RE: NXP0024 Nov 2021 15:38
GLOBAL MARKET OPPORTUNITY FOR NXP002
We look at the available market opportunity for NXP002 either as a monotherapy or as a combination therapy and in view of the changing landscape. As we have said NFX looks to take the programme to the next inflection point before seeking global business development opportunities. We consider that completion of the anticipated data packages, costing in aggregate approx. £2m over the next 18-months can be a major inflection point in terms of readiness for licensing and with an attractive market opportunity worth $3bn and growing, we calculate that NXP002 could command combined peak sales of £1bn in major markets.
OFEV and Esbriet have an average annual wholesale acquisition cost of $135k/$123k in US and around $65k in Europe. The patent expiry of OFEV and Esbriet could change pricing dynamics and so we use conservative assumptions, around 50% of prices of the incumbents, accepting that in reality this will be determined by clinical efficacy and side effect profile. On one side there will likely be more comparators in the market, but orphan disease status and differentiated modes of administration and mechanisms can justify pricing in line with the branded incumbents. A monotherapy is likely to attract higher pricing than a combination therapy, another factor that is yet to be elucidated.
Assuming that there is an approx. 0.05% prevalence in each population and assuming annual incidence of new cases of around 1.5% in Europe and US, with 60% diagnosed and 33% of the patient pool eligible for treatment, this equates to approx. 32,000 patients in US. 35,600 in Europe and 13,000 in Japan. At 33% penetration and an annual price of £52k in US, £24.5k in Europe and £38.5k in Japan, respectively gives a combined peak sales of £1bn for all major geographies, broken down as follows:
– US peak sales 32,000 x 33% x £52k = £544m
– Europe peak sales 35,600 x 33% x £24.5k = £288m
– Japan peak sales 13,000 x 33% x £38.5k = £164m
In the ‘traditional’ biotech model, drug development is a 10-year minimum process. With abbreviated timelines, a repurposed new physical form could be on the market as early as 2029 in US and Europe and 2030 in Japan following a bridging study, with patent expiry in 2038 (not including potentially available patent term extensions). We consider that the route of development and the fact that underlying drug is already known means that there is a higher likelihood of approval than via the standard drug development model, balancing the fact that NXP002 is a preclinical programme, but with the existing body of tranilast safety and PK data that NFX can leverage.
Considering that NFX is looking to prepare a package suitable for a global license deals for NXP002 in the main markets, this would position it to negotiate upfront, milestones and royalties with a partner proportionate with the stage of development. If it strikes a deal or deals at the preclinical stage then the return is likely to be a globa
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