Cardiome Pharma and Fujisawa Healthcare sign US$68 million partnership agreement
Cardiome Pharma Corp and Fujisawa Healthcare Inc, the US subsidiary of Fujisawa Pharmaceutical Co. Ltd. announced execution of a US$68 million (CDN $90 million) strategic partnership agreement for the co-development and Fujisawa Healthcare's exclusive commercialization of Cardiome's proprietary intravenous antiarrhythmic agent, RSD1235, subject to customary regulatory approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Under the terms of the agreement, Cardiome and Fujisawa Healthcare will co-develop RSD1235 as an intravenous formulation for the treatment of atrial fibrillation and atrial flutter for North American markets. Cardiome receives an up-front payment of US$10 million upon execution of the agreement. In addition, Cardiome also has the right to place US$4 million of equity with Fujisawa Healthcare at a premium to the 30-day average market price at any time over the next twelve months. Development and commercialization milestone payments totalling US$54 million will be payable to Cardiome on the achievement of specific development and commercial sales targets.
"RSD1235 is an exciting new compound that will allow us to deepen our presence in the cardiovascular market and position Fujisawa Healthcare as a leader in acute cardiovascular care," stated Hideo Fukumoto, Chairman and CEO of Fujisawa Healthcare, Inc. "Through our partnership with Cardiome, we hope to provide clinicians with a treatment option that challenges currently available therapies for atrial fibrillation."
"In partnering RSD1235, Cardiome was looking for a company with a strong cardiovascular franchise and a dedicated in-hospital sales force. With over 10 years of experience in the cardiovascular market with its successful acute use cardiovascular drugs, (Adenoscan & Adenocard), we believe Fujisawa Healthcare is the perfect partner for Cardiome" said Bob Rieder, President and CEO of Cardiome. "The deal is a true win-win. We gain a strong partner in Fujisawa Healthcare for the North American markets while retaining both non- North America IV rights and global oral rights to RSD1235. This partnership gives Fujisawa Healthcare access to a potentially great drug in a high value application - one that fits perfectly into their business strategy. We are delighted to have Fujisawa as a partner."
Fujisawa Healthcare will be financially responsible for 75% of all future clinical development costs with Cardiome responsible for the remaining 25% of costs. All development activities will be jointly managed by employees of both companies. Fujisawa Healthcare will be responsible for the development plan, NDA application and registration, along with the commercial manufacturing, marketing and sale of RSD1235. Cardiome will manage the ongoing Phase III trial known as ACT 1 and the second planned study known as ACT 2. Cardiome will also be responsible for the continued manufacturing of clinical supplies of RSD1235. Cardiome will receive royalties on end-user sales of RSD1235 reflective of Cardiome's 25% share of development costs and other financial considerations.
Product rights to the IV formulation of RSD1235 for markets outside of North America and world rights to the oral formulation of RSD1235 for chronic atrial fibrillation are not included within the scope of this partnership. Cardiome intends to form future additional alliances for these product opportunities or maintain such opportunities for commercialization on its own.
In 1999 there were 6.2 million cases of atrial arrhythmia in the developed world. The worldwide market for drugs to treat atrial fibrillation, the main category of atrial arrhythmia, was US$1.16 billion in 1999, with approximately $800 million of this in the US alone.