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Wednesday, 06/25/2008 8:06:47 AM

Wednesday, June 25, 2008 8:06:47 AM

Post# of 2446
MRK starts phase-2b I-vation trial; SRDX gets $9M milestone.

http://biz.yahoo.com/bw/080625/20080625005251.html

>>
SurModics Announces Initiation by Merck & Co., Inc. of Phase IIb Clinical Trial for I-vation

Wednesday June 25, 8:00 am ET

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--SurModics, Inc. (Nasdaq: SRDX ), a leading provider of surface modification and drug delivery technologies to the healthcare industry, announced today the initiation by Merck & Co., Inc. of a Phase IIb clinical trial to evaluate the safety and efficacy of SurModics’ I-vation™ TA in patients with diabetic macular edema. The initiation of this Phase IIb trial triggers a milestone payment of $9 million from Merck to SurModics under the companies' License and Research Collaboration Agreement announced in June 2007.

"Today’s announcement marks an important milestone and is the culmination of many months of hard work by the teams at Merck and SurModics in preparation for this next phase of clinical studies," said Bruce Barclay, president and CEO of SurModics. "The unmet clinical need relating to retinal diseases is significant. We believe the I-vation platform offers the potential for sustained release drug delivery to the back of the eye, implantation through a minimally invasive procedure and removal once the drug has been fully released.”

The I-vation Intravitreal Implant utilizes a system with the potential to deliver drug on a sustained release basis for up to two years, however, the implant being utilized in this study is designed to elute the drug for approximately 12 months. Currently, the majority of treatments being developed for retinal disease require repeat injections into the eye every one to three months. Replacing multiple injections with a single implant providing long-term, controlled drug release could represent a significant advance in therapeutic treatment due to potentially improved patient compliance and the potential for reduced risk of side effects versus intravitreal injections.
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