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Biotech / Medical : Biotechnology Value Fund, L.P. -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (4542)	12/17/2005 3:56:49 AM
From: mopgcw	Respond to of 4974

cgtk, as of the november filing, bvf still owned a chunk but dont know in the meantime.

To: rkrw who wrote (4542)	12/26/2006 2:56:23 PM
From: tuck	Read Replies (1) \| Respond to of 4974

Starting to look at this one. Burn less of an issue now that they've financed near lows ;>) Company suggests twice the opportunity in peds, but we'll use your estimate. Your concern about the device is valid, but if the kid is told it'll hurt less than a needle, not at all (and I presume the kid would be told that), that should help. The "several areas anesthetized (don't always know which spot will work)" issue . . . nurse puts on tourniquet, veins pop up, one is chosen, tourniquet taken off, LA of choice administered. With cream, two reasons for failure on first try. One, sometimes there is vasoconstriction with LAs -- including cream. Two, given onset of action of at least ten minutes and perhaps an hour for various LA formulations, the vein has that much longer to disappear. Not sure how much bigger the area covered by the cream/patch is versus the area into which Zingo is "injected," but I'd guess the nurse will be lucky to find another one in the treated area, and would have to start over. At best, assuming success on first try with cream, that's still two patient interactions. Anesiva claims one minute onset of action and no vasoconstriction at the site. The whole procedure from LA to IV start can be done in one interaction in a few minutes. I'd think that would be a real world selling point to nurses and docs. Notes from a listen to their Lazard webcast, still archived on the company website . . . investors.anesiva.com Zingo competitors: Endo's Synera and Astra Zeneca's EMLA, whose onset of action is 30 - 60 minutes versus 1 minute for Zingo. Two or more patient interactions versus Zingo's one interaction. Compressed air topical delivery is painless. Efficacy is comparable. FDA decision in 4q07 based on typical 10 month review clock in the analgesia division. Clinical guidelines require topical anesthetics for peds, hence the choice to go there first. Outpatient settings in partnership discussion for commercialization due to need for large sales force. Market opportunity 50 - 100 million for peds with 35- 40 reps. Adults ER 100 million with 35 - 40 reps. 1200 more (those that aren't Childrens' hospitals?); also need a partner to reach. COGS $2.50 at commercial scale, estimated price $12 - $16. Total market (unpartnered) opportunity in current indications/settings about 200 million. Also ex- US rights still to be partnered, I believe in all indications/settings. Presurgery settings being explored. There are plenty of other markets to go after. The market opportunity for partnered indications/settings wasn't estimated, but it would be way larger than the $150 million that the company would go after by itself near-term in peds and adult IV starts. Check out the slides for more detail. NDA filed for peds. Adult "IV start" PIII begins shortly. 4975 meeting with FDA; several paths to approval. Non-opiod, so no addictive side-effects, no COX-2 issues. Agonist of TRPV1 receptor (TRPV1 (transient receptor potential cation channel, subfamily V, member 1; may compete with NRGN, and others). 4975 targets receptors only responsible for non-acute pain, those expressed on C neurons. Will stay away from complex, large nerves like spinal. PI in 1207 data to be reported shortly. Started in October, 24 healthy volunteers, enrolling well. Six dose cohorts (.25%, .5% 1%, 2.5%, 5%, & 10% in 25cm^2 area). Single center trial. Measurement of sensory and warmth perception as well as usual safety and duration of action measures. Double blind, placebo controlled. "Not doing much" with eczema drug. I presume they'd outlicense this if they can, but it doesn't sound as if they are trying very hard, because that was the only mention of it. Assign zero value to that, and take an outlicensing as a pleasant surprise if it happens. Price is definitely cheaper than last year. Anyone want to look, or contest my thinking re Zingo? Regarding your comment about having to be put under for 4975 administration . . . good dig (actually, where did you find that; got a link?). The company doesn't make that info easy to find. But for most of the procedures targeted, isn't the patient going to be under, anyhow? So couldn't it be administered while the patient is still under, thus not making that aspect too much of a problem? Cheers, Tuck