A Medical Device Daily

GE Healthcare (Princeton, New Jersey) a developer of diagnostic imaging technologies, reported that it has entered an agreement with Draximage (Kirkland, Quebec), a division of Draxis Health (Montreal, Quebec), to become the exclusive distributor of Draximage’s Sestamibi imaging product upon its approval by the FDA and the expiration of the primary innovator patent. An abbreviated new drug application (ANDA) for Draximage Sestamibi was submitted by Draximage to the FDA in February and is currently under review.

John Chiminski, president/CEO of GE Healthcare’s Medical Diagnostics division, said “Our expertise in nuclear cardiology as the innovator of Myoview makes us ideally suited to make this new product available through our radiopharmacy operation that has the highest standards in the industry.”

Technetium-labeled radiopharmaceuticals, which include Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection), are used in about 90% of nuclear medicine studies performed to detect coronary artery disease. Over 8 million patients receive myocardial perfusion imaging each year, as the increasing rates of obesity, diabetes, and hypertension (heart failure) continue to contribute to disease progression.

According to the American Heart Association (Dallas), coronary artery disease is responsible for more than half of the deaths associated with cardiovascular diseases.

“Nuclear cardiology is a proven technology, and we’re confident that our partnership with Draximage will expand the access to and applicability of these procedures when and where they are needed. This agreement further demonstrates our commitment to nuclear medicine, through outstanding eadiopharmacy performance and the broadest product portfolio in the industry,” Chiminski added.

In other agreements: BioSphere Medical (Rockland, Massachusetts), a company developing bioengineered microspheres to treat uterine fibroids, hyper-vascularized tumors, and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy, reported an agreement with DuPont Applied BioSciences (DuPont; Wilmington Delaware) to evaluate potential peripheral vascular and embolotherapy research, development and manufacturing projects.

The agreement will combine BioSphere’s expertise in minimally invasive products for the endovascular field with the expertise of DuPont Applied, a business unit that includes DuPont BioMedical, a business that targets transformative products for the medical device industry.

The parties have also signed an agreement to collaborate on the potential application of DuPont know-how to the manufacturing of BioSphere’s Embosphere® and EmboGold® Microsphere products in an effort to accelerate the improvement of manufacturing yield of such products. BioSphere has agreed to make payments to DuPont of up to $500,000 based upon the achievement of specified milestones.

All improvements developed under the manufacturing agreement will be owned by BioSphere.

Richard Faleschini, president/CEO of BioSphere, said, “[W]e expect that our pipeline of new products will increase both within and beyond our current therapeutic focus of interventional gynecology and interventional oncology.”

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