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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