Anesiva and Transcription Factor Therapeutics, Inc. Announce Licensing Agreement for Development and Commercialization of NF-kap

Anesiva and Transcription Factor Therapeutics, Inc. Announce Licensing Agreement for Development and Commercialization of NF-kappa B Clinical Program
 
SOUTH SAN FRANCISCO, Calif., June 5 -- Anesiva,Inc. (Nasdaq: ANSV) today announced that it has out-licensed all worldwiderights to its NF-kappa B Decoy (NF-kB Decoy) program, which includes theclinical drug candidate Avrina(TM), to Transcription Factor Therapeutics, Inc.(TFT). NF-kB Transcription Factor Decoy inhibits NF-kappa B, a proteinimplicated in the inflammatory cascade in diseases such as inflammatory boweldisease (IBD), eczema, rheumatoid arthritis, and asthma.

Under the terms of the agreement, Anesiva will receive an upfront licensefee, with additional payments dependent on development and regulatorymilestones potentially totaling up to $114 million if two products arecommercialized. Anesiva would also be entitled to royalty payments uponsuccessful commercialization of any drug candidate(s). Additional terms werenot disclosed. TFT will be responsible for the future development ofAvrina(TM), and intellectual property associated with the NF-kB Decoy programwill be transferred to TFT.

'Anesiva considers TFT a capable development organization to move thisprogram forward,' said John P. McLaughlin, chief executive officer of Anesiva.'With a strong focus on anti-inflammatory transcription factor decoys, webelieve that TFT is well positioned to advance the NF-kappa B program, whichholds great potential to impact the treatment of inflammatory diseases.'

TFT initially plans to take Avrina(TM), a highly potent and selectiveinhibitor of NF-kappa B, into clinical trials in IBD in 2009. Avrina has shownhighly encouraging results in multiple preclinical models of both Crohn'sDisease and ulcerative colitis, two forms of IBD. These results have beenwell received in international scientific meetings and are published in DeVryet al., (2007) Gut 56(4):524-33 'Non-viral delivery of nuclear factor-kappaBdecoy ameliorates murine inflammatory bowel disease and restores tissuehomeostasis.' Avrina has been evaluated for safety, tolerability and anti-inflammatory drug effect in an exploratory, dose-ranging US Phase I clinicalstudy for treatment of atopic dermatitis.

'TFT is extremely pleased to expand its development program to include theAvrina(TM) assets,' said Ryan Rauch, President and COO of TFT. 'Avrina(TM) mayhave the potential to provide durable, long-lasting inflammation reductionwhile providing patients with more convenient dosing regimens and fewer sideeffects. The extremely positive pre-clinical IBD data, together with thedemonstrated safety and biological activity demonstrated in Anesiva's first-in-man studies with Avrina(TM), will help push our IBD program into the clinicin 2009. This will also help leverage our existing Atopic Dermatitis programthat is scheduled to begin Phase II clinical testing in the U.S. in the secondhalf of 2009.'

About Anesiva and its Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to bethe leader in the development and commercialization of novel pharmaceuticalproducts for pain management. The company has one FDA-approved product, Zingo,for the reduction of pain associated with peripheral venous access proceduresin 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 tomonths in multiple settings in numerous mid-stage clinical trials for site-specific, acute and chronic, moderate-to-severe pain. Anesiva is based inSouth San Francisco, CA. For more information about Anesiva's leadership inthe development of products for pain management, and an overview of theclinical challenges being addressed by its product candidates, go tohttp://www.anesiva.com.

About Transcription Factor Therapeutics

TFT is an Irvine, California based biopharmaceutical company that developsinnovative therapies for the treatment of inflammatory diseases and pain.

Forward Looking Statements Related to Anesiva, Inc.

This press release includes 'forward-looking statements' within themeaning of the safe harbor provisions of the United States Private SecuritiesLitigation Reform Act of 1995. Words such as 'expect,' 'estimate,' 'project,''budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,''should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similarexpressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve knownand unknown risks, uncertainties and other factors that may cause actualresults, levels of activity, performance or achievements to differ materiallyfrom results expressed or implied by this press release. Actual results maydiffer materially from those contained in the forward-looking statements inthis press release. Additional information concerning these and other riskfactors is contained in Anesiva's annual report on Form 10-K for the yearended December 31, 2007 and most recently quarterly report on Form 10-Q.

Anesiva undertakes no obligation and does not intend to update theseforward-looking statements to reflect events or circumstances occurring afterthis press release. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date of this pressrelease. All forward-looking statements are qualified in their entirety bythis cautionary statement.

Suggested Articles

Across its 15-year history, Omega Funds has a hand in a clutch of high-profile biotechs such as Editas Medicine and Juno Therapeutics.

After Novartis’ near $10 billion buyout of The Medicines Company, many thought cardiovascular therapies were hot again.

The data position Leo to file for approval of the Dupixent rival in atopic dermatitis next year.