SOUTH SAN FRANCISCO, Calif., June 5 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that it has out-licensed all worldwide rights to its NF-kappa B Decoy (NF-kB Decoy) program, which includes the clinical drug candidate Avrina(TM), to Transcription Factor Therapeutics, Inc. (TFT). NF-kB Transcription Factor Decoy inhibits NF-kappa B, a protein implicated in the inflammatory cascade in diseases such as inflammatory bowel disease (IBD), eczema, rheumatoid arthritis, and asthma.
Under the terms of the agreement, Anesiva will receive an upfront license fee, with additional payments dependent on development and regulatory milestones potentially totaling up to $114 million if two products are commercialized. Anesiva would also be entitled to royalty payments upon successful commercialization of any drug candidate(s). Additional terms were not disclosed. TFT will be responsible for the future development of Avrina(TM), and intellectual property associated with the NF-kB Decoy program will be transferred to TFT.
"Anesiva considers TFT a capable development organization to move this program forward," said John P. McLaughlin, chief executive officer of Anesiva. "With a strong focus on anti-inflammatory transcription factor decoys, we believe that TFT is well positioned to advance the NF-kappa B program, which holds great potential to impact the treatment of inflammatory diseases."
TFT initially plans to take Avrina(TM), a highly potent and selective inhibitor of NF-kappa B, into clinical trials in IBD in 2009. Avrina has shown highly encouraging results in multiple preclinical models of both Crohn's Disease and ulcerative colitis, two forms of IBD. These results have been well received in international scientific meetings and are published in DeVry et al., (2007) Gut 56(4):524-33 "Non-viral delivery of nuclear factor-kappaB decoy ameliorates murine inflammatory bowel disease and restores tissue homeostasis." Avrina has been evaluated for safety, tolerability and anti- inflammatory drug effect in an exploratory, dose-ranging US Phase I clinical study for treatment of atopic dermatitis.
"TFT is extremely pleased to expand its development program to include the Avrina(TM) assets," said Ryan Rauch, President and COO of TFT. "Avrina(TM) may have the potential to provide durable, long-lasting inflammation reduction while providing patients with more convenient dosing regimens and fewer side effects. The extremely positive pre-clinical IBD data, together with the demonstrated safety and biological activity demonstrated in Anesiva's first- in-man studies with Avrina(TM), will help push our IBD program into the clinic in 2009. This will also help leverage our existing Atopic Dermatitis program that is scheduled to begin Phase II clinical testing in the U.S. in the second half of 2009."
About Anesiva and its Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel pharmaceutical products for pain management. The company has one FDA-approved product, Zingo, for the reduction of pain associated with peripheral venous access procedures in children ages 3 to 18. The second product in Anesiva's pipeline, Adlea(TM), has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site- specific, acute and chronic, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.
About Transcription Factor Therapeutics
TFT is an Irvine, California based biopharmaceutical company that develops innovative therapies for the treatment of inflammatory diseases and pain.
Forward Looking Statements Related to Anesiva, Inc.
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward- looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's annual report on Form 10-K for the year ended December 31, 2007 and most recently quarterly report on Form 10-Q.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
SOURCE Anesiva, Inc.