- Lebrikizumab is a novel, investigational anti-IL-13 monoclonal
antibody under development for the treatment of people with
moderate-to-severe atopic dermatitis
- Dermira to receive an option exercise fee of $50 million and
additional potential milestone payments and royalties
- Dermira expects to initiate Phase 3 program by end of 2019
Almirall, S.A. (BME: ALM) and Dermira, Inc. (NASDAQ: DERM)
announced today that Almirall has exercised its option to license
rights to develop and commercialize lebrikizumab for the treatment
of atopic dermatitis and certain other indications in Europe.
Almirall and Dermira previously entered into an option and license
agreement in February 2019 pursuant to which Almirall was granted
this exclusive option in exchange for an upfront option fee of $30
million. As a result of Almirall’s decision to exercise its option,
the company will pay Dermira $50 million, and Dermira will be
eligible to receive additional payments upon the achievement of
certain milestones, including $30 million in connection with the
initiation of certain Phase 3 clinical studies.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20190624005834/en/
Almirall’s decision follows positive topline results reported by
Dermira in March 2019 from a Phase 2b dose-ranging study that
showed all three doses of lebrikizumab met the primary endpoint,
and demonstrated dose-dependent improvements across a range of
measures characterizing the signs and symptoms of
moderate-to-severe atopic dermatitis, including itch and skin
inflammation, compared to placebo. The safety profile observed in
the study was consistent with prior studies of lebrikizumab. The
findings suggest that lebrikizumab has the potential to be a
best-in-disease therapy for people living with moderate-to-severe
atopic dermatitis. Following an end-of-Phase 2 meeting with the
U.S. Food and Drug Administration, Dermira plans to initiate a
Phase 3 clinical development program for lebrikizumab by the end of
2019.
“We are incredibly pleased to collaborate with Dermira on the
lebrikizumab clinical development program and excited by the
prospect of delivering what could be a best-in-disease therapy for
people living with moderate-to-severe atopic dermatitis in Europe,
which Almirall believes could achieve potential peak sales of
around €450 million euros,” said Peter Guenter, chief executive
officer of Almirall. “This transaction reinforces our shared
commitment to the dermatology community and supports our vision of
offering truly meaningful, new treatment advances to people living
with chronic, life-altering skin conditions.”
Lebrikizumab is a novel, injectable, humanized monoclonal
antibody designed to bind interleukin-13 (IL-13) with very high
affinity, specifically preventing the formation of the
IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling,
thereby inhibiting the biological effects of IL-13 in a targeted
and efficient fashion. IL-13 is believed to be a central pathogenic
mediator that drives multiple aspects of the pathophysiology of
atopic dermatitis by promoting type 2 inflammation and mediating
its effects on tissue, resulting in skin barrier dysfunction, itch,
skin thickening and infection.
Under the terms of the option and license agreement entered into
between Almirall and Dermira in February 2019, Almirall paid
Dermira an upfront option fee of $30 million in exchange for an
option to acquire an exclusive license to develop lebrikizumab in
dermatology indications and commercialize lebrikizumab in all
indications in Europe. As a result of its decision to exercise its
option, Almirall will pay Dermira an option exercise fee of $50
million. In addition, Almirall will make additional payments to
Dermira upon the achievement of certain milestones, including $30
million in connection with the initiation of certain Phase 3
clinical studies and up to $85 million upon the achievement of
regulatory milestones and the first commercial sale of lebrikizumab
in Europe. Dermira will also be entitled to receive milestone
payments upon the achievement of certain thresholds for net sales
of lebrikizumab in Europe, as well as royalty payments representing
percentages of net sales that range from the low double-digits to
the low twenties.
