- Presentations will highlight Bioverativ’s
scientific innovation in hemophilia, cold agglutinin disease,
sickle cell disease and beta-thalassemia
Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical
company dedicated to transforming the lives of people with rare
blood disorders, today announced that it will present data
showcasing its work to advance therapies for people affected by
hemophilia, cold agglutinin disease (CAgD), sickle cell disease and
beta-thalassemia at the 59th Annual Meeting of the American Society
of Hematology (ASH), December 9 -12 in Atlanta, Georgia.
Highlights at ASH will include an oral presentation of Phase
1/1b safety and efficacy data on BIVV009, an investigational
first-in-class, monoclonal antibody developed to treat cold
agglutinin disease (CAgD). Cold agglutinin disease is a poorly
understood chronic, autoimmune hemolytic anemia with no approved
therapies. The company will also share new research that will help
characterize the burden of CAgD and the risk of thromboembolic
events, and increase the understanding of morbidity and mortality
associated with this rare blood disorder. Bioverativ plans to start
two Phase 3 clinical trials of BIVV009 in CAgD by the end of the
year.
The company will also have several presentations on its
hemophilia therapies, including preclinical findings from a
first-of-its-kind study using radiolabeled imaging to understand
the impact of extravascular distribution of factor IX therapies on
joint health. Data supporting extended prophylactic dosing
intervals with ELOCTATE® [Antihemophilic Factor (Recombinant), Fc
Fusion Protein] for hemophilia A and ALPROLIX® [Coagulation Factor
IX (Recombinant), Fc Fusion Protein] for hemophilia B will also be
discussed in two joint poster presentations with Sobi.
Bioverativ’s oral and poster presentations:
Hemophilia Abstracts
- Extravascular Distribution of
Conventional and EHL FIX Products Using In Vivo SPECT Imaging
Analysis in Hemophilia B Mice - Poster #1061 – Saturday, December
9, from 5:30-7:30 PM (ET) - Hall A2
- Clinical Outcomes of Weekly
Prophylaxis with rFVIIIFc: Longitudinal Analysis of the A-LONG
and ASPIRE Study Population - Poster #2368 – Sunday, December 10,
from 6:00-8:00 PM (ET) - Hall A2
- Optimization of Clot Formation Under
Blood Flow in a Tissue Engineered Blood Vessel – Poster #2304 –
Sunday, December 10, from 6:00-8:00 PM (ET) – Hall A2
- Clinical Outcomes of 14-Day Prophylaxis
with rFIXFc: Longitudinal Analysis of the B-LONG and B-YOND Study –
Poster #3667 – Monday, December 11, from 6:00-8:00 PM (ET) – Hall
A2
Cold Agglutinin Disease Abstracts
- Incidence of Thromboembolic Events Is
Increased in a Retrospective Analysis of a Large Cold Agglutinin
Disease (CAD) Cohort – Poster #928 – Saturday, December 9, from
5:30-7:30 PM (ET) – Hall A2
- Long Term Efficacy, Safety and PK/PD
Profile of the Anti-C1s Antibody (BIVV009) in Primary Cold
Agglutinin Disease Patients - Oral Presentation #703 – Monday,
December 11 at 2:45 PM (ET) –C208 – C210
Beta-Thalassemia and Sickle Cell Disease Abstract
- ST-400 as a Potential Therapy for
Beta-Thalassemia and Sickle Cell Disease – Poster #2066 – Saturday,
December 9, from 5:30-7:30 PM (ET) – Hall A2
Bioverativ and Sangamo Therapeutics, Inc. have an exclusive
worldwide collaboration to develop and commercialize ZFN-mediated
gene-edited cell therapies for the treatment of beta-thalassemia
and sickle cell disease.
About
ELOCTATE ®ELOCTATE® [Antihemophilic Factor
(Recombinant), Fc Fusion Protein] is a recombinant clotting factor
therapy developed for hemophilia A using Fc fusion technology to
prolong circulation in the body. It is engineered by fusing factor
VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a
protein commonly found in the body), enabling ELOCTATE to use a
naturally occurring pathway to extend the time the therapy remains
in the body. While Fc fusion technology has been used for more than
15 years, Bioverativ and Swedish Orphan Biovitrum AB (publ) (Sobi)
have optimized the technology and are the first companies to
utilize it in the treatment of hemophilia. ELOCTATE is manufactured
using a human cell line in an environment free of animal and human
additives.
ELOCTATE is approved and marketed by Bioverativ in the United
States, Japan and Canada. It is also approved in Australia, New
Zealand, Brazil and other countries, and Bioverativ has marketing
rights in these regions. It is also approved as Elocta® in the
European Union, Switzerland, Iceland, Liechtenstein, Norway, Kuwait
and Saudi Arabia where it is marketed by Sobi.
