Assistant Managing Editor

Transcription Factor Therapeutics Inc. (TFT), a recent spinout of Meyer Pharmaceuticals LLC, picked up rights to an NF-kappa B Decoy program, including a clinical-stage candidate, from Anesiva Inc. in a deal that could be worth as much as $114 million.

In exchange for an undisclosed up-front license fee, TFT will get intellectual property relating to NF-kappa B, a transcription factor that up-regulates pro-inflammatory genes and is believed to be implicated in diseases such as inflammatory bowel disease (IBD), atopic dermatitis, rheumatoid arthritis and asthma.

South San Francisco-based Anesiva would be eligible for milestone payments contingent upon the successful development and commercialization of two products emerging from that program. It also would be entitled to royalty payments.

TFT President and Chief Operating Officer Ryan Rauch declined to provide additional details on the financial terms, but he called the arrangement a "good value" for TFT, which picks up a product with an open investigational new drug application. Preclinical data on Avrina in IDB have been "outstanding," he added, and while the drug has generated some mixed clinical results in earlier trials, "we feel we've learned the lessons from past mistakes" when designing "our clinical plan going forward."

Avrina and other NF-kappa B programs from Anesiva also "fit in with our strategic focus," Rauch told BioWorld Today.

Irvine, Calif.-based TFT recently emerged from Meyer Pharmaceuticals, also of Irvine, the drug development division of Meyer Holdings, with the goal of developing therapeutics targeting transcription factors, starting with NF-kappa B. "We believe it's an exciting clinical space," Rauch said.

TFT anticipates targeting IBD as the initial indication and hopes to be in the clinic with that drug in mid-2009, he said. The company will test an enema-based version first, though it is in discussions to develop an oral formulation of the drug as well.

The firm also has an existing NF-kappa B drug, which it plans to move into the clinic next year in atopic dermatitis. Beyond that, TFT is staying quiet for now, "but you'll see some other transactions in the future," Rauch said.

To date, its funding has come from parent company Meyer, though the firm is in the process of raising additional capital, he added.

TFT is staffed by about 20 employees and consultants, which puts it on par with other small biotech start-ups. But unlike a lot of young firms, "we've got years of data" and "years of experience" behind the NF-kappa B program," he said. "So we know exactly what we want to do in that space."

Avrina initially was developed by South San Francisco-based Corgentech Inc., which merged its operations with AlgoRx Pharmaceuticals Inc., a Secaucus, N.J.-based firm in late 2005. The combined company later changed its name to Anesiva and narrowed its development pipeline to focus on pain management programs. (See BioWorld Today, Sept. 27, 2005.)

Most of the company's work over the past couple of years has been on its two lead products, Zingo and Adlea. Anesiva is getting ready to launch Zingo (lidocaine hydrochloride monohydrate) following the drug's 2007 approval as an analgesic in peripheral I.V. insertions and blood draws in children. Earlier this month, the FDA accepted the firm's supplemental new drug application to expand Zingo's use in adults.

Anesiva also is working to broaden the drug's availability outside the U.S. To date, it has signed licensing and distribution deals with Sigma-Tau SpA, of Rome, which covers all major European markets except the British Isles and Scandinavia, and Green Vision Co., with covers major markets in the Middle East.

Its second product, Adlea, for postoperative pain management, is in two pivotal Phase III trials in patients undergoing total knee replacement surgery and bunionectomy.

Anesiva, which reported a net loss of $21.6 million, or 54 cents, for the first quarter, had about $70 million in cash, cash equivalents and short-term investments as of March 31.

Its shares (NASDAQ:ANSV) closed at $3.73 Thursday, up 19 cents.