- Includes Phase 3 product candidate APL-130277
in development for OFF episodes associated with Parkinson’s disease
-
- Complements Sunovion’s robust portfolio and
expands the Company’s leadership in treatments for central nervous
system disorders -
Sunovion Pharmaceuticals Inc. (Sunovion) and Cynapsus
Therapeutics Inc. (Cynapsus) (NASDAQ: CYNA) (TSX: CTH) today
announced that the companies have signed a definitive agreement
under which Sunovion will acquire Cynapsus for US$40.50 per share
in cash. The transaction has received unanimous approval by the
Board of Directors of both companies and values Cynapsus at
approximately US$624 million (or approximately CAN$820 million).
The acquisition will be funded with cash on hand. The transaction
is expected to close in the fourth quarter of 2016 (third quarter
of Sunovion’s fiscal year). This agreement reflects Sunovion’s
global strategy to expand and diversify its portfolio in key
therapeutic areas, including neurology.
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Through this transaction, Sunovion would acquire Cynapsus’
product candidate, APL-130277, which is designed to be a
fast-acting, easy-to-use, on-demand treatment option for managing
OFF episodes associated with Parkinson’s disease (PD).
“Parkinson’s disease is a chronic, progressive neurodegenerative
disease that affects more than four million people around the
world, and there is a significant need for new options to treat the
OFF episodes associated with it,” said Nobuhiko Tamura, Chairman
and Chief Executive Officer, Sunovion. “We believe that APL-130277
is a novel late-stage candidate with the potential to make a real
difference for patients and their families.”
“The acquisition of Cynapsus is well-aligned with Sunovion’s
focus on the innovative application of science and medicine to help
people with serious medical conditions and complements our robust
product pipeline,” added Mr. Tamura. “We have high regard for the
Cynapsus team and their work with the APL-130277 program.”
“With its leadership in therapies for central nervous system
disorders and commercial experience specific to neurology, we
believe Sunovion is best suited to advance APL-130277 in the United
States and other key markets,” said Anthony J. Giovinazzo,
President and CEO, Cynapsus. “This transaction culminates years of
dedicated work by the Cynapsus team and represents significant
value creation for our securityholders.”
The board of directors of Cynapsus, after consultation with its
financial and legal advisors and based, in part, upon the unanimous
recommendation of an independent special committee of the board of
directors, has determined that the arrangement is in the best
interest of Cynapsus and the consideration to be received by
shareholders of Cynapsus is fair to such shareholders. The board of
directors unanimously recommends that Cynapsus shareholders and
warrantholders vote in favour of the transaction at a special
meeting expected to be held on or about October 13, 2016.
The proposed sale of Cynapsus follows a full consideration of
alternatives aimed at optimizing shareholder value for the company.
“We believe that the proposed transaction with Sunovion results in
the best outcome for our shareholders,” said Rochelle Stenzler,
chair of the board of Cynapsus. “The transaction with Sunovion
represents a significant premium to the current share price and we
are recommending that our shareholders and warrantholders vote in
favour of the transaction.”
Pursuant to the terms of the definitive agreement, upon closing
of the proposed transaction, shareholders of Cynapsus will receive
US$40.50 per common share in cash, and holders of warrants and
stock options will receive a cash payment equal to the difference
between US$40.50 and the exercise price of such warrant or stock
option. The offer of US$40.50 per common share in cash represents a
premium of 123 percent based on the volume weighted average closing
price of Cynapsus’ common shares on the NASDAQ Global Market for
the last twenty trading days. The companies expect to close the
transaction following required securityholder, court and regulatory
approvals and satisfaction of certain other customary closing
conditions.
The transaction will be completed by way of a plan of
arrangement under the Canada Business Corporations Act. The
arrangement will require approval of at least two-thirds of the
votes cast by Cynapsus shareholders and warrantholders voting
together as a single class at a special meeting of such
securityholders of Cynapsus. Voting and Support Agreements in
support of the transaction have been signed by all directors and
officers of Cynapsus and the company’s largest shareholder
representing in the aggregate, approximately 18.33 percent of the
Cynapsus securities entitled to vote to approve the
transaction.
