Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) announced today that avarofloxacin (USAN adopted, INN approval pending), has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). Avarofloxacin is a Phase III-ready broad-spectrum fluoroquinolone antibiotic for the treatment of acute bacterial skin and skin-structure infections, community-acquired pneumonia and has proven to be effective in treating methicillin-resistant staphylococcus aureus (MRSA) infections.
The designations should enable Furiex and/or any future collaborator with respect to the compound to benefit from certain incentives for the development of new antibiotics, including priority review and additional five-year market exclusivity, as provided under the Generating Antibiotic Incentives Now (GAIN) Act, which is incorporated within the FDA Safety and Innovation Act of 2012.
“We are pleased to receive QIDP and Fast Track designations from the FDA for avarofloxacin,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, “Antibiotic resistance rates are on the rise and there is a growing need for new treatment options for people with serious infections.”
About Avarofloxacin (JNJ-Q2)Avarofloxacin is a Phase III-ready investigational novel fluoroquinolone antibiotic that has been shown to be effective in a Phase II study of acute bacterial skin and skin structure infections (ABSSSI). In this study, avarofloxacin demonstrated favorable efficacy for both early clinical response endpoints (based on the new FDA guidance) as well as all clinical cure endpoints for the intent to treat population. Avarofloxacin has a low propensity for development of drug resistance and exhibits a broad range of antibacterial activities in vitro, including methicillin-resistant Staphylococcus aureus (MRSA), fluoroquinolone-resistant Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug resistant strains), gram positive, gram negative, atypical respiratory pathogens (such as legionella and mycoplasma) and anaerobic bacteria, which are often associated with abscesses of the skin and other organs. Because of emerging resistance to currently marketed antibiotics, we believe there is a large and growing unmet need for antibiotics like avarofloxacin that can treat a broad range of bacterial pathogens. The availability of IV and oral formulations for avarofloxacin differentiates it from a number of other products for MRSA infections which are only available for intravenous administration. About Methicillin-Resistant Staphylococcus aureus (MRSA) MRSA is a strain of the bacteria Staphylococcus aureus (staph) which commonly causes skin and soft tissue infections and is resistant to many antibiotics. Although MRSA had previously been primarily a hospital-acquired pathogen, its incidence has been rising in the community, and it has become the most frequent cause of skin and soft tissue infections presenting to emergency departments in the United States. There are a limited number of antibiotics approved to treat MRSA, and their frequent usage has led to emergence of multi-drug resistant bacteria. Thus, we believe there is significant unmet medical need for new antibiotics such as avarofloxacin that provide flexible (hospital and outpatient) treatment options for MRSA. About Furiex Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Our drug development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner, three products on the market and a fourth approved in the United States but not yet launched. The company's mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com. Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: the need to and risks of finding collaborators for our product candidates, including specifically avarofloxacin, which we are not currently actively developing on our own; the risks and expense of continuing the research and development activities of our existing candidates; time required to gain regulatory approvals; potential U.S. Food and Drug Administration changes to its regulatory guidance; changes in the safety and efficacy profile of our existing candidates as they progress through research and development; our continuing losses and potential need for additional capital; the demand for our products; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.
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