- Anturol: "own that product right now"...still waiting for FDA to accept NDA for review
- Comfortably more than 1 yr cash on hand
- ATD gel formulation contains proprietary permeation enhancers
- First TEVA Pen product ANDA expected to be filed 1h2011 "about this time next year" (this has slipped gradually over last several webcasts, had said 2011 previously)
- 2nd pen product is a "classical biosimilar" to file via 505b2 pathway
- Patient demand for at-home injection is driving growth of parenteral market more so that organic growth or patent expirations
- Pts report no pain on injection with Vibex prodoct
- 2 Vibex products together represent ~$400-500m market
- 2 Pen products together represent $1.5b mkt
- Methotrexate (MTX) trial is enrolling ahead of schedule
- MTX product removes variable absorption of oral products, can titrate a higher dose that oral, improved tolerability, some reports of better efficacy
- Current injectable MTX is an IM injection at Dr's office- could cover the concentrated prescriber base with 25-30 sales reps
- Vibex product perfrorms injection in 0.5-1 sec, pt hold device against skin for 3 seconds
- Overactive Bladder (OAB) market include 16% of mature western populations- 90% of pts are women
- Many OAB competitors are anticholinergic drugs which have symptoms of dry mouth and constipation
- Anturol showed similar efficacy to the market leader among the newer oral medications. less than 3% on drug discontinued
- Saw better compliance and more pts completed open label safety extension than had predicted
- Dry mouth at 11.5% was slightly higher than gelnique or patch, because getting more drug into the bloodstream
- Constipation SE similar to placebo, did not see increased dizziness or fatigue as some of the oral drugs have
- Market research survey- prescribers switching pts to anturol would not be at the expense of gel/patch (remain 4-5%) but instead would come from the oral drugs
- First webcast in which $AIS acknowledge that Libigel NDA has shifted to a 2012 event from 2011
- Sales of off label testosterone for women sell about $200-300m in the US
- Elestrin relaunched with 1 month pump vs 3 month supply- liked by pts (smaller) and payers (more copays)
- Anticipate that Nesterone contraceptive gel will now move into a phase 2b trial run by the Population Council (so no partner right now I guess)
- $12.8m company revenues in 2010 up rom <$5m in 2009
- Question and answer session:
- Phase 3 anturol data has been accepted for presentation at a scientific conference summer 2011
- Pen products- global deal, working with Teva US and European staff
- Epi pen- legal discovery is ongoing. No comment
- MTX product involves multipronged approach for approval- quite complicated pivotal clinical PK trial and usuability study
- MTX- not trying to compete with oral dosing- target pts who can't take orally (injectable use has grown from 4% to 8% and believe could go up to 15% of pts)
- Europe- prefilled syringe MTX product available- sells 3/4 of the $80m in MTX in Germany (attractive volume-value proposition0 only has 14% of prescriptions). Pricing $40-50 (per what?) total EU mkt is $150m for prefilled syringe, but pts prefer autoinjector. One of AIS MTX trials is using needle and syringe for comparison to monitor this.
Here are my notes from this morning's presentation by Antares Pharma $AIS at the Needham healthcare conference- updated or new insights are bolded.
4/14/2011 09:22:01 pm
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