Full details of the transaction will be included in the
management information circular to be filed with the applicable
securities regulatory authorities and mailed to Cynapsus
shareholders and warrant holders within approximately two weeks.
Assuming receipt of all required regulatory approvals, the parties
expect to close the arrangement in the fourth quarter of 2016.
BofA Merrill Lynch serves as financial advisor, and Borden
Ladner Gervais LLP and Troutman Sanders LLP serve as legal advisors
to Cynapsus. Stifel, Nicolaus & Company, Incorporated serves as
financial advisor and Fasken Martineau DuMoulin LLP serves as a
legal advisor to the Special Committee of Cynapsus. Nomura
Securities International, Inc. serves as exclusive financial
advisor, and Goodmans LLP, Reed Smith LLP, and Gibbons PC serve as
legal advisors to Sunovion.
Adagio Amending AgreementCynapsus and the former
shareholders of Adagio Pharmaceuticals Ltd. (“Adagio”) entered into
a share purchase agreement dated as of December 22, 2011, as
subsequently amended as of January 28, 2015 (the “Share Purchase
Agreement”), pursuant to which Cynapsus acquired Adagio.
Cynapsus and the former shareholders of Adagio have amended the
Share Purchase Agreement to provide, among other things, that if a
change of control of Cynapsus, which would include the transaction
with Sunovion, occurs before the successful completion and the
first public announcement of the top-line data of the Final Safety
Study (as defined in the Share Purchase Agreement), the
CDN$2,500,000 of the purchase price still potentially payable to
the former shareholders of Adagio shall be paid in cash (not common
shares, as was originally contemplated in the Share Purchase
Agreement) by Cynapsus, on the date on which the change of control
transaction is completed.
As Anthony Giovinazzo, President and Chief Executive Officer of
Cynapsus, is also a director, officer and majority shareholder of
Adagio, the amendment of the Share Purchase Agreement constitutes a
related party transaction pursuant to Multilateral Instrument
61-101 and the policies of the TSX. The amendment was necessary,
and appropriate, as it ensures that if Sunovion acquires all of the
common shares of Cynapsus, it would not have an obligation to
potentially issue shares to the former Adagio shareholders
post-closing of such acquisition. The amendment was entered into at
the same time as the arrangement agreement with Sunovion and
therefore was not announced more than 21 days before its
execution.
About APL-130277APL-130277, a novel formulation of
apomorphine, a dopamine agonist, is being developed as a
fast-acting, easy-to-use, sublingual thin film for the on-demand
management of debilitating OFF episodes associated with Parkinson’s
disease. Apomorphine is the only molecule approved for acute,
intermittent treatment of OFF episodes for advanced PD patients,
but is currently only approved as a subcutaneous injection in the
United States. APL-130277 is designed to rapidly, safely and
reliably convert a PD patient from the OFF to the ON state while
avoiding many of the issues associated with subcutaneous delivery
of apomorphine. It has been studied in all types of OFF episodes,
including morning OFF episodes. APL-130277 is in Phase 3 clinical
trials and has not been approved by the U.S. Food and Drug
Administration (FDA).
In the ongoing Phase 3 trial, CTH-300, the blinded safety data
was corroborated by the DSMB findings, which were announced in the
press release dated August 15, 2016. If the ongoing pivotal Phase 3
clinical trials are successful, it is expected that a New Drug
Application (NDA) for APL-130277 will be submitted to the U.S. Food
and Drug Administration (FDA) during the first half of 2017 under
the abbreviated Section 505(b)(2) regulatory pathway. A pivotal
European clinical program evaluating the safety and efficacy of
APL-130277 in PD patients is expected to be initiated in the fourth
quarter of 2016.