“The unique characteristics of lebrikizumab and positive
findings observed in our Phase 2b dose-ranging study suggest that
we have the potential to offer people living with
moderate-to-severe atopic dermatitis, and the healthcare
practitioners who care for them, a differentiated treatment option
that delivers a compelling combination of safety, efficacy,
tolerability, convenience and ease of use,” said Tom Wiggans,
chairman and chief executive officer of Dermira. “As we look to
initiate our Phase 3 program by the end of this year, Dermira is
pleased to partner with Almirall to potentially bring this exciting
new treatment option to patients in Europe, while we continue to
pursue development and potential commercialization in the United
States.”
About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema,
a chronic inflammatory condition that can present as early as
childhood and continue into adulthood. A moderate-to-severe form of
the disease is characterized by rashes on the skin that often cover
much of the body and also includes redness, cracking, dryness and
intense, persistent itching. The condition can have a negative
impact on patients’ mental and physical functioning, limiting their
daily activities and health-related quality of life. Patients with
moderate-to-severe atopic dermatitis have reported a larger impact
on quality of life than patients with psoriasis.
About Lebrikizumab
Lebrikizumab is a novel, injectable, humanized monoclonal
antibody designed to bind IL-13 with very high affinity,
specifically preventing the formation of the IL-13Rα1/IL-4Rα
heterodimer complex and subsequent signaling, thereby inhibiting
the biological effects of IL-13 in a targeted and efficient
fashion. IL-13 is believed to be a central pathogenic mediator that
drives multiple aspects of the pathophysiology of atopic dermatitis
by promoting type 2 inflammation and mediating its effects on
tissue, resulting in skin barrier dysfunction, itch, skin
thickening and infection.
About Almirall
Almirall is a leading skin-health focused global pharmaceutical
company that partners with healthcare professionals, applying
Science to provide medical solutions to patients and future
generations. Our efforts are focused on fighting skin health
diseases and helping people feel their best. We support healthcare
professionals in continuous improvement, bringing our innovative
solutions where they are needed.
The company, founded almost 75 years ago and with headquarters
in Barcelona, is listed on the Spanish Stock Exchange (ticker:
ALM). Almirall has become a key element of value creation to
society according to its commitment with its shareholders and its
decision to help others by understanding their challenges and using
Science to provide solutions for real life. Total revenues in 2018
were 811 million euros. Almirall has more than 1,800 employees.
For more information, please visit almirall.com
About Dermira
Dermira is a biopharmaceutical company dedicated to bringing
biotech ingenuity to medical dermatology by delivering
differentiated, new therapies to the millions of patients living
with chronic skin conditions. Dermira is committed to understanding
the needs of both patients and physicians and using its insight to
identify, develop and commercialize leading-edge medical
dermatology products. The company’s approved treatment, QBREXZA™
(glycopyrronium) cloth, is indicated for pediatric and adult
patients (ages 9 and older) with primary axillary hyperhidrosis
(excessive underarm sweating). Please see the QBREXZA prescribing
information. Dermira is evaluating lebrikizumab for the treatment
of moderate-to-severe atopic dermatitis (a severe form of eczema)
and plans to initiate a Phase 3 clinical development program by the
end of 2019. Dermira also has early-stage research and development
programs in other areas of dermatology. Dermira is headquartered in
Menlo Park, Calif. For more information, please visit
http://www.dermira.com. Follow Dermira on LinkedIn, Instagram and
Twitter.
In addition to filings with the Securities and Exchange
Commission (SEC), press releases, public conference calls and
webcasts, Dermira uses its website (www.dermira.com), LinkedIn page
(https://www.linkedin.com/company/dermira-inc-), corporate
Instagram account (https://www.instagram.com/dermira_inc/) and
corporate Twitter account (@DermiraInc) as channels of distribution
of information about its company, product candidates, planned
financial and other announcements, attendance at upcoming investor
and industry conferences and other matters. Such information may be
deemed material information and Dermira may use these channels to
comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Dermira’s website, LinkedIn
page, Instagram and Twitter accounts in addition to following its
SEC filings, news releases, public conference calls and
webcasts.
