Teva Pharmaceutical Industries Limited (TEVA) Citi Global Health Care Conference February 27, 2012, 14:00 p.m. ET Executives Lesley Russell - SVP, R&D Global Branded Products Kevin Mannix - IR Presentation Unidentified Analyst
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For the hydrocodone program, the safety and efficacy study is completed. We have yet to unblind the data. There has been some to-ing and fro-ing with the agency around statistical analyses. And we just wanted to make sure we cleared them up before we proceeded with unblinding. And then we are in the middle of undertaking a liking study and hopefully if the data were positive we would get some wording around liking and preference in the product label. Again that program heading for an NDA around the October timeframe.We also have a number of the respiratory programs, these ones came from the Teva side. We have dry powder nasal spray, beclomethasone spray for allergic rhinitis. We have a PDUFA action date on the end of March. So, hopefully, an approval, a new product coming onto the market shortly thereafter. And then the other programs and I’m probably missing a few now, because either are about to enter Phase III or currently in Phase III, in early stages of Phase III and clearly we decided to continue those. Unidentified Analyst So, maybe we can touch on the Nuvigil opportunity especially in light of the clinicals coming available on the bipolar indication, Provigil currently enjoys some use in that area, possibly largely off-label. Is there enough – do you believe within the clinical development of Nuvigil that there will be enough within the label to differentiate at least on the bipolar side, the product from Provigil? Lesley Russell I think it will have the advantage of having had a formal and rigorous clinical trial testing which there has been lots of small amounts of work done with Provigil but never any formal registration program done with a view to getting an indication. The other part about Nuvigil versus Provigil is the dosing is different, so there is not an automatic 200 of Provigil equals 200 of Nuvigil, because Nuvigil is single enantiomer, and the longer-lasting half life of the racemic mixture, the doses aren't equipotent in terms of dosing. So, it's not going to be, I never say never, but it’s going to be more difficult to automatically -- you can’t automatically substitute it. It will require extra work that way to substitute one for the other.
Unidentified AnalystOn the tamper-deterrent hydrocodone, certainly with some of the guidelines that have been drafted by the FDA about trying to eliminate the use of acetaminophen, how do you see this product positioning if you look at the number of units for hydrocodone and its use, whether it’s Vicodin or Vicodin generic, a lot of product is used there in pain management. How do you think about this asset and it's positioning? Lesley Russell So, this would be a pure hydrocodone product and it would be a long acting one. So, this would be a product that’s administered twice a day. The current hydrocodone products available on the market all have either acetaminophen or ibuprofen, or something linked with them and they’re all immediate release products, so they are used as rescue meds or for short-term acute pain control. This would be for chronic use. It certainly gets away from the potential liver toxicity issues of acetaminophen and certainly the concern around overdosing on these products that contain acetaminophen. And the other aspect of hydrocodone is that it has some tamper deterrent characteristics in it. So not foolproof, we will be the first to say that it's not foolproof, but certainly some tamper deterrent characteristics, that go some way to addressing some of the real public health issues around abuse and misuse of opioids. Read the rest of this transcript for free on seekingalpha.com