Replidyne’s antibiotics fight drug-resistant bacteria

LOUISVILLE – As news of drug-resistant bacteria spread, Ken Collins and Nebojsa Janjic saw an opportunity. While the larger pharmaceutical companies were focusing on drugs for chronic conditions, Collins and Janjic founded Replidyne Inc. to develop new antibiotics designed to fight this tough bacteria.

?We were looking at an evergreen, unmet medical need as bugs will continue to develop resistance to existing antibiotics,? said Collins, president and chief executive officer of Replidyne, based in Louisville.

When they combined this market need with their core technology, they saw great possibilities. The company has one product planned to go to market in the third quarter of 2007 and a second in clinical trials. Considering the drug development process typically takes 10 to 12 years, this is an incredible success for a four-year-old company.

Collins and Janjic have been able to achieve this due to their pipeline strategy. By licensing later-stage programs and products from other companies, Replidyne is able to span the entire spectrum of drug development, from discovery research to late-stage clinical development.

?It is impossible to bootstrap a biotech company,? Collins explained. ?You can?t go from concept to product in a limited period of time. To be successful, you need to raise significant amounts of venture and other funding. It definitely helps to bring in later-stage products.?

Janjic, chief scientific officer, describes it as ?portfolio diversification.? When a company is able to contract a program that is in Phase 3 of clinical trials, the last stage, it takes out a lot of risk, he said.

Raising venture capital is something Collins has excelled at in his career. Prior to co-founding Replidyne, Collins was president of Pegasus Technology Ventures, a Boulder-based firm that advised and raised seed capital for early-stage Colorado companies. During his tenure, he worked with a number of biotechnology companies including Neurogenetics Inc., Evolutionary Genomics LLC and Genomica Corp. Prior to that, he was an executive vice president and chief financial officer of Synergen Inc., and raised approximately $500 million through a number of private and public offerings.

Janjic has had his share of success as well. Before he helped found Replidyne, Janjic was senior director of drug discovery at NeXstar Pharmaceuticals in Boulder. He helped develop it into a publicly traded company valued at more than $500 million, and was responsible for creating a pipeline of aptamer-based drug candidates for preclinical and clinical development.

His work included the discovery and early development of Macugen, the first-in-class FDA-approved treatment for macular degeneration named Innovative Pharmaceutical Product of the Year in 2005 at the Pharmaceutical Achievement Awards in New York. He was also responsible for linking discovery research efforts with business development activities. Janjic is an author of 30 original research papers and an inventor on 10 issued patents.

In recognition of their successes in the biotech industry, Collins and Janjic received an Entrepreneurs of Distinction Award at the Boulder Chamber of Commerce?s 22nd Annual Esprit Entrepreneurs Awards.
?Besides the fact that they built a great company from scratch, Ken and Nebojsa have a long history of entrepreneurial endeavors,? said Laura Medina, business attorney with Cooley Godward Kronish, and member of the Esprit committee.

She said their leadership and management skills have helped them to build a really strong company and their selection as winners of an Esprit award it is a testament to that.

?They?re phenomenal at what they do and are unbelievably well respected,? added Medina. ?They have amazing vision for building companies.?

Collins and Janjic attribute much of their success to their team. ?Nebojsa and I are honored by this award, but the team we?ve been able to assemble here and at our office in Connecticut has been most impressive,? said Collins.

?We have been fortunate to have and been able to bring on board an exceptional group of people,? Janjic said. ?Various times can be rocky for any biotech company, and these are people you want in your corner.?
Janjic said their investors have also been key to Replidyne?s success. ?We were fortunate to get a number of high-quality investors early on in the company?s development,? he said.

Replidyne has been very successful in continuing to secure funding, and went public in June to increase its sources of funds.

Moving forward, Collins and Jajnic said Replidyne will establish a commercial presence when it takes its lead product, faropenem medoxomil, to market in the third quarter of 2007. Faropenem medoxomil is an oral antibiotic designed for certain skin and respiratory infections, such as bronchitis and sinusitis. Replidyne has partnered with Forest Laboratories for the development and commercialization of the drug in the U.S. Under the agreement, Replidyne may receive up to $250 million in upfront and milestone payments of which $60 million have been received to date. Replidyne also is entitled to receive royalties on any of its future sales.

They have a second product, REP8839, a topical anti-infective product being developed for treatment of skin and wound infections, and the prevention of staph infections in hospital settings. It is currently in Phase 1 physical trials.

Behind those, they have two discovery research programs moving forward. Collins said they have and will continue to be aggressive on business development and will continue to pursue additional opportunities.

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