- Obtains global rights to Phase 3
Parkinson’s disease treatment and additional clinical-stage
assets
- Positions Acorda as a leader in
Parkinson’s disease therapeutic development
- Cash transaction valued at $363
million
- Enters into agreements for $135 million
in financing through equity private placement and asset-based loan
facility
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
entered into an agreement to acquire Biotie Therapies Corp. (Nasdaq
Helsinki BTH1V; NASDAQ: BITI) for €23.5680 per ADS in cash, or
the equivalent of $25.60 per ADS based on an exchange rate of
1.0864 U.S. dollars to euros, which values Biotie at approximately
$363 million.
Acorda will obtain worldwide rights to tozadenant, an oral
adenosine A2a receptor antagonist currently in Phase 3 development
in Parkinson’s disease (PD). In a Phase 2b clinical trial,
tozadenant reduced average daily OFF time as an adjunct to
treatment regimens including levodopa/carbidopa.
Further expanding its Parkinson’s pipeline, Acorda will also
obtain global rights to SYN120, an oral, 5-HT6/5-HT2A dual receptor
antagonist for Parkinson’s-related dementia, in Phase 2 development
with support from the Michael J. Fox Foundation.
“Our acquisition of Biotie positions Acorda as a leader in
Parkinson’s disease therapeutic development, with three
clinical-stage compounds that have the potential to improve the
lives of people with Parkinson’s. Tozadenant, Biotie’s most
advanced clinical program, is a promising therapy being developed
to reduce daily OFF time,” said Ron Cohen, M.D., Acorda's President
and CEO. “Adenosine A2a receptor antagonists may be the first new
class of drug approved for the treatment of Parkinson’s in the U.S.
in over 20 years. Approximately 350,000 people with Parkinson’s in
the U.S. experience OFF periods, and if approved, tozadenant could
provide a much needed treatment option.”
Dr. Cohen added, “Tozadenant is a compelling opportunity with
potential market exclusivity to 2030. The Phase 2 data were highly
statistically significant and clinically meaningful. We are
targeting an NDA filing by the end of 2018.”
Tozadenant is an orally administered, potent and selective
antagonist of the adenosine A2A receptor. Adenosine is a
neurotransmitter, one of the naturally occurring chemical
messengers that transmit signals between neurons in the brain. The
A2a receptor is one of the types of chemical receptors on neurons
that mediate the adenosine signal. This receptor is expressed
particularly in the motor control part of the brain that is
affected in people with Parkinson’s. Activation of the A2a receptor
has effects in the brain that antagonize the action of another
neurotransmitter, dopamine, in this brain region. A loss of
dopamine input is a central mechanism of PD and treatment with
levodopa is designed to restore more normal dopamine levels in the
brain. Blocking of A2a receptors with tozadenant serves to dampen
the antagonistic effect of adenosine on dopamine and thereby
promotes motor function.
A 420-patient Phase 2b trial published in Lancet Neurology
compared four different doses of tozadenant to placebo, using
patient diaries to record OFF time in patients on a stabilized
regimen of levodopa and up to three additional medications. OFF
time is characterized by a re-emergence of PD motor symptoms, such
as impaired ability to move, muscle stiffness and tremor. The
average daily OFF time for individuals receiving tozadenant at the
120 mg dose decreased by 1.9 hours, or 1.1 hours relative to
placebo (5.9 hours per day at baseline to 4.0 hours at twelve
weeks). Notably, this improvement in OFF time was not associated
with significant increases in troublesome dyskinesia for doses
being studied in the ongoing Phase 3 program (60mg and 120 mg).
The most common adverse events in the this trial for the 60 mg
and 120 mg dose groups were: dyskinesia (14% in the 60 mg group,
16% in the 120 mg twice-daily group, 8% placebo group); nausea (6%
in the 60 mg group, 9% in the 120 mg twice-daily group, 4% placebo
group); and dizziness (5% in the 60 mg group, 5% in the 120 mg
twice-daily group, 1% placebo group). Serious adverse events were
reported in 13 patients (placebo - 3; tozadenant: 60 mg - 1, 120 mg
- 3, 180 mg - 2, 240 mg - 4). There were six deaths in this study
(placebo - 0; tozadenant: 60 mg -1, 120 mg - 0, 180 mg - 2, 240 mg
- 3). Neither the drug safety monitoring board (DSMB) nor a second
panel of experts who reviewed the data identified a relationship
between treatment with tozadenant and serious adverse events or
deaths.
Biotie is headquartered in Turku, Finland, with clinical
operations based in South San Francisco, CA. Following the close of
the acquisition, Acorda plans to maintain the South San Francisco
location and retain Biotie staff at that site. Acorda is
considering the long-term future of the Turku facility. With this
addition, Acorda will have operations in three major U.S.
biotechnology centers: New York, Boston and San Francisco.
Mr. William M. Burns, Chairman of the Board of Biotie,
commented, “We have carefully assessed the terms and conditions of
the offer and believe that it is an attractive offer to
shareholders that recognizes the strategic value of Biotie.”
