Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) Q2 2020 Earnings Conference Call - Final Transcript
Aug 10, 2020 • 04:30 pm ET
study. Our expectation is that one of these new dosing paradigm may minimize dose interruption, dose modification and potentially further enhance anti-tumor activity. We remain very optimistic about this program and look forward to updating you in future.
I will now turn it over to Tom for an update on ROLONTIS.
Thanks, Francois. Our PDUFA date is just over two months away. We are actively engaged in our commercial build-out and we would like to provide an update on the market opportunity and the progress we are making in our preparations for launch. First and foremost, we are ready and look forward to competing, if approved. We are investing a great deal of time, effort and research into our strategy and plan of execution.
Let me begin by sharing with you a perspective on the long-acting GCSF market. This market represents a compelling opportunity as it is still a $3-plus billion market despite several biosimilar entrants. Customers have demonstrated a willingness to change and there remains ample opportunity for a new entrant, especially a novel product like ROLONTIS. In addition to the deep market knowledge we have within the company, we have done a great deal of qualitative and quantitative research to understand what ultimately drives customer behavior.
Let's start with safety and efficacy. The Phase 3 program for ROLONTIS demonstrated safety and efficacy that was non-inferior to pegfilgrastim in over 600 patients with the primary endpoint of cycle one duration of severe neutropenia. While our head-to-head studies were designed to prove non-inferiority, it does not mean that these assets are the same. There are notable clinical differences that will be important considerations for customers. Severe neutropenia is viewed as a precursor to SN risk and associated complications. We know that for patients who have severe neutropenia, it most often occurs in the first cycle. We also know that for each additional day of severe neutropenia, a patient's risk of hospitalization increases by 30%. When looking at the results from our head-to-head Phase 3 program, ROLONTIS was effective at minimizing severe neutropenia in the first cycle.
Additionally, the safety profile was comparable to that of pegfilgrastim. The results of our ADVANCE trial are now available in the most recent edition of The Oncologist and the results from the identically designed RECOVER trial are now available in Cancer Medicine. These data highlights the impact of ROLONTIS on neutrophil activity, the potential benefit for patients and the value of a novel product in this space, the first in over 15 years.
In addition, a novel product like ROLONTIS enables continued development to achieve its full potential. The details of our pre-clinical and clinical findings offer a platform to enhance customer awareness prior to launch. There are 19 articles and abstracts published, presented or peer-reviewed across a range of scientific forums. Additionally, our development program had over 100 U.S. sites, which increases KOL familiarity with the product's clinical profile.
Furthermore, we continue to invest in this asset and maximize its potential as a