- Company to Leverage Lentiviral and AAV Gene
Therapy Platforms to Target Rare Genetic Diseases -
- Transaction to Advance Rocket’s Growing
Pipeline; Up to Four Clinical Trials to Begin in 2018 –
- Proof of Concept Data Expected in 2018 for
One or More Clinical Programs Focused on Rare Blood Disorders:
Fanconi Anemia, Pyruvate Kinase Deficiency, and Leukocyte Adhesion
Deficiency-1-
Inotek Pharmaceuticals Corporation (NASDAQ: ITEK) today
announced that they have entered into a definitive merger agreement
with Rocket Pharmaceuticals Ltd., a leading US-based gene therapy
company. Subject to shareholder approval, the combined company will
retain the name Rocket Pharmaceuticals and will be headquartered in
New York City. The combined company will focus on developing and
advancing its pipeline of gene therapies based on lentiviral virus
(LVV) and adeno-associated virus (AAV) gene therapy platforms, with
a focus on treating devastating rare diseases.
“We have conducted an exhaustive strategic process focused on
proactively identifying assets that have clear biological
plausibility and a high unmet need. As a result of this process,
I’m delighted to announce a merger with Rocket as the best scenario
for value creation for our stockholders,” said David P. Southwell,
President and Chief Executive Officer of Inotek.
“Rocket is a leader in developing first-in-class gene therapies
for patients with rare genetic diseases with complex and
challenging treatment options, such as bone marrow and organ
transplants. We believe the combined company will be well-funded,
and it will be led by Gaurav Shah, MD, who was formerly a CART-19
Global Program Head in the Cell and Gene Therapies Unit at
Novartis. In addition to Gaurav, Rocket has a seasoned team of gene
therapy and rare disease drug development experts,” said Southwell.
“The proposed transaction will provide significant and immediate
value to accelerate the development of Rocket’s five distinct
programs.”
Rocket’s focus for its lentiviral gene therapies is bone marrow
disorders caused by gene mutations. Lead programs include Fanconi
Anemia (FA), Leukocyte Adhesion Deficiency-1 (LAD-1) and Pyruvate
Kinase Deficiency (PKD). Current treatment options available for
patients with these diseases are limited and include allogeneic
bone marrow transplant procedures, which are often complicated by
graft versus host disease and a lack of available donors. Rocket’s
gene therapy approach could be potentially curative and replace or
pre-empt the need for transplant. Longer term, Rocket is also
developing a lentiviral-based gene therapy for infantile malignant
osteopetrosis, an inherited bone disorder.
In addition, Rocket is advancing an AAV-based program for an
undisclosed rare pediatric disease with a significant estimated
patient population size (15,000+ prevalence in the US/EU).
“Our vision is to create a fully-integrated platform gene
therapy company with a portfolio of distinct treatments for
devastating genetic diseases,” said Gaurav Shah, MD, Chief
Executive Officer of Rocket. “FA, LAD-1 and PKD are near term
opportunities in rare bone marrow-derived disorders. The AAV-based
approach, while earlier, will target treatment of a broader range
of challenging diseases.”
Shah continued, “We are inspired by the passion for science and
dedication to patients which David and his team have exemplified,
and honored to be on this journey together. With this transaction,
Rocket’s rich pipeline will progress even more rapidly into what we
already see as a transformational year for the company. We expect
to enter the clinic in 2018, with clinical proof of concept data
from one or more of the lentiviral programs in 2018.”
Proposed Transaction DetailUnder the terms of the merger
agreement, shareholders of Rocket will receive shares of newly
issued Inotek common shares in a private placement. Rocket
shareholders are expected to own approximately 81% of the combined
Company and current Inotek shareholders will own approximately 19%
of the combined Company. The percentage of the combined Company
that Rocket’s shareholders will own as of the close of the
transaction is subject to adjustment based on the amount of
Inotek’s net cash at the closing date. The merger agreement
contains further details with respect to this adjustment and the
transaction. The transaction has been unanimously approved by the
Board of Directors of both companies. The merger is expected to
close in the first quarter of 2018, subject to customary closing
conditions, including the approval by stockholders of Inotek.
Perella Weinberg Partners LP is acting as financial advisor to
Inotek and Goodwin Procter, LLP is serving as legal counsel to
Inotek and Gibson, Dunn & Crutcher LLP is serving as legal
counsel to Rocket.