About Parkinson’s Disease and OFF EpisodesMore than 1
million people in the U.S. and an estimated 4 to 6 million people
worldwide suffer from PD. The European Parkinson's disease
Association estimates that 1.2 million people have PD in the
European Union. PD is a chronic, progressive neurodegenerative
disease characterized by motor symptoms, including tremor at rest,
rigidity and impaired movement, as well as significant non-motor
symptoms, including cognitive impairment and mood disorders. It is
the second most common neurodegenerative disease behind Alzheimer’s
disease, and PD’s prevalence is increasing with the aging of the
population. OFF episodes are a complication of the disease. Up
to 40 percent of all people with PD whose symptoms are otherwise
managed with ongoing drug therapy experience OFF episodes at least
once daily and up to six times daily, with each episode typically
lasting between 30 and 120 minutes.1,2
About Sunovion Pharmaceuticals Inc. (Sunovion)Sunovion is
a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious
medical conditions. Sunovion’s spirit of innovation is driven by
the conviction that scientific excellence paired with meaningful
advocacy and relevant education can improve lives. The Company has
charted new paths to life-transforming treatments that reflect
ongoing investments in research and development and an unwavering
commitment to support people with psychiatric, neurological, and
respiratory conditions. Sunovion’s track record of discovery,
development and commercialization of important therapies has
included Brovana® (arformoterol tartrate), Latuda® (lurasidone
HCI), and most recently Aptiom® (eslicarbazepine acetate).
Headquartered in Marlborough, Mass. Sunovion is an indirect,
wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
Sunovion Pharmaceuticals Europe Ltd., based in London, England, and
Sunovion Pharmaceuticals Canada Inc., based in Mississauga,
Ontario, are wholly-owned direct subsidiaries of Sunovion
Pharmaceuticals Inc. Additional information can be found on the
Company’s web sites: www.sunovion.com, www.sunovion.eu and
www.sunovion.ca. Connect with Sunovion on Twitter @Sunovion and
LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.Sumitomo
Dainippon Pharma is among the top-ten listed pharmaceutical
companies in Japan operating globally in major pharmaceutical
markets, including Japan, the United States, China and the European
Union. Sumitomo Dainippon Pharma aims to create innovative
pharmaceutical products in the Psychiatry & Neurology area and
the Oncology area, which have been designated as the focus
therapeutic areas. Sumitomo Dainippon Pharma is based on the merger
in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has
about 7,000 employees worldwide. Additional information about
Sumitomo Dainippon Pharma is available through its corporate
website at www.ds-pharma.com.
BROVANA is a registered trademark of Sunovion Pharmaceuticals
Inc.LATUDA is a registered trademark of Sumitomo Dainippon Pharma
Co., Ltd.APTIOM is used under license from BIAL.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo
Dainippon Pharma Co., Ltd.© 2016 Sunovion Pharmaceuticals Inc.
Sunovion Forward-Looking StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are subject
to risks, uncertainties and other factors. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements, including all statements
regarding the intent, belief or current expectation of the
companies' and members of their senior management team.
Forward-looking statements include, without limitation statement
associated with the following: the timing of the closing of
Sunovion’s acquisition of Cynapsus; Sunovion’s ability to expand
and diversify its portfolio in key therapeutic areas, including
neurology; APL-130277’s ability to be a fast-acting, easy-to-use,
on-demand treatment option for managing OFF episodes associated
with Parkinson’s disease (PD) or make a real difference for
patients and their families; Sunovion’s ability to advance
APL-130277 in the United States and other key markets; whether the
transaction will result in the best outcome for Cynapsus’
shareholders; the parties’ ability to receive the required
securityholder, court and regulatory approvals, satisfy other
customary closing conditions and close the transaction; whether
APL-130277 will be the first treatment for OFF episodes associated
with PD that is administered sublingually (under the tongue);
whether APL-130277 will avoid many of the issues associated with
the currently available injectable formulation; whether APL-130277
will be easier for patients and caregivers to use; the timing of
the data from the ongoing Cynapsus pivotal Phase 3 clinical trials;
the potential success of the trials and the timing of a New Drug
Application (NDA) for APL-130277, if any, to the U.S. Food and Drug
Administration (FDA) during the first half of 2017 under the
abbreviated Section 505(b)(2) regulatory pathway; the timing of a
pivotal European clinical program evaluating the safety and
efficacy of APL-130277 in PD patients; the timing and content of
the details of the transaction included in the management
information circular to be filed with the securities regulatory
authorities and mailed to Cynapsus shareholders and warrant holders
in advance of the special meeting; the ability to receive all
required regulatory approvals, and the ability of the parties to
close the arrangement in the fourth quarter of 2016. Investors are
cautioned that any such forward-looking statements are not
guarantees of future performance and involve risks and
uncertainties and are cautioned not to place undue reliance on
these forward-looking statements. Actual results may differ
materially from those currently anticipated due to a number of
risks and uncertainties. Risks and uncertainties that could cause
the actual results to differ from expectations contemplated by
forward-looking statements include: the effects of the transaction
on relationships with employees, customers, other business partners
or governmental entities; other business effects, including the
effects of industry, economic or political conditions outside of
the companies' control; actual or contingent liabilities; and other
risks and uncertainties detailed by Sunovion’s parent company
Sumitomo Dainippon Pharma in the Summary of Consolidated Financial
Results [Japanese GAAP] (Unaudited) for quarterly earnings. All
forward-looking statements are based on information currently
available to Sunovion, and Sunovion assumes no obligation to update
any such forward-looking statements.
