La Jolla Pharmaceutical Company has just announced it has entered two exclusive licensing agreements with the Indiana University Research and Technology Corporation (IURTC), and the IURTC and the University of Alabama at Birmingham (UAB). The agreements cover intellectual property rights for the company’s next-gen gentamicin derivatives, LJPC-30Sa and LJPC-30Sb, as antimicrobial agents and for the treatment of genetic diseases such as cystic fibrosis.
While gentamicin is associated with nephrotoxicity, it remains one of the most frequently prescribed antimicrobials in the hospital setting because of its superior efficacy and broad spectrum action. La Jolla’s two newly licensed agents are purified versions of the traditional gentamicin formulation, but no longer cause nephrotoxicity.
The company will be working on a dual development plan for the two antimicrobial agents. LJPC-30Sa and LJPC-30Sb will not be advanced solely as antibiotics for serious infections, but for application in rare genetic diseases as well, such as in cystic fibrosis and Duchenne muscular dystrophy. La Jolla is gearing to begin a Phase I clinical study upon approval of its Investigational New Drug Application with the US Food and Drug Administration.
“We are delighted by the continued progress of our next-generation gentamicin derivative program with our colleagues at IURTC and UAB,” said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “Following a positive pre-IND meeting with the FDA, we look forward to further advancing this program with the filing of an IND followed by the commencement of a Phase 1 clinical trial.”
In other CF-related industry news, PARI Respiratory Equipment, Inc., a leading, worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, cystic fibrosis, RSV, VAP, and HAP, recently reported on important news concerning its therapeutic products for US patients living with cystic fibrosis. Its proprietary Kitabis Pak (co-packaging of tobramycin inhalation solution and the PARI LC PLUS Reusable Nebulizer), indicated for the management of CF in adults and pediatric patients 6 years of age and older with P. aeruginosa, has been added to the Preferred Drug List (PDL) in more states across the country.
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