# Is it possible to sell/partner on drug application in each pillar separately?
Yes - although I think they would only do this at a regional level (most likely Asia because of the size of the markets there and RACE's MD Philip Lynch has M&A experience in Asia from his days at J&J).
Until such time that RACE achieve a buyout or partnership with a Big Pharma which are focused on the big US/Canadian, European markets (top 5 Europe) and Australia, RACE will aim to retain 100% of the rights for Bisantrene for all indications. If RACE don't do this they will limit the amount that a Big Pharma is willing pay in a partnership or buyout deal.
I found some good data on the size of the global pharmaceutical market.
The chart below is confusing but the 2017 bars are the size of the market at 2017 and the 2022F bars are the overall size of the market at 2022, hence the USD $37B growth mentioned for China (from USD $123B to USD $160B).
You can see that the bulk of the revenues are from US. You can see why Big Pharma is focused on this market and approvals in this market. For Europe you need to look at the top 5 ( Germany, France, Italy, UK, Spain). If you combine these you get USD $187B, which is comparable to the Chinese market (USD $160B) and both of these markets are dwarfed by US at USD $600B in 2022.
Also in the report is this table on Deals - both the upfront value and the total value. The data covers a 4 year window from 2013 to 2017 and is across multiple indications so doesn't tell us the averages that apply for Oncology (which would be higher).
So on these figures USD $18M to USD $27M upfront for a regional deal. Allowing for inflation and RACE having a focus on oncology which has greater $ investment in the industry, plus the clinical history and the emergent new preclinical data I think fair to say that these numbers are conservative.
# How might milestone payments really work
Here's an example. It's for patient enrolment in a pivotal trial (that is a trial that can be used as basis for approval). RACE are planning for their EM AML trial to be a pivotal trial using the FDA 505(b)(2) pathway.
# How long do we have entitlement to drug revenues? what do we actually own here? what does orphan drug designation and priority paediatric designation mean. are the latter terms special rights granted to us as owners or are they the restricted nature of ownership. I mean if you only have the rights to drug revenues for 7 years, saving/losing a year on development is a large slab of potential cash flows.
The Orphan Drug designation grants 7 years commercial exclusivity for the drug from the time of approval. This relates to the use of the drug for rare diseases such as AML.
This means that if the drug is approved in 2022 there will be commercial exclusivity to 2029. Important to note that it is common to see drugs launched within 2-3 months of approval being achieved ( I have another post with data on this somewhere ).
Patent protection provides provides an additional layer of commercial protection. Patent protection is something that the pharma industry are quite smart about. There are lots of strategies they can employ to extend commercial protection.
RACE have a first layer of protection their initial patents - how the drug is used and formulated, use of the drug in combination. The MST report has a good summary of all the patents - a large number in play.
The generic patents provide general protection of formulation ( including preventing analogues ) as well as use of cancer. Then a second layer of specific indications is added.
29 December I found this data with a google search:
Priority Review Voucher
From July 2018 presentation:
RAC Price at posting:
$3.49 Sentiment: Buy Disclosure: Held
(20min delay)