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04
Apr
2020

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 or B Patients with Inhibitors

by John Holt | with no comments | Uncategorized

First bypassing agent approved for the treatment and control of bleeding episodes in hemophilia A and B patients with inhibitors...

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10
Apr
2018

Update Regarding the FDA Submission for Coagulation Factor VIIa (Recombinant), activated eptacog beta*

by John Holt | with no comments | Uncategorized

On January 9, 2017, HEMA Biologics, LLC announced Food and Drug Administration (FDA) acceptance of the Biologics License Application (BLA),...

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13
Sep
2017

Bleeding Disorders Awareness Month at HEMA Biologics

by John Holt | with no comments | Uncategorized

Pictured above are some highlights from March. We loved seeing how our team incorporated bleeding disorder awareness into their everyday...

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13
Sep
2017

HEMA Biologics Connects With the Community at HFA

by John Holt | with no comments | Uncategorized

[caption id="attachment_524" align="alignnone" width="300"] Pictured at our HFA Booth, from left to right: HEMA Biologics’ Whitney Mardis, Mary Norton, Kate...

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13
Sep
2017

Texas Bleeding Disorders Conference

by John Holt | with no comments | Uncategorized

[caption id="attachment_528" align="alignleft" width="300"] Vince Poma, Dr Marsh, Blake Buckman, and Elyse Bergeron at our booth, before visitors came by...

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13
Sep
2017

National Hemophilia Foundation’s 69th Annual Meeting

by John Holt | with no comments | Uncategorized

This August was our second year at NHF’s Annual Meeting — an incredible venue for meeting the community and learning...

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03
Mar
2017

HEMA Biologics heading to Providence, RI for the HFA annual meeting – April 6, 2017

by John Holt | with no comments | Uncategorized

From HFA’s site: HFA's Annual Symposium is a community-centered educational event that draws hundreds of members from the bleeding disorders...

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02
Mar
2017

FDA accepts the submitted Biologic License Application for Coagulation Factor VIIa (Recombinant), activated eptacog beta – Jan. 9, 2017

by John Holt | with no comments | Uncategorized

LOUISVILLE, Ky., Jan. 9, 2017 /PRNewswire/ -- HEMA Biologics, LLC announced that the FDA has accepted the BLA for their first...

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SAVE & ACCEPT

A Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) LR769 for the Prevention of Excessive Bleeding in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX Undergoing Elective Surgery or Other Invasive Procedure (LR769)

Phase: 3 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT02548143

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

A Phase 3 Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients From Birth to <12 Years Old With Inhibitors to Factor VIII or IX: PERSEPT 2

Phase: 3 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT02448680

PERSEPT 2

OBJECTIVE:

To assess the safety, efficacy, and pharmacokinetics of two separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients (birth to <6 years old), and 12 patients (≥6 years old to <12 years)

PRIMARY OUTCOME MEASURES:

  • Bleeding episode treatment success [Time Frame: 12 hours after first administration of study drug]
  • No additional hemostatic product required after 12 hours of first dose

SECONDARY OUTCOME MEASURES:

  • Time to bleeding success [Time Frame: 12 hours]
  • Patients shall rate the treatment of each bleeding episode. If treatment occurs under direct supervision of treating physician, the physician shall rate the response. Ratings based on a four-point scale; Excellent, Good, Moderate, None

Learn more about this trial at clinicaltrials.gov

PERSEPT 1: A Phase 3 Trial of Activated Eptacog Beta For On-Demand Treatment of Haemophilia Inhibitor-Related Bleeding

Wang, et al. 2017
Phase: 3 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT02020369 | doi: 10.1111/hae.13301

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

HUMAN RESOURCES

Melanie Comella, PHR, Senior Director, Human Resources

Melanie is the Senior Director of Human Resources at HEMA Biologics. She brings 20 years of Human Resources and Employee Relations expertise, and holds her Professional in Human Resources certification. In her free time, Melanie enjoys spending time with her family, traveling, and is an avid sports fan.

Rebecca DeVore, Talent Acquisition Specialist

Rebecca is passionate about accelerating company growth and sourcing top talent to assist in achieving company goals. Offering over 10 years of expertise in HR, Executive Search, Talent Management and Leadership Development, Rebecca has expertise in a wide variety of areas within Human Resources. Rebecca holds her Bachelor’s degree in Business/ HR Management from Indiana Wesleyan University. Outside of the office, Rebecca loves enjoying life with her husband and 2 sons, being outdoors, playing sports, and cooking.

