Dermira, Inc. (NASDAQ:DERM) and UCB (Euronext:UCB) today announced
the companies have agreed to end their development and
commercialization agreement for CIMZIA (certolizumab pegol) in
psoriasis. Following positive Phase 3 clinical trial results, UCB
and Dermira announced U.S. and EU regulatory submissions for CIMZIA
for the treatment of moderate-to-severe chronic plaque psoriasis in
July of this year. Pending regulatory approval, UCB remains
committed to commercializing CIMZIA in psoriasis worldwide.
Dermira expressed its intent to terminate the collaboration
agreement, and Dermira and UCB have entered into a transition
agreement to effect an orderly transition of the development and
commercialization activities, pursuant to which UCB will regain
U.S. and Canadian development and commercialization rights for
CIMZIA for the treatment of psoriasis. Both parties will undertake
a transfer of data and Dermira will not participate in any future
development or commercialization activities for the product. The
collaboration agreement will terminate on February 15, 2018 and the
companies anticipate the completion of the transition by such
date.
“This decision reflects a careful review of Dermira’s strategic
priorities and our focus on our other late-stage product
candidates, in particular, on the launch preparedness and execution
for glycopyrronium tosylate,” said Tom Wiggans, chief executive
officer at Dermira. “We are proud of our partnership with UCB and
the development objectives that we achieved to date, and we remain
committed to the millions of patients with skin conditions and the
healthcare professionals who serve them. If approved, we believe
that CIMZIA will be an important treatment option for patients with
moderate-to-severe plaque psoriasis.”
“We would like to thank Dermira for their commitment to helping
successfully develop CIMZIA in psoriasis and for a fruitful
partnership over the past three years,” said Emmanuel Caeymaex,
UCB’s Head of Immunology and Executive Vice President. “UCB has a
strong expertise in auto-immune disorders and psoriasis is an
indication we are aiming to add to our portfolio. The regulatory
filings of CIMZIA in psoriasis in the EU and the U.S. bring us one
step closer to helping women and men living with this
difficult-to-treat, chronic skin condition. We will use the
experience we have gained with existing CIMZIA indications to
best serve the needs of psoriasis patients, caregivers, physicians
and other healthcare stakeholders.”
Pursuant to the collaboration agreement, there are no
termination or penalty payments required by either party. In
consideration for the repurchase of all product rights, licenses
and intellectual property relating to CIMZIA, UCB will pay to
Dermira $11.0 million by November 13, 2017 and, upon approval of
CIMZIA in psoriasis in the United States, an additional $39.0
million within 30 days of such approval. Dermira is obligated to
reimburse UCB for up to $10.0 million of development costs incurred
by UCB in connection with the development of CIMZIA between January
1, 2018 and June 30, 2018. If the aggregate development costs
reimbursed by Dermira to UCB during this six-month period are less
than $10.0 million, Dermira will pay to UCB the difference between
such aggregate costs and $10.0 million.
In addition, Mr. Caeymaex, a Dermira director, has resigned from
his position as a member of the board and, pursuant to the
transition agreement, UCB will no longer have a right to designate
a director nominee to Dermira’s board of directors.
Dermira Webcast and Conference Call Information
Dermira will host a webcast and conference call today to discuss
this announcement beginning at 1:30 p.m. Pacific Time / 4:30 p.m.
Eastern Time. Analysts and investors can participate in the
conference call by dialing (877) 359-9508 for domestic callers and
+1 (224) 357-2393 for international callers using the conference
ID# 5089079. The webcast can be accessed live on the Investor
Relations page of Dermira’s website, http://investor.dermira.com,
and will be available for replay for 30 days following the call. A
telephone replay of the call will be available by dialing (855)
859-2056 for domestic callers or +1 (404) 537-3406 for
international callers and entering the conference code:
5089079.
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 and develop leading-edge medical dermatology programs.
Dermira’s pipeline includes three late-stage product candidates
that could have a profound impact on the lives of patients:
glycopyrronium tosylate (formerly DRM04), for which a Phase 3
program has been completed for the treatment of primary axillary
hyperhidrosis (excessive underarm sweating beyond what is needed
for normal body temperature regulation); olumacostat glasaretil
(formerly DRM01), in Phase 3 development for the treatment of acne
vulgaris; and lebrikizumab, for which Dermira plans to
initiate a Phase 2b dose-ranging study for the treatment of
moderate-to-severe atopic dermatitis. Dermira is headquartered
in Menlo Park, Calif. For more information, please
visit http://www.dermira.com. Follow @DermiraInc on Twitter
and LinkedIn.
