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.
For the moment, this will be the final installment of the BiotechDueDiligence AACR Annual Meeting preview..thanks for sticking with us. As always, see below for another collection of presentations from biotech companies covered on the website.
Full coverage:
Introduction
Preview Part 1 (SNTA, ASTX, NVS, INFI)
Preview Part 2
Preview Part 3 (ARRY, ASTX)
Preview Part 4 (ASTX, ARQL, BPAX)Preview Part 5 (TKMR, EXEL, PCYC, IMMU, VRTX)Preview Part 6 (CRIS INFI ISIS CLDX LGND PCYC)
Quick notes from Biosante Pharma $BPAX CEO Stephen Simes at Jefferies:
- We still don't know teva-abt launch date agreement. $1.6b total market. royalty 7.5-10%
- two new trial to initiate 1h2013 same co primary endpoints and key secondary, but some design changes with goal of decreasing placebo response
- over 7000 patient-years in LibiGel safety trial now
- this is first public disclosure of specific changes that they are seeking via SPA with FDA
- daily diary was also used unsuccessfully by B-I for flibanserin
- we will not proceed if FDA will not let us switch to less frequent diary
- next safety report by the end of august (9th unblinded look) with top-line safety data 4q-2012
- patent thru year-end 2028 (method of use) and 2022 (formulation)
- sexual dysfunction is the #1 complaint in gynecologist's office
- [rehash of old GVAX cancer vaccine data]
- ~$40m net cash 3/31/2012, report results in new few weeks.
- We hope for SPA agreement in 4q-2012 with FDA
- no Question and answer session on webcast
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.
Continue reading below for a round-up of 2q-2012 earnings commentary from Momenta Pharma's $MNTA partners and competitors, as well as about biosimilars in general. Includes Sanofi $SNY, Mylan $MYL, Watson Pharma $WPI, Pfizer $PFE, and Teva Pharma $TEVA:
OncoGeneX $OGXI has licensed its lead prostate and lung cancer drug custirsen to Teva Pharma. Any inkling that the partnership was in jeopardy would be a huge blow to the small Canadian biotech. Custirsen is an antisense drug targeting clusterin, using technology licensed from isis Pharma.
Teva Pharma 2q-2012 earnings transcript courtesy on Morningstar.
"And second, I'm not sure if Michael Hayden is on the phone, but if you guys are going through some of the strategic review of the key products you currently have in the pipeline, I was wondering if you can comment about where you are in terms of your thinking, specifically about things like DiaPep277, the oncology portfolio and perhaps Laquinimod now that it's being submitted in Europe?"
Well, thank you, Ronny, for that question. We are currently undergoing a very detailed review of every project that's part of the R&D portfolio. DiaPep is part of that, and we will be reporting on the outcome of all of this during our Investor Day in December. But let me just talk about one of the drugs you mentioned in the pipeline, which has been a wonderful and a very pleasant surprise for me is the drug, Laquinimod. As you know, showed very significant results in terms of its ability to reduce disability progression and also brain volume loss. In fact, what's really quite remarkable about this unique asset is that many of its mode of actions and its ability to prevent inflammatory changes are already potentially extrapolateable to some of the more common and more serious disorders for which there really are no therapies. These include some of the neurodegenerative disorders. And so I would say as part of this review, of course, we are very interested at the potential utilization of drugs in our portfolio for other indications which would match the mechanism of action, which then would very suitably match the cores and the pathways perturb in some of these other diseases. So we're looking at this. And I'd say Laquinimod is one of those that has been a wonderful surprise in terms of understanding more deeply as to mechanisms of actions and its potential utility in other diseases.
