Here are my notes from this morning's presentation by Antares Pharma $AIS at the Needham healthcare conference- updated or new insights are bolded.
- 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.
RSS Feed
