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Post# of 253588
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Alias Born 10/05/2005

Re: None

Friday, 12/09/2005 10:26:05 PM

Friday, December 09, 2005 10:26:05 PM

Post# of 253588
XNPT

This is not a RMF. Yet.

After evaluating and rejecting several candidates for a recently opened position in my portfolio, I think I may have found a winner.

XNPT currently has three drug candidates. All three are identical to currently available agents, with the addition of a moiety that improves intestinal absorption.

1) XP13512 is a prodrug of gabapentin with completed phase II clinical trials for restless legs syndrome and neuropathic pain. In neuropathic pain, it has several advantages over gabapentin and/or its newer cousin pregabalin, including reduced dosing frequency in neuropathic pain (BID vs TID), predictable and higher exposure (gabapentin has saturable absorption), ability to maintain drug levels during the night, and efficacy in gabapentin non-responders. In RLS, XP13512 may have advantages over Requip in terms of efficacy, tolerability, titration, sleep improvement, and several other domains.

A phase III study of XP13512 will be initiated in the first half of 2006. It is partnered with Astellas in Japan and several other Asian countries; under the agreement Xenoport will receive a payment of $25 million plus milestone payments of $10 million at initiation and $5 million at completion of the US Phase 3 clinical trial in RLS patients plus mid-teens royalties on sales.

2) XP19986 is a prodrug of baclofen targeting the GERD market. In preclinical studies it was shown to be well-absorbed, and rapidly converted to R-baclofen. In an ongoing phase I trial, XP19986 was found suitable for BID dosing and was well tolerated.

3) XP21279 is a prodrug of L-Dopa in preclinical studies

4) A prodrug of propofol is in early development for migraine and nausea

Milestones by mid-2006 include
1) Initiating a Phase 3 study in RLS
2) Phase 2a results in GERD
3) Partnership for either XP13512 or XP19986

Market cap is currently $330 million. Anyone have any opinions as to whether XNPT represents a biotech value? I like the strategy of improving currently available agents; seems to be somewhat lower risk than pursuing novel drug candidates.

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