Client Challenge: The client, a US biotechnology firm, had a novel mid-stage drug – both in terms of MOA and route of administration — for two indications in women’s health. The client needed to ensure that the drug had sufficient economic development to warrant development and decide which indication to pursue first.
Our Approach: Working with our client we developed a brief on the drug, including a Target Product Profile and putative clinical trial data. This served as the basis for a series of in-depth interviews with clinicians treating the two indications to understand the level of unmet medical need and the patients for whom they would prescribe the drug. Using this information, as well a review of the current and future markets, we built a forecast model that allowed us to value each indication and determine the preferred indication.
Results: Based on our study, we were able to advise the client on an indication that had both the highest economic value and the clearest and shortest path to approval. The client used our findings to secure next stage funding.
Client Challenge: A biotechnology company was considering developing an early-stage asset for hypercholesterolemia, but was concerned that the existing drugs, primarily the statins, left little unmet medical need or market potential for their asset.
Our Approach: Working with our client, we developed a Target Product Profile for the drug, which we then tested in a series of in-depth interviews with a broad range of physicians – academicians, specialists, and PCPs – treating hypercholesterolemia. The goal of these interviews was to both assess level of unmet medical need and the type of clinical evidence – clinical trial endpoints – required for acceptance.
Results: Our interviews disclosed a number of important findings. First, there was a divergence among types of physicians regarding unmet needs, with those most actively involved in treating patients perceiving significant unmet needs and academicians far less so. Second, the level of evidence required for physician use did not require large and lengthy outcomes trials. Based on our recommendations the company decided to continue pursuing development of the drug.
Client Challenge: An ex-US biotechnology firm with a novel approved drug needed to ascertain the optimal method of entering the US market in terms of both indications to be pursued and prescription or OTC status.
Our Approach: BioAsset employed a dual-pronged methodology to address our client’s needs. We profiled the US market for current comparable drugs in both the Rx and OTC markets to establish comparables and determine the potential size of the market. We also conducted extensive primary market research with a broad cross section of physicians to understand their propensity to prescribe/recommend the drug as either an Rx or OTC and also ascertain the level of clinical evidence required for acceptance.
Results: Based on our work, a strong recommendation was made that the drug be used in both pediatric and adult indications as a prescription drug, which was agreed to by the client. The company was subsequently acquired by a global pharmaceutical company at an attractive valuation based, in part, on the US market potential for the drug that we demonstrated.