- Momenta presented 8/17/11 at the Wedbush conference - check the Past Events page for webcast link.
- More company info can be found on MNTA research page.
- My notes from the webcast are below:
- Analyst host: MNTA is one of my two favorite companies on drug side of my coverage universe
- In 2005 enoxaparin ANDA filed, approved 7/2010 along w/ rejection of SNY citizen petion requesting clinical trial requirement.
- This approval was validation for collaboration discussions and our FOB approach.
- Our generic with Sandoz has about 50% market share [Slide says 45-50%]
- Teva now says no comment until when/if approved. We have sued teva on basis of potential infringment of two of our patents. When we identified structures on branded product, we patented methods for ensuring our generic product contains those structures
- Copaxone deal: MNTA pays development costs, Sandoz pays commerical/legal. 50/50 profit share, NVS made $75m equity invesment, they own 9% currently.
- Copaxone ANDA filed 12/2007. 3 citizen's petitions filed by Teva and rejected by FDA (now under deadline to respond w/in 6 months). 3rd filed 12/2010
- When and if approval of ANDA, we expect FDA to issue CP indicating their criteria for approval as they did with enoxaparin [misstated I believe, this wouldn't be called a CP if published by FDA right?]
- Amgen coninues to insist there will never be an interchangable generic biologic... we disagree. Science is always moving forward, we are moving forward with it...I don't know about Amgen. In biotech, things are possible w/ enough time, effort, and good science.
- We think we are the only company working to create true biogenerics. If this isn't your goal when you start a development program, you certainly won't achieve this. Others, only trying for biosimilars, acknowledged to be different from branded product.
- 2 step process contemplated by FDA. 1) characterization, comare to branded. 2) determine how similar or not...then determine what is required clinical path
- Congressional act that created FOB pathway has interchangeable in the title and that is part of the objective for the healthcare system and the FDA.
- M118: presently in discussions with potenial partners. But hasn't been easy. Crowded space, phase 3 is expensive. Slide: Collaboration listed as 2011 objective
- M402: IND planned for 2011. Multipathway inhibitor with novel mechanism of action. Downregulation of heparin's anticoagulation properties while take advantage of antiproliferative and anti-metastatic properties. Slide: phase 1 trial listed as 2011 objective.
- Follow on biologics (FOBs): in discussions with many of the major players. Will be looking for a partner. Slides: deal not listed as 2011 objective
- With so much cash on balance sheet - when will you increase R&D expenditure rate? Development of our strategy is still in process and will discuss this more as that progresses. FOB could potentially require substantial investment if we want a broad portfolio in the clinic, that could add up to quite a bit. We do believe some clinical work will be needed. We've seen estimates for FOB development for start to commercialization ranging at $100-250m per product. So to get good economics on deal for product, requires you to provide some of the investment in the program. This is all under consideration in partnering discussions.
- If you get lovenox and copaxone thru FDA without trials, why should FOB be different? One difference is cell based manufacturing...we initially assume FDA will want some clinical work. We'll work to minimize this, but must assume this from financial planning perspective.
- It has been a long term search for partners for FOB and M118 - any reason to assume we are any closer today than X months ago? M118 phase 3 trials needs 10,000 + pts...continues to be a challenge. Companies in CV space have been spending a lot of money , especially on oral Xa inhibitors. It has been hard to get their attention and get them to spend on this product.... FOB we always weighing potential benefits of partnerships vs economics. The challenge we face is that the partner has to agree with our fundamental strategy of seeking interchangable biogeneric products. They must agree that the upfront investment will pay off (characterization, cell line engineering). We are cautious about looking to sign a deal too early just to give temporary pop to sock; we are thinking long-term, or creating marketed prouct w/ life over next 8-15 yrs.
- Will FOB deal be product by product vs geography-based vs broad? Generally speaking, we are more likely to do a broad partnership, due to issues of technology, IP, know-how.
- Are you open to acquisition? I think the answer always is, we are a public company, so we probably don't have a choice there
- Rather than developing blockbuster biologics where clinical studies may cost $100m...would you consider orphan products with smaller population and studies, as a "proof of concept" project for working thru pathway with the FDA? It is certainly possible that some of these in portfolio could be large blockbuster, but certainly open to smaller market drugs. There are a variety of considerations to decide what to addres early vs later, they tend to be more scientific/technical related to characterizing the drug, not market related. The right drug for POC could be large or small market, has more to do w/ drug vs market characteristics.