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Takeda and Resolve Therapeutics Enter Autoimmune Partnership

Partners to Develop Novel Nuclease Proteins for Lupus

OSAKA, Japan and SEATTLE, Feb. 27, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and Resolve Therapeutics, LLC ("Resolve") today jointly announced that they have entered into a partnership to develop compounds for the treatment of lupus (also known as Systemic Lupus Erythematosus, or SLE) and other autoimmune diseases.  The lead compound, RSLV-132, a novel nuclease*1 Fc fusion protein*2, will begin clinical development later this year. 

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Additional Resolve clinical candidates are in the pre-clinical proof-of-concept stage.  These compounds target the degradation and elimination of autoantibody-containing immune complexes, which are thought to be the most proximal pathophysiological trigger of lupus.

Resolve will conduct all development work under the collaboration until completion of the first RSLV-132 Phase 1b/2a trial*3 in lupus patients.  Takeda has the exclusive option to license the lead compound and all other compounds from the Resolve platform upon the completion of the Phase 1b/2a trial.  Upon exercise of its option, Takeda would assume lead responsibility for worldwide development and commercialization of the Resolve products.

Under the terms of the agreement, Takeda will help fund continued development of RSLV-132 through an initial payment of $8 million to Resolve in fiscal 2012. Upon exercise of its option, Takeda would pay Resolve an option exercise fee, plus the potential for additional development milestones totaling $247 million.  Furthermore Resolve is eligible to receive royalties on product sales.

"This collaboration with Resolve is very exciting as its innovative pipeline of nuclease fusion proteins has the potential to provide a new approach to helping lupus patients" said Tetsuyuki Maruyama (former name: Paul Chapman), Ph.D., General Manager of the Pharmaceutical Research Division at Takeda.

"We are delighted to begin work with our Takeda colleagues," said James Posada, Ph.D., MBA, chief executive officer of Resolve.  "We feel strongly that Takeda's expertise, commitment to inflammation, and considerable resources will give the Resolve compounds the best possible chance of success." 

Resolve was advised in the transaction by Fenwick & West, LLP

About Lupus
Lupus is an autoimmune disease that can affect any part of the body. As occurs in other autoimmune diseases, the immune system attacks the body's cells and tissue, resulting in inflammation and tissue damage. It most often harms the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. The course of the disease is unpredictable, with periods of illness (called flares) alternating with remissions. The disease occurs nine times more often in women than in men, especially in women in child-bearing years ages 15 to 35, and is also more common in those of non-European descent.  It is estimated that at least five million people worldwide have a form of lupus. As current treatments only manage the symptoms of lupus, a significant medical need exists.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

About Resolve Therapeutics
Resolve Therapeutics is a privately held biotechnology company based in Seattle that is dedicated to helping patients with lupus through the development of RSLV-132, its novel targeted biologic therapy.  RSLV-132, a nuclease Fc fusion protein, represents a new approach to eliminating immune complexes which are recognized as one of the most important and proximal triggers of the inflammatory cascade in lupus.   RSLV-132 is currently in IND-enabling studies and is expected to begin human clinical studies in 2013. For more information please visit the Resolve Therapeutics website at http://www.resolvebio.com.  

*1 A general term for enzymes which hydrolyze nucleic acid into nucleotides.
*2 A recombinant nuclease fused to the Fc domain of human immunoglobulin.
*3 A phase 1b/2a trial designed to demonstrate proof of biological activity.

Contact:

James Posada, Ph.D.
Chief Executive Officer
Resolve Therapeutics, LLC
(208) 876-4057
jp@resolvebio.com

Joan Kureczka
Kureczka/Martin Associates
(415) 821-2413
Joan@kureczka-martin.com

Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Tel: +81-3-3278-2037

SOURCE Resolve Therapeutics, LLC

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