Takeda Launches CDPATH™, a Personalized Prognostic Tool, Advancing Innovation for Patients with Crohn's Disease

• CDPATH supports shared decision-making between patients and healthcare providers; provided at no cost to eligible adult patients who have not yet experienced serious complications*

CAMBRIDGE, Mass., Sept. 14, 2022 /PRNewswire/ -- Takeda ( TSE:4502/NYSE:TAK ) today announced the national launch of the CDPATH™ program, which includes an innovative, validated personalized prognostic tool that uses blood tests† to help predict the potential risk of developing serious Crohn's disease-related complications within three years.1,2 CDPATH is available for use by US-based physicians and offered at no cost to eligible patients††, providing an opportunity for patients to partner with their physicians to map out a personalized disease management plan.

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/8826751-takeda-cdpath-tool-for-crohns-disease/

CDPATH is for adult patients (≥18 years old) diagnosed with Crohn's disease (CD) within the past 10 years who have yet to experience serious complications defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).1,2 Patients can have blood drawn for the CDPATH test at one of more than 2,500 participating locations nationwide.

"At Takeda, we are driven by the challenge of making a meaningful difference in the lives of patients with inflammatory bowel disease, and working with partners to provide solutions that can help transform their care," said Gamze Yüceland, Head, Gastroenterology Business Unit, Takeda Pharmaceuticals U.S.A., Inc. "Offering CDPATH at no cost to eligible patients with CD will help deliver an innovative tool to the community that can help inform and personalize CD management."

CD is a chronic inflammatory disease that affects the gastrointestinal (GI) tract. CD is one of the two most common types of inflammatory bowel disease (IBD). In the U.S., IBD impacts approximately three million people.3 CD may be progressive and has the potential to lead to irreversible and destructive complications, which may require surgery.4 Complications—which may include fistulas, abscesses and strictures—can occur, yet the course of CD is variable and difficult to predict.5,6,7

CDPATH integrates patient-specific serologic markers and genetic marker status, identified via a blood sample, with a patient's CD characteristics to predict a low, medium or high risk for potentially developing serious CD complications over a three-year period. Test results are intended to be used in combination with a physician's clinical assessment and should not be the primary factor in diagnosing or making treatment decisions. Healthcare providers will receive a CDPATH test report with a graphical risk profile that can then be used to facilitate discussions with patients.1,2

To learn more and find a participating location for the required blood draw, visit www.CDPATH.com. Download additional news and multimedia assets here: https://www.multivu.com/players/English/8826751-takeda-cdpath-tool-for-crohns-disease/.

Takeda has partnered with MiTest Health ("MiTest") and Prometheus Laboratories Inc. ("Prometheus") to establish the CDPATH program. MiTest Health defined and established the clinical relevance of the CDPATH model through an independent clinical study. Prometheus, a certified Clinical Laboratory Improvement Amendments (CLIA) laboratory, validated the model, and has received approval from the New York State Department of Health (NYS DoH) for CDPATH as a Laboratory Developed Test (LDT). Prometheus is the processing laboratory for the CDPATH program.

"Prometheus Laboratories is pleased to partner with Takeda on the CDPATH program as they share our commitment to patients," said Mike Walther, President of Prometheus Laboratories Inc. "CDPATH is a prognostic tool that we believe can be important when considering an appropriate management approach for an individual patient."

"Having a better understanding of their underlying disease can help patients take a more proactive role in their Crohn's disease management," said Corey Siegel, MD, MS, MiTest Co-Founder, Section Chief of Gastroenterology and Hepatology and Co-Director of the IBD Center at the Dartmouth Hitchcock Medical Center. "For physicians, shared decision-making is a key component to a patient-centric management approach. CDPATH will allow healthcare providers to evaluate the potential variability and complexity of Crohn's disease for each individual patient, and support a more collaborative approach to managing their patient's CD."

*Serious complications are defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).