Dermira Forward-Looking Statements
The information in this news release contains forward-looking
statements and information within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to
the “safe harbor” created by those sections. This news release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements with respect to: the
anticipated timing and initiation of Dermira’s Phase 3 clinical
development program of lebrikizumab for the treatment of
moderate-to-severe atopic dermatitis; the potential milestone
payments and royalties payable to Dermira under the terms of the
option and license agreement entered into between Almirall and
Dermira; the belief that lebrikizumab could become a
best-in-disease therapy for the treatment of moderate-to-severe
atopic dermatitis; the opportunity to offer a differentiated
treatment option that delivers a compelling combination of safety,
tolerability, efficacy, convenience and ease of use to people
living with moderate-to-severe atopic dermatitis and the healthcare
practitioners who care for them; Dermira’s plans to continue to
pursue the development and potential commercialization of
lebrikizumab in the United States; Almirall’s plans to bring
lebrikizumab as a new treatment option to patients in Europe and
Almirall’s belief that sales of lebrikizumab in Europe for the
treatment of moderate-to-severe atopic dermatitis could achieve
potential peak sales of around €450 million; Dermira’s goal of
bringing biotech ingenuity to medical dermatology by delivering
differentiated, new therapies to the millions of patients living
with chronic skin conditions; Dermira and Almirall’s shared vision
of offering truly meaningful, new treatment advances to people
living with chronic, life-altering skin conditions; and potential
regulatory approval and the future availability of lebrikizumab for
the treatment of moderate-to-severe atopic dermatitis in the United
States and in Europe. These statements deal with future events and
involve known and unknown risks, uncertainties and other factors
that may cause actual results, performance or achievements to be
materially different from the information expressed or implied by
these forward-looking statements. Factors that could cause actual
results to differ materially include risks and uncertainties such
as those relating to the design, implementation and outcomes of the
clinical trials; dependence on third-party clinical research
organizations, manufacturers, suppliers and distributors; the
outcomes of future meetings with regulatory agencies; Dermira’s
ability to develop and maintain collaborations and license products
and intellectual property; Dermira’s ability to attract and retain
key employees; Dermira’s ability to obtain necessary additional
capital; market acceptance of Dermira’s current and potential
products; the impact of competitive products and therapies;
Dermira’s ability to manage the growth and complexity of its
organization; Dermira’s ability to maintain, protect and enhance
its intellectual property; and Dermira’s ability to continue to
stay in compliance with its material contractual obligations,
applicable laws and regulations. You should refer to the section
entitled “Risk Factors” set forth in Dermira’s Annual Report on
Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other
filings Dermira makes with the SEC from time to time for a
discussion of important factors that may cause actual results to
differ materially from those expressed or implied by Dermira’s
forward-looking statements. Furthermore, such forward-looking
statements speak only as of the date of this news release. Dermira
undertakes no obligation to publicly update any forward-looking
statements or reasons why actual results might differ, whether as a
result of new information, future events or otherwise, except as
required by law.
Almirall Disclaimer
This document includes only summary information and does not
intend to be comprehensive. Facts, figures and opinions contained
herein, other than historical, are "forward-looking statements".
These statements are based on currently available information and
on best estimates and assumptions believed to be reasonable by the
Company. These statements involve risks and uncertainties beyond
the Company's control. Therefore, actual results may differ
materially from those stated by such forward-looking statements.
The Company expressly disclaims any obligation to review or update
any forward-looking statements, targets or estimates contained in
this document to reflect any change in the assumptions, events or
circumstances on which such forward-looking statements are based
unless so required by applicable law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190624005834/en/
Almirall Contacts: Media: bcw Adriana Ibargüen +34 913 84
67 20 adriana.ibarguen@bcw-global.com
Investors & Corporate Communications: Almirall Pablo
Divasson del Fraile +34 93 291 30 87
pablo.divasson@almirall.com
Dermira Contacts: Media: Erica Jefferson Vice President,
Corporate Communications 650-421-7216 media@dermira.com
Investors: Andrew Guggenhime Chief Financial Officer
650-421-7200 investor@dermira.com
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Apr 2023 to Apr 2024