ASCO:Oncogenex $OGXI will present updated (first data presentation was at ASCO-GU in early 2012) randomized phase 2 prostate cancer data for OGX-427 at ASCO 2012 - stay tuned as the abstract will be released May 16th.1q-2012 Partner Update:OGXI is partnered with Teva Pharma $TEVA for their lead cancer drug custirsen, with phase 3 trials ongoing in prostate cancer and proposed for non-small cell lung cancer. This program is virtually never mentioned on Teva webcasts, and that was again the case this quarter. However, it is important to note that following the acquisition of Cephalon by Teva, the combined research and development pipelines are ongoing a thorough review and re-prioritization led by the newly appointed CEO Jeremy Levin. Here is what he said about the process:"So let me just touch on the reviews. As I've said to you the -- we are conducting an extensive review. This is not just of pipeline, it's across the board, it's the business, it's the -- in the different geographies. It's also the manufacturing footprint. It's the pipeline, our capabilities in R&D and the individuals, the people that we have. This is part of a normal process that any CEO does. It's not something unusual to what -- is undergoing in Teva. We've identified a number of different processes that we'll undergo to look at that. And amongst those is the process to look hard at the pipeline. Now as you know, that pipeline was looked at last year, and I think at this stage it's premature to say that there's any changes whatsoever from that. But I anticipate as Michael comes on board and works with me and others around the table, we'll have a much clearer view of that a little later in the year."It goes without saying that if Teva abandoned the OGXI partnership, OncoGenex would be in deep trouble - they do not have nearly the required resources to fund and operate the global phase 3 program for custirsen. However, there is no immediate reason to worry about this outcome. If OGXI was truly on the chopping block, it would be an odd decision by Teva to commit to a brand new phase 3 overall survival prostate cancer clinical trial in combination with the second-line chemotherapy agent JEVTANA (cabazitaxel), rather than simply abandoning the SATURN pain palliation trial. In any case, it is a situation that bears monitoring for all OGXI investors.
ASCO:
Momenta will present preclinical data for M402, their heparin-based drug that has just started a phase 1/2 trial in combination with gemcitabine for pancreatic cancer. Abstract will be out May 16th.
m-Enoxaparin (generic LOVENOX):
-no mention of the MNTA-BAX follow-on biologics (FOBs) / biosimilars collaboration on the Baxter quarterly conference call
-no mention of the long lost Teva Pharma $TEVA generic lovenox program on their 1q-2012 conference call.
-no discussion of enoxaparin on Novartis $NVS (Sandoz) 1q-2012 conference call.
-Sanofi $SNY 1q-2012 conference call comments (sorry for poor transcript) from Seeking Alpha and Morningstar has not yet posted one): "On the right side of the chart Lovenox performance even more remarkable, I believe was in €400 million just during the first quarter, a growth of 12%. So it says outside the U.S. where the product more or less never has been patent protected and is undergoing direct competition from [inaudible] many years. I believe [inaudible] inside US Lovenox performed [inaudible] patients mainly but not only due to the fact that we have seen no additional entries of a generic product. But I think it’s fair to say that also we have extreme customer loyalty [inaudible] evidently helped by continued supply problems of our existing competitors."
-Watson Pharma $WPI 1q-2012 conference call excerpts:
"Could you just comment a little bit about generic LOVENOX? How's that product doing for you?"
"I think it's going all right. We're getting much better supply now. We were building up supply in the beginning. I think where the issue is, just to remind you, we only have the retail part of the business versus the non-retail. There were challenges in the beginning to only sell to the retail because many of our customers supply both retail and non-retail, including the hospitals. I think we have sorted those technical issues out pretty well, and we have steadily getting more market share. I think the prices have gone a little bit lower than we expected. We clearly see that both Sandoz and Sanofi have reacted to the market. But overall, we are quite pleased with where we are with the LOVENOX product."
Momenta Pharma $MNTA (click for additional info) was down over 7% today following release of first quarter 2012 operating results. The only true news was the long-awaited initiation of a phase 1/2 trial of their novel heparin-based oncology candidate M402 in combination with gemcitabine for pancreatic cancer. However, I believe the stock weakness can be ascribed to this statement, which is hardly news to anyone who follows the stock closely:"Our return to profitability will most likely come from the launch of our generic Copaxone, which if we’re not successful on our patent litigation, could be delayed until the expiration of the patent in the third quarter of 2015. During that time, over the next 3.5 years, our operating expenses will likely increase as we move up to six biosimilar product candidates through development and could further increase if we expand the number of products and our Baxter biosimilar collaboration or if we choose to develop biosimilars outside that collaboration. Our operating expenses are also likely to increase as M402 and potentially other novel drug candidates advance in the clinic."This comment does not contemplate a victory against Amphastar/Watson Pharma $WPI to restore more favorable market dynamics for generic Lovenox (enoxaparin) for Sandoz/Momenta. While a possible outcome that some (not I) see as generating a huge windfall for MNTA, MNTA management are certainly not counting on this scenario playing out, but it was discussed to some extent during the Q&A session. Basically Wheeler said that if there was any enox victory, it would be a scenario not contemplated by the Sandoz $NVS contract and would have to be worked out after the fact.
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