Molecular Insight Pharmaceuticals will acquire a commercial-scale radiopharmaceutical manufacturing facility from NeoRx Manufacturing Group.
"Acquisition of a comprehensive radiopharmaceutical manufacturing facility is in line with our strategy to expand our options for the manufacture of our portfolio of product candidates, including molecular imaging pharmaceuticals such as Zemiva™ and Trofex™, and targeted radiotherapeutic products such as Azedra™, Onalta™, and Solazed™," comments David S. Barlow, chairman and CEO of Molecular Insight. "The ability to produce our own products will complement our existing strong relationships with contract vendors.”
Located in Denton, TX, the facility contains more than 80,000 sq. ft. of pharmaceutical manufacturing, warehouse, cleanroom, and administrative office space. Molecular Insight states that it has 45 days to conduct a due diligence inspection of the site.
“Financially,” Barlow adds, “our previously disclosed cash forecasts have factored in the possibility of such an acquisition, which we believe will be operational in time for the potential launch of Zemiva."
Molecular Insight’s lead molecular imaging pharmaceutical product candidate, Zemiva, is being developed for the diagnosis of cardiac ischemia. The company has completed two multicenter Phase II trials, which were designed to assess safety and efficacy. A Phase II study to develop a database of normal Zemiva images of the heart using SPECT camera imaging is on going. Molecular Insight says that it intends to commence a pivotal Phase II evaluation of the product in the first half of 2007 in approximately 600 to 700 patients.