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HEMA Biologics

About HEMA Biologics

HEMA Biologics is dedicated to helping those living with rare bleeding disorders.

"Through our services and resources, we want patients living with hemophilia A or B
with inhibitors to have a positive disease management experience."

OUR MISSION

Meeting the needs of those who need it most

HEMA Biologics is a privately held biopharmaceutical company focused on the rarest bleeding disorders. We aspire to support patients living with these disorders, partner with the broader community that cares for them, and bring meaningful treatments and services to help better their daily lives.

OUR PRINCIPLES

A personal touch is at the heart of our company.

And it comes out in everything we do.

Highly focused on serving patients with the rarest bleeding disorders

Agile in responding to our customers’ needs and requests and relentless in finding solutions that work

Closely aligned and collaborative with our patients and partners

Empathetic to the needs of those living with a rare bleeding disorder

Persistent in our development of high-quality investigational therapies

OUR RESPONSIBILITY

We take our mission seriously

We believe that our focused approach can help advance our mission to improve the health and care for people living with rare bleeding disorders. We are committed to:

Upholding the highest ethical standards
Responding to our customers' needs
Pursuing solutions for patients, their families, and the healthcare professionals who care for them

Rooted in Europe, making a difference in the US

We take pride in the heritage of LFB SA, a French state-owned company and the developer and manufacturer of our product.

LFB SA is an innovative European biopharmaceutical company dedicated to the development, manufacture, and safety of therapeutic proteins.

OUR HERITAGE

Through our partnership with LFB SA, HEMA Biologics is responsible for the distribution and commercialization of our product in the United States.

PERSEPT 3

OBJECTIVE:

To evaluate LR769 for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgical or other invasive procedures. Administration of LR769 will be performed just prior to surgery/procedure and will be repeated during and after the surgery/procedure to achieve and maintain adequate hemostasis as determined by the investigator’s judgment.

PRIMARY OUTCOME MEASURES:

Percentage of surgical or other invasive procedures with a “good” or “excellent” response to LR769 treatment [Time Frame: 48 (±4) hours after the last administration of LR769]

SECONDARY OUTCOME MEASURES:

Percentages of success as defined as the combination of “good” and “excellent” responses by the investigator or designee [Time Frame: Immediately postoperative to 48 (±4) hours after the last administration of LR769]
Percentages of “poor,” “moderate,” “good,” and “excellent” response by the investigator or designee [Time Frame: Immediately post operative to 48 (±4) hours after the last administration of LR769]
Percentages of success as defined as the combination of “good” and “excellent” responses by the surgeon /practitioner [Time Frame: Intraoperative period]
Percentages of “poor,” “moderate,” “good,” and “excellent” response by the surgeon/practitioner [Time Frame: Intraoperative period]
Intraoperative blood loss [Time Frame: Intraoperative period]
The maximum expected volume of blood loss and the estimated volume of blood loss during the procedure will be recorded.
Number of events requiring transfusion [Time Frame: Intraoperative period to 48 (±4) hours after last administration of LR769]
Changes in hemoglobin [Time Frame: Intraoperative period to 48 (±4) hours after last administration of LR769]
Amount of LR769 used [Time Frame: Intraoperative period to last dose of LR769]
Number and type of bleeding episodes at the surgical site [Time Frame: Intraoperative period to 48 (±4) hours after last administration of LR769]
Number of surgical interventions/re-explorations for bleeding episodes [Time Frame: Intraoperative period to 48 (±4) hours after last administration of LR769]

Learn more about this trial at clinicaltrials.gov

PERSEPT 1

Abstract

INTRODUCTION:

Haemophilia A or B patients with inhibitors have been treated with Factor VIIa (FVIIa)-containing bypassing agents for over 20 years. However, due to uncertainty regarding dose response and thrombotic risk, the use of a gradual, titrated, minimal dosing strategy remains prevalent, potentially hampering early hemostasis.

AIM:

Evaluate the dose-dependent efficacy, safety, and immunogenicity of activated eptacog beta (rhFVIIa)—a new recombinant inhibitor bypassing agent for the treatment of bleeding episodes (BEs).

METHODS:

A Phase 3, randomized, crossover study of two Initial Dose Regimens (IDRs) in 27 bleeding congenital haemophilia A or B subjects with inhibitors was conducted to evaluate on-demand treatment of mild/moderate BEs. Intravenous 75 μg/kg or 225 μg/kg initial doses with 75 μg/kg subsequent doses by schedule were administered until clinical response.

RESULTS:

The primary endpoint was sustained clinical response 12 hours following initiation of treatment, determined by a composite of objective and patient-reported indicators of clinical response. In the 75 μg/kg IDR, 84.9% (95% confidence interval [CI]; 74.0%, 95.7%) of mild/moderate BEs at 12 hours were successfully treated compared to 93.2% (95% CI; 88.1%, 98.3%) treated in the 225 μg/kg IDR. Efficacy between the IDRs was statistically different (P<.020) in mild/moderate bleeding episodes. Both IDRs were well tolerated with no detectable immunogenic or thrombotic responses to rhFVIIa or host cell proteins.

CONCLUSION:

The dose-dependent efficacy seen in this study supports individualizing the initial dose of eptacog beta to optimize clinical response. By reducing uncertainty, the PERSEPT 1 results should increase the adoption of early hemostasis as a treatment goal for clinicians who treat haemorrhage in the inhibitor population.

To access the peer-reviewed article, visit https://onlinelibrary.wiley.com/doi/10.1111/hae.13301/epdf

To learn more about this trial visit: clinicaltrials.gov

MARKETING

	Brandon King, Director of Marketing Brandon is focused on commercializing innovative therapy options for the bleeding disorder community through HEMA Biologics. He has over 15 years of experience in pharmaceutical marketing, business development, sales, and brand management. Prior to HEMA Biologics, Brandon was in sales and brand management at Procter and Gamble Pharmaceuticals. In his spare time, Brandon loves spending time with his family and friends and traveling to new places.
	Kate Nyormoi, MA, Associate Director of Marketing Kate has a passion for engaging with the bleeding disorder community and developing resources that positively impact the lives of individuals affected by rare bleeding disorders. Prior to HEMA Biologics, she spent 10 years working for Eli Lilly and Company, with the majority of that time in oncology. In her free time, Kate loves spending time outside with her husband, son, and four-legged child.
	Elyse Bergeron, Consumer Brand Manager As a consumer brand manager at HEMA Biologics, Elyse is responsible for consumer marketing initiatives. Prior to HEMA Biologics, she spent 4 years creating and marketing consumer programs and services for the rare bleeding disorder community at Shire. Elyse earned a B.S. in Life Sciences Communication from the University of Wisconsin. In her spare time Elyse enjoys spending time with family, cooking, and reading.
	Darcie Spaulding, Marketing Project Manager Darcie attended Florida State University and practiced marketing in New York City before she moved back to her hometown of Louisville, KY. For HEMA Biologics, Darcie manages commercial marketing efforts, including media and advertising, promotional materials, and conference/symposia initiatives and execution. She loves spending time with friends and family, hiking with her dog Bailey, and any excuse to escape to the beach.
	Blake Buckman, Social Media Coordinator As Social Media Coordinator, Blake is always in search of new ways to connect with the community in the digital space. He is a recent graduate of the University of Kentucky where he earned his Bachelor’s Degree in Kinesiology. In his spare time, Blake enjoys playing his guitar, listening to music, and spending time with his friends. For links to all HEMA Biologics Social Media accounts, check the bottom of the page!