OSAKA, Japan & SAN DIEGO & SEATTLE–(BUSINESS WIRE)– Takeda Pharmaceutical Company Limited (“Takeda”) ( TOKYO:4502) en PvP Biologics, Inc. (“PvP”) maken vandaag bekend dat ze een wereldwijde overeenkomst hebben gesloten voor de ontwikkeling van KumaMax, een nieuw enzym dat is ontwikkeld om de immuun-reactieve delen van gluten in de maag af te breken, waardoor de pijnlijke symptomen en schade in de dunne darm door inname van accidentele gluten wordt vermeden.
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In de overeenkomst hebben de partijen afgesproken dat PvP alle onderzoek en ontwikkeling zal uitvoeren in fase 1 van de studie volgens een vooraf gedefinieerd ontwikkelingsplan. Takeda draagt financieel bij met 35 miljoen dollar in ruil voor het verwerven van het exclusiviteitsrecht.
Takeda and PvP Biologics Announce Development Agreement around Novel Therapeutic for Celiac Disease
OSAKA, Japan & SAN DIEGO & SEATTLE–(BUSINESS WIRE)– 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
Takeda’s Commitment to Gastroenterology
About Takeda Pharmaceutical Company
Takeda’s 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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