Jab9
CEO PW: It’s a great day for us to be presenting to day. Last nite we revd our NDA acceptance letter for our Otrexup, so we hit a big milestone four ourselves yesterday and a natural fact this is just another step in the transition of the company.
Antares is a company that has world leading injectable technology platforms and we r using those platforms to develop pharmaceutical products and Otrexup was our first pipeline product that we r developing ourselves and we have historically worked with companies like Teva, Pfizer, Ferring, Meda, etc.
• We have 5 products with Teva
• Partnership strategy
• Forward integrate
• Home setting for drugs
• Re-engineer existing drugs with Antares devices
• October 14, 2013 PDUFA date for Otrexup
• Will be seeking international partners.
LeRoux Jooste:
• MTX is the gold standard as a DMARD
• Stand alone DMARD or with a biologic (see my post titled Formula: MTX + Medi-Jet = delivery of Biologics)
• MTX(Otrexup) revs between $100 - $200 million peak sales potential which DOES NOT include potential sales of another indication like psoriasis.
• I suggest listening to his very detailed segment on the replay!
CEO PW:
• On QS-T: Testosterone is a $2 billion dollar market – highly viscous drug – oily drug
• Potential is a much larger opportunity for Antares than MTX
• Other molecules for VIBEX – 40 drugs we have identified that could be applicable
• We are active on the patent front
• We want to develop drugs that people want to buy
IP question regarding ability to protect both injector and drug (Vibex)
• We’ve protected the platform and you can protect things like the speed of delivery out of the device, the strength of the spring, the lbs / sq in., the design of the devices, all the way thru to what is called the QS system.
• We’ve adopted it for highly viscous material and what we’ve done is we’ve applied that patent base to classes of drugs.
• We have a patent filing called Hazardous Agent filing which we filed 4 yrs ago which will protect Otrexup.
• We are building on that data that’s coming out of clinical trials on the project specific applications of the device
Epi-Pen discussion:
• June 2015 product lauch
• We are manufacturing devices right now
• Market oppty is significant – by the time 2015 comes along this product will be a $2 Billion dollar product, even Mylan estimates the projected sales, we could be looking somewhere between 25-40%
• It’s a very important product for us but its less than important product for us in terms of rev than it use to be because of the impact of Otrexup and now Testosterone as well.
• Pipeline snap shot is 2014 – Otrexup
• 2015 Generic Epi-pen
• 2016 QS T
• I believe the real opportunity for epinephrine injection lies in the substitutable product because the epi pen is such a well known brand that the substitutable angle of that cant be ignored
• Pursuing AB rating and not the 505B2
Moderator question regarding regulatory agency approval of epi pen
• You’ll have to ask Teva about that as I’m not privy to their regulatory sheet dialogue, all I’ll say is we’ve got a date in 2015 when we are expecting to launch.
• Teva and ourselves are committing all our efforts on manufacturing expertise of our devices for the launch so you can read between the lines.
Question regading being acquired, staying an independent pharma concern etc.
• First of all, we are not for sale
• The reality is you are dead on with this platform
• We have I think the best devices on the market when you look at other devices on the market they are not as good as ours.
• The applicability of that technology to drugs is quite large and as a company like ours it would be difficult to develop 40 drugs on our own so we will be continuing to seek partnerships
• And of course what happens when you file an NDA with your own product, we’ve been inundated with business development inquires since December when we filed that NDA on Otrexup
• I would anticipate we see more agreements with pharmaceutical companies coming down the road.
Question regarding Valuation:
• This year we are focused on getting approval on Otrexup
• Expect another filing out of Teva pipeline coming along……Moderator: can u tell which one?.......ATRS: NO! (laughter)
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