Akebia in HIF compounds play with Johnson & Johnson

Akebia CEO John Butler

Johnson & Johnson has outlicensed its portfolio of hypoxia-inducible factor (HIF) to Cambridge MA-based Akebia as the biotech boosts its early-stage pipeline.

On top of this, Johnson & Johnson’s Innovation unit (aka JJDC) has also written in a clause for it to “take an ownership interest” in Akebia through a common stock purchase warrant for 509,611 shares.

This can be used by JJDC, in whole or in part, at any point over the next five years with a payment to Akebia of up to $5 million.

The first part of the deal, which sees the biotech cough up $1 million to J&J, also sees the biotech gain access to a library of HIF pathway compounds, which it says in a statement has the potential to be used across “multiple therapeutic areas.”

Getting a little more into the specifics, the pact includes AKB-5169 (formerly JNJ5169), a differentiated preclinical compound in the works as an oral treatment for inflammatory bowel disease (IBD).

Akebia’s current leading med is late-stage anemia candidate vadadustat, itself an oral hypoxia-inducible factor (HIF) stabilizer, which at the end of last year was at the center of a potential $1 billion codevelopment and comarketing deal with Otsuka.

The drug has been touted as a blockbuster in waiting, and Akebia will be hoping its newly filled HIF preclinical pipeline can yield it strong returns in the future.

“This research agreement accelerates our strategy to develop a portfolio of HIF-targeted products that address the unmet medical needs of patients, and builds long-term value for Akebia,” explained John Butler, president and CEO of Akebia.

“While our global phase 3 development program for vadadustat remains the core focus of our company, this agreement with Janssen allows us to build upon our expertise in HIF biology and will accelerate our efforts to maximize the potential of this pathway across multiple indications.”

Early data have already shown that AKB-5169 “may be highly differentiated from standard of care systemic therapies in its potential to reduce inflammation and promote mucosal healing at the site of disease,” according to the biotech.

It plans to do a few more early studies before turning in an IND application to the FDA, which is slated to be submitted within the next 12 to 18 months.

The biotech currently has a market cap of just under $380 million, trading at around $10 a share.