Star R&D Duo Nabs $65 Million for Iterum to Develop Shelved Pfizer (PFE) Antibiotic

London, UK-based Arix Biosciences (ARIX) announced that Iterum, a new Arix Group Business located in Dublin, Ireland, closed a Series B financing for $65 million. Arix led the round and brought in new investors Advent Life Sciences, Domain Associates, Bay City Capital and Pivotal bioVenture Partners. All previous investors participated, including Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners.

Iterum is working to develop sulopenem, an oral and intravenous antibiotic, called penem, to treat Gram-negative multi-drug resistant infections. Iterum acquired the antibiotic from Pfizer (PFE), which abandoned it several years ago.

Iterum’s chief executive officer is Corey Fishman, who was chief financial and chief operating officer of Durata Therapeutics (DRTX) from 2010 to 2015. Michael Dunne is the chief scientific officer, who was chief medical officer of Durata from 2009 until it was acquired by Actavis (ACT) in 2014, then remained in a leadership position until 2015. Durata, under their leadership, successfully developed another antibiotic, dalbavancin, which was another Pfizer castoff.

John Carroll, writing for Endpoints News, says, "The feds have tried adding incentives to help encourage more antibiotic development work as the threat of drug resistance continues to grow, but it’s still fairly unusual to see late-stage programs like this. Older antibiotics are cheap, margins are thin and Big Pharma, including Pfizer, didn’t see a lot to gain by staying in the field."

Sulopenem has shown broad-spectrum coverage as well as potent in-vitro affect against Enterobacteriaceae (ESBL) mutants of E. coli and K. pneumonia. These are typically associated with uncomplicated urinary tract infections (uUTI), complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

The company expects to use the funds to finish a Phase III pivotal trial in uUTI and to move the broader Phase III program forward. Trials are planned to begin in the first half of 2018. Iterum expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by the end of 2019.

Carrol writes, "Taking advanced experimental drugs off the shelves of Big Pharma in exchange for some equity has become a business model in biotech. Fishman and Dunne helped pioneer it and now they’re out to prove just how durable a strategy this can be."

The Series B follows Iterum’s Series A, which raised 40 million pounds last year.

"Iterum has made great progress since its launch and we are very excited about its potential," said Joe Anderson, Arix Bioscience’s chief executive officer, in a statement. "We are privileged to join the company at this stage in its development and to help support the achievement of its goals. Arix is delighted to have led this $65 million funding round comprising many of the biotech sector’s leading specialist investors. This is a significant deal for Arix, the first since our recent IPO, and one which further demonstrates the depth and quality of our pipeline."

If Iterum can get sulopenem to the market, it will be a boon for the company as well as adding an important antibiotic for physicians to use. Antibiotic resistance continues to grow, and is widely viewed as an increasing threat to global public health. Yet it is an area many pharmaceutical companies have declined to invest in. And even when they do, there’s no guarantee of success in bringing a compound to market.

Carroll notes a recent failure of Cempra (CEMP)’s solithromycin earlier this year.

Other companies, such as Auspherix and Nemesis Bioscience, are developing new approaches to developing antibiotics.