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Perhaps it depends on who is doing the talking. It was LeRoux Jooste today, who stated specifically to MTX rev's of between 100-200m peak opportunity - then he said not including potential sales of another indication like psoriasis.
"EWING, N.J. (AP) -- Shares of Antares Pharma Inc. climbed Wednesday after the drug developer said U.S. regulators will review its application for the potential rheumatoid arthritis and psoriasis treatment Otrexup.
Second perhaps is Paul may have been talking about not only MTX but "other" indications. I think the PDUFA on Oct will yield a two headed monster- maybe more??? Not trying to make excuses for the disconnect in numbers but this could be an explanation. These guys don't make up stuff is my point.
Just my two cents worth.
jab9
Correction!
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%
I mistakenly wrote $2 billion, Paul stated (and I just rechecked on the webcast @ time 19:50), " a billion". $1 billion, not 2.
Sorry about that.
jab9
TDPetersson:
I just reformatted your last name into the Scandinavian original format.;)
That last topic on the expected Teva filing was a little cryptic wasn't it. I'm of the mind that "filing" means a "NDA" and in a way I don't want to get myself overly excited about what it may be - as in the biggest surprise would be for Copaxone. And the "pipeline" comment I took away as meaning the Teva/Antares pipeline or more broadly, Antares/Teva partnership. Other than those thoughts, I'm as much in the dark as perhaps you - no offense.
Here's where myself and a few of my friends are having a disconnect however. LeRoux stated Otrexup revs between $100-200million peak sales (not including the tag along psoriasis product). Then Ceo PW goes on to state, regarding the generic epi-pen, that this product will be a $2billion dollar product by the time of launch (2015) with revs between 25-40% - BUT the epi pen is less important rev wise for Antares because of the impact of Otrexup followed by Testosterone.
So, if 2015 rev for epi is est $2 billion and if we take off the est revs of say $200 million for Otrexup, that leaves $1.8 billion for testosterone revs!
Is Wotton talking about bottom line revs, where the $2 billion epi pen portion goes to Teva's bottom line whereas (ATRS gets royalties, etc), but the Otrexup and then QS-T bottom line revs (at closer to 100% sans partnerships) foots into Antares pockets.
Also, I did not note this in my summary, but I wrote it down as something LeRoux Jooste stated about the 25-30 rep force was all the was needed to reach the RA docs, was "Quintiles". I just googled it:
http://www.quintiles.com/locations/north-america/united-states/commercial-services/
I believe these are the guys Antares will be using as a 3rd party marketing force.
jab9
My recap of the RBC Healthcare Conference, Wednesday February 27, 2013 - and I am not responsible for the accuracy, etc, etc......
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)
This post of mine from the ymb ties in with what LeRoux Joostes' talking point.
jab9
Formula: MTX + Medi-Jet = ATRS (+TNF alpha) = ATRS delivery of Biologics for the treatment of DMARD’s
MTX = methotrexate
Medi-Jet = Antares delivery device
TNF alpha = tumor necrosis factor (Currently available biologic agents act as inhibitors of the cytokines IL-1 or TNF. Cytokines are messenger molecules made by many of the body's cells that act to excite other immune system cells. Interleukin-1 (L-1) and tumor necrosis factor (TNF) are made in large amounts in rheumatoid arthritis and other forms of inflammation)
DMARD = Disease Modifying antirheumatic drugs
MTX is considered the first line therapy for the treatment of rheumatoid arthritis (RA) and a top line therapy for poly-articular-course juvenile RA and moderate to severe psoriasis.
Antares has the first and only Subcutaneous, MTX single use, once weekly disposable device (the Medi-Jet) capable of administering MTX doses from 10, 15, 20 to 25 mg.
I’m going to argue, this avenue of MTX delivery by Antares is unique, forward thinking and a potential “trend setter” for the delivery of future biologics when used in combination with MTX.
The biologics listed below, are agents the may be used alone, but are often given in conjunction with other DMARD’s
The predicted top 10 best-selling medicines in 2014 included 3 treatments for arthritis.
1. Humira (adalimumab) by Abbott with 2010 sales of 6.8 billion.
2. Enbrel (etanercept) by Pfizer(Wyeth) with 2010 sales of 7.1 billion.
3. Remicade (infliximab) by Merck/J&J with sales of 7.4 billion.
The three above are biologics that are facing patent loss protection and lets not forget about biosimilars and 2013 biggest patent expiry Amgens Neupogen (filgrastim) for the treatment of Neutropenia with sales 2010 sales of 4.8 billion.
