Allschwil, Switzerland, April 12, 2019
Polyphor's antibiotic murepavadin receives US FDA Qualified Infectious Disease Product designation in four new indications
Polyphor AG (SIX: POLN) today announced that the US Food and Drug Administration (FDA) has designated murepavadin as a Qualified Infectious Disease Product (QIDP) in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection and complicated intra-abdominal infection.
Under the QIDP program, which was created by the Generating Antibiotic Incentives Now (GAIN) Act of 2012 to incentivize the development of new antibiotics in response to the growing threat of antibiotic resistance, Polyphor will get certain incentives for the development of murepavadin, such as eligibility for priority review and Fast Track designation for these indications. Murepavadin already has a QIDP status for ventilator-associated bacterial pneumonia (VABP). Additionally, a five-year extension of market exclusivity will be gratned upon approval of the first QIDP indication.
"These additional QIDP designations highlight the importance of our research in this area and recognizes the innovativeness of our Outer Membrane Protein Targeting Antibiotic (OMPTA) program," says Giacomo Di Nepi, Chief Executive Officer of Polyphor. "It will give us incentives such as an expedited regulatory review to develop murepavadin in four additional indications to bring this promising antibiotic to the patients who need it the most."
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About Murepavadin (POL7080)
Murepavadin is Polyphor's most advanced product candidate and the first OMPTA in clinical development. It is being developed for the treatment of nosocomial pneumonia (including both hospital-acquired (HABP) and ventilator-associated bacterial pneumonia (VABP)) due to Pseudomonas aeruginosa and has been granted Qualified Infectious Disease Product (QIDP) and fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of VABP due to Pseudomonas aeruginosa. Murepavadin is a pathogen specific antibiotic functioning through a novel mechanism of action involving binding to an outer membrane protein of Pseudomonas aeruginosa. In contrast to commonly used broad-spectrum antibiotics, murepavadin is a precision medicine and as such it supports the growing practice known as "antibiotic stewardship" which, among other things, seeks to reduce the excessive use of broad-spectrum products to avoid the buildup of resistance and to preserve the microbiome of the patients. Based on promising Phase II results, Polyphor has agreed on a streamlined development pathway for murepavadin with the FDA and EMA and has started its Phase III clinical program.
Polyphor is a clinical stage, Swiss biopharmaceutical company focused on the discovery and development of antibiotics and immuno-oncology compounds. It has discovered and is developing the OMPTA (Outer Membrane Protein Targeting Antibiotics). The OMPTA are potentially the first new class of antibiotics against Gram-negative bacteria to have reached phase III stage in the last 50 years. The company's lead OMPTA, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa - recognized as a critical priority 1 pathogen by WHO; in addition, Polyphor is developing a pipeline of further preclinical antibiotics based on its OMPTA platform. In addition, Polyphor is developing an immuno-oncology candidate, balixafortide (POL6326), which is starting a Phase III trial in combination with eribulin in patients with advanced breast cancer, and exploring in parallel its potential for further combinations and indications. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.
This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor's results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.