About CynapsusCynapsus is a specialty central nervous
system pharmaceutical company that has been developing a
fast-acting, easy-to-use, sublingual thin film for the on-demand
management of debilitating OFF episodes associated with PD. For
additional company information, please visit
http://www.cynapsus.ca.
For more information about the Phase 3 studies, including
enrollment criteria, please visit the following
website: http://cth300and301trials.cynapsus.ca/
Cynapsus Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of
applicable securities laws, including, without limitation,
Cynapsus’s expectation for filing an NDA in the first half of 2017;
expectations regarding Cynapsus’s clinical and regulatory
activities, including the anticipated timing, completion and
results of Phase 3 and other clinical studies; beliefs related to
potential benefits, effectiveness and demand for, Cynapsus’s
product candidate; statements relating to the proposed acquisition
of Cynapsus, including (i) receipt of securityholder, court and
regulatory approvals of, and the satisfaction of other conditions
for, such transaction and (ii) the anticipated benefits, timing and
closing of such transaction; and beliefs regarding Sunovion’s
ability to advance APL-130277 in the United States and other
markets. These forward-looking statements include information about
possible or assumed future events or results of Cynapsus’s
business, products, plans and objectives. These forward-looking
statements are based on current expectations and beliefs and
inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ from those
anticipated in such forward-looking statements as a result of risks
and uncertainties, and include, but are not limited to, shareholder
and warrantholder approval of the proposed transaction; Cynapsus’
ability to obtain court, regulatory and other approvals in
connection with the proposed transaction; uncertainties as to the
timing of the completion of the transaction, including that a
governmental entity may prohibit, delay or refuse to grant approval
for the consummation of the transaction and those factors
identified under the caption “Risk Factors” in Cynapsus’s Form 10-Q
for the quarter ended June 30, 2016 filed with the United States
Securities and Exchange Commission (the “SEC”) on August 10, 2016,
and its other filings and reports in the United States with the SEC
available on the SEC’s web site at www.sec.gov, and in Canada with
the various Canadian securities regulators, which are available
online at www.sedar.com. Furthermore, unless otherwise stated, the
forward-looking statements contained in this press release are made
as of the date of this press release, and Cynapsus has no intention
and undertakes no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events, changes or otherwise, except as required by law.
Additional Information and Where to Find ItFurther
information regarding the transaction will be contained in an
information circular that Cynapsus will prepare and mail to its
shareholders and warrantholders in connection with the Cynapsus
shareholders’ and warrantholders’ meeting, with closing expected to
occur in the fourth quarter of 2016. Cynapsus securityholders are
urged to read the information circular once it becomes available,
as it will contain important information concerning the proposed
transaction. Cynapsus securityholders may obtain a copy of the
arrangement agreement, information circular and other meeting
materials when they become available at http://www.sec.gov and
www.sedar.com.
This press release is for informational purposes only. It does
not constitute an offer to purchase securities of Cynapsus or a
solicitation or recommendation statement under the rules and
regulations of the SEC or other applicable United States laws.
1 Denny 1999 J Neurolog Sci, v165, p18-23, table 3.2 Schrag 2000
Brain v123, p2297-2305
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160831006494/en/
Sunovion Pharmaceuticals Inc.Patrick Gaffey,
508-787-4565Executive Director, Corporate
Communicationspatrick.gaffey@sunovion.comorCynapsus Therapeutics
Inc.Andrew Williams, 416-703-2449 x253COO &
CFOawilliams@cynapsus.ca
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