Providence, R.I., and Osaka, JAPAN, April 23, 2020 – ProThera Biologics, Inc. and Takeda Pharmaceutical Company Limited [TSE:4502/NYSE:TAK] (“Takeda”) today announced that they have entered into a global licensing agreement to develop a novel plasma-derived Inter-alpha Inhibitor Proteins (IAIP) therapy for the treatment of acute inflammatory conditions.

Early research has indicated that this IAIP technology has the potential to deliver a highly innovative, disease-modifying treatment for a range of acute inflammatory diseases. In such conditions, dysregulated inflammation plays a key role in the pathology, and there are no effective treatments available today. IAIP are naturally occurring proteins that circulate in the blood, and extensive research at ProThera has shown that these proteins play an essential role in human health by controlling inflammation. They exert their anti-inflammatory effects through multiple mechanisms and have the potential to change the paradigm of treatment for patients with dysregulated immune responses. During acute illnesses, however, the levels of these anti-inflammatory proteins rapidly decline. A replenishment strategy for patients using Inter-alpha Inhibitors is supported by numerous preclinical studies.

“Our goal is to successfully treat patients with severe inflammatory conditions and this is now possible through our alliance with Takeda,” said Denice Spero, president and chief business officer of ProThera. “Takeda’s R&D expertise is well aligned with the potential uses of our Inter-alpha Inhibitor technology. We are delighted that Takeda and ProThera are collaborating and that Takeda shares our enthusiasm for tackling unmet medical needs.”

As part of the agreement, ProThera and Takeda will work together on IND-enabling activities, with development led by Takeda’s dedicated Plasma Derived Therapies R&D organization. The broad collaboration will also explore the development of companion diagnostics with the goal of personalizing patient treatment and maximizing real-world outcomes. Takeda will assume responsibility for funding all development and commercialization activities. The financial terms of the licensing agreement are not being disclosed.

“We believe ProThera’s expertise in IAIP technology represents a potentially powerful opportunity to explore the untapped potential of plasma in order to address challenging rare and complex diseases,” commented Dr. Chris Morabito, Takeda’s Head of Research and Development, Plasma-Derived Therapies Business Unit. “Leveraging this potent technology using our deep expertise and robust dedicated plasma infrastructure, this collaboration reflects our patient-centered R&D efforts and could represent an important new avenue to deliver meaningful innovation to patient populations in need.”

“ProThera is proud to join forces with a world-class company like Takeda to tackle a number of challenging diseases.Takeda is one of the leaders in plasma-derived therapies, and we are confident that this partnership may advance this promising therapeutic into the clinic,” said Dr. Yow-Pin Lim, co-founder and CEO of ProThera. “It has been a long journey to study these extraordinary proteins, and we are excited about the possibilities of achieving positive clinical outcomes.”

About ProThera Biologics

ProThera Biologics has focused since inception on developing Inter-alpha Inhibitor Proteins for the treatment of life-threatening inflammatory diseases along with a rapid, point of care diagnostic test to determine IAIP levels for use as a biomarker for patient progression to severe outcomes. ProThera has demonstrated the potential of IAIP therapy in numerous preclinical models and the use of IAIP as a biomarker in clinical samples.

The company was co-founded by Yow-Pin Lim, M.D., Ph.D., and Douglas Hixson, Ph.D., faculty members at the Warren Alpert Medical School of Brown University, based upon research originating in the labs at Lifespan/Rhode Island Hospital, with seed funding from the R.I.-based Slater Technology Fund. In developing its technology, ProThera has collaborated with investigators at multiple academic research institutions and has been awarded in excess of $12 million in federal funding from agencies within the National Institutes of Health pursuant to Small Business Investment Research (SBIR) grants. The company has received continued investment from the Slater Fund, and has also received support from R.I. Commerce Corp. through its Innovate RI Small Business Fund.

Approximately $4M in Phase II SBIR grants from the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Allergy and Infectious Disease (NIAID) is currently supporting collaborative research with Care New England/Women & Infants Hospital on neonatal brain injury as well as the rapid test to assist therapy in infants with life-threatening diseases.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

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