The Antares Pharma $ATRS CEO described the third quarter of 2012 as "the most productive quarter in the company's history" - we will see if this statement was warranted. Continue reading below for news and updates from the conference call.
- Compared to partnering, we will seek commercial opportunities where we can fully enjoy the economics
- all vibex MTX (methotrexate) clinical studies were completed ahead of schedule- this resulted in accelerated r&d costs, NDA filing on track for 1q-2013
- injection vs tablets in RA (rheumatoid arthritis) patients - to confirm clinical PK benefits...this data is important for patients, doctors, and payors - we will report data after finalized
- human usability/use studies with positive outcomes - testing of device in both simulation and actual patient use settings. 100% delivery of dose, no discontinuations due to AE, minimal ISR (injection site reactions)
- We are filing additional patent applications and we held pre-NDA meeting with FDA last week despite the hurricane. We will file the NDA within 3 months. Our team and consultants are working on "the paperwork" now. no surpries at preNDA meeting (so guiding for by mid-February 2013)
- We are evaluating several options for commercialization of "MTX medijet" - most likely outcome/best shareholder value is to create a commercial business in US, we will consider ex-US deals as we go.
- 10/2012 stock offering raised proceeds of $53m at $4.00 - pro forma cash $88m as of today
- We plan to launch one product per year through 2016 with or without partners (this guidance has been stated for the past several years with varying accuracy)
- Teva has filed the tevtropin 10mg sNDA 5 mg dose is currently approved)
- this quarter: first gelnique royalties from Watson $WPI plus $0.75m milestone form PFE
- We will reinvest revenues in our pipeline products
- ATRS is "that much closer" to being an earnings story and becoming a specialty pharma company
- what will commercial organization look like? when? new sales/markeing head who launched enbrel, joined 6 months ago. continue to evluate options and prepare to launch on own. we want all critical and strategic capabilties in house. we will recruit those with experience in this therapeutic area. We just added product director. Vibex MTX product with speciality focus with rheumatologists -call on 2500-3000 reps - need about 25-30 reps, plus additional stafd to call on payors, patient and professional organizations. About 40-50 total people.
- leverage commercial infrastructure for other products in pipeline? "absolutely"; easy to branch into other therapeutic areas. All of our products will be specialitties (testosterone = urologist), 3rd product (undosclosed specialty area) - so yes, except not the actual sales reps any time soon
- Teva partnerships update? We will start to sell epi-pen devices to Teva in 2013/2014 ahead of the date-certain 2015 launch. The pen programs for the US and EU are moving along. EU leading, US getting ready for ANDA filing early 2013 for one program - development revenue continues to grow. 2nd autoinjector we hope to launch next year, finishing up development work, have to submit requests/questions on drug and device from FDA
- how is gelnique working so far in market? launched halfway thru 2q. now makes up 25-30% of gel prescriptions for Watson. Heavy sampling right now, hope these will translate to longterm prescription growth. Believe we are taking a little bit of market share from the 10% gel
- elestrin - how is it going with (yet another) new owner? Sales are continuing to grow. smooth transition to Meda. They are more focused on product than Jazz was- largest drug in protfolio that their bought. Elestrin was not in jazz core mix. Patients seem to stay on product for a long time
- tev tropin- when will 10 mg be approved? It was filed less than a month ago, should be 6 month review, then launch about 3 months after that. As child gets older, 5 mg is not enough, so they tend to change to another product in their teens. Most products in market are 10mg. Despite this Teva still has been able to increase market share past year or so. 10mg approval would be opportunity to relaunch device
- QST what is the next milestone in development? Next item would be preIND meeting, which will be in 2012. then move into clinic 2013 - dose patients in start of 2q-2013. We hope all studies will be completed within 18m period like MTX
- expect AB [interchangeable] rating for epipen? yes. because it was filed as ANDA and all questions we're getting from the FDA are around substitutability.
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