XenoPort, Inc. (XNPT)
Q2 2009 Earnings Call Transcript
August 5, 2009 5:00 pm ET
Jackie Cossmon – IR
Ron Barrett – CEO
Bill Harris – SVP, Finance and CFO
Bill Rieflin – President
Eric Schmidt – Cowen and Company
David Amsellem – Piper Jaffray
Michael Yee – RBC Capital Markets
Lucy Lu – Citi
Raghuram Selvaraju – Hapoalim Securities
Yale Jen – Maxim Group
Michael Aberman – Credit Suisse
Previous Statements by XNPT
» XenoPort, Inc., Q1 2009 Earnings Call Transcript.
» XenoPort Inc. Q4 2008 Earnings Call Transcript
» XenoPort, Inc. Q3 2008 Earnings Call Transcript
Thank you, Ellie. 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, our partners’ clinical development plans, the release of additional clinical trial data and the timing thereof, the regulatory process 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 will turn the presentation over to Ron.
Thank you, Jackie. And thank you all for joining us on the call today. I’ll be reviewing our progress during the quarter, then I’ll turn the call over to Bill Harris, who will be providing the summary of our financial results. We will then take your questions. As outlined in the press release, Q2 was a busy quarter for XenoPort, as we continued to meet our development and business objectives.
The most recent announcement that Astellas will employ a bridging strategy for filing the 512 NDA for RLS in Japan is particularly noteworthy and that it may accelerate the approval for 512 for RLS in Japan. Japan is the world’s second largest pharmaceutical market, and I’ll remind you that there are no approved drugs for RLS in Japan and we will receive a mid-teen royalty on Astellas sales of 512 if it is approved. We are working with our Astellas colleagues to file the NDA in Japan by the end of March of 2010.
We also continue to work with GSK and the FDA on the 512 RLS NDA. While I won’t discuss the interactions with the FDA, we continue to believe that our NDA is complete and provides strong evidence of the safety and efficacy of 512 for treating moderate to severe primary RLS.
We announced today that we completed in Q2 the one year open-label study of 512 in RLS patients. This study allowed patients from a number of placebo-controlled trials to roll over into one year extension study. The study had a target dose of 1,200 milligrams per day that allowed 600 milligrams or 1,800 milligrams per day based on efficacy and tolerability experienced by the subject. 512 is generally well tolerated. 11% of subjects withdrew due to adverse events. And most common adverse events were somnolence and dizziness. We plan to present the full results of this study at medical conferences of the future.
Turning now to arbaclofen placarbil, or AP, we also made some significant progress this past quarter. An important milestone is the successful completion of a human cardiovascular safety study or thorough QTc prolongation study. There is no evidence of QTc prolongation after repeated doses of up to 180 milligrams per day, 90 milligrams BID. The positive control of moxifloxacin provided the necessary evidence of assay sensitivity. This was an important milestone to achieve prior to initiation of large clinical trials in GERD were other potential indications.
At the DDW meeting in June, we presented a more complete set of data from the Phase 2 monotherapy GERD trial. The presentation provided additional evidence, including a new data on complete relief of heartburn and regurgitation symptoms, suggesting that AP maybe an important new potential treatment for GERD patients who remain symptomatic to despite PPI therapy.
This past quarter we also met with the FDA to discuss our GERD development program. We believe it was a productive meeting. Importantly, there was clear recognition of the unmet medical needs of GERD patients and an agreement in principle on how to approach development of a new therapy for patients with incomplete response to PPI. For competitive reasons, we are not going to describe all that we learned in the meeting and the specific FDA responses to our proposals.
Although one outcome of the meeting is that we have modified the protocol for our upcoming Phase 2b adjunctive therapy trial, in a way that increased the total cost of the trial. We are on track to initiate this trial later in the year, and this trial will include AP added to PPI in subjects with any complete response.