FINANCE

Heather Van Camp, Accounting Manager

Heather is an experienced accounting manager with an established history of working in the healthcare industry. At HEMA Biologics, she has focused on creating a supportive accounting department for both internal and external customers. Prior to her role with HEMA Biologics, Heather spent 9 years in the accounting and finance department in the physical therapy industry. In her spare time, Heather enjoys spending time with family and friends, exercising, and reading.

Safety and Dose-Dependency of Eptacog Beta (Activated) in
a Dose Escalation Study of Non-Bleeding Congenital
Hemophilia A or B Patients, With or Without Inhibitors

Ducore, et al. 2017
Phase: 1 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT01708564 | doi: 10.1111/hae.13357

Abstract

INTRODUCTION:

The availability of different initial doses of activated eptacog beta
(recombinant human FVIIa, rhFVIIa) may provide therapeutic options when treating
bleeding in patients with congenital haemophilia who have developed inhibitory antibodies to
factor VIII (FVIII) or factor IX (FIX). This study evaluated escalated doses of a new
rhFVIIa product as a prelude to selecting the doses for clinical efficacy evaluation in
haemophilia patients.

AIM:

To assess the safety, pharmacokinetics, and laboratory pharmacodynamics of 3 doses
of rhFVIIa in non-bleeding patients with congenital haemophilia A or B with or without
inhibitors.

METHODS:

Adult male patients (18-75 years old) with congenital haemophilia A or B (with
or without inhibitors) received infusions of rhFVIIa at doses of 25, 75, or 225 μg/kg body
weight. Ten patients were treated at each dose level, and each patient received two different
dose levels. Descriptive methods were used to analyse the data.

RESULTS:

Administration of rhFVIIa at all doses was well tolerated. Pharmacokinetic
analyses showed that peak FVIIa plasma levels (Cmax) were approximately proportional to
dose and correlated well with peak thrombin generation. Total AUC0-inf also was
approximately dose proportional. Clot formation and duration correlated with FVIIa activity.
Repeat doses did not produce an immunological response.

CONCLUSION:

In the first dose-escalation study of rhFVIIa to support product registration,
eptacog beta at doses of 25, 75, and 225 μg/kg was pharmacodynamically active and well
tolerated in non-bleeding patients with congenital haemophilia A or B.

To access the peer-reviewed article, visit https://onlinelibrary.wiley.com/doi/10.1111/hae.13357/epdf

MEDICAL AFFAIRS

 

Allan Alexander, MD, Senior Medical Director

W. Allan Alexander, MD brings 26 years of experience in the care and management of clinical bleeding in rare disorders and acute illness. A Cardiac Anesthesiologist who practiced in elite hospitals, Dr Alexander’s drug and device career includes leadership roles with Thermo CardioSystems, Inc, Micromed Technologies, Inc, CEDRA Clinical Research, ZymoGenetics, Inc (a subsidiary of Novo Nordisk then BMS) and CSL Behring, USA. Dr Alexander was the first employee of HEMA Biologics, in January 2016.

 

Christi Marsh, PharmD, Director, Medical Affairs, Medical Information and Scientific Communication

Dr Marsh brings over 20 years of experience in clinical pharmacy, industry medical affairs work, and leadership experience at pharmaceutical companies including GlaxoSmithKline, Meditech Media, Solvay Pharmaceuticals (now Abbvie), MedInfo Results, and UCB, Inc. Dr Marsh joined HEMA Biologics in 2017 to build the Medical Affairs practice team with a focus on helping offer solutions for healthcare providers, caregivers, and patients in the rare bleeding disorders community. Dr Marsh enjoys fitness, family time, and cheering on her daughter in competitive figure skating.

MARKET ACCESS

 

Gary Grote, Vice President, Market Access

Gary leads the customer interface team that has responsibility for payer and specialty channel relationships and contracting, as well as contributing to the managed markets marketing strategy for HEMA Biologics. Gary has worked in the industry for over 30 years and built the HEMA Biologic’s Market Access team.

Gary is a fan of the Cincinnati Reds and Bengals and the Ohio State Buckeyes. He resides in Ohio with his wife, Cathy, and enjoys traveling, fishing, golf, fine wines, and Kentucky’s great bourbons.

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!

SALES

 

Vince Poma, National Sales Director

Vince is the National Sales Director for HEMA Biologics and has over 20 years’ experience in healthcare in various specialties, including cardiovascular, neurology, hematology, and immunology. He is particularly passionate about the hemophilia community and building lasting and meaningful relationships. He has been with HEMA Biologics since its beginning and is enthusiastic about building a company that has winners (products, people, culture, leadership, and vision).

Vince has a degree in Finance from Clemson University and lives in Louisville, KY, with his wife, son, and daughter. He enjoys watching his kids compete in athletics and is a Clemson Football Fanatic.