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The latest from HEMA Biologics

	HEMA Biologics^™ Announces FDA Approval of SEVENFACT^® [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors HEMA Biologics, LLC, (“HEMA Biologics”) today announced that the U.S. Food and Drug Administration (FDA) approved SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] as the first new bypassing agent in over 20 years for adults and adolescents (12 years of age and older) with hemophilia A and B with inhibitors. Read more --April 6, 2020--
	Update Regarding the FDA Submission for Coagulation Factor VIIa (Recombinant) On January 9, 2017, HEMA Biologics, LLC announced Food and Drug Administration (FDA) acceptance of the Biologics License Application (BLA), for what could become their first commercial treatment for rare bleeding disorders in the United States. Read more --April 10, 2018--
	NHF's 69th Annual Meeting This August was our second year at NHF’s Annual Meeting — an incredible venue for meeting the community and learning more about the day-to-day experience of living with a bleeding disorder. Read more --August 28, 2017--
	Texas Bleeding Disorders Conference It was hard to feel alone in the Lone Star State while surrounded by the more than 800 passionate attendees of this year’s Texas Bleeding Disorders Conference. Read more --August 7, 2017--
	HEMA Biologics connects with the community at HFA This April, Hema Biologics had a great time interacting with the hemophilia community at HFA’s annual symposium. At the booth, we spoke with some of the 1100 participants who came to the event. Read more --April 10, 2017--
	Bleeding Disorders Awareness Month at HEMA Biologics Every March is a chance to increase knowledge and awareness about bleeding disorders. Read more --March 15, 2017--

Update Regarding the FDA Submission for Coagulation Factor VIIa (Recombinant)

On January 9, 2017, HEMA Biologics, LLC announced Food and Drug Administration (FDA) acceptance of the Biologics License Application (BLA), for what could become their first commercial treatment for rare bleeding disorders in the United States.

--April 10, 2018--

NHF's 69th Annual Meeting

This August was our second year at NHF’s Annual Meeting — an incredible venue for meeting the community and learning more about the day-to-day experience of living with a bleeding disorder.

--August 28, 2017--

Texas Bleeding Disorders Conference

It was hard to feel alone in the lone star state while surrounded by the more than 800 passionate attendees of this year’s Texas Bleeding disorders conference

--August 7, 2017--

HEMA Biologics connects with the community at HFA

This April, Hema Biologics™ had a great time interacting with the hemophilia community at HFA’s annual symposium. At the booth, we spoke with some of the 1100 participants who came to the event.

--April 10, 2017--

Bleeding Disorders Awareness Month at HEMA Biologics

Every March is a chance to spread knowledge and awareness about bleeding disorders.

--March 15, 2017--

Archive (Click to expand/hide content)

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!

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