A timely and well targeted response.
Just to reformat and edit some of this Bell report to make it easier to process:
"MSB’s existing cash reserves provide cash runway to end of FY17.
2 interim analyses from Phase III trials in 1QCY17 could be the trigger for partnering deals: These include interim analysis from the Phase III CHF (congestive heart failure) trial and the Phase III CLBP (Chronic low back pain due to disc degeneration).
Temcell aGVHD
(Japan) FY17 will be the first full year of sales from launch and as such good adoption and uptick in revenues for MSB, will not only alleviate cash burn but also set the stage for expectations for the much larger US market.
aGVHD MSC-100-IV (Ex-Japan markets)
We expect Top-line results in 2QCY17. MSB expects to file for approval in the US by mid CY17, positioning it for FDA approval by end of 4QCY17.
CHF MPC-150-IM:
We expect that the interim analysis will be based on 12 month follow up of the majority of the 240 patients already recruited in the trial. The FDA’s independent data monitoring committee (DMC) will look at the data on primary end point of the trial and provide their recommendation to MSB based on pre-specified thresholds.
A positive recommendation to continue the trial as per protocol (already reached) OR that it meets the test of overwhelming efficacy at that point will strengthen the partnering prospects of this asset.
Back Pain MPC-06-ID
(3 arms of trials) The first interim analysis from this back pain Phase 3 trial will be released in 1QCY17. MSB has received written guidance from the FDA around the approvable endpoints, the thresholds for each to show benefit and the time points of 12 months and 24 months. The positive Phase 2 results displayed overall treatment success of MPC treatment using the end-points being used in Phase 3 and also showed durability of effect. This bodes well for prospects of success in the ongoing Phase 3 trial. In our view, the commercial prospects for MPC-06-ID in back pain is very strong and if comparable results to Phase II are achieved in the Phase III trials, it will leave MSB with a potential blockbuster product with attractive licensing prospects. MSB continues to be in advanced partnering discussions with major companies for this back pain product. The potential partners include companies with existing presence and distribution capabilities in this space. We are optimistic of a deal materialising in FY17.
Rheumatoid arthritis RA (MPC-300-IV)
24 weeks data from Phase II Rheumatoid Arthritis Trial due in 4QCY16 While MPC treated patients performed better over placebo on ACR20 response criteria, the difference in benefit was even more profound on the ACR50 and ACR70 response criteria, which clearly suggests that the drug has biological activity. This positive data makes us believe that MPCs are well positioned to be a preferred 1st-line agent in treatment of biologic refractory RA patients. MSB will look to partner the asset to move the product forward into Phase 3 development. We believe that MSB should be able to attract a strategic partner in the next 12 months to move the program forward. Our belief is based on the strength of the results seen so far, as well as the high interest and licensing/M&A activity seen in this space. RA is a space in which most big and specialty pharma companies are active in.
This high interest from multiple parties ensures that the negotiating power of a company such as MSB able to provide strong mid-stage results is high. Most of the deals in this space have been between ~$1bn-$1.5bn and front loaded with upfront payments of ~$100-$175m, with some exceptions having upfront payments as high as $725m. Given the multi-billion dollar market opportunity and threat of biosimilars and upcoming patent expiries of the top selling RA drugs we are not surprised either by the high partnering activity or the high value deals in the space. MSB will report further 24 weeks data from the trial in 4QCY16, which would give additional insights into the durability of the clinical benefit seen with MPC treatment. If results at 24 weeks are consistent with benefits observed at 12 weeks, it should further enhance the partnering prospects of MPC-300-IV."
[My comment:
Overall, it validates the view that many of us have had that strategically it makes sense for the future partners and MSB to hold back and wait for the confirmation of clinical trials, it makes their positions more certain but importantly MSB has the security of being financed through to end 2017 which strengthens their bargaining power. It also has the security of knowing the robustness of previous clinical trials are likely to continue. This is what I have referred to in the past as being that the risks with respect to the science are largely baked out. This is a subjective but logical view of mine. Others may disagree but they had better have some good rationale rather than blind fear. Remember, there is no risk to the patient, the only remaining risk is in relation to efficacy and MSB is demonstrating time and again not just efficacy but that the most damaged patients get the highest benefit. This places us in the most lucrative end of renumeration. Bedridden patients are extremely expensive, so eliminating that cost with a therapy provides colossal benefits which can be expected to be reflected in remuneration. This is in the mix of factors which would be included in any deal.
Simply put, it means that rather than grab at the nearest and cheapest deal being offered, MSB can hold out for much more lucrative deals, because it's not in a position of desperation. Much as some posters like to pretend otherwise.....]
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