The latest from HEMA Biologics
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HEMA Biologics™ Announces FDA Approval of SEVENFACT® [coagulation factor VIIa (recombinant)-jncw]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 bypassing agent in over 20 years for adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors. Read more--April 6, 2020-- |
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--
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--
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--
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--
Every March is a chance to spread knowledge and awareness about bleeding disorders.
--March 15, 2017--
LOUISVILLE, Ky., Jan. 9, 2017 /PRNewswire/ -- HEMA Biologics, LLC announced that the FDA has accepted the BLA for their first potential product for commercialization in the United States.
--January 9, 2017--
We look forward to being at HFA and meeting the community. If you plan to attend, visit us at Booth 16.
--December 1, 2016--
Sign up to learn more about our focus on the rare bleeding disorder community
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Phase: 3 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT02548143
Learn more about this trial at clinicaltrials.gov
Phase: 3 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT02448680
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)
Learn more about this trial at clinicaltrials.gov
Wang, et al. 2017
Phase: 3 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT02020369 | doi: 10.1111/hae.13301
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.
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).
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.
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.
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
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Melanie Comella, PHR, Senior Director, Human ResourcesMelanie 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. |
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Rebecca DeVore, Talent Acquisition SpecialistRebecca 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. |
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Heather Van Camp, Accounting ManagerHeather 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. |
Ducore, et al. 2017
Phase: 1 | Status: Completed | Intervention: Eptacog Beta (LR769) | NCT01708564 | doi: 10.1111/hae.13357
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.
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.
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.
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.
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
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Allan Alexander, MD, Senior Medical DirectorW. 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. |
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Christi Marsh, PharmD, Director, Medical Affairs, Medical Information and Scientific CommunicationDr 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. |
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Gary Grote, Vice President, Market AccessGary 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. |
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Brandon King, Director of MarketingBrandon 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. |
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Kate Nyormoi, MA, Associate Director of MarketingKate 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. |
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Elyse Bergeron, Consumer Brand ManagerAs 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. |
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Darcie Spaulding, Marketing Project ManagerDarcie 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. |
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Blake Buckman, Social Media CoordinatorAs 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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Vince Poma, National Sales DirectorVince 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. |