Board of DirectorsGaurav Shah, MD, will serve as Chief
Executive Officer of the combined Company. The combined Company
Board of Directors will be chaired by Roderick Wong, MD, Managing
Partner of RTW Investments, and will include David Southwell,
President and Chief Executive Officer of Inotek, Gaurav Shah, MD,
Chief Executive Officer of Rocket, as well as four additional
members.
Inotek Operational UpdateInotek also announced today that
it is reducing its workforce by approximately 60% to a total of 7
full-time employees, which is expected to be completed in the third
quarter. All affected employees are being offered severance and
transition benefits.
Conference Call InformationInotek and Rocket will host a
conference call and webcast tomorrow, September 13, 2017, at 8:30
am ET. To participate in the conference call, please dial (844)
358-9183 in the U.S. or (478) 219-0400 outside of the U.S. five
minutes prior to the start of the call and provide the Conference
ID: 85020110 or access the listen-only webcast by visiting the
Company’s website www.inotekpharma.com.
An archive of tomorrow’s conference call will be available
shortly after the conclusion of the call and accessed by dialing
(855) 859-2056 in the U.S. or (404) 537-3406 outside of the U.S.
and referencing the Conference ID: 85020110, or by visiting
Inotek’s website. The audio replay will be available for two weeks
following the call and the webcast for thirty days.
About Inotek Pharmaceuticals CorporationInotek
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
therapies for ocular diseases, including glaucoma. In July 2017,
the Company announced top-line results of its Phase 2 fixed-dose
combination trial of trabodenoson and latanoprost for the treatment
of glaucoma. The trial did not meet its primary efficacy endpoint
and the Company has since discontinued development of trabodenoson
in order to focus on evaluating strategic alternatives. For more
information, please visit www.inotekpharma.com. The inclusion of
our website address here and elsewhere in this press release does
not include or incorporate by reference the information on our
website into this press release.
About Rocket Pharmaceuticals, Ltd.Rocket Pharmaceuticals,
Ltd. is an emerging biotechnology company focused on developing
first-in-class gene therapy treatment options for rare,
undertreated diseases. The Company’s lead program is a
lentiviral-based gene therapy for the treatment of Fanconi Anemia
(FA), a difficult to treat genetic disease that leads to bone
marrow failure and potentially cancer. Preclinical studies of
additional bone marrow-derived disorders are ongoing and target
Pyruvate Kinase Deficiency (PKD), Leukocyte Adhesion Deficiency-1
(LAD-1) and Infantile Malignant Osteopetrosis. The Company is also
developing an AAV-based gene therapy program for an undisclosed
rare pediatric disease. For more information about Rocket
Pharmaceuticals Ltd., please visit www.rocketpharma.com.
Additional Information for Inotek Common StockholdersIn
connection with the proposed transaction, Inotek plans to file with
the Securities and Exchange Commission (SEC) a proxy statement
relating to the approval of the merger agreement. The information
in the preliminary proxy statement is not complete and may be
changed. The proxy statement and this press release are not offers
to sell Inotek securities and are not soliciting an offer to buy
Inotek securities in any state where the offer and sale is not
permitted.
The definitive proxy statement will be mailed to stockholders of
Inotek. INOTEK URGES INVESTORS AND SECURITY HOLDERS TO READ THE
DEFINITIVE PROXY STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC
CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION. Investors and security holders will be able to obtain
free copies of the definitive proxy statement (when available) and
other documents filed with the SEC by Inotek through the web site
maintained by the SEC at www.sec.gov. Free copies of the definitive
proxy statement (when available) and other documents filed with the
SEC can also be obtained on Inotek’s website at
http://ir.inotekpharma.com/phoenix.zhtml?c=254118&p=irol-sec.
Participants in Solicitation
Inotek, Rocket and their respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies from the stockholders of Inotek in connection with the
merger. Information about the directors and executive officers of
Inotek is set forth in Inotek’s Form 10-K for the fiscal year ended
December 31, 2016 and filed with the SEC on March 16, 2017 and the
proxy statement filed with the SEC on April 26, 2017. Additional
information regarding the interests of these participants and other
persons who may be deemed participants in the merger may be
obtained by reading the proxy statement regarding the proposed
transaction when it becomes available.
This document will not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor will there be
any 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 any such
jurisdiction.
Cautionary Statement Regarding Forward-Looking
StatementsThis communication contains “forward-looking”
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, known as the PSLRA. These
statements, as they relate to Inotek or Rocket, the management of
either such company or the proposed transaction between Inotek and
Rocket, involve risks and uncertainties that may cause results to
differ materially from those set forth in the statements. These
statements are based on current plans, estimates and projections,
and therefore, you are cautioned not to place undue reliance on
them. No forward-looking statement can be guaranteed, and actual
results may differ materially from those projected. Inotek and
Rocket undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise, except to the extent required by law.
