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Actavis $ACT (renamed from Watson Pharma $WPI after merger) is one of numerous companies pursuing biosimilars, in collaboration with Amgen $AMGN. Here are there recent comments from the 1q-2013 earnings call (c/o SeekingAlpha). Note that their commercialization deal with Antares Pharma $ATRS for GELNIQUE was not discussed.
Antares Pharma $ATRS has a number of product partnerships with Teva Pharmaceuticals $TEVA based around a series of parenteral injection devices. These deals have been shrouded in secrecy and also littered with delays over the years. Recently though Teva briefly addressed the Epi-pen program on their 1q-2013 conference call (excerpt via SeekingAlpha).
Just curious to know your confidence level in the FDA's ability to approve EpiPen, an AB-rated EpiPen in 2015?
So, just to your second on question on EpiPen, I will let you know we had a settlement with Mylan and we have an entry date in 2015. The trial Is progressing well.
This post features comments from the Teva Pharmaceuticals $TEVA year-end 2012 earnings conference call that are relevant to companies covered here at BiotechDueDiligence.
As usual the discussion centers COPAXONE for multiple sclerosis, which Momenta Pharmaceutical $MNTA and partner Sandoz (Novartis $NVS) are seeking approval for a generic version of.
MNTA and biosimilars - notes from other biotech/pharma conference calls
Other blog posts related to TEVA and MNTA
Another set of investor relations (IR) questions and responses from biotechs provided by Mike O'Neill has been posted, covering financials and upcoming catalysts for each biotech stock.
This round of responses features Antares Pharma ATRS, Durata Therapeutics DRTX, AcelRx Pharma ACRX, Acasti Pharma ACST, and IntelGenx Technologies IGXT.
Check out the complete index of all IR Questions and Answers if you missed the previous editions (covering >50 biotech and pharmaceutical companies)
While Watson Pharma WPI did not discuss their GELNIQUE line (including the oxybutynin gel product licensed from Antares Pharma) on their 3q-2012 earnings call, they did make some general business comments that are relevant to the partnership:
"We are definitely committed to a long-term brand strategy. We are committed to women's health. We're committed to urology, and we're committed to a biosimilar franchise. So we will continue to look for business development opportunities. I would expect that you'll see some from us over the next few months, as we can bring home some of the deals we're currently working on. But we have not wavered in our commitment to our brand franchise
Yes, we're continuing to focus our development efforts around women's health, and this is widespread women's health, not just contraception, but we will continue to look for opportunities of underserved needs in women's health care. And there are those areas. We're looking at new therapies. We're looking at NCEs. We're looking at new delivery devices, new delivery systems. We're looking across the board at all of the options that we have presented -- we have available to ourselves. On the urology front, we continue to be focused on that. As we think about going forward, we will continue to look for opportunities to maybe add on perhaps some additional therapeutic category. We have to be careful about how we approach that. That's a challenging effort, and we would probably need to do a substantial acquisition to get ourselves into another category, but we haven't certainly said we wouldn't do that. So we are focused on all of those categories." (transcript quote via SeekingAlpha)
For archival purposes, see below for my notes from the March 2012 Antares Pharma (stock symbol ATRS, formerly AIS) fourth quarter and full-year 2011 earnings conference call.
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.
Teva Pharma $TEVA presented at the Barclays Capital Global Healthcare Conference - check out the complete transcript courtesy of Seeking Alpha. See below for quick excerpts related to Antares Pharma $AIS partnered product and Copaxone market dynamics in response to a question about the generic Copaxone being developed by Momenta Pharma $MNTA and Novartis' $NVS Sandoz generics unit.
"So we thought about this ahead of time and we actually have played in this area by marketing our own human growth hormone Tev-Tropin and here’s a product that we knew that we had to have a clinical packet, had to put a sales force out there. We had to have a managed care strategy and we were able to sell the product even though we were not one of the big players in this market.
We didn’t sell as much as we’d like but we didn’t have -- you needed a 5-milligram and a 10-milligram, we only had a 5-milligram. You needed a device. We sold our product without a device, our product was lyophilized. We had a lot of disadvantages but we built our product over time and we realized early in, this is what the model’s going to look like."
