Guidant Corporation, a world leader in the treatment of cardiac and vascular disease, announced that the company has entered into a definitive agreement to acquire certain assets of Biosensors International's everolimus eluting stent program. The agreement provides an exclusive worldwide license to Biosensors' bioabsorbable polymer formulation technology in the field of everolimus eluting stents. Guidant also obtained a nonexclusive license to utilize this technology with other drugs in drug eluting stents. Additionally, Guidant acquired the option of manufacturing and commercializing the Biosensors everolimus eluting stent that has been used in Biosensors' clinical trials.

Under the terms of the agreement, Biosensors will receive an up-front cash payment of $20 million in March for the asset purchase and licensing fee, and may receive additional milestone payments over the course of clinical development and royalties on future sales of products that utilize Biosensors' technology. These milestone payments will be accounted for as in-process research and development. Guidant previously acquired an exclusive, worldwide license to the drug everolimus from Novartis Pharma AG and Novartis AG for use in drug eluting stents.

“We are enthusiastic about everolimus as a compound for drug eluting stents, given our own preclinical and Biosensors' early human clinical results,” said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. “This agreement provides intellectual property and valuable preclinical and clinical data that will complement our everolimus program. The ability to develop both non-erodible and bioabsorbable polymeric elution technologies is an important step forward for our drug eluting stent program.

“In light of the Biosensors transaction and additional insight into the FUTURE I results, the agreement will enable Guidant to potentially accelerate its path to commercialization of an everolimus eluting stent outside of the United States,” continued Mead.

Preliminary results presented from the FUTURE I first-in-man clinical trial utilizing everolimus demonstrated no restenosis in 11 patients receiving the drug eluting stent at six-month angiographic follow up. Additional results from the trial will be presented by Dr. Eberhard Grube of the Herzzentrum Siegburg in Germany, principal investigator of the study, at the American College of Cardiology conference taking place March 30 – April 2 in Chicago.

“The early FUTURE I clinical results were highly promising,” said Dr. Grube. “The use of a bioabsorbable polymer to deliver drugs from a stent may offer unique clinical advantages. I look forward to analysis of data from the larger FUTURE II trial, which recently completed enrollment.”

Guidant announced an agreement in principle to enter into this transaction earlier this year. Guidant and Biosensors previously received clearance for the transaction from the Federal Trade Commission under the United States Hart-Scott-Rodino Antitrust Improvements Act, and the agreement will take effect immediately.

Guidant also updated the status of its everolimus eluting stent program. In addition to the first-in-man experience from FUTURE I and II now accessed via the Biosensors transaction, Guidant plans to initiate the SPIRIT FIRST trial, a dose-selection feasibility study with Guidant's MULTI-LINK VISION Coronary Stent System and everolimus, upon successful completion and analysis of its current preclinical studies. Although analysis of three-month preclinical data of Guidant's everolimus eluting stent revealed excellent results in the majority of animals, a higher-than-expected foreign body response was observed in a small subset. Guidant conducted a thorough investigation that yielded possible root causes, and the company has initiated additional animal studies to validate the findings.

“Due to our multiple stent platforms, multiple polymers, and promising early clinical and preclinical data, we remain confident in our 2005 everolimus eluting stent launch timing,” commented Mead.