Insert Teva / Antares collaboration:
Two pen injectors (disposables) products – Global programs
– One Generic (ANDA) and One Branded (505B2) product – $1.5 Billion in current sales
– ANDA filing anticipated within 12-18 months – Pen 1
– 505B2 program has completed PK work – Pen 2
I will further argue ( assuming approval and success of Antares Otrexup) that the path of biologics delivery (particularly for the 3 mentioned above) will find their way into an Antares delivery device.
Footnotes:
Dosing
For rheumatoid arthritis, the starting doses have been established by large clinical trials and are shown in Table 2. Biologic agents must be given by an injection under the skin (etanercept (brand name Enbrel), adalimumab (brand name Humira) and anakinra (brand name Kineret)) or by intravenous (IV) infusion (infliximab (Remicade)). These medications must be stored in a refrigerator and warmed to room temperature prior to use. Patient education information and videos are available for the self injectable medicines. A nurse or physician can teach you about the medicine and how to give the injections. It often helps to bring a spouse or friend with you to learn how to do the injections.
Major biologicals facing loss of patent protection include Amgen and Pfizer’s rheumatoid arthritis drug Enbrel (etanercept), Roche’s blood cancer and rheumatoid arthritis medicine Rituxan (rituximab), and Merck and Johnson & Johnson’s anti-inflammatory drug Remicade (infliximab). These three drugs alone are reported to have worldwide sales of more than US$12 billion in 2010 [2].
From GaBi online are these notes:
Biologicals boom Posted 15/02/2013
Researchers predict that the present list of top 10 blockbuster drugs will change dramatically by 2014. The predictions are that by 2014 biological drugs will topple the present market leaders Pfizer’s Lipitor (atorvastatin) and Sanofi’s Plavix (clopidogrel), both of which are small molecule chemical entities [1].
By 2014 at least six out of the top 10 best-selling drugs are expected to be biological drugs, mainly for treating cancer and rheumatoid arthritis. This compares to five drugs making it into the top 10 during 2008 and just one in 2000, see Table 1.
Table 1: Top 10 best-selling medicines 2010
The situation is predicted to change dramatically by 2014, see Table 2. At least six, and as many as eight, of the top 10 best-selling drugs are expected to be biological drugs. Moreover, biological drugs are predicted to account for 75% of sales, an almost two-fold increase in the relative contributions of biological drugs to the pharmaceutical sector.
Table 2: Predicted top 10 best-selling medicines 2014
The reason for this expected change is generics competition for small molecule drugs that will be off patent by 2014, including current bestsellers Lipitor (atorvastatin), Plavix (clopidogrel), Advair (fluticasone/salmeterol) and Diovan (valsartan).
There is also an opportunity here for biosimilars, with an estimated US$17 billion worth of sales in biologicals in the US alone set to lose patent protection between 2011 and 2015.
Major biologicals facing loss of patent protection include Amgen and Pfizer’s rheumatoid arthritis drug Enbrel (etanercept), Roche’s blood cancer and rheumatoid arthritis medicine Rituxan (rituximab), and Merck and Johnson & Johnson’s anti-inflammatory drug Remicade (infliximab). These three drugs alone are reported to have worldwide sales of more than US$12 billion in 2010 [2].
Nazareth:
You mentioned in your post that 'buying now is pointless'. Is that your belief or was that from some source that you read? I wasn't sure how to take that.
I guess whether or if one thinks the current sub offering pps of $4.00 by Institutions who (at least to me) have the wherewithal of due diligence into equities (like ATRS) that would put me to shame, is at the buying level to be labeled "pointless", is a matter of opinion.
To me, the Offering at $4.00 (and gobbled up) by the Institutional Investment firms, were just another confirmation that my long term investment horizon is still the right choice.
I happen to agree with you regarding any pps sustainability will come with bottom line rev's fostering profitability. Until then, the pps will trade in a volatile (relatively speaking) manner in both directions. And I'm looking for those swings (up and down)to be in an overall uptrend as we work the way through the year.
jab9
TD, thanks. The take away when I talked last week with Jack about the very same subject, was that at the end of the day, the FDA is somewhat of a wild card - in the sense that the timetables are goals that they do have and sometimes, if the agency or particular reviewing committee assigned to your particular NDA doesn't have enough time for the thorough review, they then will issue a "cover you rear end" type of letter which is disguised as a "RTF" (refusal to file)or to request more info. But he did say they hold true to the initial 60 day 'filing review' time frame.