Forward-looking statements are not historical facts, but rather are
based on current expectations, estimates, assumptions and
projections about the business and future financial results of the
pharmaceutical industry, and other legal, regulatory and economic
developments. We use words such as “anticipates,” “believes,”
“plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,”
“should,” “could,” “estimates,” “predicts,” “potential,”
“continue,” “guidance,” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results could differ materially from the results contemplated by
these forward-looking statements due to a number of factors,
including, but not limited to, those described in the documents
Inotek has filed with the SEC as well as the possibility that (1)
the parties may be unable to obtain stockholder or regulatory
approvals required for the proposed transaction or may be required
to accept conditions that could reduce the anticipated benefits of
the merger as a condition to obtaining regulatory approvals; (2)
the length of time necessary to consummate the proposed transaction
may be longer than anticipated; (3) the parties may not be able to
satisfy the conditions precedent to consummate the proposed
transaction; (4) the proposed transaction may divert management’s
attention from Inotek’s ongoing business operations; (5) the
anticipated benefits of the proposed transaction might not be
achieved; (6) Rocket’s clinical programs and pre-clinical studies
may not be successful or completed on time; (7) Rocket may not be
able to successfully demonstrate safety and efficacy of its
clinical programs or pre-clinical studies; (8) Rocket’s
expectations regarding the future development of its clinical
programs and pre-clinical studies may not materialize; (9) Rocket’s
clinical programs may not obtain necessary regulatory or other
approvals; (10) Rocket’s clinical programs may not meet proof of
concept; (11) Rocket may not be able to raise the necessary capital
to conduct Rocket’s clinical programs and pre-clinical studies or
such capital may not be available; (12) the prospective market size
of Rocket’s drug candidates may be different than currently
anticipated; (13) the proposed transaction may involve unexpected
costs; (14) the business may suffer as a result of uncertainty
surrounding the proposed transaction, including difficulties in
maintaining relationships with third parties or retaining key
employees; (15) the parties may be unable to meet expectations
regarding the timing, completion and accounting and tax treatments
of the transaction; (16) the parties may be subject to risks
related to the proposed transaction, including any legal
proceedings related to the proposed transaction and the general
risks associated with the respective businesses of Inotek and
Rocket, including the general volatility of the capital markets,
terms and deployment of capital, volatility of Inotek share prices,
changes in the biotechnology industry, interest rates or the
general economy, underperformance of Inotek’s or Rocket’s assets
and investments, decreased ability to raise funds and the degree
and nature of Inotek’s and Rocket’s competition, as well as the
risk that unexpected reductions in Inotek’s cash balance could
adversely affect the portion of the combined company that the
Inotek stockholders retain; (17) activist investors might not
approve of the proposed transaction; or (18) the risks that are
more fully described in the section titled “Risk Factors” in
Inotek’s most recent Quarterly Report on Form 10-Q filed with the
SEC, as well as subsequent and other documents filed from time to
time with the SEC by Inotek could materialize. Additionally,
forward-looking statements related to Rocket’s future expectations
are subject to numerous risks and uncertainties, including risks
that planned development milestones and timelines will not be met.
Additional risks relating to Rocket’s business and operations will
be set forth in the proxy statement that Inotek will file to seek
stockholder approval of the merger. Neither Inotek nor Rocket gives
any assurance that either Inotek or Rocket will achieve its
expectations.
The foregoing list of factors is not exhaustive. You should
carefully consider the foregoing factors and the other risks and
uncertainties that affect the businesses of Inotek described in the
“Risk Factors” section of its Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q and other documents filed by Inotek from time
to time with the SEC, as well as Risk Factors relating to Rocket
that will be contained in definitive proxy statement for the
proposed merger between Inotek and Rocket. All forward-looking
statements included in this document are based upon information
available to Inotek and Rocket the date hereof, and neither Inotek
nor Rocket assumes any obligation to update or revise any such
forward-looking statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170912006734/en/
Inotek Contact:Claudine Prowse, PhD, 781-552-4305Vice
President, Corporate Development and
IROcprowse@inotekpharma.comorInotek Media & Investor
Contact:Joe Rayne,
781-327-5610jrayne@inotekpharma.comorRocket
Contact:investors@rocketpharma.com
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