Liquid formulations extend Treakisym lifecycle
SymBio has in-licensed two liquid formulations of bendamustine HCl (Treakisym) from Eagle Pharmaceuticals (Eagle). The new formulations will be an important component of Treakisym life cycle management, as they are protected by patents that extend to 2031, whereas orphan exclusivity on the company’s currently marketed FD powder Treakisym product expires in October 2020. The new formulations are more convenient for healthcare workers and patients and will be important advantages as SymBio seeks to switch users away from the FD formulations.
The first in-licensed product is a ready-to-dilute (RTD) liquid formulation that will significantly reduce dose preparation time, making it easier and safer for health professionals. This compares to the FD Treakisym which has to be reconstituted before administration, is time consuming and carries the risk of exposing healthcare workers to cytotoxic powders and vapors.
The second in-licensed product is a rapid-infusion (RI) formulation that will cut drug infusion time to 10 minutes from 60 minutes for the current Treakisym product (and the RTD formulation).
Exhibit 4 illustrates the differences in usage between the current FD Treakisym and the new liquid RTD and RI formulations.
Exhibit 4: Comparison of the current FD powder and new liquid formulations
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Liquid formulations aim to maintain SymBio’s market share
We expect the approval pathway for the RTD Treakisym formulation to be relatively straightforward, as the same dose of drug is administered to patients in the same way, with the only difference being in the way the dose is prepared. SymBio is aiming to launch the RTD product in H121, which would allow the product to be well established in the marketplace before the expected entry of the first FD generics in 2022.
The RI product represents a greater change to the current treatment protocols, so approval of this product is expected to take longer – we model a 95% chance of a launch by the start of 2023. Given the greater convenience for patients of the rapid 10-minute infusion with the RI formulation, we expect over 95% of patients to be switched to this product.
SymBio is pursuing a similar strategy to that adopted by Teva in the US, where it markets bendamustine HCl under the brand names Treanda and Bendeka. Teva in-licensed the RI bendamustine HCl formulation from Eagle and now markets it as Bendeka.
Teva launched an RTD liquid formulation of Treanda in November 2014; it launched the Bendeka RI product in January 2016. FD Treanda powder for injection is still available, but its use has substantially declined in favor of Bendeka. Eagle disclosed in a corporate presentation in September 2017 that Bendeka has achieved a 97% market share in the US, which is testament to the appeal of the short infusion time.
Orphan exclusivity for SymBio’s Treakisym expires in October 2020, so the first generic copies of the FD Treakisym powder could be launched as early as the start of 2022. This means that SymBio may have less than 12 months to convert clinicians to using the liquid Treakisym formulations before the launch of the first FD Treakisym generics. This shorter time period creates additional uncertainty as to how large a market share the RTD and RI products will be able to gain before they potentially face competition from FD generics.
In our forecasts we model SymBio’s strategy being quite successful at maintaining market share, with dry powder Treakisym generics slowly growing market share from 2022 onwards to reach 25% market share by 2031, in line with company guidance. We model the growth in Treakisym generics’ market share accelerating in 2032 after the patents on the liquid formulations expire.
In our scenario analysis on page 10, we note that if Treakisym generics were to gain a 50% market share by 2031 (vs 25%), this would reduce our valuation by around $20m ($0.3/ADR).
Self-commercialization after 2020 preferred for Treakisym
Treakisym is currently marketed by Eisai under a business partnership agreement which expires in December 2020. SymBio’s mid-range plan is to shift Treakisym sales to its own salesforce from 2021 in order to improve profitability, which it rates as a top priority. We estimate that SymBio could earn an operating profit margin of 50% of net sales of Treakisym under a self-commercialization model.
SymBio intends to make a decision regarding the establishment of its salesforce in 2018, after considering the progress of development of rigosertib IV, as well as the timing of introducing new drug candidates for development. It has included an allowance for expenses related to the establishment and operation of its own salesforce in its performance targets from 2019 onwards, with hiring expected to begin in 2019 so that the salesforce can be fully operational from the start of 2021.
While the company has not yet made a final decision, we have formed the view that establishing its own salesforce is the most likely strategy that SymBio will pursue. In light of this assessment we have now adopted the self-commercialization of Treakisym after 2020 in our base-case forecasts (we previously considered this option in scenario analysis).