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Acorda Announces Expiration of the Hart-Scott-Rodino Waiting Period for Its Tender Offer for Biotie Therapies

02/17/2016
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ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR), for its tender offer for Biotie Therapies Corp. (Nasdaq Helsinki: BTH1V; Nasdaq: BITI) has expired.

Acorda announced on January 19, 2016 that it entered into an agreement to acquire Biotie for €0.2946 per share and €23.5680 per ADS in cash. Pursuant to the terms of the agreement, Acorda will offer to acquire all outstanding shares, American Depositary Shares, and other equity securities of Biotie through a public tender offer.

The expiration of the HSR waiting period satisfies one of the conditions to the tender offer, which has not yet been commenced. The closing of the tender offer will be subject to customary terms and conditions, unless waived by Acorda, including the valid tender to (or other acquisition by) Acorda of at least 90 percent of the issued and outstanding shares and voting rights of Biotie on a fully diluted basis as described in more detail in the agreement between Acorda and Biotie.

Lazard, MTS Health Partners and J.P. Morgan Securities LLC are serving as financial advisors, and Kirkland & Ellis LLP, Roschier Attorneys Ltd., Covington & Burling LLP and Jones Day LLP are serving as legal advisors to Acorda in connection with the tender offer. Guggenheim Securities is serving as Biotie Therapies’ financial advisor, and Davis Polk & Wardwell LLP and Hannes Snellman Attorneys Ltd. are serving as Biotie’s legal advisors.
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Source: press release, 2/17/16. http://ir.acorda.com/investors/investor-news/investor-news-details/2016/...

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Acorda to Acquire Biotie Therapies

01/19/2016

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
ARDSLEY, N.Y.--(BUSINESS WIRE)-- 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.
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Source: press release, 1/19/16. http://ir.acorda.com/investors/investor-news/investor-news-details/2016/...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Portfolio of compounds.N/AN/AN/AN/A

Mechanism of action: N/A

Phase of Development: N/A

Event Type: Corporate: Merger and Acquisition Closing

Dates: 2016-07-01 - 2016-09-30

Results: Pending