Challenge:

An inflammation and oncology-focused biotech company was looking to expand the clinical footprint of one of its phase II products. Our client was discussing the potential positioning of this product in three different patient segments in combination with ruxolitinib for the treatment of myelofibrosis (MF). The client reached out to Alacrita for help in analyzing the rationale and opportunity in each of these patient settings and to map out a clinical development plan (CDP) and estimate the market potential that could be addressed in these MF patient settings.

Solution:

We started out by working alongside our client to develop a TPP for each of the target patient populations, outlining the achievable and competitive set of product performance parameters. We derived information from critical analysis of the current disease burden and unmet medical need, treatment guidelines and available therapies, patient journey and disease course, standards of care, clinical trial and price benchmarking of approved therapies and analysis of the current competitor pipeline and market dynamics. These TPPs included an indication statement, target patients at launch, dose form and administration (including combinations), clinical efficacy requirements, safety and tolerability thresholds, potential warnings, precautions and restrictions, a value proposition, outcomes data, product pricing and assumed dates for launch and loss of market exclusivity.

We then proceeded to establish a development path for the asset in the three populations, outlining the characteristics of the phase II and phase III trials. We performed a benchmark analysis of other drugs developed for MF with a special focus on those with the same mechanism of action as our client's asset.

We also reviewed the prescribing information and clinical development history of relevant drugs approved in the target indications to ultimately derive insights on the number, structure, size, duration and cost of these trials and the primary and secondary endpoints to include.

Finally, we characterized the peak year sales potential for this asset in the US if launched as described in the TPP.

 


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