Furiex Receives Qualified Infectious Disease Product and Fast Track Designations from the U.S. Food and Drug Administration for

  Furiex Receives Qualified Infectious Disease Product and Fast Track
  Designations from the U.S. Food and Drug Administration for Avarofloxacin

Business Wire

MORRISVILLE, N.C. -- February 25, 2013

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)

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

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.


Furiex Pharmaceuticals, Inc.
Sailash Patel, 919-456-7814
Press spacebar to pause and continue. Press esc to stop.