Antares Pharma, Inc. (ATRS)

[jab91252]

Hi TD and thanks!

The relationship with TEVA, when listening to CEO Wotton talk, seems to have been elevated - there has been some expansion in their collaboration.

I'm not sure about the use of the word "molecule" as sometimes I believe the word molecule in this space can be a catch all in that both methotrexate and testosterone are also considered, "molecules". And at one time these drugs or molecules were all considered by the FDA, a NME (New Molecular Entity) filing, yes? Today, they are not NME's but still molecules or even at some point, "generic".

Along the same lines as your hypothesis, I'm curious about some language Apple used back in March in describing one of the TEVA/Antares pen programs when he stated: "that will be an ANDA filing shortly or, at least, an acceptance of one. And we're looking forward to that moving along. That would typicallyinsert-text-here." Typically??? Usually, it's an "automatic" filing of a potential patent infringement by the branded holder. I'm still trying to figure this one out.


What is rattling around in my head these days is a potential Copaxone future using Antares business model or as Paul put it, Antares Therapeutic Product (ATP) business model. Question is when could this molecule come into that fold? Would Antares wait until a TEVA Copaxone patent expiry? Could they be in a current collaboration regarding Copaxone? (By that I don't mean the current 3TW 40mg dose TEVA program). Could Antares actually be working in concert with TEVA (in Europe) for the 505b2 approach that would tie in with what TEVA's Jeremy Levin said about a "potentially a follow on COPAXONE on May 14." See below.

Could Antares already be in the infancy of developing a Copaxone drug / pen combo - with the blessing of TEVA with favorable financial partnership terms to Antares? TEVA does acknowledge that time is running out and Copaxone is a big revenue producer for them. I remember Apple last March addressing the shift in how TEVA was viewing Antares capabilities - in this case with sumatriptan - see below. Could TEVA want Antares to do the same thing with their Copaxone?

A lot of pure speculation for sure. But at some point, imo, Copaxone will have an Antares footprint on it!


Recent notes from TEVA and Antares CC's and from which produced the above brain dump.

Jon Congleton - Senior Vice President and General Manager, Global CNS
"We know that there is great interest in the efficacy and safety and tolerability of COPAXONE and looking to advance the way that patients can administer it, how they can utilize it.[url][/url][tag]insert-text-here[/tag] It has always been of interest to them. We have always tried to bring improvements to the market.

So we will be prepared for as big of one uptake as can be met by the market. It could be anywhere from a third to a half, based on the research we have right now. I think it's also critical to know what the timing, as Jeremy said, in his statements of an approval early next year, with the planning of potentially a follow on COPAXONE on May 14."[url][/url][tag]insert-text-here[/tag]

Also, : Jeremy Levin - President, Chief Executive Officer
Good morning, everyone, and welcome to Teva's second quarter earnings call.

As you all know, we have had a very busy week. The U.S Federal Court of Appeals confirmed validity of select COPAXONE patents through May 2014, but not others including one patent expiring September 2015. We are disappointed with this part of the Appeals Court decision and we will appeal that decision.

To me this paragraph above may be what Wotton was referencing regarding his Copax comment during the last Healthcare Conference (and I noted this before as well), meaning Copaxone to be another Antares drug to be delivered via their injector platform once it goes off patent.

Robert F. Apple - Chief Financial Officer, Chief Accounting Officer, Executive Vice President, Secretary and President of the Parenteral Products Division
Sure. On the epinephrine program, obviously, we have a date that's been settled between Teva and Myelin and Pfizer, a launch date of June of '15. And we believe we'll hit that target date. And we're hoping to get the approval of our auto-injector, obviously, well before that. With regards to the one of the pen programs, the ANDA, we believe that's very -- that will be an ANDA filing shortly or, at least, an acceptance of one. And we're looking forward to that moving along. That would typically -- once it's filed, it would probably be subject to a 30-month stay, but we'll see where that goes once that filing is made. [url][/url][tag]insert-text-here[/tag]And then as far as the sumatriptan program, we are finishing up our final information that we need to send to the agency to get that approved, and we're hoping that happens as far as the filing next few months. And then it's really up to the FDA as to how quickly they'll review the information that they requested before. It's not like we're back in Q of a review process, but obviously, responding to questions has its own kind of timeline that is unknown to most people.

Paul K. Wotton - Chief Executive Officer, President and Director
Yes. And there's another program with the multi-dose pen as well, which is being spearheaded in Europe, Matt, which will be initially, what I would say, a branded generic 505(b)(2) type of approach. [url][/url][tag]insert-text-here[/tag]And that program is moving along real well, too. So all of our programs actually with Teva have gone extremely well the past few months. And I would say that the relationship with Teva goes all the way up to the top of the company and across the company. And I'm going to tell you this for nothing, it's better than it's ever been before. And I'm very pleased with the amount of progress and the attention we get at Teva now

From March 13, 2013:
Apple to Aaron Hartley, Ladenburg Thalmann. Teva came to us and realized that we've been doing much more insert-text-hereYes, and we're going to be doing all these with the same equipment that were used in methotrexate, that were doing all the methotrexate manufacturing and commercial packaging until there's a real synergy from a capital standpoint to be able to do this