XenoPort Inc. (XNPT)
Q4 2008 Earnings Call Transcript
February 12, 2009; 5:00 pm ET
Ron Barrett - Chief Executive Officer
Bill Harris - Senior Vice President of Finance and Chief Financial Officer
Bill Rieflin - President
Jackie Cossmon - Investor Relations
Michael Aberman - Credit Suisse
David Amsellem - Piper Jaffray
Michael Yee - RBC Capital Markets
Gene Mack - Lazard Capital Markets
Rachel McMinn - Cowen
Davis Bu - Goldman Sachs
Steve Harr - Morgan Stanley
Yale Jen - Maxim Group
Juan Sanchez - Ladenburg
Boris Peaker - Rodman & Renshaw
Previous Statements by XNPT
» XenoPort, Inc. Q2 2009 Earnings Call Transcript
» XenoPort, Inc., Q1 2009 Earnings Call Transcript.
» XenoPort, Inc. Q3 2008 Earnings Call Transcript
I would now like to turn the call over to Ms. Jackie Cossmon. Ma’am, you may begin your conference.
Thank you, Kayla. Good afternoon and thank you for joining us on the call. Here with me today are Ron Barrett, our Chief Executive Officer; Bill Rieflin, our President; and Bill Harris, our Senior Vice President of Finance and Chief Financial Officer.
Before we begin our discussion of today’s news, I would like to note that the information to be discussed on this conference call and webcast, including answers to questions asked during this call will include forward-looking statements that involve risks and uncertainties, including statements related to our current and future clinical development programs and clinical trials and the timing thereof, our partners, clinical development plans, the release of additional clinical trial data, the regulatory process and the timing thereof, milestone payments and the timing thereof and the commercial potential for our product candidates. XenoPort can give no assurance with respect to these statements and we assume no obligation to update them.
For a detailed information about the risks and uncertainties that could cause actual results to differ materially from those implied by or anticipated in these forward-looking statements, please refer to the risk factors section of our most recent SEC filings, including our discussion of the inherent risks of clinical trials. This webcast is a copyright of XenoPort.
At this time I would like to turn the presentation over to Ron.
Thank you, Jackie. Thank you all for joining us on today’s call. I will be speaking today about our clinical development programs and then Bill Harris will spend a few moments discussing our financial results for the fourth quarter and other financial matters. We will then take your questions.
Our press release earlier today outlined progress in several areas of our business, but I’d like to take a few moments to highlight a couple of particularly significant events, including the 279 results released today. First, we are very pleased that GSK has re-filed the NDA for Solzira for the treatment of moderate to severe primarily RLS. We expect the initial action date for the Solzira NDA to be near the end of this year.
In the fourth quarter of 2008, GSK initiated another clinical trial of Solzira, a Phase 3B polysonography trial in RLS patients, the purpose of which is to provide additional evidence of the sleep benefits of Solzira. This is the fifth trial of Solzira that GSK has initiated in the last year, all of which are being funded entirely by GSK. We are pleased by the substantial resources that GSK is putting behind Solzira’s development and we look forward to the results from the three neuropathic pain trials later this year.
Astellas, our partner in Japan and other Asian countries is also making progress in developing 512. Astellas announced that it completed enrollment in a Phase 2 trial of 512 in RLS patients in Japan and we anticipate the results of this trial will be available later this year. Another important event for us in the fourth quarter was the completion of our Phase 2 multidose GERD clinical trial of 986.
We have now examined in depth the data from this study and we remain encouraged by the tolerability and efficacy of 986 in the PPI experienced population. We intend to report the more detailed results from this clinical trial and medical conference later this year.
We’ve also been moving forward on the design of the next Phase 2 clinical trial of 986, which will evaluate 986 or placebo taken along with a PPI in GERD patients who our incomplete responders to PPI therapy. We intend to initiate this trial in the second half of this year after we have completed our concentration with experts and with the FDA.
We are pleased to report today that we have completed enrollment of the Phase 2 trial of 986 in spinal cord injury patients experience spasticity. We expect to announce the top-line results of this trail by midyear. In December, we initiated a phase 2 safety and pharmacokinetics trials 986 for the treatment of acute back spasms of neuromuscular origin and we expect the results of this trial by the end of the year. The results of these trials will be an important factor determining the development path for 986 beyond GERD.
Finally we are pleased to announce today encouraging results from a Phase 1 clinical trial of two new formulations of 279. In this single-dose trial that compared 279 to Sinemet, both formulation of 279 produced a more sustained exposure of L-Dopa and we’re well tolerated.
The formulations demonstrated improved by availability compared to original prototype formulation of 279 and had bioavailability equivalent to that of Sinemet. The new formulations also have advantages over the prototype formulation in terms of manufacturability, shelf life and pill size. The observed single-dose PK properties of the new formulations are anticipated to translate into reduced peak to tough ratio of L-Dopa compared to Sinemet when dosed multiple times day.