Acorda Picks Up Late-Stage Parkinson's Candidate With $363m Biotie Buy
This article was originally published in Scrip
Acorda Therapeutics Inc.'s president and CEO Ron Cohen has been dropping hints for some months that he was pursuing significant business development opportunities and the EU was his preferred hunting ground. Finally, on Jan. 19, Acorda said it has agreed to acquire Biotie Therapies Corp. of Finland for around $363m. Biotie has a Parkinson's disease drug candidate in Phase III which has a mechanism of action that has caused problems for other companies.
Biotie Pipeline
The acquisition gives Acorda worldwide rights to tozadenant, an oral adenosine A2a receptor antagonist currently in a Phase III trial called TOZ-PD for the treatment of Parkinson's disease.
The product had been partnered with Belgium's UCB but Biotie regained full rights in 2014 after a "portfolio reprioritization" on UCB's part. Tozadenant was originally licensed to UCB in 2010 and UCB paid Biotie $20m to exercise its license in February 2013.
The Phase III study, initiated in July 2015, is a randomized, double-blind, placebo controlled trial evaluating tozadenant in 450 Parkinson's patients experiencing end-of-dose wearing off episodes. Biotie reached an agreement with the US FDA on a Special Protocol Assessment of this study. Top-line data from the double-blind portion of the study are expected to be available by the end of 2017.
"Tozadenant is a compelling opportunity with potential market exclusivity to 2030. The Phase II data were highly statistically significant and clinically meaningful. We are targeting an NDA filing by the end of 2018," said Cohen.
Biotie is headquartered in Turku, Finland, with clinical operations based in South San Francisco, CA. Acorda plans to maintain the South San Francisco location and retain Biotie staff at that site, but it is "considering the long-term future" of the Turku facility.
Acorda will also obtain global rights to SYN120, an oral 5-HT6/5-HT2A dual receptor antagonist for Parkinson's-related dementia, in Phase II development with support from the Michael J. Fox Foundation.
The acquisition also includes two other assets: BTT1023, a fully human monoclonal antibody in Phase II for treatment of primary sclerosing cholangitis (PSC), a chronic liver disease; and double-digit royalties from sales of Selincro, an EU approved therapy for reduction in alcohol consumption marketed by Lundbeck in multiple European countries.
William Burns, chair of Biotie's board, said: "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."
Late Stage Concerns
A number of adenosine A2a receptor antagonists for Parkinson's disease have previously waded into trouble in late-stage development. These include Merck & Co's preladenant and Kyowa Hakko Kirin's istradefylline.
"While we like Acorda's continued investment into neurology and diversification away from Ampyra, we believe clinical risk remains for Biotie's lead asset tozadenant as it advances through a much larger Phase III program in Parkinson's disease," commented analysts from Leerink.
Terms
Acorda has offered €0.2946 in cash for each Biotie share, a 95% premium over the closing price of Biotie shares on Nasdaq Helsinki on Jan. 18, the last trading day preceding the announcement. It is a premium of around 84% over the 90 trading day volume-weighted average on Nasdaq Helsinki.
Acorda Update
Cohen was appointed chair of the US industry group the Biotechnology Industry Organization (BIO) in 2015.
Speaking at the recent JP Morgan healthcare conference, Cohen noted that Acorda expected clinical milestones in 2016 for all three of its late-stage programs.
"We are aiming to complete pivotal trials for CVT-301 in Parkinson's disease and PLUMIAZ in seizure clusters this year; if successful, we plan to file New Drug Applications for both in 2017. We project that these two therapies could generate combined peak sales of over $700m. We also expect to perform an interim analysis in our Phase III trial of dalfampridine for post-stroke walking deficits. This analysis, combined with results from our development efforts on a once-daily formulation of dalfampridine, will establish the next steps for the program."
Dalfampridine (Ampyra) is Acorda's FDA-approved multiple sclerosis drug that has been the subject of a series of unsuccessful patent challenges in 2015 filed by Kyle Bass – the hedge fund manager the drug industry loves to hate – and his Coalition for Affordable Drugs.
"Ampyra's growth in 2015 allowed us to remain cash flow positive while still investing in our late stage pipeline. We expect to remain active on the business development front, focusing on late stage or marketed products that leverage the strength of our neurology development and commercial capabilities," said Cohen on Jan. 11.
The company provided 2016 guidance for Ampyra net revenue of $475-485m. At year-end 2015, the company had cash and equivalents of $353m.