This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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
TheStreet Open House

XenoPort's CEO Presents At Morgan Stanley Healthcare Conference (Transcript)

Stocks in this article: XNPT

Regnite launched in July this year, in Japan. We are very excited to see the Astellas' efforts in launching that product, its 1,200 sales reps; they are making a big effort. They estimate about $2 million moderate-to-severe primary RLS patients in Japan, so we'll get our first indication of the sales for the third quarter in the fourth quarter when Astellas presents their financial results. We have a high-teen royalty from sales of the product in Japan.

As you know launches in Japan, the prescriptions are limited to 14 days. People have to come back every 14 days in the first year of the launch, so it may take off little slowly, but Astellas has been a great partner for us so far there.

Next, for this long is arbaclofen placarbil or AP. We have an upcoming big event, the completion of our Phase III study for the treatment of spasticity and multiple sclerosis patients. We anticipate the results of that study in the first quarter of next year. We hope to file an NDA for that product in the second half of next year using a 505(b)(2) process that we have agreed to with the FDA and we do have an SPA for that Phase III study.

Next furthers along is 279, and L-Dopa, prodrug for the treatment of advanced Parkinson's disease. We had some interesting feedback from the FDA in June of this year, where they agreed to a 505(b)(2) path gave us very specific guidance on what a pivotal study has to look like and we are taking some efforts to get an SPA and to do some work in preparation for Phase III, but we won't proceed with Phase III until we have a partner or a financial resources change.

Finally, I think what has lot of investors excited as well as ourselves is an earlier stage product that started human studies recently and it is a fumarate-based product that we are potentially developing for the treatment of relapsing-remitting MS, and potentially psoriasis and it shares in common an active metabolite monomethyl fumarate, which is the same active metabolite that's found with the Biogen product BG-12 and the psoriasis product Fumaderm in Germany, and Phase I study the in-life phase has been completed and we expect the results of that study in October of this year.

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,191.37 -195.84 -1.13%
S&P 500 2,002.16 -27.39 -1.35%
NASDAQ 4,637.9940 -43.5030 -0.93%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs