Isis Pharmaceuticals, Inc. Earns $4 Million From Achaogen For The Initiation Of A Phase 3 Study Of Plazomicin
CARLSBAD, Calif., Sept. 17, 2014 /PRNewswire/ -- 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.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 32 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO®, in the United States and other countries for the treatment of patients with homozygous FH. Isis' patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding Isis' and Achaogen's licensing agreement and the development and therapeutic potential of plazomicin and the discovery and development of aminoglycoside drugs to combat drug-resistant bacteria. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2013, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries.
Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc. KYNAMRO® is a registered trademark of Genzyme Corporation.
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SOURCE Isis Pharmaceuticals, Inc.