As with any factor replacement therapy, allergic-type
hypersensitivity reactions and development of inhibitors may occur
in the treatment of hemophilia A. Inhibitor development has been
observed with ELOCTATE, including in previously untreated patients.
For more information, please see the full U.S. prescribing
information for ELOCTATE. Note that the indication for previously
untreated patients is not included in the EU Product
Information for Elocta.
About ALPROLIX®ALPROLIX® [Coagulation Factor IX
(Recombinant), Fc Fusion Protein] is a recombinant clotting factor
therapy developed for hemophilia B using Fc fusion technology to
prolong circulation in the body. It is engineered by fusing factor
IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a
protein commonly found in the body), enabling ALPROLIX to use a
naturally occurring pathway to extend the time the therapy remains
in the body (half-life). While Fc fusion technology has been used
for more than 15 years, Bioverativ and Sobi have optimized the
technology and are the first companies to utilize it in the
treatment of hemophilia. ALPROLIX is manufactured using a human
cell line in an environment free of animal and human additives.
ALPROLIX is approved and marketed by Bioverativ for the
treatment of hemophilia B in the United States, Japan and Canada.
It is also approved in Australia, New Zealand, Brazil and other
countries, and Bioverativ has marketing rights in these regions. It
is also authorized in the European Union, Iceland, Liechtenstein,
Norway and Switzerland, where it is marketed by Sobi.
Allergic-type hypersensitivity reactions and development of
inhibitors have been observed with ALPROLIX in the treatment of
hemophilia B, including in previously-untreated patients. For more
information, please see the full U.S. prescribing
information for ALPROLIX. Note that the indication for
previously-untreated patients is not included in the EU
Product Information.
About the Bioverativ and Sobi CollaborationBioverativ and
Sobi collaborate on the development and commercialization of
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein]
and ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion
Protein], which is marketed as Elocta® in Europe. Bioverativ has
final development and commercialization rights in North America and
all other regions in the world excluding the Sobi territory, and
has manufacturing responsibility for ELOCTATE and ALPROLIX. Sobi
has final development and commercialization rights in the Sobi
territory (essentially Europe, North Africa, Russia and most Middle
Eastern markets).
About the Bioverativ and Sangamo CollaborationBioverativ
and Sangamo have an exclusive worldwide collaboration to develop
and commercialize ZFN-mediated gene-edited cell therapies for the
treatment of beta-thalassemia and sickle cell disease. Based on the
terms of the agreement, Sangamo is responsible for conducting the
ST-400 Phase 1/2 clinical trial, and Bioverativ will be responsible
for subsequent worldwide clinical development, manufacturing, and
commercialization.
About BioverativBioverativ is a global biopharmaceutical
company dedicated to transforming the lives of people with
hemophilia and other rare blood disorders through world-class
research, development and commercialization of innovative
therapies. Launched in 2017 following separation from Biogen Inc.,
Bioverativ builds upon a strong heritage of scientific innovation
and is committed to actively working with the blood disorders
community. The company’s mission is to create progress for patients
where they need it most and its hemophilia therapies when launched
represented the first major advancements in hemophilia treatment in
more than two decades. For more information,
visit www.bioverativ.com or follow @bioverativ on Twitter.
Bioverativ Safe HarborThis press release contains
forward-looking statements, including statements about research and
development programs, and early stage findings, potential benefits,
clinical effects and clinical trials relating to such programs.
These statements may be identified by words such as "believe,"
"expect," "may," "plan," "potential," "will" and similar
expressions, and are based on Bioverativ’s current beliefs and
expectations. Drug development and commercialization involve a high
degree of risk, and only a small number of research and development
programs result in commercialization of a product. Results in early
stage research or clinical trials may not be indicative of full
results or results from clinical trials and do not ensure
regulatory approval. Factors which could cause actual results to
differ materially from Bioverativ’s current expectations include
uncertainties relating to the initiation, enrollment and completion
of stages of clinical trials, unexpected concerns may arise from
data, findings, analysis or results obtained during research and
clinical trials, regulatory authorities may require additional
information or further studies, or may fail or refuse to approve or
may delay approval of product candidates, or Bioverativ may
encounter other unexpected hurdles. For more detailed information
on the risks and uncertainties associated with Bioverativ’s drug
development and commercialization activities, please review the
Risk Factors section of Bioverativ’s most recent annual or
quarterly report filed with the Securities and Exchange Commission.
Any forward-looking statements speak only as of the date of this
press release and Bioverativ assumes no obligation to update any
forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20171101006075/en/
BIOVERATIVMedia Contact:Marianne McMorrow, +1
781-663-4376media@bioverativ.comorInvestor Relations Contact:Susan
Altschuller, +1 781-663-4360IR@bioverativ.com
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