Furiex Pharmaceuticals Announces Scientific Publications for JNJ-Q2
MORRISVILLE, N.C.--(BUSINESS WIRE)--Oct 11, 2011 - Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced recent and upcoming publications and presentations about the novel investigational antibacterial drug JNJ-Q2. These include recent presentations at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the American College of Clinical Pharmacology (ACCP) and upcoming presentations at the Infectious Diseases Society of America (IDSA) annual meeting.
Several research papers covering clinical trial and microbiology results for JNJ-Q2 have also recently been published in peer review journals, with others having been accepted for publication. The microbiology studies demonstrate JNJ-Q2's potent activity against a variety of diverse, clinically important gram positive and gram negative pathogens, including those resistant to other fluoroquinolones. Pharmacology studies demonstrate JNJ-Q2 has favorable intravenous and oral pharmacokinetic profiles. Results of the Phase II clinical study demonstrated that JNJ-Q2 is statistically non-inferior to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI).
Citations for JNJ-Q2 publications are listed below. Copies of abstracts and certain publications can be obtained at www.furiex.com.
- “JNJ-Q2, a New Fluoroquinolone with Potent In Vitro Activity against Staphylococcus aureus, Including Methicillin- and Fluoroquinolone-Resistant Strains.” Antimicrobial Agents and Chemotherapy, July 2011, Vol. 55, No. 7, p. 3631–3634 (D.J. Farrell, et al.)
- “Determination of Disk Diffusion and MIC Quality Control Guidelines for JNJ-Q2, a Novel Quinolone.” Journal of Clinical Microbiology, August 2011, Vol. 49, No. 8, p. 3009–3011 (J. E. Ross, et al.)
- “Surveillance of JNJ-Q2 Activity Tested Against Staphylococcus aureus and Beta-Hemolytic Streptococci as a Component of the 2010 Sentry Antimicrobial Surveillance Program.” In press at Diagnostic Microbiology and Infectious Disease (D.J. Farrell, et al.)
- “Studies of the Efficacy of a New Fluoroquinolone, JNJ-Q2, in Skin, Respiratory, and Systemic Murine Models of Staphylococcus aureus and Streptococcus Pneumoniae Infection.” Published online ahead of print in Antimicrobial Agents and Chemotherapy (J. Fernandez et al., 12 September 2011) http://aac.asm.org/cgi/reprint/AAC.00471-11v1.pdf
- “Antistaphylococcal Activities of the New Fluoroquinolone JNJ-Q2.” Published online ahead of print in Antimicrobial Agents and Chemotherapy (B.J. Morrow et al, 12 September 2011) http://aac.asm.org/cgi/reprint/AAC.00470-11v1?view=long&pmid=21911562
- “Evaluation of Single and Repeat Dose Pharmacokinetics, Accumulation, Absolute Bioavailability and Safety of JNJ-Q2.” American College of Clinical Pharmacology, Abstract, 2011 (J. M. Davenport, et al.)
- “Activity of JNJ-Q2, a New Fluoroquinolone, Tested Against Contemporary Pathogens Relevant to Acute Bacterial Skin and Skin Structure Infection (ABSSSI).” Abstract, ICAAC 2011, C2-1794 (D.J. Farrell, et al.)
- “Activity of JNJ-Q2, a New Fluoroquinolone, Tested Against Contemporary Pathogens Isolated from Patients with Community-Acquired Bacterial Pneumonia (CABP).” Abstract, ICAAC 2011, C2-1795 (D.J. Farrell, et al.)
- “A Randomized, Double-Blind, Phase II, Multicenter Study Evaluating the Safety/Tolerability and Efficacy of JNJ-Q2, A Novel Fluoroquinolone, Compared With Linezolid (Zyvox®) for the Treatment of Acute Bacterial Skin and Skin Structure Infection.” Published online ahead of printing in Antimicrobial Agents and Chemotherapy (P.S. Covington, et al., 26 September 2011) http://aac.asm.org/cgi/reprint/AAC.05044-11v1
- “Activity of JNJ-Q2, a Novel Fluoroquinolone, Tested Against Neisseria gonorrhoeae, Including Ciprofloxacin-Resistant Strains.” Abstract, IDSA 2011 (D.J. Farrell, et al.)
- “Activity of JNJ-Q2 and Comparators against Genetically Defined MRSA Clones.” Abstract, IDSA 2011 (D.J. Farrell, et al.)
JNJ-Q2 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, JNJ-Q2 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. JNJ-Q2 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 JNJ-Q2 that can treat a broad range of bacterial pathogens. The availability of IV and oral formulations for JNJ-Q2 differentiates it from a number of other products for MRSA infections which are only available for intravenous administration. JNJ-Q2 is also in Phase II development for community-acquired bacterial pneumonia.
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 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, there is significant unmet medical need for new antibiotics such as JNJ-Q2 that provide flexible (hospital and outpatient) treatment options for MRSA.
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of internal and partnered drug programs by advancing them through the drug discovery and development process in a cost-efficient manner. 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 strong, diversified product portfolio and pipeline with multiple therapeutic candidates including late-stage assets and two products on the market. 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: changes in the safety and efficacy profile of our existing candidates as they progress through research and development; potential FDA changes to its regulatory guidance applicable to approval of anti-infective drugs; the risks and expense of continuing the research and development activities of our existing candidates; new collaborative agreements that we might enter into in the future; progress of product candidates in clinical trials as it relates to receiving future milestone payments; time required to gain regulatory approvals; the demand for our potential products, if and when approved; the costs of defending or prosecuting any patent opposition or litigation necessary to protect our proprietary technologies; 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
Posted: October 2011