AstraZeneca PLC AZ enters US licensing agreement with Ironwood (3470W)
April 26 2016 - 04:29AM
UK Regulatory
TIDMAZN
RNS Number : 3470W
AstraZeneca PLC
26 April 2016
ASTRAZENECA ENTERS INTO US LICENSING AGREEMENT WITH IRONWOOD
PHARMACEUTICALS FOR LESINURAD
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(R) (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.
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 a serious, progressive and debilitating form of
inflammatory arthritis. Approximately two million patients in the
US on urate lowering therapy remain inadequately controlled, as XOI
treatment alone is not sufficient to achieve their treatment
goals.
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, potent
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.
Financial considerations
Revenue from the licensing agreement will provide AstraZeneca
with recurring Externalisation 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.
About Zurampic
ZURAMPIC(R) (lesinurad) is the first in a new class of medicines
called Selective Uric Acid Reabsorption Inhibitors (SURI) that work
selectively to complement xanthine oxidase inhibitors (XOIs) in the
treatment of hyperuricemia associated with uncontrolled gout.
ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia and should not be used as monotherapy. XOIs reduce
the production of uric acid; ZURAMPIC increases the excretion of
uric acid. Together, the combination of ZURAMPIC and an XOI
provides a dual mechanism of action that both decreases production
and increases excretion of uric acid, thereby lowering serum uric
acid (sUA) levels in patients who have not achieved target serum
acid levels with XOI treatment alone. ZURAMPIC selectively inhibits
the function of transporter proteins urate transporter (URAT1) and
organic anion transporter 4 (OAT4), involved in uric acid
reabsorption in the kidney. In people, it does not inhibit OAT1 and
OAT3, which are drug transporters in the kidney associated with
drug-drug interactions. The efficacy of ZURAMPIC was established in
three Phase III clinical trials that evaluated a once daily dose of
ZURAMPIC in combination with the XOI allopurinol or febuxostat
compared to XOI alone.
About Ironwood
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.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation 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.com
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease,
ING - Infection, Neuroscience and Gastrointestinal
26 April 2016
-ENDS-
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The company news service from the London Stock Exchange
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