†The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda, and has received approval from the New York State Department of Health (NYS DoH) as an LDT. Test results are provided via Prometheus Laboratories Inc. to physicians.2

About CDPATH
††CDPATH is only validated in, and can only be performed on, adult Crohn's disease patients (≥18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn's disease complication, defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty). Beneficiaries must be covered by a commercial insurance plan or be uninsured. Those with state or federal health insurance program (including, but not limited to, Medicare, Medicaid, Department of Veteran's Affairs, Coast Guard, Public Health Service, or Department of Defense) are excluded from participating in this program. No insurance claims should be collected or processed, and no charges should be billed to the patient for CDPATH and shipping. Takeda has made arrangements to directly cover these charges. The cost of the blood draw, CDPATH, and shipping will be covered, provided a participating location is used for the blood draw. Participating locations include Quest Diagnostics (NYSE:DGX) Patient Service Centers, Prometheus-contracted phlebotomy locations and a mobile phlebotomy program. To find a participating location, please call CDPATH client services at 1-877-556-87662 or visit www.CDPATH.com. Only the cost of CDPATH and blood sample shipping will be covered if the blood draw is completed in a physician's office and it is shipped to Prometheus, the processing laboratory, with the provided shipping label.

Due to the nature of clinical testing, there are limitations to consider for CDPATH model1

• Testing was conducted with only patients from North America; the results for patients from other regions have not been established1
• Patients were recruited from large referral centers and may not be representative of all CD patients1
• The model was built and validated in CD patients with 15 years as the maximum duration of disease; as such, it is not understood whether the model is applicable for patients with long-standing CD beyond 15 years from diagnosis1
• The validity of the model after the first complication or surgery has not been tested or established; therefore, CDPATH is not intended to be used as a monitoring tool and may only be used one time for each patient1

Healthcare Providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient. CDPATH should only be considered an additional piece of information in combination with a doctor's evaluation of a patient's CD. Doctors can decide if this tool is appropriate for individual patients as part of their overall assessment. More information is available at www.CDPATH.com.

About Crohn's Disease
Crohn's disease (CD) is one of the most common forms of inflammatory bowel disease.8 It is a chronic, relapsing, remitting, inflammatory condition of the gastrointestinal (GI) tract that is often progressive in nature.4,9,10 CD can affect any part of the GI tract from mouth to anus, and can affect the entire thickness of the bowel wall.11 CD can present with symptoms of abdominal pain, diarrhea, and weight loss.10 The cause of CD is not fully understood; however, recent research suggests heredity, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to CD.12,13

Takeda's Commitment to Gastroenterology in the United States
Takeda sees an urgent need for improving patient care in gastroenterology (GI) and has focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for more than 25 years. We push boundaries and work across modalities, taking on the most complex GI conditions and the most neglected patient needs, boldly advancing original thinking and creatively tackling barriers to make a meaningful difference for patients. Challenging expectations and enabling innovative thinking, Takeda is part of more than 200 collaborations connecting people with a mutual commitment to action. Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, short bowel syndrome and motility disorders. Our GI Research & Development team is also exploring solutions in immune-related diseases, motility and liver diseases.

About Takeda
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, 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 and regions. For more information, visit https://www.takeda.com.

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Japanese Media
Jun Saito
Jun.Saito@Takeda.com
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Media Outside Japan
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Amy.McCarthy@Takeda.com
+1 781-496-7761

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References

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2 Data on file. Takeda Pharmaceuticals.
3 Crohn's and Colitis Foundation. Inflammatory Bowel Disease vs Irritable Bowel Syndrome (Brochure). October 2019.
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5 Mazor Y, et al. J Crohns Colitis. 2011;5(6):592-597.
6 Definitions and Facts for Crohn's Disease. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Retrieved from: https://www.niddk.nih.gov/health-information/digestive-diseases/crohns-disease/definition-facts. Accessed March 14, 2022.
7 Veloso FT. Eur J Gastroenterol Hepatol. 2016;28(10):1122-1125.
8 Baumgart DC, Carding SR. Lancet. 2007;369(9573):1627-1640.
9 Liverani, et al. World J Gastroenterl. 2016;22(3):1017-1033.
10 Baumgart DC, Sandborn WJ. Lancet. 2012;380(9853):1590-1605.
11 Feuerstein JD, Cheifetz AS. Mayo Clin Proc. 2017;92:1088-1103.
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