XenoPort, Inc. (XNPT)

Morgan Stanley Healthcare Conference

September 11, 2012 03:00 pm ET


Ron Barrett - Chief Executive Officer and Director


David Friedman - Morgan Stanley


David Friedman - Morgan Stanley

All right, so I think we'll get started. Thanks everyone for joining us and I'm David Friedman, Biotech Analyst here. In terms of our disclosure statement, you can find research disclosures at morganstanley.com/researchdisclosures, and I am joined by Ron Barrett here, CEO of XenoPort, and one of the best performing stocks in all of small and midcap biotech this year, so a lot going on and I would to go into it, so maybe if you can just a one or two-minute overview of the company, and then we can just jump right into the program.

Ron Barrett

Sure. Thanks for the invitation to speak today and I am going to be making forward-looking statements and you should consult SEC documents with information with regard to risks and uncertainties of our business.

XenoPort, it's a very interesting time for the company. We have a series of products and product candidates that are in different stages and walk through them one at a time. Our gabapentin enacarbil is an approved product in the U.S. and Japan, and Horizant is the trade name in the U.S. and Regnite in Japan.

It's approved for the treatment of moderate-to-severe primary RLS in the U.S. and Japan, and also for postherpetic neuralgia in the U.S. we are partnered with GSK in the U.S. and Astellas in Japan, and I would say that I really don't have an update on Horizant's. It launched last July. The sales have been blockbuster and it's been very frustrating for us as a company, and as you undoubtedly know we are in litigations with GSK, I don't really have any update on the litigation today.

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.

Question-and-Answer Session

David Friedman - Morgan Stanley

Maybe we can start quickly with AP, the spasticity drug. You guys had positive Phase II data there and a slightly different population, so for people that may or may not have been following along with this program, can you just briefly describe what types of data you are looking to generate out of the Phase III program, and whether you see a lot of risk going from spinal cord injury to MS, or is spasticity given the underlying pathology.

Ron Barrett

I think most experts in the field would say that spasticity response to treatment independent of the original [neurology] of the spasticity, whether it's spinal cord, whether it's MS stroke or traumatic brain injury, and there are differences in the patient population, the spinal cord injury population, typically that's had spasticity for longer.

Multiple sclerosis patients obviously lot of things going with their disease progression, and it's the reason why we really took pretty stringent requirements of patient selection that's taken us while to recruit the right patients. We're requiring certain minimal level of spasticity, minimal level of disability and a maximum level of disability. We are looking at the spasticity to measurement of what's called the Ashworth Score.

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