Bayer and Johnson & Johnson's Ortho-McNeil unit announced Wednesday that the companies have signed an agreement to jointly develop and market antithrombosis drug BAY 59-7939 (Factor Xa inhibitor), currently in Phase II trials. Under the deal, Bayer will receive an upfront payment and milestone payments in the range of $290 million.
Arthur Higgins, head of Bayer's health care division, noted that Johnson & Johnson will pay more than 50 percent of the global development costs for BAY 59-7939 under the agreement, Bloomberg reports. If the drug receives regulatory approval, Johnson & Johnson will pay Bayer royalties of up to 30 percent on the drug's US sales.
Additionally, the Johnson & Johnson unit will have exclusive marketing rights for the cardiology, primary care and hospital specialty markets in the US, while Bayer will have an option to co-promote the drug in hospital and specialty markets in the US under the deal. Bayer will have sole marketing rights for the compound outside the US as well as gaining rights to co-promote Ortho-McNeil's Elmiron, for the relief of bladder pain associated with interstitial cystitis, in the US urology market.
"This is a very, very important step in Bayer's strategy to regain profitability for its pharmaceuticals business,'' commented HVB Group analyst Andreas Heine, Bloomberg reports. "It has found a strong US partner in Johnson & Johnson and the price emphasises that this product is also important for Johnson & Johnson. It's a very rounded deal.''
Within the next few weeks, Bayer said it expects to start Phase III trials of BAY 59-7939 for the prevention of venous thromboembolism after major orthopaedic surgery. The company plans to file for approval of the drug in this indication by the end of 2007, as reported in Forbes. The drug is also in Phase IIb dosing trials as a venous thromboembolism treatment and stroke prevention in patients with atrial fibrillation. Bayer hopes to file for approval for these indications in 2009, new sources report.
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