EXTON, Pa., Feb. 10, 2021 /PRNewswire/ -- Despite the potential for setbacks brought forth by the COVID-19 pandemic, Amgen recently reported strong year-over-year growth for their newly acquired psoriasis (PSO) and psoriatic arthritis (PsA) agent, Otezla.¹ In late 2019, the brand was sold to Amgen in order to clear the path for Bristol-Myers Squibb's acquisition of Celgene, considering future regulatory conflicts with BMS' pipeline psoriasis drug, deucravacitinib, an oral TYK2 inhibitor anticipated to be in direct competition with Otezla.

Amgen's purchase of Otezla strengthens the company's long-standing immunology portfolio, including TNF inhibitor, Enbrel, which has been approved in RA for over two decades and also holds a dual PSO/PsA indication. However, according to ongoing feedback collected from US dermatologists and rheumatologists included in Spherix's RealTime Dynamix™ services, rheumatologists are much more likely than dermatologists to view Amgen as a strong corporate partner. This is particularly due to a lackluster performance of Enbrel in psoriasis compared to recently introduced competitors, including IL-17 inhibitors (Novartis' Cosentyx, Eli Lilly's Taltz, and Ortho Dermatologics' Siliq) and IL-23 inhibitors (Janssen's Tremfya, Sun Dermatology's Ilumya, and AbbVie's Skyrizi).

The addition of Otezla to Amgen's portfolio presents an opportunity for the manufacturer to bolster their presence in the dermatology sector and shine a new light on the PDE-4 inhibitor under their management. Though Amgen still has their work cut out for them, as the majority of dermatologists surveyed at the end of last year did not agree that they will increase their use of Otezla now that Amgen is the manufacturer.

However, Otezla became more top of mind for dermatologists when adjusting to the shifting dynamics caused by the COVID-19 pandemic. In the most recent wave of Spherix's Special Topix™: Multi-Specialty Impact of COVID-19, fielded last month, one-third of surveyed dermatologists indicated they were more likely to prescribe Otezla now than they were prior to the pandemic.

Additionally, more respondents reported they are most comfortable prescribing Otezla to new patients and continuing established patients on the oral drug via telemedicine than they are any other inquired advanced mechanism. As for drivers behind systemic brand choice, nearly one-half of dermatologists indicate required monitoring, administration (IV, SC, oral), and safety profile are more important drivers than prior to the pandemic – all aspects that work in favor of an Otezla prescription.

In their Q4 earnings call, Amgen also announced the upcoming label expansion for the mild to moderate psoriasis indication is coming this quarter.² Spherix reports that dermatologists are already comfortable prescribing the brand to less severe PSO patients, as Otezla share for mild PSO has been approximately 5% since 2016. Nonetheless, feedback from the Q4 2020 wave of the RealTime Dynamix™ report reveals 31% of dermatologists report a formal mild indication would have a high impact on prescribing – possibly bringing additional lift to the brand and giving it solid placement in the pre-biologic realm.

Spherix's RealWorld Dynamix™ service examines the naïve and switched psoriasis patient populations via retrospective, large-scale chart audits. In the 2020 new starts audit, Spherix confirms Otezla's strong positioning in the pre-biologic PSO segment. The brand continues to dominate as a first-line advanced systemic option, mainly a result of the agent's oral administration and safety. However, Otezla use diminishes as a patient advances in lines of therapy, making it imperative to secure and grow the pre-biologic space.

Holding on to the Otezla patients may be harder, particularly as practice patterns return to normal and patient flow resumes to pre-COVID levels. Indeed, according to Spherix's switching audit (conducted in late 2020), 71% of all psoriasis patients switching from Otezla did so due to lack of efficacy– a figure significantly higher than all currently available biologics. Additionally, while Otezla is typically applauded for its safety profile, tolerability (namely GI issues) poses a threat for the brand. Demand for Otezla is typically driven by patient preference for the oral formulation and safety considerations.

BMS recently announced positive topline results from a Phase 3 trial evaluating deucravacitinib in plaque psoriasis, including meeting key secondary endpoints of achieving superiority to Otezla in the proportion of patients reaching PASI 75 and sPGA 0/1 at Week 16.³ Yet, Amgen remains positive at the prospect of oral competition, stating in their Q4 earnings call, "We think we've got a good opportunity for growth… We also said when we gave that guidance that it assumed a successful competitive program from the TYK2 asset."²

Interestingly, the RealWorld Dynamix™ switching audit also revealed that patients who were switched to (or currently treated with) Otezla were most likely to be considered candidates for deucravacitinib and Eli Lilly's mirikizumab, had the pipeline agents been commercially available.

Will Otezla's double digit growth continue past the pandemic? Will Amgen be able to differentiate the brand enough from incoming oral competition? How much will an official FDA indication for mild plaque psoriasis boost the brand? How much will Otezla cannibalize Enbrel as both compete for the first-line advanced systemic patients? Spherix will continue to dive deep into the impacts of these shifting market events.

About Our Services
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the "why" behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

Special Topix™: Multi-Specialty Impact of COVID-19 (US) is an ongoing series of monthly monitoring that evaluates the impact of COVID-19 on physicians and their practices – including, but not limited to, the utilization of telemedicine, at-risk patient groups, key concerns, support from industry, and future changes in prescribing patterns. Specialty reports are available for dermatology, gastroenterology, nephrology, neurology, and rheumatology.

Learn more about our services here.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

Sources:

1. Q4 2020 Amgen Earnings Conference Call Presentation. Amgen. February 2, 2021. https://investors.amgen.com/static-files/f4ddd625-93ef-4f9c-bc28-db0e42026709 

2. Amgen Inc. (AMGN) CEO Bob Bradway on Q4 2020 Results - Earnings Call Transcript. Seeking Alpha. February 2, 2021. https://seekingalpha.com/article/4402916-amgen-inc-amgn-ceo-bob-bradway-on-q4-2020-results-earnings-call-transcript

3. Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast). BMS. February 2, 2021. https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-from-Second-Pivotal-Phase-3-Psoriasis-Study-Showing-Superiority-of-Deucravacitinib-Compared-to-Placebo-and-Otezla-apremilast/default.aspx

For more information contact:
Kristen Henn, Business Development Manager
Email: info@spherixglobalinsights.com
www.spherixglobalinsights.com

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SOURCE Spherix Global Insights