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Great Lakes Pharmaceuticals raises $3.1M for catheter lock trial

Great Lakes Pharmaceuticals Inc. has completed a $3.1 million Series B equity financing led by Charter Life Sciences, the Palo Alto, California venture capital firm with an office in Cincinnati, Ohio. Early Stage Partners in Cleveland also participated in the round along with existing investors Everett Partners Ltd. in Akron, Ohio TechAngel Fund in Columbus […]

Great Lakes Pharmaceuticals Inc. has completed a $3.1 million Series B equity financing led by Charter Life Sciences, the Palo Alto, California venture capital firm with an office in Cincinnati, Ohio.

Early Stage Partners in Cleveland also participated in the round along with existing investors Everett Partners Ltd. in Akron, Ohio TechAngel Fund in Columbus and North Coast Angel Fund in Cleveland, Great Lakes Pharmaceuticals said in a release.

Great Lakes Pharmaceuticals, which was formed by Case Western Reserve University, University Hospitals Case Medical Center and Ricerca Biosciences LLC in 2005, plans to use the investment to complete a pivotal clinical study of B-Lock, the company’s antimicrobial catheter lock solution.

The clinical-stage company in Beachwood, Ohio has been driven by infection rates related to central-line catheters, often used for chemotherapy or dialysis. The Centers for Disease Control and Prevention estimates 250,000 catheter-related bloodstream infections cost the U.S. healthcare system about $4.6 billion a year. Many efforts nationwide aim to improve patient safety by reducing bloodstream infections caused by catheters.

Meanwhile, some events have limited hospitals’ choices for preventing or treating bloodstream infections. Heparin, a blood thinner long used as a sterile catheter lock, had a major recall in 2008 because of a fake ingredient used by a Chinese producer. Now, recent changes in Medicare policy keep hospitals from being reimbursed for treating preventable bloodstream infections.

Driven by the same reimbursement changes, the market for antimicrobial catheter devices, such as the Spectrum peripherally inserted central catheter by Cook Medical in Bloomington, Indiana, grew to $3 billion last year, according to iData Research.

Great Lakes Pharmaceutical says it can eliminate microbial catheter infections with its B-Lock, a potent and fast-acting biocide that kills methicillin sensitive and resistant strains of Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE), Pseudomonas aeruginosa, Klebsiella, Acinetobacter, resistant strains of Candida and other microbial species that can invade catheters and cause life-threatening infections. B-Lock targets biofilms often associated with catheter infections.

The company has completed extensive pre-clinical safety testing and intends to file an Investigational Drug Exemption with the Food and Drug Administration in the third quarter of 2010 so it can begin clinical trials in humans.

“We are pleased with the recent equity financing as it will position the company to conduct key clinical trials and international regulatory filings for this critical product,” said Krzysztof Appelt, president and CEO of Great Lakes Pharmaceuticals, in his company’s release. “We believe our antimicrobial lock solution can reduce life-threatening [catheter-related bloodstream] infections, improve patient care and reduce overall healthcare costs.”

The company also is seeking regulatory product approval in Canada and European and South American jurisdictions where infection rates can exceed those of U.S. hospitals.

“Not only is the clinical and market need very significant outside the U.S., but fortunately the regulatory process appears to be more streamlined,” said Gino DiSciullo, partner at Charter Life Sciences and chairman of Great Lakes Pharmaceuticals, in the release.

“We believe this product addresses a pressing global concern and has the potential to be widely adopted upon approval,” DiSciullo said.

“The economic and human impacts of catheter related infections are one of the most serious issues facing our healthcare system today, and Great Lakes has the potential to greatly reduce hospital costs and save lives,” said Mike Bunker, managing director of Early Stage Partners, in the release.

Great Lakes raised $2.4 million during its Series A round in 2008. Cleveland-based venture developer JumpStart Inc. invested $300,000 in Great Lakes Pharmaceutical in early 2006.