By Brady Huggett

AVI BioPharma, in its first deal with a device company, is licensing out its NeuGene antisense compound rights for vascular disease through a potential $100 million agreement with Medtronic Inc.

The deal gives Minneapolis-based Medtronic a worldwide license to a family of antisense compounds that includes AVI¿s Resten-NG. Medtronic will attach the antisense compounds to its medical devices ¿ first and foremost, stents.

Bringing the medical device and biotechnology industries together in this deal means no one loses, said Alan Timmins, president and chief operating officer at AVI.

¿It actually is a win-win situation for both companies,¿ he said. ¿What we are dealing with is a new type of device, or a new usage for a device. It functions as a stent and helps deliver a drug. The drug is there because the application is a drug application.¿

AVI, of Portland, Ore., gets $10 million up front through an equity investment from Medtronic, giving the medical technology company an approximate 5 percent or 6 percent stake in AVI, Timmins said. More could follow, as the deal stipulates additional equity investments based on certain undisclosed benchmarks. Medtronic may also pay additional license fees, based on milestones, and it gets rights of first refusal for compounds in the vascular field. Add it all up, and it could mean as much as $100 million to AVI, exclusive of royalties, Timmins told BioWorld Today.

While the agreement is not for Resten-NG alone, limited to stent use for antisense compounds, or focused solely on restenosis, the deal will begin there.

¿At this point, stents are the primary use for us,¿ Bob Hanvik, director of global public and media relations at Medtronic, told BioWorld Today. ¿This is one of several solutions to the prevention of restenosis and we feel it is a very good one.¿

Restenosis is the narrowing or reclogging of arteries following balloon angioplasty or placement of a stent. It is a healing response gone awry. Timmins likened it to a wound that heals like a ¿scar with a bump over it.¿ During the balloon angioplasty process, Timmins said restenosis can occur in 20 percent to 40 percent of cases.

AVI¿s Resten-NG targets the cell proliferation gene, called c-myc, and shuts it down, stopping cell regrowth and protecting the vessel. The product is in Phase II trials now, and reworking the trials to incorporate the new application will take some effort, Timmins said.

¿[Medtronic and AVI] need to garner our regulatory resources and figure out the best way to do that,¿ he said. ¿The path isn¿t clear at the moment. We¿ll figure that out with the FDA. Rather than set a timeline, I¿ll say that the thing that has been impressive and continues to be about Medtronic, is that they like to do things quickly.¿

Medtronic will pay for development of Resten-NG for vascular disease treatment, but AVI will do the manufacturing. While Resten-NG is the jewel of the deal, Timmins said all is not lost if the product does not survive the clinical gauntlet.

¿Worst-case scenario in this first time at-bat, if we swing and miss, [the companies] will look at other opportunities,¿ he said. And, while cautioning against putting words in Medtronic¿s mouth, he added that it is AVI¿s antisense compound program as a whole that attracted Medtronic, not just Resten-NG.

But Medtronic doesn¿t seem worried.

¿We are pleased to work with AVI because we are both striving for the same kind of solutions: We want the best patient outcomes without compromising safety or the natural healing process following intervention,¿ Hanvik said. ¿We believe Resten-NG shows a lot of promise.¿

AVI said Monday it began a Phase I/II trial of another of its NeuGene antisense drugs, this one for cancer, at Oregon Health Sciences University in Portland. That product also targets c-myc. The company has Avicine, a therapeutic cancer vaccine, in a Phase III trial in colorectal cancer patients. (See BioWorld Today, Jan. 5, 2001.)

Through the agreement with Medtronic, AVI has found another use for its antisense compounds.

¿We are thrilled to have [Medtronic] as a partner because they are a demonstrated leader in the vascular disease area,¿ Timmins said. ¿This is a big company in appreciation of leading technology from a smaller company. We are building on each other¿s strengths to provide a solution, maybe the best solution, for patients with this disease.¿

AVI BioPharma¿s stock (NASDAQ:AVII) rose 74 cents Wednesday, or about 8.5 percent, to close at $9.39.

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