Bayer HealthCare (Bayer) has entered into an exclusive license agreement with Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) on ISIS-FXIRx, an antisense investigational drug in clinical development for the prevention of thrombosis. Under the agreement Bayer will further develop and commercialize ISIS-FXIRx in areas of high unmet medical need. As part of the clinical development program, Bayer plans to evaluate the therapeutic profile of ISIS-FXIRx in an appropriate patient community.
"Bayer is committed to developing therapies in areas of patient need and we share a common vision with Isis in developing ISIS-FXIRx," said Dr Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
"We believe Bayer, a leading pharmaceutical company in the treatment of thrombotic disease, is the ideal partner for ISIS-FXIRx. This transaction further demonstrates Bayer's commitment to the field. Bayer has the expertise, commitment and resources to develop ISIS-FXIRx in areas where unmet medical needs exist. We are pleased with the value of this partnership, which supports a robust development program to maximize the value of ISIS-FXIRx globally and which allows us to participate significantly in future commercial success," said Stanley Crooke, Ph.D, M.D., Chief Executive Officer at Isis Pharmaceuticals. "We believe that this transaction represents the right deal, with the right partner and the right development plan."
Under the terms of the agreement, Isis is eligible to receive near-term payments, including an up-front payment and payment upon advancement of the program following a Phase II study in patients with compromised kidney function. Isis is also eligible to receive milestone payments as the drug advances toward the market. In addition, Isis is eligible to receive tiered royalties on gross margins of ISIS-FXIRx. After completion of ongoing activities at Isis, Bayer will assume all global clinical development as well as worldwide regulatory and commercialization responsibilities for ISIS-FXIRx.
This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.
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