Agreement includes US rights to ZURAMPIC and lesinurad/allopurinol fixed-dose combination in gout
AstraZeneca today announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to ZURAMPIC® (lesinurad). ZURAMPIC was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.1
Under the terms of the agreement, Ironwood will acquire exclusive US rights to ZURAMPIC. In addition, Ironwood will gain the exclusive US rights to the fixed-dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination programme for regulatory review in the second half of 2016. Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on Product Sales. AstraZeneca will manufacture and supply ZURAMPIC, provide certain support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.
Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “We’re pleased to be entering into this agreement with Ironwood, a company with whom we already have a number of successful commercial partnerships. Our new agreement with Ironwood will ensure the successful launch of ZURAMPIC in the US, while allowing us to concentrate our resources on the innovative medicines in our main therapy areas.”
Tom McCourt, Chief Commercial Officer of Ironwood, said: “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. With focused investment into the gout franchise over time, we believe we can maximize cash flows and accelerate our efforts to build a top-performing commercial biotechnology company.”
Gout is the most common form of inflammatory arthritis caused by hyperuricemia (elevated serum uric acid (sUA)).2,3 Gout affects millions of Americans,4 many of whom do not reach recommended sUA treatment goals on XOIs, which decrease production of uric acid.5 For those inadequately controlled patients, the addition of a urate-lowering therapy to increase excretion of uric acid, may help them achieve treatment goals.6
The development of AstraZeneca’s gout portfolio is led by Ardea Biosciences, a wholly owned subsidiary. The transaction does not include the transfer of any AstraZeneca or Ardea employees or facilities. AstraZeneca also retains the rights to the rest of the Ardea portfolio, including RDEA3170, a Phase IIb ready, selective uric acid reabsorption inhibitor. Under the terms of the agreement, Ironwood will have certain rights to potentially access RDEA3170 in gout indications in the US. The licensing agreement is expected to close in the second quarter of 2016, subject to antitrust approval in the US.
Revenue from the licensing agreement will provide AstraZeneca with recurring Externalization Revenue from any expected milestone payments and tiered single-digit royalty payments on Product Sales. The agreement does not impact AstraZeneca’s financial guidance for 2016.
Important Safety Information
WARNING: RISK OF ACUTE RENAL FAILURE MORE COMMON WHEN USED WITHOUT A XANTHINE OXIDASE INHIBITOR (XOI
- Acute renal failure has occurred with ZURAMPIC and was more common when ZURAMPIC was given alone
- ZURAMPIC should be used in combination with an XOI
- Severe renal impairment (eCLcr less than 30 mL/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis
- Tumor lysis syndrome or Lesch-Nyhan syndrome
Warnings and Precautions:
- Renal events: Adverse reactions related to renal function have occurred after initiating ZURAMPIC. A higher incidence was observed at the 400-mg dose, with the highest incidence occurring with monotherapy use. Monitor renal function at initiation and during therapy with ZURAMPIC, particularly in patients with eCLcr below 60 mL/min, and evaluate for signs and symptoms of acute uric acid nephropathy. ZURAMPIC should not be initiated in patients with an eCLcr less than 45 mL/min.
- Cardiovascular events: Major adverse cardiovascular events were observed with ZURAMPIC; a causal relationship has not been established
- Most common adverse reactions with ZURAMPIC (in combination with an XOI and more frequently than on an XOI alone) were headache, influenza, blood creatinine increased, and gastroesophageal reflux disease
Indication and Limitations of Use for ZURAMPIC:
ZURAMPIC is a URAT1 inhibitor indicated in combination with an XOI for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with an XOI alone.
- ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia
- ZURAMPIC should not be used as monotherapy
NOTES TO EDITORS
About ZURAMPIC (lesinurad) 200 mg tablets
ZURAMPIC® (lesinurad) 200 mg tablets inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid.1 By inhibiting URAT1, ZURAMPIC increases uric acid excretion and thereby lowers serum uric acid (sUA).1 ZURAMPIC also inhibits organic anion transporter (OAT) 4 a uric acid transporter involved in diuretic-induced hyperuricemia.
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology company focused on creating medicines that make a difference for patients, building value for our fellow shareholders, and empowering our passionate team. We are advancing an innovative pipeline of medicines in multiple areas of significant unmet need, including irritable bowel syndrome with constipation (IBS-C)/chronic idiopathic constipation (CIC), vascular and fibrotic diseases, and refractory gastroesophageal reflux disease, among others. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader in the IBS-C/CIC category, and we are applying our proven R&D and commercial capabilities to advance multiple internally-developed and externally-accessed product opportunities. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
About Ardea Biosciences
Ardea Biosciences is a member of the AstraZeneca Group, located in San Diego, California. Ardea is leading the development of AstraZeneca’s gout portfolio, including ZURAMPIC and RDEA3170.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca-us.com.
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- Prescribing Information for ZURAMPIC. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
- Perez-Ruiz F, Herrero-Beites A. Evaluation and Treatment of Gout as a Chronic Disease. Adv Ther. 2012;29(11):935–946.
- Schumacher HR. The pathogenesis of gout. Cleve Clin J Med. 2008;75(5):S2-S4.
- Zhu Y, et al. Prevalence of Gout and Hyperuricemia in the US General Population.Arthritis Rheum. 2011;63:3136–3141.
- Singh J, Akhras K, Shiozawa A. Comparative effectiveness of urate lowering with febuxostat versus allopurinol in gout; analyses from large U.S. managed care cohort.Arthritis Res Ther. 2015;17:120.
- Khanna D, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res. 2012;64:1431-1446
3248201 Last Updated 4/16