Mr. Burns continued, “With the shared mission to improve the
lives of patients with neurological diseases, this transaction will
allow Acorda and Biotie to bring together their expertise and
resources in order to fully maximize the potential of tozadenant,
an A2a receptor antagonist in Phase 3 for Parkinson’s disease, and
SYN120 a dual 5-HT6/5-HT2A receptor antagonist in Phase 2 for
cognitive and psychotic disorders, and to bring new medicines to
patients. We are excited about this offer for our shareholders, the
Biotie team and for patients.”
The acquisition also includes two other assets: BTT1023, a fully
human monoclonal antibody in Phase 2 development for treatment of
primary sclerosing cholangitis (PSC), a chronic liver disease; and
double-digit royalties from sales of Selincro®, a European
Medicines Agency (EMA)-approved therapy for reduction in alcohol
consumption marketed by H. Lundbeck A/S in multiple European
countries.
The $363 million all-cash tender offer in Finland and the United
States is unanimously recommended by Biotie’s Board of Directors.
The transaction was also unanimously approved by Acorda’s Board of
Directors. Subject to customary closing conditions, the tender
offer is expected to be completed in the first or second quarter of
2016, and the acquisition is expected to be completed in the third
quarter of 2016.
Financing Transactions
Concurrently with the announcement of the Biotie transaction,
Acorda announced two separate financing transactions.
Acorda has agreed to issue $75 million of common stock (the
“Shares”) in a private placement transaction exempt from
registration under the Securities Act of 1933, as amended (the
“Securities Act”). Acorda intends to use the net proceeds from the
issuance of the Shares to fund, in part, the acquisition of Biotie
described above. The issuance of the Shares is not contingent upon
the consummation of the acquisition of Biotie or the terms of the
acquisition. If the acquisition of Biotie is not consummated for
any reason, the Company will use all of the net proceeds from the
issuance of the Shares for general corporate purposes. The closing
of the private placement is expected to occur in January 2016 and
is subject to customary closing conditions.
Acorda also received a commitment from JPMorgan Chase, N.A. for
an asset-based loan facility for up to $60 million. The closing of
this transaction is expected to occur within six weeks and is
subject to customary closing conditions.
The Shares will not be registered under the Securities Act or
any state securities laws and may not be offered or sold in the
United States absent an effective registration statement or an
applicable exemption from registration requirements or a
transaction not subject to the registration requirements of the
Securities Act or any state securities laws.
This press release is issued pursuant to Rule 135(c) under the
Securities Act and shall not constitute an offer to sell or the
solicitation of an offer to buy any security and shall not
constitute an offer, solicitation or sale in any jurisdiction in
which such offering, solicitation or sale would be unlawful.
Acorda had $353 million in cash at year-end 2015 (unaudited).
Following the close of the transaction, the Company expects the net
proceeds from the common stock issuance, together with the
availability under the asset-based credit facility, to be
sufficient to fund ongoing operations.
Lazard, MTS Health Partners and J.P. Morgan Securities LLC
served as financial advisors, and Kirkland & Ellis, Roschier,
Covington & Burling LLP and Jones Day LLP served as legal
advisors to Acorda in connection with this transaction. Guggenheim
Securities served as Biotie Therapies’ financial advisors, and
Davis Polk & Wardwell LLP and Hannes Snellman Attorneys Ltd.
served as Biotie’s legal advisors.
Webcast and Conference Call
Ron Cohen, President and Chief Executive Officer, and Michael
Rogers, Chief Financial Officer, will host a conference call today
at 8:00 a.m. ET.
To participate in the conference call, please dial 855-542-4209
(domestic) or 412-455-6054 (international) and reference the access
code 31734527. The presentation will be available via a live
webcast on the Investor section of www.acorda.com.
A replay of the call will be available from 11:00 a.m. ET on
January 19, 2016 until midnight on January 26, 2016. To access the
replay, please dial 855-859-2056 (domestic) or 404-537-3406
(international) and reference the access code 31734527. The
archived webcast will be available for 30 days in the Investor
Relations section of the Acorda website at www.acorda.com.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company
focused on developing therapies that improve the lives of people
with neurological disorders.
Acorda has an industry leading pipeline of novel neurological
therapies addressing a range of disorders, including multiple
sclerosis, Parkinson’s disease, post-stroke walking deficits,
epilepsy and migraine. Acorda markets three FDA-approved therapies,
including AMPYRA® (dalfampridine) Extended Release Tablets, 10
mg.
About Biotie Therapies
Biotie Therapies is a biopharmaceutical company primarily
focused on developing therapeutics for central nervous system
disorders. Its pipeline includes product candidates designed to
address unmet medical needs in Parkinson’s disease and related
dementia, other neurodegenerative indications and primary
sclerosing cholangitis, an orphan fibrotic liver disease. In
addition, Biotie has successfully developed a product for alcohol
dependence that is being commercialized by Lundbeck and is a source
of further potential milestone payments and ongoing royalties.
