Teva Pharmaceutical Industries' Management Presents At Citi Global Health Care Conference (Transcript)

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

We will get started. Our next session will be Teva Pharmaceuticals. We have the great pleasure of introducing Lesley Russell, seated on my left. She is a hematologist, oncologist with over 19 years of international pharmaceutical industry experience in leadership in the therapeutic areas of hematology, oncology, neurology, psychiatry, pain and inflammation, respiratory medicines, cardiovascular medicines, and stem cell therapies, all important areas within Teva’s branded focus going forward. And to Lesley’s immediate left, everyone knows Kevin, Kevin Mannix also from Teva.

So, Teva has obviously been able to expand its critical mass, it now has an R&D about 1.5 billion in R&D. It seems as though a good chunk or a large portion of that or about $1 billion is certainly allocated towards the branded portfolio.

Can you maybe help walk us through from a prioritization standpoint some of those products that both Teva and Cephalon has in terms of what those priorities are that might be on that A list, B list or C list going forward?

Lesley Russell

So, what we did after the acquisition in October last year was to really bring the two portfolios together, and as you said, rank them in terms of priorities in terms of what should absolutely get from this, what should absolutely not get from this, those two are the kind of easy ones to do and then that sort of group that fell in between, which we call B, that had some clinical data that suggested potential utility, but probably really far and long and up in [ph] clinical development to know how successful they were going to be. I think in terms of the A list, it was really the late stage assets, so anything in either portfolio that was in currently in Phase III development, we clearly decided to continue. And then some of those cases of the programs nearing fruition and hopefully data become available in the very near future. Those in particular are from the Cephalon side of the acquisition, Nuvigil for bipolar depression, our tamper-deterrent hydrocodone. Both of those have data coming up in the very near future. Nuvigil shortly in the second quarter for the first study and then about a quarter late for the second study. With hopefully, both of those things successful, then an NDA, a supplemental NDA application going in about three months thereafter.

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 Analyst

On 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

If you liked this article you might like

Novartis May Sell U.S. Generic Pill Business Amid Industry Struggles

Novartis May Sell U.S. Generic Pill Business Amid Industry Struggles

Five-Day Winning Streak in Stocks Expected to Continue

Five-Day Winning Streak in Stocks Expected to Continue

Dow Jumps Over 300 Points, Posting Its Fifth Straight Day of Gains

Dow Jumps Over 300 Points, Posting Its Fifth Straight Day of Gains

Stock Markets Around the World Are Soaring Again

Stock Markets Around the World Are Soaring Again

Jim Cramer: The SEC Should Admit It Goofed With These Crazy Instruments

Jim Cramer: The SEC Should Admit It Goofed With These Crazy Instruments