This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Neurocrine Biosciences' Management Presents At Morgan Stanley Global Healthcare Conference - Transcript

So with that …

Unidentified Analyst

Great. Thanks for the overview. So maybe we can start with Elagolix and endometriosis.

Kevin C. Gorman


Unidentified Analyst

The first Phase 3 you just started a few months back, can you walk us through the Phase 3 design and how that compares with your Phase 2 Daisy PETAL child?

Kevin C. Gorman

Sure. Just as a background, prior to partnering with Abbott we had treated well over a 1,000 women with Elagolix, about 700 of them for up to six months, continuous treatment with Elagolix. And what Elagolix does is it’s a GnRH antagonist, it’s a small molecule orally active and it does definitely lowers Estradiol levels in women. Estradiol is the main growth factor in – for endometrial tissue. Its in endometriosis, the endometrial tissue moves outside the uterus causes adhesions throughout the body, causes bleeding, causes pain by lowering Estradiol levels we found a range of Estradiol levels in which the pain of endometriosis, the main problem is ameliorated or completely eliminated. And yes, there is enough Estradiol circulating such if you still have good bone health.

The Daisy PETAL study was our last Phase 2b study that we had done in the program. And that study was done in order to validate the primary end points have now gone into the Phase 3 program. And these were end points that we had validated in conjunction with the FDA, working very closely with them over several years.

So, the design of the Phase 3 study is actually extremely similar to the design of that last Phase 2b study. In that the patients are treated six months continuously with Elagolix. The primary end point is actually taken at month three and the primary end points are two that both [toxicity] independently hit. One is Dysmenorrhea, which is pelvic pain during menstruation and the second is Non-menstrual Pelvic Pain. Both of those end points have to be hit independently. And then they can – and as I said that is at month three. So it’s comparing their baseline scores on Dysmenorrhea and Non-menstrual Pelvic Pain versus month three scores on both of those.

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $92.55 -0.74%
FB $119.25 1.20%
GOOG $711.65 1.50%
YHOO $37.28 0.92%
TSLA $214.75 1.50%


Chart of I:DJI
DOW 17,718.62 +57.91 0.33%
S&P 500 2,056.05 +5.42 0.26%
NASDAQ 4,729.6070 +12.5130 0.27%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs