XenoPort, Inc. (XNPT)
Citi 2013 Global Healthcare Conference Call
February 27, 2013 9:35 am ET
Ronald W. Barrett – Chief Executive Officer
XenoPort and from XenoPort we have Dr. Ronald Barrett, the Chief Executive Officer. Ronald.
Ronald W. Barrett
Previous Statements by XNPT
» XenoPort's CEO Presents at Credit Suisse 2012 Healthcare Conference (Transcript)
» XenoPort's CEO Discusses Q3 2012 Results - Earnings Call Transcript
» XenoPort's CEO Hosts XenoPort XP23829 Clinical Trial Results Call (Transcript)
» XenoPort's CEO Presents at Morgan Stanley Global Healthcare Conference (Transcript)
I am going to start by giving a high-level overview of XenoPort. The company was founded in the beginning of 2000 and today it’s a very different company than it was in the years passed with the return of the commercial rights of our lead product Horizant. We are very transitioning and building a commercial company with a set of neurology assets that we are very excited about, our commercial product gabapentin enacarbil, the trade name is Horizant in the U.S. is approved for the treatment of moderate-to-severe primary restless legs syndrome and also for the management of postherpetic neuralgia in adults.
In Japan, trade name is Regnite where it is approved for the treatment of restless legs syndrome and we have a partnership with Astellas for commercialization of Regnite in Japan and five other Asian countries. In addition to that commercial product, we have a very robust pipeline of assets that are primarily in the neurology area, including our arbaclofen placarbil in which we are currently conducting a Phase III specificity study, we expect the results in the second quarter and assuming positive results there we’ll be filing an NDA by year-end.
279 is an L-Dopa drug for the treatment of advanced Parkinson’s disease and that has completed Phase II. And then earlier I said 829 which is a fumaric acid ester compound is in Phase I and multiple indications we’re considering for that indication.
Before I talk about these opportunities individually, I’m going to make a couple of points about the value of these assets. First of all, they are being developed and they are intended to have differentiated profile. In the case of gabapentin enacarbil, we have very unique pharmacokinetics that we think that leads to the benefit of the product and we’re the only non-dopaminergic agent approved for the treatment of restless legs syndrome. For AP, we have the potential for extended duration of efficacy and low side effects for 279, reduced off time compared to L-Dopa and for 829, the opportunity for improved efficacy, tolerability as well as development new indication.
Another distinguishing feature of the asset for the company is the fact that we have novel chemical compositions and so we have issued composition of maritime that have long lives with expires into 2022 to 2029, timeframe is illustrated in the slide. All of these times we would expect to apply for patent illustration leading to extension of exclusivity beyond the current exploration data. And importantly now with the return of the right to Horizant to XenoPort we own all of the rights for all of these assets excluding the Astellas rights in Japan and five other Asian countries.
Now a very big event for us occurred at the end of last year which is in the return of the rights to our most advanced product Horizant in the United States. Starting May 1, we are going to be taking over that, all development, manufacturing and commercialization of Horizant. We had partnered this program with GSK in 2007, the partnership ended in November of last year. The transition from that November date to May 1 in which GSK will continue to commercialize the product, they’ve already transferred the NDA to XenoPort. During that transition period, we are not responsible for losses under the previous joint P&L.
GSK is funding existing ongoing clinical trial looking at our low dose, but finished that at their extent. And also as part of the deal, they provided us with a very large inventory of API, which we will be paying small payments in the future for but this will supply our needs for many years to come.
In addition, GSK purchased $40 million of XenoPort shares as part of the negotiated and termination of the agreement. So how has Horizant done well? One of the reasons why the relationship ended was that we were disappointed with GSK’s performance under the contract. They launched Horizant in July 2011. We expect syndrome and in July 2012 for the management of PHN, currently there are approximately 5,000 prescriptions per month in the U.S. with 60% of those prescriptions being generated by specialists and majority of that being from the neurologist.
The use of Horizant currently is highly concentrated with about 80% of prescriptions coming from approximately 2000 physicians, and 70% of the prescriptions are through commercial clients. The managed care access was little to narrow contracting done but despite that the access is not bad. The commercial lies about 65% of insured lives and unrestricted Tier II or Tier III with by far the majority of that being in Tier III position.
Access to Medicare Part B is limited and an opportunity for us to improve access through contracting. The RLS market has not changed substantially from when we initiated the development of this content, or about five million adults in the U.S. who suffer from moderate to severe RLS. Nearly 60% of those sufferers are aware of the condition that they haven’t received a prescription. That is an opportunity for increased use of therapy in this population. So that 6 million prescriptions for RLS agents in the United States annually with dopamine agonist pramipexole and ropinirole representing 80% to 85% of those prescriptions.