In my own experience with submitting approval documents to a local governmental authority having jurisdiction on a project I was assigned to, oft times I'd get back a rejection when one was not deserved, only then to find out that they were too busy to get to the review- so they kick it back out.
My point here is, I believe the NDA has been accepted for review and as you noted the "clock" started clicking when the application was received. The PDUFA date is a target that could come sooner or later.
Tigrdog (Rik) - yes, we need to get Koufax over here so kudos on your message post on the carnival venue!
jab9
Rymankoly, great job on that intro! I had to hunt for that link for a few seconds (I think I'm right there with tappy on the tech side).
jab9
For now, here's a partial repeat of a post a made recently on the ymb, sans the front part to the infestation addressed to the carnival characters appearing on the board. This was a post or reply to tappy - not that I'm telling him anything he doesn't know or subscribe to........
I (and I know you as well as others) plan to win big and winning big will be fostered by understanding the long term vision and plan that has been put into place by CEO Wotton and filtered on down. It's a good plan, I'm sure of it and I will wait along with the rest of us all.
Lastly, lets define success with Antares. Is it a one trick wonder? Nope
Is it a sustainable growing game plan that uses big pharma partnerships to fund their proprietary platforms? Yep.
Are they engaged in risky drugs that live and die in the FDA fire pan and investment markets? Nope.
I look at these things in ANY company.
1. Leadership. Antares has it big time - from the top to the bottom.
2. Relationship building. Antares has that and does that with the likes of Pfizer, Teva and Watson - 3 big players in the pharma industry.
3. Experience. The on board intellectual capital is tremendous with seasoned veterans who are on top of their game.
4. Proactive business mentality. Antares is going after it in all directions whether in house or partnerships. Who wants the best pens on the market? Who wants to deliver their drugs with the best delivery device available? Who understands the drug delivery space better than Antares Pharma?
Antares Pharma who.
jab9
Wait a second tappy, your son and my nephew joining the worlds oldest profession?? I thought there was one other older profession ahead of a medical doctor!
jab9
You'll get use to it SP1. And just think, so far, no interlacing of bs from the carnival factor.
jab9
That's what I figured TD. My question was also based on wondering how you came up with that, given a select few of us who are in direct personal email contact refer to our core group as the "Antares Mafia" - tongue in cheek!
jab9
TDPeterson, good to have you here as I always appreciate and make sure to read your posts. Curious about your "mafia" comment - you just make that up?
jab9
Good point Carcimore00. However I for one will be more selective - which is also good. This gives me (us) an avenue for solid social and financial intercourse without the carnival factor of the ymb.
jab9
Nice job with this bsav! Excuse me, "very" nice job! No wait a sec, GREAT JOB!
Did you copyright this - I know you are an attorney so I don't want to do any toe stomping on the wrong foot! But seriously, If you don't mind, I'm going to hang onto this to use myself as a work / study / tool.
I'm looking forward to the RBC Conference this coming Wednesday, then the soon to follow 4Q and 2012 yr end CC. I think we will be getting some nice updates with what they been cooking up! Maybe some more color on the latest in-house Quick Shot (QS- M) project in the Neurology space - (perhaps a self administered in home treatment for Migraines).
I know you are off again to Brazil tomorrow so have a good / safe trip.
jab9
I'm here bsav and ryman and others!
jab9
I was there in 9/16/03 for that 3.75 high. It came off of partnership news with Bristol Myers Squib. But that was it, then we never saw that high again!
Very nice day today. It seemed like some large shares (buys) in the morning helped the cause and maybe that share pps jump also fostered some short covering. Maybe the warrants expiry someone mentioned as well.
jab9
Thanks for the heads up ryman!
jb
Moderator!
This is a low life impersonator of me from the yahoo board.
I came to this board because it is moderated.
I request that this persons privileges here be revoked and why not post his identity and email address.
Thanks,
the real jb
Also:
Pfizer Inc. (PFE)’s experimental pill for rheumatoid arthritis was as effective as Humira from Abbott Laboratories (ABT) and showed no new side effects in study results the company plans to submit for U.S. approval this year.
Nine study summaries were released today and will be presented at the American College of Rheumatology conference in Chicago in November. In one trial, both doses of Pfizer’s drug, called tofacitinib, were slightly more effective than Humira across six categories of improvement in symptoms and patient mobility, though the study wasn’t big enough to establish the pill’s superiority.
