BAY 59-7939 (Factor Xa inhibitor) is currently undergoing phase II clinical trials. Phase III clinical trials to assess its effectiveness in the prevention of venous thromboembolism will also be initiated in the coming weeks.
According to the terms of the agreement, Ortho-McNeil will share the global development costs and will make an upfront payment along with payments based on achieving certain development milestones. Following the US launch, Ortho-McNeil will pay royalties of up to 30%, depending on sales thresholds.
In the US, Ortho-McNeil will receive exclusive marketing rights for the cardiology, primary care and hospital specialty markets. Bayer HealthCare (BHC) will retain an option to co-promote BAY 59-7939 in the hospital and specialty markets through its specialty pharmaceuticals unit in the US. BHC will also retain sole marketing rights for the compound in countries outside the US.
“We are confident that this alliance will help us to fully exploit the potential of our Factor Xa inhibitor and will also support our strategic plans for the US market, where we intend to focus on our specialty business,” said Arthur Higgins, chairman of BHC’s executive committee
In addition the agreement gives BHC the rights to co-promote Ortho-McNeil’s Elmiron for the relief of bladder pain or discomfort associated with interstitial cystitis to the urology audience in the US. BHC will receive the full profit from the urology prescription sales of Elmiron in the US. This will strengthen the company’s specialty business in this region.