- please do not ask epipen questions, we are not in a position to comment
- expect Watson gelnique launch 1h-2012...our royalties will be based on our product and the sales of already marketed gelnique 10%
- HgH sales reached a record in 4q-2011. Elestrin is showing month over month growth
- MTX NDA will be filed in next 12 months, EU filing in 2013. Plan to commercialize in US in 2014, seek EU partner
- IND by year-end 2012 for next product, details later this year [testosterone]
- PFE branded drug did ~$500m in 2011 sales. Pfizer bears full cost for clinical development, etc
- Epi-pen patent trial ended last week, don't know when ruling will occur. They have as much time as they need, so we would just be guessing.
- 2012: revenue growing in the 30-50% range without new injector launches or other business development
will you be booking WPI royalties in arrears? yes
MTX program update, including plans for Europe? methotraxate studies progressing well, on track to complete this year and expect data to be announced 4q-2012. We have met w/ regulatory agency, know what we need to do. if anything, FDA program is more comprehensive than what is needed for europe. We are hoping to sign up a partner to commercialize that in next couple years over there. We are ramping up R&D...external MTX costs at least $6m in 2012 (>20% increase in costs over 2011...all in r&d line)
We expect increasing royalties for HGH (mostly from teva, plus device sales. also some growth from ferring, perhaps additional indication in US) and from Watson overactive bladder gel launch.
Unlike other launches, our gelnique is not starting at zero, gelnique was doing well in excess of $30m in sales last we looked and growing nicely.
Increased activity in Teva programs also drives increased development revenue. Late in 2011 teva started developing for europe as well.
MTX user and usabiity studies are ongoing. We have to do a lot of CMC work, that is on track. FDA required us to produce additional strengths of product, we're working on those (prescriptions vary from 7.3-30 mg doses, we had gone in w/ 5 mg dose increments, but after discsisons w/ FDA and rheumatologists, we learned that we needed 2.5 mg increments, but this isn't a rate-limiting step...everything is on a parallel track)
gelnique 3% and 10%, WPI has a strategy (didn't specify). Expect launch around April/May 2012 timeframe, coinciding with AUA society meeting. Our version is in pump, theirs is in sachet. Watson plans to maintain both until they see if ours takes market share. Ours has lower conc but higher blood level- efficacy with less side effects (this is not really actually true if you look at the data)