Pfizer, the world’s biggest drugmaker, designed tofacitinib to compete with injectable drugs that dominate the market, led by Humira from Abbott Park, Illinois-based Abbott, Johnson & Johnson (JNJ)’s Remicade and Amgen Inc. (AMGN)’s Enbrel, which New York-based Pfizer shares. The new drug may bring in more than $2.6 billion a year, said Catherine Arnold, an analyst at Credit Suisse Group AG in New York.
“This is a game-changing drug,” Arnold said. “Our peak sales of $2.6 billion are likely conservative.”
Repeating: "Pfizer, the world’s biggest drugmaker, designed tofacitinib to compete with injectable drugs that dominate the market."
We both know about Antares venture into the RA arena with VIBEX MTX - could this be a PFE transition to an injectable form of their drug, Tofacitinib, to further compete with Abbott, JNJ and AMGN??
jb
Some more thoughts on this PFE/AIS deal:
The market(s) take on the pps of AIS, imo, seems to be never in line with our expectations. But another deal with the likes of PFE will most likely be a future driver and there's the rub I believe.....'most likely' a future driver. We hope it is, but we just don't know given lack of the intimate details and that slippery slope to the future.
That limitation on the royalties is both interesting and curious...." royalties on net sales for three years post launch in the US"....an existing PFE product(?).
Also given this statement prior to the royalty info its noted: "Pfizer will assume full cost and responsibility for all clinical development, manufacturing, and commercialization of the product in the licensed territory, which also includes certain non-exclusive territories outside of North America"......
perhaps the 3 yr royalty post launch in the US while signifying a time end date certain, does not privy us to a potential global transition deal to territories outside the US. Meaning, 3yrs, let us see where this goes and if the numbers and market is there - we take it to the next level - tranche two.
"Non-exclusive" to whom? Could Antares have cut a deal outside the US, in that PFE will assume that full cost for those territories while Antares takes the lead role?
3 yr royalty limit???? Could this correspond to an approximate date of an existing PFE product patent expiration?
This is interesting.
Ron,
I've note another "lesser" board that CEO Wotton is a Rain Maker.
And he is.
I think he's just getting warmed up.
jb
Nice call!
jb
I don't think so. As you note BPAX is involved and they seem to be in the drivers seat as far as news release(s). And I can't see then being so benevolent and hold on any news for AIS.
In fact, I'd rather have FDA approval first, forcing in a way investors to hold through Libigel news. That would still get us the desired effect I believe.
Interesting times with AIS!
jb
I agree with your posts/thoughts on this trading Ron.
And, imo, the closer we get to the approval day, without hearing
anything from the FDA, the more likely an approval.
jb
I caution anyone who tries an early withdrawl before she's (AIS) is finished....couldn't resist either.
The when or decision to sell question is not in my game plan pre - post Anturol and Libigel. Too many variables to try to guess at when the best time or pps is to exit, not with so much on the Antares dinner plate.
jb
Looks like you (we)got it!
jb
Thanks Ryman:
Anyone have thoughts on this updated presentation?
What do you make of the obvious focus on the injectable side of
Antares platform - with no mention of the gel side?
jb
aud, ok, I think I got it now. You mean reference to the J Richards buy/post I made. When I said I wanted to verify a 'reference' to him buying, it was in reference to a post on the yboard from SD. So in that case, yes.
I'm feeling pretty confident about AIS moving forward here on out to year end 2011 and in 2012. I think things should fall into place starting with a green light from the FDA re Anturol which will be a good rev stream.
jb
Aud, sorry just saw your post.
Answer, no.
jb
Fyi, fwiw,
I received an email from last nite from Jeremy Richards that "We have bought a speculative long position."
Regards,
J Richards
I wanted to verify a reference to his potential purchase by a poster on yahoo.
jb
Ron, Wotton stated his conservative timely during the recent Q&A which due to his latest timeline comments - the sentiment now is that the 'timeline has slipped'. Maybe, to early to tell.
Ryman, I believe u mentioned on the yhoo bd about Deerfields latest sale, lets note also that they still have +2million shs in reserve and a bunch of warrants. I heard that Deerfield have a number of different investing entities but they report as one unit. One unit may have sold out while the other(s) remain fully invested.
Plus, perhaps and assuming that Deerfield has now sold what they intended to sell, that was what had the lid on none movement of the pps and the sideways trend for so long. With that done, the lid is off.
jb
Hi Ryman,
I just signed up. But gotta run for now.
Futures are positive right now. Lets see if that translates
for a rise in AIS as well.
Later!
jb