#Biopharma News: Eleven
Biotherapeutics (NASDAQ: $EBIO) Announces Effectiveness of Investigational New
Drug Application for EBI-031
Eleven entitled to
receive $22.5 million milestone payment for IND effectiveness
CAMBRIDGE, Mass. - July 8, 2016 (Investorideas.com
Newswire) Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a biopharmaceutical
company discovering and developing protein therapeutics to treat diseases of
the eye, today announced that the company's Investigational New Drug (IND)
application for EBI-031, a humanized monoclonal antibody that potently binds
interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling,
for treatment of ocular diseases, has become effective. As a result of the
achievement of this milestone, Eleven is entitled to receive a $22.5 million
payment from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche)
pursuant to the terms of its license agreement with Roche.
On
June 13, 2016, Eleven announced that it had entered into an exclusive license
agreement with Roche for the further development and commercialization of
EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven.
Under the terms of the agreement, Eleven could receive up to $262.5 million
upon the achievement of certain regulatory, development and commercialization
milestones, including this $22.5 million payment upon the effectiveness of the
IND for EBI-031. In addition, Eleven could be entitled to receive royalties for
net sales of potential future products containing EBI-031 or any other
potential future products containing other Eleven IL-6 compounds. Effectiveness
of the license agreement, including Roche's obligation to make the $22.5
million milestone payment, is subject to approval of the license by holders of
at least a majority of the outstanding shares of Eleven's common stock.
"We
look forward to Roche advancing EBI-031 into the clinic to explore its
potential use for ocular diseases, such as diabetic macular edema, in an effort
to bring this potential treatment to patients," said Abbie Celniker,
Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics.
About EBI-031
Eleven
Biotherapeutics' most advanced preclinical product candidate is EBI-031 for
treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed
and engineered for intravitreal delivery using Eleven's AMP-Rx platform.
EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble
IL-6 receptor (IL-6R). Eleven filed an IND with the FDA in June 2016 for the
purpose of conducting clinical trials of EBI-031 in DME and uveitis.
About Eleven Biotherapeutics
Eleven
Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company with a
proprietary protein engineering platform, called AMP-Rx, that it applies to the
discovery and development of protein therapeutics to treat diseases of the eye.
Eleven's therapeutic approach is based on the role of cytokines in diseases of
the eye, the Company's understanding of the structural biology of cytokines and
the Company's ability to rationally design and engineer proteins to modulate
the effects of cytokines. Cytokines are cell signaling molecules found in the
body that can have important inflammatory effects.
Important Information
The
Company plans to file with the Securities and Exchange Commission
("SEC") and mail to its stockholders a proxy statement in connection
with the transactions contemplated by the license agreement. Additionally, the
Company will file other relevant materials with the SEC in connection with the
transactions contemplated by the license agreement. The proxy statement will
contain important information about the Company, the transactions contemplated
by the license agreement and related matters. Investors and security holders
are urged to read the proxy statement carefully when it is available before
making any voting or investment decision with respect to the proposed
transactions because they will contain important information about the proposed
transactions.
Investors
and security holders will be able to obtain free copies of the proxy statement
and other documents filed with the SEC by the Company through the web site
maintained by the SEC at www.sec.gov. In addition, investors and security
holders will be able to obtain free copies of the proxy statement from public
company by contacting Leah Monteiro at (617) 714-0619.
The
Company and its directors and executive officers may be deemed to be
participants in the solicitation of proxies in respect of the transactions
contemplated by the license agreement. Information regarding the Company's
directors and executive officers is contained in the Company's Form 10-K for
the fiscal year ended December 31, 2015, and its proxy statement dated April
29, 2016, each of which has been filed with the SEC. Additional information
regarding the participants in the solicitation of proxies in respect of the
transactions contemplated by the license agreement and a description of their
direct and indirect interests, by security holdings or otherwise, will be
contained in the proxy statement and other relevant materials to be filed with
the SEC when they become available.
Cautionary Note on
Forward-Looking Statements
Any
statements in this press release about future expectations, plans and prospects
for the Company, including statements about the potential effectiveness of the
license agreement or receipt of payments thereunder, the future rights and
obligations of the parties under the license agreement, the Company's strategy,
future operations, advancement or maturation of its product candidates and
product pipeline, clinical development of the Company's product candidates,
including expectations regarding timing of regulatory submissions and
initiation of clinical trials, regulatory requirements for initiation of
clinical trials and registration of product candidates, the review of its
strategic alternatives and the outcome of such review, the completion and
results of potential strategic transactions, the sufficiency of its cash
resources and other statements containing the words "anticipate,"
"believe," "estimate," "expect,"
"intend," "may," "plan," "predict,"
"project," "target," "potential,"
"will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation Reform Act
of 1995. Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors, including:
the occurrence of any event, change or other circumstances that could give rise
to the termination of the license agreement, the outcome of any legal
proceedings that could be instituted against the Company or its directors
related to the license agreement, the inability to consummate the transactions
contemplated by the license agreement due to the failure to obtain the
requisite approval of the Company's stockholders, the uncertainties inherent in
the initiation and conduct of clinical trials, availability and timing of data
from clinical trials, whether results of early clinical trials or preclinical
studies will be indicative of the results of future trials, the adequacy of any
clinical models, uncertainties associated with regulatory review of clinical
trials and applications for marketing approvals and other factors discussed in
the "Risk Factors" section of the Company's quarterly report on Form
10-Q for the quarter ended March 31, 2016 as filed with the Securities and
Exchange Commission and other reports on file with the Securities and Exchange
Commission. In addition, the forward-looking statements included in this press
release represent the Company's views as of the date hereof. The Company
anticipates that subsequent events and developments will cause the Company's
views to change. However, while the Company may elect to update these
forward-looking statements at some point in the future, the Company
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company's views as of
any date subsequent to the date hereof.
Source:
Eleven Biotherapeutics, Inc.
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