"When I think about the exclusivity of the products and people ask me how long do you think this is going to last? I try to guide them to the latest patent date 2015, because that’s the way we feel based on the knowledge we have today of where the challengers are and where we feel that we’re going to be in the litigation.
We feel and we still haven’t engaged yet on the marker patents, which go out to 2019, 2020. So we’ve got -- we believe that the franchise is relatively safe from any generic competitors at this point in time or so-called generic competitors, at least let’s think about 2015.
Where we’ve cautioned is that the product its 15 years and it’s quite remarkable that last year in the face of 15 years of marketing the product actually grew. And it speaks volumes for our safety and our efficacy and that’s what we think is so important in MS therapy.
When you think about treatment, which is not for weeks or months or even years, its decades, safety and efficacy is extremely important and that’s what Copaxone is. So I think that, that’s one of the true values.
Now why does our projection go down because of that? Well, we do look at this market and say, hey, it’s becoming a crowded space. When we started in this market we started with an orphan, was an orphan exclusivity, it was an ODE and so we had a longer patent protection, well not patent protection, actually a longer regulatory protection for this product because of the ODE.
But now here we are years and years later. You’ve got lot of entrants coming in, you -- and by the way you’ve never had anything that really expanded the market until Gilenya. Gilenya has come in and this last year we grew, the market grew.
Now all other therapies other than Copaxone from the looks of our data, all other therapies other than Copaxone and Gilenya, they all suffered. Copaxone and Gilenya both grew.
My concern is, is it responsible for me to keep forecasting growth in the face of increased competition whether it’s from Gilenya or BG-12 or whatever. And I think it’s irresponsible for me to say this will not impact my business.
I’m very happy if they continue to expand the market and I’m 40% today and I’m the market leader. If I’m 35% in a couple of years of an expanded market then we’ll be at the same numbers and that’ll be a great thing. But I don’t think it’s good for me to forecast that, right.
So back when we gave the guidance back in 2010, we had said at that point in time that we would suffer from the crowding of the space and not really from any sort of competition, some glatiramer competition at that level and I don’t see competition to glatiramer acetate at that level. I see us really dealing with new therapies coming down the pipe.
From our perspective, we never have been the price leader. We don’t intend to be the price leader. But I don’t want to be far down in the pricing pack as well. From my perspective, I’ve always tried to be in the second position or the third position and that’s where we are right now, and as long as prices move up, if market prices do continue to move up, we’ll have price increases.
I don’t see us taking multiple price increases in a year. I think those days are gone. But if there’s opportunity, the responsible thing for our shareholders and we are -- I do believe we’re the standard of care. So I think we have a right to take those price increases and we do whenever we can.
Now we also have to deal with the managed care side and the push back, and when we take a price increase, if it’s -- we took one earlier this year, 14.9%. We don’t yield then on a product. We yield about half of that, about 50% of that goes back to either rebates or some sort of level of patient care, and our indigent programs or patient assistance programs are very, very important to us and we keep funding those."
You may have noticed the news stories this morning announcing a patent litigation settlement between Mylan/Pfizer (the makers of the branded Epi-Pen epinephrine product) and Intelliject/Sanofi.
Intelliject and SNY received tentative FDA approval for their 505(b)(2) application for e-cue, a novel epinephrine delivery device in July 2011. This agreement will allow this competing product to enter the market in November 2012.
Antares $AIS and Teva are developing a generic epi-pen and have filed an ANDA. Pfizer (originally King Pharma $KG) filed patent infringement lawsuits (based on more recently issued patents around a "next-generation" autoinjector) against Teva/AIS and Intelliject/SNY. The consolidated trial was scheduled to begin this week, but now will only involve TEVA/AIS vs PFE.
What does the settlement mean for AIS? Keep in mind that TEVA and AIS are seeking approval for a generic (ANDA pathway) device that closely resembles the branded product, while the Intelliject auto-injector is vastly different (link). Therefore the degree to which the two products potentially infringe on the branded epi-pen is dramatically different.
Certainly a settlement between PFE and TEVA/AIS is still possible, but one shouldn't read much into the terms (especially negotiated launch date) in the settlement announced today as an example. For now, the trial is underway and we will await further developments. Launch of the epi-pen or another Teva-partnered injector product is a crucial milestone on the path to profitability for Antares Pharma that has been repeatedly delayed.