Pharma Licenses University Antibiotic Enhancements

(Centers for Disease Control and Prevention)

5 August 2015. Technologies that remove side-effect causing toxicity from gentamicin, a powerful antibiotic drug, are being licensed from two universities by La Jolla Pharmaceutical Company. Financial terms of the agreements between the San Diego biopharmaceutical developer and University of Alabama in Birmingham and University of Indiana were not disclosed.

Gentamicin is one of a class of antibiotics known as aminoglycosides that prevent the bacteria’s DNA from producing proteins, thus killing the bacteria and preventing the microbes from infecting healthy cells. The antibiotic, given as an injection, is effective against a wide range of infections, including infections from Staphylococcus bacteria resistant to antibiotics found in health care settings.

But gentamicin also has serious side effects, including toxicity that damages kidneys and hearing, particularly among elderly people and infants. Those side effects limit gentamicin to serious infections, and where other antibiotics no longer work.

La Jolla Pharmaceutical is licensing purified derivatives of gentamicin that the company says act as effectively against infections as original gentamicin, but without the toxicity to kidneys. La Jolla claims its product candidates, code-named LJPC-30Sa and LJPC-30Sb, work the same way as original gentamicin — by preventing the transcription of bacterial DNA into proteins — but without the chemical components causing toxicity to the kidneys.

The company says it is also looking into applying the drug candidates to diseases caused by rare inherited genetic abnormalities, such as cystic fibrosis and Duchenne muscular dystrophy. Because the gentamicin derivatives act by preventing transcription of DNA into proteins, they could be formulated to block the disease-causing mutations from acting. The toxicity of original gentamicin prevented its consideration as a treatment for these disorders.

Under the deal, La Jolla Pharmaceutical gains an exclusive worldwide license to commercialize the gentamicin derivatives, exercising options the company earlier enacted with the two universities. The company says it already met with the U.S. Food and Drug Administration, and the agency provided guidance clearing the company to proceed with early-stage clinical trials of LJPC-30Sa and LJPC-30Sb after filing an investigational new drug application.

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