Mr. Anthony Giovinazzo reports
SUNOVION PHARMACEUTICALS TO ACQUIRE CYNAPSUS THERAPEUTICS
Sunovion
Pharmaceuticals Inc. and Cynapsus
Therapeutics Inc. have signed a definitive agreement under
which Sunovion will acquire Cynapsus for $40.50 (U.S.) per share in cash. The
transaction has received unanimous approval by the boards of directors of
both companies and values Cynapsus at approximately $624-million (U.S.) (or
approximately $820-million). The acquisition will be financed with cash
on hand. The transaction is expected to close in the fourth quarter of
2016 (the 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.
Through this transaction, Sunovion would acquire Cynapsus's 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 advisers 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 Oct. 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 the closing of the
proposed transaction, shareholders of Cynapsus will receive $40.50 (U.S.) per
common share in cash, and holders of warrants and stock options will
receive a cash payment equal to the difference between $40.50 (U.S.) and the
exercise price of such warrant or stock option. The offer of $40.50 (U.S.)
per common share in cash represents a premium of 123 per cent based on
the volume-weighted average closing price of Cynapsus's common shares on
the Nasdaq Global Market for the last 20 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 total, approximately 18.33 per cent 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 warrantholders within approximately two weeks. Assuming receipt of all required
regulatory approvals, the parties expect to close the arrangement in the
fourth quarter of 2016.
Bank of America Merrill Lynch serves as financial adviser and Borden Ladner
Gervais LLP and Troutman Sanders LLP serve as legal advisers to
Cynapsus. Stifel, Nicolaus & Co. Inc. serves as financial
adviser and Fasken Martineau DuMoulin LLP serves as a legal adviser to
the special committee of Cynapsus. Nomura Securities International Inc.
serves as exclusive financial adviser and Goodmans LLP, Reed Smith LLP
and Gibbons PC serve as legal advisers to Sunovion.
Adagio amending agreement
Cynapsus and the former
shareholders of Adagio Pharmaceuticals Ltd. entered into a
share purchase agreement dated as of Dec. 22, 2011, as subsequently
amended as of Jan. 28, 2015,
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 $2.5-million 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 Mr. Giovinazzo, president and CEO 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 Toronto Stock Exchange. 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 postclosing 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-130277
APL-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 (PD).
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 continuing phase 3 trial, CTH-300, the blinded safety data were
corroborated by the DSMB (data safety and monitoring board) findings, which were announced in the press
release dated Aug. 15, 2016. If the continuing pivotal phase 3 clinical
trials are successful, it is expected that a new drug application (NDA)
for APL-130277 will be submitted to the 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 PD and off episodes
More than one
million people in the United States and an estimated four million to six 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 per cent of all people with PD whose symptoms are
otherwise managed with continuing 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
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 continuing investments in
research and development and an unwavering commitment to support people
with psychiatric, neurological and respiratory conditions. Sunovion's 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, Ont., are
wholly owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
About Sumitomo Dainippon Pharma Co. Ltd.
Sumitomo Dainippon
Pharma is among the top 10 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 and neurology areas and the oncology area, which have been designated 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.
Brovana is a registered trademark of Sunovion Pharmaceuticals Inc.
Latuda
is a registered trademark of Sumitomo Dainippon Pharma Co. Ltd.
Aptiom
is used under licence from Bial.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co. Ltd.
Additional information and where to find it
Further
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
shareholder and warrantholder 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 on the U.S. Securities and Exchange Commission website and on SEDAR.
Notes:
- Denny, 1999, Journal of the Neurological Sciences, Volume 165, pages 18 to 23, third table;
- Schrag, 2000, Brain, Volume 123, pages 2297 to 2305.
We seek Safe Harbor.
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