- Almirall acquires option to license rights
to develop and commercialize lebrikizumab for atopic dermatitis in
Europe- Dermira to receive an option fee of $30
million- Lebrikizumab is an investigational anti-IL-13
monoclonal antibody currently in Phase 2b development with topline
data expected by early April 2019
Almirall, S.A. (BME: ALM) and Dermira, Inc. (NASDAQ: DERM)
announced today that the companies have entered into an option and
license agreement under which Almirall has acquired an option to
exclusively license rights to develop and commercialize
lebrikizumab for the treatment of atopic dermatitis and certain
other indications in Europe. In exchange, Dermira will receive an
upfront option fee of $30 million. If Almirall exercises its option
to obtain the license following the results of the ongoing Phase 2b
study, Dermira will receive a $50 million option exercise fee and
will be eligible to receive additional development, regulatory and
sales milestone payments, as well as double-digit royalties.
Lebrikizumab is an investigational monoclonal antibody that
blocks signaling of IL-13, a cytokine that plays a key role in the
pathogenesis of moderate-to-severe atopic dermatitis. Based on the
central role of IL-13 in atopic dermatitis and lebrikizumab’s
unique molecular profile, combining a differentiated mechanism of
action, high affinity for its target and robust pharmacokinetics,
Dermira and Almirall believe targeting IL-13 with lebrikizumab
presents an opportunity to deliver a therapy with 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.
“As a prevalent, debilitating condition with limited treatment
options, moderate-to-severe atopic dermatitis represents a
significant unmet medical need. Almirall shares our commitment to
dermatology and excitement about the opportunity for lebrikizumab
to advance the standard of care for the millions of people living
this condition,” said Tom Wiggans, chairman and chief executive
officer of Dermira. “This transaction is an excellent financial,
operational and strategic fit for Dermira, and we are pleased to
have the opportunity to enlist Almirall’s development and
commercial expertise to help make lebrikizumab available in Europe
while we continue to pursue development and potential
commercialization in the U.S.”
Under the terms of the agreement, Almirall will make an initial
payment of $30 million to Dermira in exchange for an option to
acquire an exclusive license to develop lebrikizumab in dermatology
indications and commercialize lebrikizumab in all indications in
Europe. Following the availability of topline data from Dermira’s
ongoing Phase 2b clinical study of lebrikizumab in
moderate-to-severe atopic dermatitis, Dermira will provide to
Almirall a data package consisting of topline and additional data,
after which Almirall will have 45 days to exercise its option. If
Almirall elects to exercise its option, the company will pay
Dermira an option exercise fee of $50 million.
If Almirall exercises its option, Almirall will be obligated to
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. In addition, Dermira will 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.
“At Almirall, we continue to deepen in our commitment to
dermatology,” said Peter Guenter, chief executive officer of
Almirall. “Atopic dermatitis is a condition that affects millions
of people living in Europe, and we are pleased to support the
development and commercialization of lebrikizumab, a differentiated
treatment that we believe could become a best-in-disease therapy
for these patients. We are excited to be collaborating with Dermira
and look forward to positive results from the Phase 2b study and
subsequently moving into registrational studies.”
Lebrikizumab Phase 2b Study DesignDermira is
conducting a randomized, double-blind, placebo-controlled,
parallel-group Phase 2b study evaluating the safety and efficacy of
lebrikizumab as monotherapy in patients with moderate-to-severe
atopic dermatitis. Based on early clinical experience with
lebrikizumab, the study is designed to build on the body of
evidence supporting targeting of IL-13 in atopic dermatitis by
evaluating three different dosing regimens, with the objective of
optimizing the clinical profile of lebrikizumab and establishing
the dosing regimen for a potential Phase 3 program. The study
enrolled 280 patients ages 18 years and older with
moderate-to-severe atopic dermatitis in the United States,
randomized in a 3:3:3:2 fashion as follows:
- Group 1: A loading dose of 250 mg of
lebrikizumab at week 0, followed by 125 mg of lebrikizumab every
four weeks.
- Group 2: A loading dose of 500 mg of
lebrikizumab at week 0, followed by 250 mg of lebrikizumab every
four weeks.
- Group 3: A loading dose of 500 mg of
lebrikizumab at each of weeks 0 and 2, followed by 250 mg of
lebrikizumab every two weeks.
- Group 4: Placebo at week 0 and every two weeks
thereafter.
The primary endpoint of the study is the percent change in the
Eczema Area Severity Index (EASI) from baseline to week 16. Key
secondary endpoints that will be evaluated during the 16-week
treatment period include: the proportion of patients with a 75
percent improvement from baseline in EASI (EASI-75); the proportion
of patients with an Investigator’s Global Assessment (IGA) score of
0 (clear) or 1 (almost clear) and a reduction of 2 or more points
(on a 5-point scale) from baseline; the proportion of patients
achieving EASI-50 and EASI-90; and changes in pruritus (itch) and
sleep loss scores from baseline, both scored using an 11-point
numerical rating scale (NRS). Key inclusion criteria for patients
enrolled in this study included chronic atopic dermatitis for at
least one year, an EASI score of 16 or greater, an IGA score of 3
or greater, and a body surface area involving at least 10 percent
at screening and baseline. Following the end of the 16-week
assessment period, patients will be followed for an additional 16
weeks. Topline safety and efficacy results from the study are
expected by early April 2019.
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 persistent itching and red, dry, cracked skin that
covers much of the body. The skin 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,
humanized monoclonal antibody designed to bind IL-13 with 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 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 AlmirallAlmirall is a leading skin-health
focused global pharmaceutical company that partners with healthcare
professionals, applying Science to provide medical solutions to
patients & future generations. Our efforts are focused on
fighting against skin health diseases and helping people feel and
look their best. We support healthcare professionals in its
continuous improvement, bringing our innovative solutions where
they are needed. The company, founded 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 major shareholders
and its decision to help others, to understand their challenges and
to use Science to provide them with solutions for real life. Total
revenues in 2017 were 755.8 million euros. It has more than 1,830
employees. For more information, please visit almirall.com
linkedin.com/company/almirall.
About DermiraDermira 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 nine and older) with primary axillary hyperhidrosis
(excessive underarm sweating). Dermira is also evaluating
lebrikizumab in a Phase 2b clinical trial for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and
has early-stage research 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.
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: 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; the opportunity to deliver a product
having a 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; the
hope that lebrikizumab will advance the standard of care for the
millions of people living with atopic dermatitis; the belief that
lebrikizumab could become a best-in-disease therapy for the
treatment of moderate-to-severe atopic dermatitis; the successful
completion of, and timing expectations for the receipt and
announcement of topline data from, the Phase 2b study of
lebrikizumab for the treatment of moderate-to-severe atopic
dermatitis; the potential exercise of the option by Almirall and
the anticipated fees, payments and royalties associated therewith;
future registrational studies of lebrikizumab in patients with
moderate-to-severe atopic dermatitis; potential regulatory approval
and the future availability of lebrikizumab for the treatment of
moderate-to-severe atopic dermatitis; and the anticipated creation
of a growth platform for Dermira and Almirall. 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 current and future
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 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
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 Contacts:
Media: Cohn & WolfeMarta Gállego+34 915 31 42
67marta.gallego@cohnwolfe.com
Investors & Corporate Communications: Almirall Pablo
Divasson del Fraile+34 93 291 30 87pablo.divasson@almirall.com
Dermira Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216erica.jefferson@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@dermira.com
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