The bid by Guidant to buy fellow interventional device firm Cook appears to be unraveling due to disappointing results for a drug-eluting stent that Cook is developing.
Indianapolis-based Guidant yesterday reported that the preliminary results of a U.S. clinical study comparing its Multi-Link Penta coronary stent system with the paclitaxel-coated Achieve drug-eluting coronary stent system manufactured by Bloomington, IN-based Cook did not meet conditions outlined in a merger agreement by the two companies.
The study was designed to demonstrate a 40% reduction in the primary endpoint of a 270-day target vessel failure (TVF) for the Achieve system as compared to the Penta system. The preliminary analysis indicates that although there is a trend toward improvement in TVF, the primary endpoint will not be met, according to Guidant. In addition, the trend toward a reduced angiographic binary restenosis rate appears to be less than the planned 50% reduction, the firm said.
On the basis of the results, the terms of the merger agreement are not expected to be satisfied. Under the agreement, Guidant would pay a break-up fee of $50 million to Cook, and an amendment would be made to an existing stent-delivery system agreement.
Officials at Cook said that regardless of the outcome of the study or any termination of the proposed merger, the company will remain privately held. "We have always said that it is business as usual at Cook until the conditions of the proposed merger were met," said Cook founder and chairman of the board William Cook.
In other news, Guidant has agreed in principle to an exclusive worldwide license of Singapore-based Biosensors International’s everolimus-eluting stent intellectual property. The firm also obtains a nonexclusive license to Biosensors’ drug and bioabsorbable polymer formulation technology for use with other drugs. Guidant previously acquired an exclusive, worldwide license to the drug everolimus from Basel, Switzerland-based Novartis Pharma for use in drug-eluting stents.
Under terms of the proposed agreement, Biosensors will receive a cash payment for the asset purchase and licensing fee and may receive additional cash milestone payments on the basis of the performance of its everolimus stent products in clinical trials. Guidant will make an additional cash payment upon CE Mark approval, as well as royalty payments on future product sales that utilize Biosensors' technology.
The transaction is subject to further due diligence and the completion of a definitive agreement, which is expected to be completed within the next 90 days, according to Guidant.
By AuntMinnie.com staff writers
January 3, 2003
Related Reading
Guidant gets CE Mark for stent system, December 19, 2002
Guidant sees record third quarter, October 17, 2002
Cook gets OK to test new vascular stent, August 16, 2002
Guidant to buy Cook, July 30, 2002
Guidant, Cook file to initiate stent trial, October 9, 2001
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