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Gore Partners with Medinol on the Rebound in Global Stent Deal

Executive Summary

WL Gore & Associates and Tel Aviv, Israel-based Medinol, both privately-held companies, enetered into a worldwide partnership agreement covering stents and stent systems, the exact terms of which have not been disclosed. What's clear, however, is that the deal enables each company to fill a significant hole in their interventional cardiology product lines, while also restoring worldwide distribution channels for Medinol. The Israeli company, which focuses exclusively on developing and manufacturing innovative stent technology, lost its sales and marketing channel this year after dissolving a longstanding agreement with Boston Scientific. Now, it will be able to utilize the balloon and stent delivery system that Gore plans on unveiling later this year, along with Gore's distribution network, while Gore will have access to Medinol's ionnovative stent line, including the new NIRflex stent.

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Stroke Prevention: The Newest Frontier in Interventional Cardiology

The neurology community has amassed a great deal of evidence that a certain type of heart defect known as a PFO is associated with an increased risk of stroke. This finding has prompted companies with transcatheter devices developed for a niche pediatric congenital defect market to migrate to adult stroke prevention. In the new field, the risk isn't so much technical--a history of device use in the pediatric market has obviated alot of this risk--as clinical. In stroke prevention, clinical trials not only have to prove a negative, which is always difficult, but will also have to confirm the role of PFOs in stroke, as yet scientifically unproven, at the same time as they validate devices.

Medinol: Can Technology Still Win In Stents?

Medinol, a small Israeli stent company, used innovative stent design and manufacturing processes to develop products that propelled its marketing partner, Boston Scientific, to early leadership in what became the biggest cardiovascular device market of the past decade. Problems resulting in litigation led Medinol to recently terminate the collaboration after six years, leaving the small firm with the choice of going it alone and having to build a worldwide sales and marketing network, or seeking another partner. The break-up occurs at a pivotal point in the development of coronary stent technology; bare metal stents are apparently about to give way to the next-generation drug-eluting stents (DES), which present perhaps an even larger opportunity than that enjoyed bvy their predecessors. Medinol is skipping over DES and is already working on the next-generation stent/drug therapy. Because of consolidation, the stent market is now dominated by four major playuers. Yet, Medinol chose to end its alliance with one of the Big Four to join forces with a much smaller player in this space, WL Gore & Associates Inc. Both Medinol and Gore are R&D-driven, and are betting that the rules of the stent game haven't changed: that ultimately in interventional cardiology, the best technology still wins.

Testing Drugs Against New Targets: Like Playing Blind Man's Bluff?

As companies move into development of drugs against novel targets, including a host of genomically derived drugs, they are assuming a new kind of target risk. The heightened risk exists largely because the targets revealed by genomics techniques for the most part have not been validated by linking them empirically to the initiation or maintenance of a disease state, nor through the use of biomarkers during clinical development. Stumbles in the pursuit of drugs against EGFR are symptomatic of this new pharma industry problem. In this context, the cancer drugs Herceptin and Gleevec, widely touted as the first examples of rapidly developed, rationally designed molecular medicines, will prove to be much more the exception than the rule. And importantly, the emerging pattern of EGFR drug development suggests that pursuit of novel targets will do little to ameliorate the industry's R&D productivity problem.


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