Despite Promising AbbVie Partnerships, Neurocrine Biosciences Halts Two Clinical Trials

Despite Promising AbbVie Partnerships, Neurocrine Biosciences Halts Two Clinical Trials
June 9, 2015
By Mark Terry, Breaking News Staff

Neurocrine Biosciences, Inc. , headquartered in San Diego, announced yesterday that it had halted two planned clinical trials that had been evaluating Neurocrine’s CRF antagonist NBI-77860 for the treatment of classic congenital adrenal hyperplasia.

After informing the U.S. Food and Drug Administration (FDA) of some concerns related to preclinical findings in animal studies, the FDA placed the NBI-77860 development program on a partial clinical hold.

Seven analysts have rated the company’s stock as “Buy” and two rated it as “Strong Buy.”

The company stock has been on an increase over the last year. It sold for $12.78 on July 17, 2014 with a high of $44.25 on May 19, 2015. It is currently selling for $43.03. Prior to yesterday’s announcement it was selling for $42.25.

Despite the recent halt, the company seems to have a strong pipeline. It has partnered with AbbVie for elagolix, which is in a Phase III clinical trial for endometriosis and a Phase II trial for uterine fibroids. It is also conducting pre-clinical work for a GnRH Antagonist with Abbvie for a range of health issues. It also has NBI-98854, which is in a Phase III clinical trial for tardive dyskinesia and in a Phase I trial for Tourette Syndrome.

Six of the company’s programs are in clinical development, with another five in various research and development stages. In addition to the women’s market, it has programs focused on diabetes, stress-related disorders, pain and insomnia.

Analysts appear hopeful for the company’s products in the women’s market, specifically for treating endometriosis and uterine fibroids. If the drugs are approved for those diseases, they could create more than $1 billion in sales each.

While endometriosis and uterine fibroids are not life-threatening, they can be unpleasant and life-limiting. AbbVie and Neurocrine estimate there are about 300,000 new diagnoses each year for endometriosis and about 450,000 annually of uterine fibroids. They would not necessarily be severe enough to be candidates for elagolix, but there are more than 100,000 hysterectomies annually connected to endometriosis and more than 200,000 related to uterine fibroids. AbbVie has a related medication on the market, Lupron, which is used to control symptoms.

It’s not yet clear how much of a hit the company will take with the halted NBI-77860 studies. “Out of an abundance of caution, we halted the implementation of these studies and notified the FDA of certain recent preclinical findings that we had not observed in previous animal studies,” said Chris O’Brien, Neurocrine chief medical officer in a statement. “We intend to work closely with the FDA to elucidate these findings and determine the next steps for NBI-77860 in congenital adrenal hyperplasia.”

When Will Pfizer's Breakup Happen?
Speculation that the revamping of Pfizer Inc. ’s internal business structure could happen as soon as this year has biotech wondering just when this Big Pharma company could see changes.

Last week an analyst with J.P. Morgan said he thinks there will be a much faster timeline than most of Wall Street had predicted for Pfizer’s stated mission to refocus its efforts on new medicines.

Pfizer initially announced in 2012 that it would be shedding units that were non-essential to that goal. It then promptly sold its nutrition silo to Nestle for $11.85 billion, which was rapidly accompanied by a public spin-off of its animal health business for $2.2 billion.

“While a Pfizer break-up would likely be a 2017 event, we see potential catalysts in 2015-2016," said Chris Schott, an analyst at J.P. Morgan. "Three years of audited financial statements (2014-2016) are required before any part of Pfizer can be spun off, and we also see 2017 as an attractive time for action as investors see Pfizer’s innovative pipeline clearly contributing to growth and the established business having transitioned to a more stable profile."

BioSpace wants to know what you think: Will Pfizer be a changed company by the end of 2015?

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