SAN DIEGO, June 27, 2012 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) today commented on the approval by the United States Congress of the Prescription Drug Users Fee Act (PDUFA V) which contains key incentives for antibiotic drug developers under what is known as Generating Antibiotic Incentives Now or the GAIN Act. The Act contains provisions that provide the pharmaceutical and biotech industry with incentives to develop antibiotics to treat life-threatening infections caused by drug resistant pathogens. PDUFA V is expected to be signed into law by President Obama before July 4, 2012.
"The GAIN Act provides companies like Trius with new regulatory options that can facilitate our efforts to develop effective new treatments for infections caused by drug resistant bacteria," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Trius. "The fact that PDUFA V received overwhelming bipartisan support in both houses in Congress, as evidenced by yesterday's 92-4 vote of support by the Senate, should serve as ample testimony of the growing recognition for the urgent need for new antibiotic drugs."
Specific provisions of the GAIN Act include an additional five years of market exclusivity for companies developing antibiotics targeting life-threatening infections caused by drug-resistant pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA). In addition, new drug applications for such products could qualify for Priority and Fast Track review with the US Food and Drug Administration (FDA), potentially reducing the time to approval for qualifying new antibiotic products.
A more detailed explanation of the GAIN Act and its implication for antibiotic drug developers can be found on Dr. Stein's blog posting: http://www.thechairmansblog.com/jeff-stein/2012-06/gain-act-implications-for-antibiotic-drug-developers/.
About Trius Therapeutics
Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections. The Company's lead investigational drug, tedizolid phosphate, is a once daily, IV and orally administered second generation oxazolidinone in Phase 3 clinical development for the treatment of ABSSSI. Trius has two Special Protocol Assessments with the FDA for its two Phase 3 ABSSSI trials and has partnered with Bayer HealthCare for the development and commercialization of tedizolid phosphate outside of the U.S., Canada and the European Union. In addition to the Company's tedizolid phosphate clinical program, Trius has initiated IND-enabling studies for its Gyrase-B development candidate with potent activity against Gram-negative bacterial pathogens including multi-drug resistant strains of E. coli, Klebsiella, Acinetobacter and Pseudomonas. The Gyrase-B program is one of the two preclinical programs supported by federal contracts. For more information, visit www.triusrx.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trius' ability to successfully complete its ongoing clinical trials and development programs. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Trius' estimates regarding expenses, future revenues and capital requirements; the success and timing of Trius' preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Trius' plans to develop and commercialize its product candidates; Trius' ability to obtain additional financing; Trius' ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Trius' most recently filed SEC documents, including its Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.