Shire Announces Collaboration With Microhealth To Address Unique Needs Of Hemophilia A And B Patients With Inhibitors

Shire Announces Collaboration with MicroHealth to Address Unique Needs of Hemophilia A and B Patients with Inhibitors

Collaboration leverages digital technology to provide free and secure care monitoring tool

Lexington, Mass. - August 25, 2017 - Shire plc (LSE: SHP, NASDAQ: SHPG), the biotech leader in rare diseases, today announced a collaboration with MicroHealth to support a free and secure care monitoring tool for hemophilia A and B patients with inhibitors and their care teams. MicroHealth, a digital health company co-created by a hemophilia patient, developed the tool, in the form of an app, to help improve hemophilia patient care and outcomes through the ability to set reminders, track, store and selectively share personal health data, including photos and bleed alerts, with care team members. Shire’s collaboration with MicroHealth will help the start-up customize the tool with new features and information specifically for the 5-7 percent of hemophilia patients with inhibitors.¹ Both companies remain independent in this collaboration and Shire does not have access to any patient, caregiver or other third-party data through this collaboration.

“At Shire, we want to do everything we can to help people manage their hemophilia and to limit the burden of the disease on their everyday lives,” said Patty Torr, Head of U.S. Hematology, Shire. “Shire is a long-standing partner to the hemophilia community and has served hemophilia patients with inhibitors for more than 40 years. Enhancing the existing MicroHealth app with new functionality and resources to address the needs of hemophilia patients with inhibitors is an important innovation for this group of patients.”

Inhibitors are a serious complication in hemophilia patients that can occur when the patient’s immune system prevents standard treatments from working by producing antibodies that “inhibit” the necessary formation of blood clots.^2,3 Inhibitors destroy clotting factor treatments as if they were harmful foreign substances before they have a chance to stop the bleeding, making patients with inhibitors very difficult to treat.³ Bypassing agents are an alternative method to control bleeding and are the current standard of care for hemophilia patients with a high amount of inhibitors.⁴

Though prophylactic treatment, or preventative care, is now recommended for managing many patients with hemophilia, the difficulties associated with maintaining this type of treatment regimen can result in a lack of adherence that leaves patients at risk for bleeds and subsequent joint damage.^5,6 The aim of the MicroHealth app is to make it easier for hemophilia patients to manage their care with their healthcare provider.

“I created the MicroHealth app with a keen understanding of the challenges and complexities of managing hemophilia based on my own experiences living with severe hemophilia A,” said Aaron Craig, Co-Founder, MicroHealth. “I wanted to develop a tool that would help streamline hemophilia care to produce stronger adherence. We’re excited to partner with Shire on extensions to the app to better support patients with inhibitors and their care teams.”

Launched in 2011, the MicroHealth app is already widely used among hemophilia patients without inhibitors.⁷ An estimated 20 percent of American hemophilia patients on prophylactic treatment are MicroHealth app users, and it has been linked to a meaningful reduction in bleed rates.⁷ A recent 12-month observational study of 256 patients showed that hemophilia A patients who received digital monitoring by their healthcare provider via the app reported bleeding rates that were 57 percent lower than patients without digital monitoring.⁷ This translates into nearly 3.5 fewer bleeds per year.⁷

The MicroHealth app is free and available for download worldwide in both English and Spanish on Apple and Android devices. Patient data is protected through industry-standard security and privacy protocols.

About Hemophilia
Hemophilia is a challenging chronic disease that causes longer-than-normal bleeding due to absent or deficient clotting factor in the blood.⁸ Hemophilia A is more common than hemophilia B;⁸ hemophilia A affects about 150,000 people, whereas hemophilia B affects about 30,000 people worldwide.⁹

People with hemophilia, working closely with their healthcare professionals, can live healthy lives with proper care and adequate treatment.¹⁰ Treatment regimens typically include on-demand and/or regular prophylactic infusions of factor replacement therapy to control or prevent the risk of bleeding.^8,11

Inhibitors are a serious complication in patients with hemophilia.² They form when the body’s immune system attacks the proteins in factor therapy, causing it to be ineffective.² Immune tolerance induction and bypassing agents are essential therapies for this patient population that help either train the body to tolerate the factor concentrate or bypass the inhibitor to help the body form a clot and stop bleeding. ^2,10,12

NOTES TO EDITORS

For further information please contact:

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

www.shire.com

About MicroHealth
MicroHealth is a digital health company whose goal is to improve health outcomes by making it easy for patients and healthcare professionals to monitor chronic care plans together. At MicroHealth, we see ourselves as a trusted partner in the delivery of evidence-based, personalized medicine. The company was co-founded in 2011 by a team including Aaron Craig, a person with severe hemophilia A, and Dr. Marc Lara, then a medical researcher at Columbia University.

References

1. Wight J. Paisley S. “The Epidemiology of Inhibitors in Haemophilia A: A Systematic Review.” Haemophilia. 2003.

2. World Federation of Hemophilia. “What are inhibitors?” World Federation of Hemophilia website. http://www.wfh.org/en/page.aspx?pid=651. Accessed January 12, 2017.
3. National Hemophilia Foundation. “Inhibitors & Other Complications.” National Hemophilia Foundation website. https://www.hemophilia.org/Bleeding-Disorders/Inhibitors-Other-Complications. Accessed August 9, 2017.
4. World Federation of Hemophilia. “What are the treatment options for inhibitors?” World Federation of Hemophilia website. https://www.wfh.org/en/page.aspx?pid=652. Accessed August 9, 2017.

5. World Federation of Hemophilia. “What is prophylaxis?” World Federation of Hemophilia website. https://www.wfh.org/en/abd/prophylaxis/what-is-prophylaxis. Accessed August 9, 2017.
6. Furlan R, Krishnan S, Vietri J. “Patient and parent preferences for characteristics of prophylactic treatment in hemophilia.” Patient Preference and Adherence. Published November 23, 2015. Available at: https://www.dovepress.com/patient-and-parent-preferences-for-characteristics-of-prophylactic-tre-peer-reviewed-fulltext-article-PPA

7. National Hemophilia Foundation. “Digital Hemophilia Treatment Center Monitoring Linked to Significant Reduction in Bleeding Rates.” National Hemophilia Foundation website. https://www.hemophilia.org/Newsroom/Medical-News/Digital-Hemophilia-Treatment-Center-Monitoring-Linked-to-Significant-Reduction-in-Bleeding-Rates. Published April 15, 2016. Accessed August 9, 2017.
8. World Federation of Hemophilia. “What is hemophilia?” World Federation of Hemophilia website. http://www.wfh.org/en/page.aspx?pid=646. Accessed August 9, 2017
9. World Federation of Hemophilia. Report on the Annual Global Survey 2015. World Federation of Hemophilia website. http://www1.wfh.org/publication/files/pdf-1669.pdf. Accessed August 9, 2017.
10. World Federation of Hemophilia. “About Bleeding Disorders: Treatment.” World Federation of Hemophilia website. http://www.wfh.org/en/page.aspx?pid=642. Accessed August 9, 2017.
11. National Hemophilia Foundation. “Hemophilia A”. National Hemophilia Foundation website. https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Hemophilia-A. Accessed August 9, 2017.
12. Hemophilia Federation of America. “Treatment & Eradication of Inhibitors.” Hemophilia Federation of America website. http://www.hemophiliafed.org/bleeding-disorders/inhibitors/treatment-eradication-inhibitors/. Accessed August 9, 2017.

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