities in the U.S. related to that investigational drug.
A quick look into the company's balance sheet...
Since its inception in 1992, the company has incurred significant net losses and, as of December 31, 2011, had an accumulated deficit of $724.7 million. For the year ended December 31, 2011, the company reported a profit of $37.57 million or $0.67 per share, reversing a year-ago loss of $7.97 million or $0.15 per share.
The company has no marketed drugs and, consequently, has not generated revenues from the sale of product. Revenue is generated from collaborative research and development arrangements, milestones and license fees. In 2011, the company's total revenues were $77.4 million , up from $33.5 million in 2010.
Neurocrine went public in May 1996 pricing its shares at $10.50 each. The stock has thus far hit a 52-week low of $5.42 and a 52-week high of $9.98.
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