Exclusive: Following Up Akebia, Johnson & Johnson's Research And License Agreement

On Monday, Akebia Therapeutics Inc AKBA signed a $1 million research and license agreement with Johnson & Johnson JNJ to access hundreds of hypoxia inducible factor (HIF)-targeted compounds. This access includes a coveted preclinical candidate for inflammatory bowel disease (IBD) called AKB-5169.

Akebia CEO John Butler told Benzinga the company is “very excited about the deal,” which secured compounds with “significant preclinical data.”

Akebia was keen to acquire AKB-5169, but it was also eager to tap into other elements of the HIF portfolio. Butler said the company targeted a number of compounds yielding “interesting opportunities,” including those related to anemia.

Research Implications

“We have a second program internally, AKB-6899, which has a really robust, profound hemoglobin effect in preclinical models,” he said. “We want to move that forward. We are looking at that in models of sickle cell disease in MDS, but now we can say we need to look at that in comparison to compounds from the J&J library, now the Akebia HIF library.”

The acquisition was also part of the company’s strategy to advance ongoing Phase 3 clinical trials for vadadustat to treat anemia in chronic kidney disease (CKD) — and possibly more.

“As we have explored the compound and explored the [related] HIF, the hypoxia inducible factor pathway, we have recognized that there is a tremendous amount of opportunity to develop therapeutic products from the biology of HIF,” Butler said.

Related Link: Exclusive: Akebia CEO On Huge New Partnership Deal

HIF detects changes in oxygen levels in the body and is critical in maintaining function limited by numerous disorders. Extension into the realm of HIF expands Akebia’s research purview significantly.

“Every cell in the body survives because of access to oxygen,” Butler said. “There are so many indications that we think about beyond anemia of CKD, like IBD, like radioprotection, like wound healing, like retinopathy, oxygen issues. There are just a tremendous number of places where we can go, and that is what we are looking for. The deal with J&J really does push our development efforts much faster than we could by doing discovery work de novo.”

What’s Up Next

Akebia's process is to design therapeutic product profiles around particular HIF-targeted conditions, compare them against original compounds, and develop preclinical models to identify matches.

Johnson & Johnson’s files provide a shortcut through some of the early research stages.

“We can kind of go straight into looking at indications and matching indications and compounds,” Butler said.

That is largely the extent of the deal's impact on Akebia, as Butler said the company will not altogether alter its business strategy moving forward. He noted that little had changed since Akebia finalized a December deal with Otsuka Holdings Co Ltd 4578 OTSKF.

“As a matter of fact, this has been our overall strategy to build this company for some time,” he said.

A Focus On Partnerships

He added that the Otsuka deal laid the groundwork for the Johnson & Johnson agreement by providing financial stability and ensuring the capacity to complete the vadadustat trial.

The study is primarily financed through collaborations rather than capital markets, so Akebia has long invested in securing international partners. In 2015, it signed a collaboration with Mitsubishi Tanabe, and throughout 2016, it began focusing on Europe and other parts of the world.

“Otsuka really was the ideal partner for us,” Butler said. “We got a contract where the governance is very favorable for us, which allows for us to continue development very efficiently and not have any impact on our timeline, but we got a partner who has a significant commercial presence in the U.S.”

He noted Otsuka’s corps of 1,000 U.S. sales representatives ready to be deployed for Akebia product launches.

“They were a great supportive partner, and it was a financial deal that was really quite favorable for us, as well,” he said, referencing an immediate $125 million transaction and at least an additional $140 million R&D investment. “So, it was an extraordinarily important financing event, if you will, for us as well as an important strategic event.”

Apart from mentioning those few figures, Butler would not comment on the implications of the two transactions on the company’s financial strategy. However, he said that discussions of European partnerships may result in “no need to raise money to finance the Phase 3 program. We will have the cash we need for that program.”

Nick Donato contributed reporting.