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-) 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 and Twitter account in addition to following
its SEC filings, press releases, public conference calls
and webcasts.
About UCB UCB, Brussels, Belgium (www.ucb.com)
is a global biopharmaceutical company focused on the discovery and
development of innovative medicines and solutions to transform the
lives of people living with severe diseases of the immune system or
of the central nervous system. With more than 7,500 people in
approximately 40 countries, the company generated revenue of €4.2
billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB).
Follow us on Twitter: @UCB_news.
For full prescribing information on CIMZIA, please visit
www.ucb.com
CIMZIA® is a registered trademark of the UCB Group of
Companies.
Dermira Forward-Looking StatementsThe
information in this press 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 press release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements with respect to Dermira’s
goal of building a leading medical dermatology company dedicated to
delivering differentiated, new therapies to the millions of
patients living with chronic skin conditions and the healthcare
professionals who serve them; Dermira’s commitment to focus on its
other late-stage product candidates, in particular, on the launch
preparedness and execution for glycopyrronium tosylate; potential
regulatory approval of CIMZIA for the treatment of
moderate-to-severe plaque psoriasis; CIMZIA becoming an important
treatment option for patients with moderate-to-severe plaque
psoriasis if regulatory approval is obtained; the anticipated
timeline for completion of the transfer of data from Dermira to
UCB; Dermira’s potential receipt of payment following approval of
CIMZIA for psoriasis in the United States; and Dermira’s plan to
initiate a Phase 2b dose-ranging study of lebrikizumab for
moderate-to-severe atopic dermatitis. 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 Dermira’s clinical trials; the
outcome of future discussions with regulatory authorities;
Dermira’s dependence on third-party clinical research
organizations, manufacturers and suppliers; competition; 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 press 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.
UCB Forward-Looking Statements This press
release contains forward-looking statements based on current plans,
estimates and beliefs of management. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
information, expected legal, political, regulatory or clinical
results and other such estimates and results. By their nature, such
forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and assumptions which could
cause actual results to differ materially from those that may be
implied by such forward-looking statements contained in this press
release. Important factors that could result in such differences
include: changes in general economic, business and competitive
conditions, the inability to obtain necessary regulatory approvals
or to obtain them on acceptable terms, costs associated with
research and development, changes in the prospects for products in
the pipeline or under development by UCB, effects of future
judicial decisions or governmental investigations, product
liability claims, challenges to patent protection for products or
product candidates, changes in laws or regulations, exchange rate
fluctuations, changes or uncertainties in tax laws or the
administration of such laws and hiring and retention of its
employees.
Additionally, information contained in this document shall not
constitute an offer to sell or the solicitation of an offer to buy
any securities, nor shall there be any offer, solicitation or sale
of securities in any jurisdiction in which such offer, solicitation
or sale would be unlawful prior to the registration or
qualification under the securities laws of such jurisdiction. UCB
is providing this information as of the date of this document and
expressly disclaims any duty to update any information contained in
this press release, either to confirm the actual results or to
report a change in its expectations.
There is no guarantee that new product candidates in the
pipeline will progress to product approval or that new indications
for existing products will be developed and approved. Products or
potential products which are the subject of partnerships, joint
ventures or licensing collaborations may be subject to differences
between the partners. Also, UCB or others could discover safety,
side effects or manufacturing problems with its products after they
are marketed.
Moreover, sales may be impacted by international and domestic
trends toward managed care and health care cost containment and the
reimbursement policies imposed by third-party payers as well as
legislation affecting biopharmaceutical pricing and
reimbursement.
Dermira Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216media@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@dermira.com
Robert H. UhlWestwicke PartnersManaging
Director858-356-5932robert.uhl@westwicke.com
UCB Contacts:
Corporate Communications:France NivelleGlobal Communications,
UCBT +32.2.559.9178 france.nivelle@ucb.com
Laurent Schots Media Relations, UCBT+32.2.559.92.64
Laurent.schots@ucb.com
Investors:Antje WitteInvestor Relations, UCBT +32.2.559.94.14
antje.witte@ucb.com
Isabelle GhellynckInvestor Relations, UCB T+32.2.559.9588
isabelle.ghellynck@ucb.com
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