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
Note that TEVA is partnered with OncoGenex OGXI for their phase 3 custirsen cancer program and with Antares Pharma ATRS on various parenteral products. None of these programs were mentioned at all on the conference call, which is typical.
Transcript highlights c/o SeekingAlpha.
4q2012 Copaxone sales $1.1 billion
Full-year 2012 sales ~$4 billion
Market share in Multiple Sclerosis (MS) ~40% on strength of "unsurpassed long-term safety and efficacy"
"While we anticipate a potential approval and launch of the competitive product in the MS space, we expect Copaxone with its well-established safety record, efficacy, favorable side effect profile and deep, clinical experience to maintain its market leadership position in relapsing remitting multiple sclerosis."
Analyst Question: "at the Investor Day you mentioned that there could be a publication for a comparison of Copaxone versus a purported generic, where Copaxone down regulates whereas the purported generic up regulates. I was wondering where that stands if you are now willing to tell us who that generic is? Or if all of the generics maybe have that same component? This publication is submitted and under final review. We expect it to be accepted for publication in a well-established journal in the next few weeks. So – and as we delivered to you on the Investor Day, it highlights the differences in the activation of certain genes with Copaxone compared to some other generic product. More details on the manuscript will be readily available once the manuscript is in press."
[Clearly the implication here is to highlight some deficiency of generic Copaxone. It appears as though the paper has not come out - here is the PubMed reference - and involves an Indian knockoff from Natco, some gene expression arrays, virtually no functional verification of findings, and a lower tier journal. As we suspected, TEVA has no way to access MNTA's product and the mention of this paper is meant simply to implicate the Momenta/Sandoz drug via guilt by association. MNTA fans need not lose any sleep]
"We continue to enhance and expand the Copaxone franchise with our 3TW, otherwise known as a three times a week, 40-milligram dosing with the submission plan for March of this year with the FDA."
Analyst Question: "I think you made a pretty bold prediction at the Analyst Day that the company could switch up to half of Copaxone to the new form within a year or two. So can you walk us through the logistics of how that would occur? It certainly suggest that existing patients would have to switch because there aren’t a ton of new patient starts in a given year. I ask because it has such important implications for the duration of the franchise and the value of the franchise....
I said what we’re modeling right now is about a third – 30% to 33% of the existing patients as well as new ones will come over to the 3TW. And that’s based on talking to customers, talking to patients. There’s some thought that it could get to 50% within that timeframe, but we’re modeling about 30%. And what leads us to believe that, that will happen is just the patients’ experience with the product depends as well as what we can basically do to support those patients who are interested in making 3TW their choice of Copaxone. We’ll have both available in the marketplace but obviously with shared solutions we can address patients specifically if they have questions about wanting to go from a daily to three times a week. We can certainly facilitate that. We’ll be introducing a new injector a new auto-inject device, 3TW as well. So again, if those patients want to continue with their daily, we’ll continue to obviously support that but we’ll also make it very easy for patients to transition to the 3TW if they’re looking for that kind of experience."
[There doesn't seem to be anyone outside of TEVA that believes their three times weekly formulation will gain anywhere near this amount of market share. If it had that much potential, you'd think TEVA would have put the slightest amount of serious effort into the clinical development / filing package a couple years ago, which they didn't. There is occasional message board banter about the new device being part of the partnerships with Antares Pharma ATRS, but there has not been any convincing evidence to support this]