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.

Media Contacts:
Japanese Media
Jun Saito
Jun.Saito@Takeda.com
+81 (0) 3-3278-2325

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

Important Notice
For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.

Medical information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

References

¹ Siegel CA, Horton H, Siegel LS, et al. Aliment Pharmacol Ther. 2016;43(2):262-271.
² Data on file. Takeda Pharmaceuticals.
³ Crohn's and Colitis Foundation. Inflammatory Bowel Disease vs Irritable Bowel Syndrome (Brochure). October 2019.
⁴ Fiorino G, et al. J Crohns Colitis. 2016;10(4):495-500.
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.
¹² Henckaerts L, et al. Gut. 2007;56:1536-1542.
¹³ Kaser A, et al. Dig Dis. 2010;28:395-405.

View original content:https://www.prnewswire.com/news-releases/takeda-launches-cdpath-a-personalized-prognostic-tool-advancing-innovation-for-patients-with-crohns-disease-301624209.html

SOURCE Takeda Pharmaceutical Company Limited