Isis receives $4 million in milestone payment from Achaogen for initiation of plazomicin Phase 3 study

Isis Pharmaceuticals, Inc.Sep 17 2014

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced that it has earned a $4 million milestone payment from Achaogen, Inc. (NASDAQ: AKAO) associated with the initiation of a Phase 3 study of plazomicin in patients with serious multi-drug resistant (MDR), gram-negative bacterial infections. The Phase 3 study is designed as a superiority study to evaluate the efficacy and safety of plazomicin compared to colistin in patients with bloodstream infections and nosocomial pneumonia caused by carbapenem-resistant Enterobacteriaceae (CRE). Achaogen announced last year that it has reached a special protocol assessment, or SPA, with the U.S. Food and Drug Administration for this Phase 3 study.

"Our innovation in the field of RNA-targeted therapeutics has provided us with an extensive and broad intellectual property position that not only covers the discovery, development and manufacturing of our antisense drugs, but also other therapeutic areas, including the discovery of aminoglycosides," said B. Lynne Parshall, chief operating officer at Isis Pharmaceuticals. "Our business strategy allows us to maximize the value of our technology and our drugs by partnering with other companies, like Achaogen, to develop our drugs and technologies in areas that are outside of our primary focus. We have been very successful with this strategy and have a number of satellite company partners that broaden the scope of our innovations. To date, we have generated well over $400 million from the sales and licensing of our intellectual property."

Plazomicin is a novel aminoglycoside drug that Achaogen is developing for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including CRE. Aminoglycosides are a group of antibiotics that inhibit bacterial protein synthesis and that clinicians use to treat serious bacterial infections. Achaogen's development and commercialization of plazomicin is subject to a license agreement with Isis. Isis is eligible to receive up to $19.5 million, which includes $3 million previously received and the $4 million earned today from Achaogen, as plazomicin advances in development. Isis is also eligible to receive up to $20 million in milestone payments as well as royalties based on sales of plazomicin.