To help fund a Phase IIb trial for its molecular imaging product, Molecular Insight Pharmaceuticals Inc. completed its Series B round, raising $7 million.
The Cambridge, Mass.-based company expects to use the funds mainly for its recently begun trial of BMIPP, a molecular imaging candidate being developed to detect cardiac ischemia in emergency room patients.
"The financing will enable us to maintain the critical path of our lead compound with the expected filing of the NDA in 2006," said David Barlow, the company's chairman and CEO. "And it allows us to expand our research and development capabilities to support our pipeline."
Barlow said Molecular Insight received commitments from investors several months ago, but needed to hold a shareholder meeting before the financing could complete. The company already is working on its next financing, expected to occur within the next six to 12 months. The latest funds of $7 million will take the company up until that time.
Lead investors in the Series B included Frederick Frank, who is the vice chairman of New York-based Lehman Brothers Inc., and Cerberus International LP, also of New York. Managing director of Cerberus, Daniel Frank (not related to Frederick Frank), will join Molecular Insight's board. Other new and existing investors also participated in the round. Since Molecular Insight's 1998 inception, the company has raised $23 million and has secured another $3 million through 20 National Institutes of Health grants.
The Phase IIb trial of BMIPP is expected to enroll about 120 patients at various emergency room sites throughout the U.S. Researchers will examine chest pain patients who present in the acute settings, then track them with BMIPP to validate the accuracy of the diagnosis. The company expects to move the product into a Phase III trial sometime in 2005.
A founder of Molecular Insight invented BMIPP, but the product made its way into the market in Japan through Nihon Medi-Physics Co. Ltd., a company that is partially owned by Amersham plc, of London.
"They went ahead and simply developed it on their own because there were no patent constraints," Barlow told BioWorld Today. "That's actually fortuitous for us. It's really a rare event to have that kind of sneak preview. But the compound will be protected once launched in the U.S."
BMIPP demonstrated it could safely identify cardiac ischemia in a Phase IIa trial. The product has been the subject of more than 200 peer-reviewed journal articles.
Upon approval, BMIPP would be marketed solely by Molecular Insight and has a market potential of "several hundreds of millions of dollars," Barlow said. He expects the company will need 50 to 100 sales representatives to cover the marketplace.
Barlow said BMIPP could potentially be used in emergency room settings, reducing health care costs. He cited a National Institutes of Health study that showed emergency imaging reduced hospitalization by 20 percent. Currently available compounds have certain constraints that keep them from widespread adoption in the emergency setting, he said.
"Our compound, in contrast, allows us to image the patients at rest, so there isn't a need for a stress test, and we can also capture evidence of cardiac events," Barlow said.
BMIPP is able to capture evidence of cardiac ischemia within 30 hours following a stress test, while current compounds show evidence within two hours.
Aside from its lead imaging compound, Molecular Insight also is focused on targeted radiotherapeutics for cancer. Its preclinical product, MIBG, is used to detect a rare cancer, called neuroblastoma, in children. That product is marketed in Europe as a first-line therapy, allowing Molecular Insight to benefit from previous experience.
"We're dealing with compounds that have substantial histories behind them and meaningful benefits," Barlow said.
Several investors have shown an interest in molecular imaging following General Electric Co.'s $9.5 billion acquisition of Amersham plc. GE made the acquisition in an effort to accelerate development of molecular imaging and personalized medicine. (See BioWorld Today, Oct. 13, 2003.)
That same attraction is what brought Barlow to Molecular Insight four years ago, when he first made his investment in the company and joined as chairman. He focuses on investing in technologies and business sectors that are undervalued, he said. In December 2002, he joined the company as CEO.
"Our view is that molecular imaging can have a significant impact on improving the quality of health care while also managing the costs," Barlow said. "We're just scratching the surface on that."