Forward-Looking Statement
This press release includes forward-looking statements. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects
should be considered forward-looking. These statements are subject
to risks and uncertainties that could cause actual results to
differ materially, including the ability to complete the Biotie
transaction on a timely basis or at all; the ability to realize the
benefits anticipated to be realized by the Biotie transaction and
the Civitas transaction; the ability to successfully integrate
Biotie’s operations and Civitas’ operations, respectively, into our
operations; we may need to raise additional funds to finance our
expanded operations and may not be able to do so on acceptable
terms; our ability to successfully market and sell Ampyra in the
U.S.; third party payers (including governmental agencies) may not
reimburse for the use of Ampyra or our other products at acceptable
rates or at all and may impose restrictive prior authorization
requirements that limit or block prescriptions; the risk of
unfavorable results from future studies of Ampyra or from our other
research and development programs, including CVT-301, Plumiaz, or
any other acquired or in-licensed programs; we may not be able to
complete development of, obtain regulatory approval for, or
successfully market CVT-301, Plumiaz, or any other products under
development; the occurrence of adverse safety events with our
products; delays in obtaining or failure to obtain regulatory
approval of or to successfully market Fampyra outside of the U.S.
and our dependence on our collaboration partner Biogen in
connection therewith; competition; failure to protect our
intellectual property, to defend against the intellectual property
claims of others or to obtain third party intellectual property
licenses needed for the commercialization of our products; and
failure to comply with regulatory requirements could result in
adverse action by regulatory agencies. In addition, the compounds
being acquired from Biotie are subject to all the risks inherent in
the drug development process, and there can be no assurance that
these compounds will receive regulatory approval or be commercially
successful. These and other risks are described in greater detail
in our filings with the Securities and Exchange Commission. We may
not actually achieve the goals or plans described in our
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in
this release are made only as of the date hereof, and we disclaim
any intent or obligation to update any forward-looking statements
as a result of developments occurring after the date of this
release.
Additional Information
The tender offer described in this release has not yet
commenced, and this release is neither an offer to purchase nor a
solicitation of an offer to sell securities. At the time the tender
offer is commenced, we will file, or will cause a new wholly owned
subsidiary to file, with the SEC a tender offer statement on
Schedule TO. Investors and holders of Biotie Equity Interests are
strongly advised to read the tender offer statement (including an
offer to purchase, letter of transmittal and related tender offer
documents) and the related solicitation/recommendation statement on
Schedule 14D-9 that will be filed by Biotie with the SEC, because
they will contain important information. These documents will be
available at no charge on the SEC’s website at www.sec.gov upon the
commencement of the tender offer. In addition, a copy of the offer
to purchase, letter of transmittal and other related tender offer
documents (once they become available) may be obtained free of
charge by directing a request to us at www.acorda.com or Office of
the Corporate Secretary, 420 Saw Mill River Road, Ardsley, New York
10502.
In addition to the offer to purchase, the related letter of
transmittal and certain other offer documents, as well as the
solicitation/recommendation statement, we file annual, quarterly
and special reports, proxy statements and other information with
the SEC. You may read and copy any reports, statements or other
information filed by us at the SEC public reference room at 100 F
Street, N.E., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 for further information on the public reference
room. our filings with the SEC are also available to the public
from commercial document-retrieval services and at the website
maintained by the SEC at www.sec.gov.
THE OFFER WILL NOT BE MADE DIRECTLY OR INDIRECTLY IN ANY
JURISDICTION WHERE EITHER AN OFFER OR PARTICIPATION THEREIN IS
PROHIBITED BY APPLICABLE LAW OR WHERE ANY TENDER OFFER DOCUMENT OR
REGISTRATION OR OTHER REQUIREMENTS WOULD APPLY IN ADDITION TO THOSE
UNDERTAKEN IN FINLAND AND THE UNITED STATES.
IN ADDITION, THE TENDER OFFER DOCUMENTS, THIS RELEASE AND
RELATED MATERIALS AND ACCEPTANCE FORMS WILL NOT AND MAY NOT BE
DISTRIBUTED, FORWARDED OR TRANSMITTED INTO OR FROM ANY JURISDICTION
WHERE PROHIBITED BY APPLICABLE LAW. IN PARTICULAR, THE TENDER OFFER
IS NOT BEING MADE, DIRECTLY OR INDIRECTLY, IN OR INTO, CANADA,
JAPAN, AUSTRALIA, SOUTH AFRICA OR HONG KONG. THE TENDER OFFER
CANNOT BE ACCEPTED BY ANY SUCH USE, MEANS OR INSTRUMENTALITY OR
FROM WITHIN CANADA, JAPAN, AUSTRALIA, SOUTH AFRICA OR HONG
KONG.
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version on businesswire.com: http://www.businesswire.com/news/home/20160118005877/en/
Acorda TherapeuticsInvestorsFelicia Vonella,
914-326-5146fvonella@acorda.comorMediaJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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