Takeda and PvP Biologics Announce Development Agreement around Novel Therapeutic for Celiac Disease

Takeda Pharmaceutical Company Limited (“Takeda”) (TOKYO:4502) and PvP Biologics, Inc. (“PvP”) today announced a global agreement for the development of KumaMax, a novel enzyme designed to break down the immune-reactive parts of gluten in the stomach, thereby avoiding the painful symptoms and damage done in the small intestine from accidental gluten ingestion.

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Under the terms of the development agreement, PvP will conduct all research and development through phase 1 proof-of-principle studies per a pre-defined development plan. Takeda will fund $35 million for PvP’s expenses related to the plan in exchange for an exclusive option to acquire PvP following receipt of a pre-defined data package. Upon PvP’s successful completion of the development plan, Takeda may exercise its option to acquire PvP by paying an undisclosed fee as well as development and regulatory milestones.

“This agreement with PvP Biologics reinforces Takeda’s commitment to developing therapeutics targeting celiac disease. KumaMax could address a significant unmet need for celiac patients who try, but are unable to completely avoid gluten exposure in their diets, and thus continue to experience debilitating symptoms,” said Asit Parikh, head of the gastroenterology therapeutic area for Takeda. “We are pleased to be partnering with PvP Biologics, a company whose management team has a proven track record of successfully bringing assets that target chronic inflammatory GI diseases through development.”

“Takeda’s GI experience and capabilities are a great fit with our goal of developing a novel oral enzyme therapy to make a meaningful impact on the lives of people with celiac disease,” said Adam Simpson, president and CEO of PvP Biologics. “In addition, the significant non-dilutive financing provided by Takeda will accelerate therapeutic development of KumaMax.”

KumaMax is a preclinical, uniquely engineered, recombinant enzyme that is active under acidic stomach conditions and has high specificity for the parts of gluten that cause the autoimmune reaction leading to celiac disease. Currently, the only treatment available for celiac disease patients is a strict gluten-free diet, which is challenging to maintain. For celiac patients attempting to maintain a gluten-free diet but who may accidentally ingest gluten, KumaMax has the potential to degrade the immune-reactive parts of gluten before they exit the stomach in order to decrease an immune response and reduce the symptoms and intestinal damage associated with celiac disease.

“Celiac disease is a disorder in which the ingestion of even a trace amount of gluten can damage the small intestine,” said Tadataka "Tachi" Yamada, MD, chairman of PvP Biologics. “In pre-clinical experiments, KumaMax has shown the ability to degrade gluten with sufficient efficiency and effectiveness to indicate its exciting potential as an oral therapy for a disease that impairs the lives of millions.”

It is estimated that celiac disease affects 1 in 100 people worldwide. Celiac disease causes significant health problems, including acute gastrointestinal symptoms, malnutrition, weakness, and failure to thrive. Celiac disease can develop at any age and, if left untreated, can lead to additional serious health problems.¹

¹ https://celiac.org/celiac-disease/understanding-celiac-disease-2/what-is-celiac-disease/. Accessed on December 7, 2016

About PvP Biologics
PvP Biologics is developing an oral enzyme for the treatment of celiac disease. Our mission is to develop a highly effective therapeutic product to reduce the burden of living with this disease. Towards this end, we are advancing a product candidate designed to break down the immuno-reactive parts of gluten in the stomach and thereby avoid the painful symptoms and damage done in the small intestine from accidental gluten ingestion. The technology was invented at the Institute for Protein Design at University of Washington and exclusively in-licensed by PvP Biologics. PvP Biologics has corporate offices in San Diego and research laboratories in Seattle. For more information, please visit www.pvpbio.com.

Takeda’s Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. Beginning in the 1990’s Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors. Since that time, Takeda’s global capabilities have expanded into the specialty care market in gastroenterology and biologics with a focus on ulcerative colitis and Crohn’s disease. Takeda's expertise also remains focused on therapeutic agents that work to reduce the production of acid in the stomach, and options for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation and opioid-induced constipation. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Takeda’s Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither PvP Biologics nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

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Contact information

For PvP Biologics:
Jessica Yingling, Ph.D.
jessica@litldog.com
+1.858.344.8091
or
For Takeda:
Tsuyoshi Tada – Japan
tsuyoshi.tada@takeda.com
+81-3-3278-2417
Julia Ellwanger – USA
julia.ellwanger@takeda.com
+1-224-554-7681