- I highly recommend listening to the Momenta Pharma $MNTA presentation at Goldman Sachs conference if you are interested in the biosimilars/biogenerics/follow-on biologics (FOBs) story and environment. Sometimes my notes are enough, but I urge you to invest the time to listen to this free flowing q&a session (the webcast link is on the Upcoming Events page)
- Additional information and resources on Momenta can be found on the MNTA research page.
- My complete notes are after the jump- fair warning they are pretty lengthy this time!
- [Note there was no formal presentation by MNTA CEO Craig Wheeler, just q&a moderated by $GS analyst]
- Perspective on what the FDA guidance that will come out later this year will be? The signs we are seeing from FDA are very positive. FDA should not have one set of standards. Body of data determines whether and/or what clinical trials necessary
- Will there be different standards for each product/company? Ultimately, yes.
- Analytics of these complex drugs "are a tractable problem" (as was shown wth enoxaparin approval). MNTA confident they can do full "mass balance characterization" (define and describe all species in the complex mixture of ie, an monoclonal antibody)
- Biologics- need cell line modifications and to choose clones to match manufacturing of innovator (at a base level- must ask/answer: how do cells put molecules together?). If you can't do this, chances of equivalent molecule are very low, hard to achieve substitutable. This is where a lot of research dollars at MNTA have been spent -even before they could afford to advance into clinic. [Note the phrasing confirming that MNTA would now be comfortable conducting at least some form of FOB clinical trials on their own without a partner]
- Branded companies- they really don't see biosimilars for years, many don't think substitutability is possible. Where does MNTA get conviction to be the only one who says otherwise? That is a fair question. Clear discretion for FDA was written into legislation. The burden is on the applicant for characterization and manufacturing. We accept this and others wold have to also.
- MNTA can look at innovator drug and tell which cell line it was made in. Then just have to "move left and right" to alter manufacturing processes
- 351k pathway- as it evolves, one could take EU data, augment the package for US and submit. EPO, GCSF etc, will be first because leg up on clinical work [But these sorts of simple molecules don't interest MNTA for its programs it seems]
- Expect conservativism at FDA. Might not get substitutability until 2016, 2017 time frame. We hope for earlier, but trying to be realistic. But even those dates are earlier than others think
- As w/ Lovenox, MNTA could start later than competitors and still could end up approved first due to reduced clinical trial burden
- Who are your competitors in FOB space? Many have declared, which doesn't surprise him- FOB is a de novo mkt with $20-30b potential- this is unique in healthcare space. But don't think you will find that 20 companies succeed. It will take different stuff to succeed as compared to branded or generic drug space. Compare to mainframe to PC transition-all companies involved had the assets needed, but most failed. They failed because they couldn't challenge their own legacy business. In pharma/FOB, we have this issue in spades. Legacy pharma have completely opposite view on patents, regulatory, clinical trials. This can create internal fights at those companies. So think those that will succeed are those who can externalize the FOB business. Companies have approached MNTA with interest in analytics, but don't want reduced clinical trial requirement for the sake of their existing products.
- There are fewer analytic companies than production companies. How will MNTA decide what path, what options to choose? Company has a plan of how they would like to take programs forward. But we have the cash to take forward for quite a while without partner. A potential partner must bring in capabilites- manufacturing, commercial. Plus must be strategic fit- no competing w/ legacy business. We need freedom to compete effectively. An all-in platform partnership would be best. Many molecules will be available in a short time (ie due to patent expirations)- need resources to work on multiple at same time.
- "Several" potential companies out there. Very few have the lack of concern for legacy. We need a deal structure than allows them to "let it go"
- Comment of potential introduction of Teva lovenox? I am a pragmatist. We have never said they can't come to market. We currently have a generic that does $1b in sales annually, so naturally many companies would like to get an approval. The FDA helped MNTA by setting out the criteria in the TEVA CP response. The newest appliations will take longest to review but have better chance. Immunogencity is a measure of sameness- so either you have a problem with your product or with supply chain. It typically it takes FDA 6-9 months to respond to a minor deficiency letter reply. If it took Teva a couple months to respond, you are looking at end of 2011 as earliest possible launch. If the issues were anything more serious, "all bets off"
- Will teva give up? If I were Bill Marth, why ever give up on $1B mkt. Have lots invested already. Expect them to keep fighting for long time, unless maybe they really need to redo supply chain. Take a look at how hard amphastar is fighting on behalf of their ANDA application
- Conservative company management: all new projects undertaken must have funding to reach mid-2014 -to get to copaxone patent expiration. Ie, they must be viable under a worst case scenario (teva gets immediate lovenox approval and copaxone launch is as late as possible)
- MNTA/NVS/TEVA are all smart business people. Despite rhetoric in public and each's pride in their own business, settlement is always possible and would be strictly a business decision, despite emotonal history between Novartis and Teva. MNTA and NVS/Sandoz are joined at the hip for settlement discussions- neither one can act on their own. Possibility of this outcome will always depends on new info (ie, perceived strenght of patent case)
- What effect on the market for generic copaxone as MS market changes? The new data is great for pts. This will have some impact on copaxone. Gilenya has its own set of side effects. BG-12 ($BIIB) very compelling first trial safety and efficacy data. Next will be head to head trial against Copaxone -could have a significant impact. But regardless Copaxone will still have good sales and will continue to grow because it is much less toxic than interferons. There is real potential for combo of bg-12 plus copaxone (it would be easier to get reimbursement for this if one of the drugs was generic) Current companies have been taking fast price increases, and will eventually face backlash. This has no effect on regulatory actions, but MS community is profoundly upset at 25% y/y price increases and is very supportive of MNTA generic. High prices vastly help rapid adoption of genric at launch. Current great MS franchises at risk of losing patients and payers
- MNTA could already launch at risk upon approval [30 month stay has expired], but trial is coming in sept 2011. MNTA won't go out on a limb about approval timing, (this didn't work several times with lovenox). FDA backlog is growing, now over 30 months. Same staff numbers, each with 3x more documents to review than before. User fees are coming, pretty soon hopefully. These could be in PDUFA 5 or in their own bill. This may not happen quick enough for copaxone (and they hope not at the pace government moves...)
- Generic lovenox supply chain is at capacity, with caveat that this is a market so you have fluctuations month to month. It would take 18-24 months to get a new manufacturing plant online, this is too risky given the current unknown market [ie, possibility of Teva entry]
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