Akebia Therapeutics said today it agreed to exclusively license a portfolio of hypoxia-inducible factor (HIF) prolyl hydroxylase-targeted compounds from Johnson & Johnson’s Janssen Pharmaceutical in a deal that could generate at least up to $232.5 million for Janssen.
The number of HIF-targeting compounds covered by the agreement was not specified, though Akebia said Janssen’s collection numbered in the hundreds and includes AKB-5169 (formerly JNJ5169), a preclinical nonabsorbed oral HIF stabilizer being developed as an oral treatment for inflammatory bowel disease (IBD).
According to Akebia, preclinical data has shown that AKB-5169 may show greater potential than standard-of-care systemic therapies in reducing inflammation and promoting mucosal healing at the site of disease.
Akebia said it plans to conduct additional preclinical studies of AKB-5169, then submit an Investigational New Drug (IND) application to the FDA in the next 12–18 months.
Akebia characterized the portfolio in a statement as “an extensive proprietary library of well-characterized HIF pathway compounds with potential applications across multiple therapeutic areas.”
According to an Akebia regulatory filing, Akebia agreed to pay Janssen $1 million upfront and up to $16.5 million per product tied to achieving development milestone payments. Akebia also agreed to pay Janssen up to $215 million in commercial milestone payments, plus tiered, escalating royalties ranging from a low to mid single-digit percentage of net sales, on a product-by-product basis.
Through the agreement, Janssen has granted Akebia a license for a 3-year research term to conduct research on the HIF compound portfolio, with Akebia having the right to extend the research term for up to two additional 1-year periods upon payment of an undisclosed extension fee. During the research term, Akebia may designate one or more compounds as candidates for development and commercialization.
Once a compound is designated for development and commercialization, Akebia will be solely responsible for the development and commercialization of the compound worldwide at its own cost and expense.
Under the companies’ agreement—facilitated by Johnson & Johnson Innovation—J&J’s venture capital subsidiary Johnson & Johnson Innovation-JJDC (JJDC) can take an ownership interest in Akebia through a Common Stock Purchase Warrant issued by Akebia to JJDC for 509,611 shares of Akebia’s common stock at an exercise price of $9.81 a share, five cents below the company’s closing stock price on Friday.
The Warrant is exercisable by JJDC, in whole or in part, at any time before the fifth anniversary of the date of issuance with a payment to Akebia of up to $5 million, Akebia disclosed.
“While our global Phase III 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,” Akebia president and CEO John P. Butler said in a statement.
Vadadustat is in ongoing Phase III studies as a potential treatment for anemia associated with chronic kidney disease, both dialysis-dependent and nondialysis-dependent. The candidate is the subject of the PRO2TECT studies for nondialysis patients with anemia associated with chronic kidney disease and the INNO2VATE studies for dialysis-dependent patients.