Ironwood Pharmaceuticals said today it has licensed exclusive U.S. rights from AstraZeneca to all products containing lesinurad—including the gout-associated hyperuricemia drug ZURAMPIC® (lesinurad), expected to launch in the second half of this year.
Ironwood agreed to pay AstraZeneca $100 million upfront for exclusive U.S. rights to all products containing lesinurad. That money will be funded from cash on hand, Ironwood said.
In addition to ZURAMPIC—which won FDA approval in December 2015 for use with a xanthine oxidase inhibitor (XOI)—those rights include a fixed-dose combination of lesinurad and allopurinol which AstraZeneca plans to submit to the FDA for regulatory review in the second half of this year.
Ironwood also agreed to pay AstraZeneca up to $165 million in payments tied to sales and other unspecified milestones, as well as tiered single-digit royalties on product sales.
In return, AstraZeneca agreed to manufacture and supply ZURAMPIC, provide certain product support services to Ironwood, and complete the FDA postapproval commitment for Ironwood.
ZURAMPIC is designed to work by selectively inhibiting the function of transporter proteins urate transporter (URAT1) and organic anion transporter 4 (OAT4), involved in uric acid reabsorption in the kidney.
AstraZeneca acquired ZURAMPIC when it shelled out $1.26 billion in 2012 to acquire Ardea Biosciences, now a wholly owned subsidiary of the pharma giant. AstraZeneca retains ownership of the rest of the Ardea portfolio—including RDEA3170, a Phase IIb-ready, potent, selective uric acid reabsorption inhibitor.
Under the licensing deal with AstraZeneca, Ironwood will have rights to RDEA3170 in gout indications in the U.S.
“Our new agreement with Ironwood will ensure the successful launch of ZURAMPIC in the U.S., while allowing us to concentrate our resources on the innovative medicines in our main therapy areas,” Luke Miels, evp, global product and portfolio strategy, AstraZeneca, said in a statement.
ZURAMPIC is one of “at least” five launches planned by Ironwood in the U.S. by 2020, added Ironwood Chief Commercial Officer Tom McCourt.
“This transaction enables Ironwood to leverage our strong commercial capabilities to advance a durable franchise of innovative medicines addressing a significant unmet need in which patients are highly motivated and seeking relief,” McCourt said.
Ironwood expects the deal to generate positive cash flow in 2019 and beyond as well as add significant revenue, with annual U.S. sales estimated to exceed $300 million at peak in 2022. ZURAMPIC and the lesinurad–allopurinol fixed-dose combination product have patent protection into at least 2028, Ironwood said.
To reflect the deal with AstraZeneca, Ironwood has updated its 2016 cash flow guidance, and now expects to use less than $70 million in cash for operations in 2016, up from less than $60 million, to fund ZURAMPIC integration and the launch.
Ironwood said it expects to provide updated guidance regarding total operating expenses for 2016 during its second quarter 2016 investor update.