ALPROLIX® Demonstrates Higher Tissue Distribution & Retention in Joints Compared to Other Factor IX Molecules in a Preclinic...
December 09 2017 - 9:02AM
Business Wire
Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical
company dedicated to transforming the lives of people with rare
blood disorders, today announced findings from a novel imaging
study investigating extravascular distribution of factor IX
therapies, including its leading extended half-life therapy,
ALPROLIX® [Antihemophilic Factor IX (Recombinant), Fc Fusion
Protein]. The preclinical study showed ALPROLIX had a higher level
of extravascular distribution and retention in certain joint areas
when compared with conventional factor IX and a glycoPEGylated
factor IX analog. The study was conducted in collaboration with
Invicro, LLC, a leading imaging services provider, and is being
presented today at the 59th Annual Meeting of the American Society
of Hematology.
Joint disease, which is caused by frequent bleeding into joints
over time, is one of the most common complications for people with
hemophilia and often results in chronic pain and significant
disability. The ability to prevent or effectively treat joint
bleeds is crucial to reduce the risk of joint damage over the long
term.
“It is becoming evident that the modification used to extend
half-life may influence the way factor IX therapies are distributed
in the body and their potential therapeutic benefit for patients,”
said Rob Peters, Ph.D., Senior Vice President of Research at
Bioverativ. “This preclinical study shows that ALPROLIX
consistently delivered more factor to certain critical joint areas.
We are committed to raising the standard of care for people with
hemophilia B, and we intend to explore the impact of factor
distribution in the joints further through ongoing studies with
Invicro.”
In this study, radiolabeled ALPROLIX, conventional factor IX
therapy (rFIX) and a glycoPEGylated factor IX (GP-rFIX) analog were
administered in a preclinical model of hemophilia B and imaged at a
total of five time points. In vivo SPECT imaging revealed ALPROLIX
showed significantly higher distribution to extravascular areas
such as knee and shoulder joints throughout all time points
measured (up to five half-lives post dosing) when compared to
conventional factor IX therapy (rFIX) and the glycoPEGylated factor
IX (GP-rFIX) analog, even when factor IX plasma levels were below
detectable levels. Of the three therapies evaluated, the
glycoPEGylated factor IX (GP-rFIX) analog showed the lowest
distribution to joint areas. Ongoing studies are aimed at further
characterizing the extravascular distribution of factor therapy
using innovative means of imaging.
Bioverativ and Invicro entered into a strategic imaging
collaboration to study the importance of factor IX distribution to
tissue and its role in improving joint health. The companies will
also work to develop standardized protocols to monitor and assess
joint health using ultrasound imaging in people with hemophilia in
research studies of their marketed and pipeline products and in
clinical practice.
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 its collaboration partner,
Swedish Orphan Biovitrum AB (publ) (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, Switzerland, Kuwait and Saudi Arabia 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 Hemophilia BHemophilia B is caused by having
substantially reduced or no factor IX activity in the blood, which
is needed for normal clotting.1 The World Federation of Hemophilia
estimates that approximately 29,700 people are currently diagnosed
with hemophilia B worldwide.2
People with hemophilia B may experience bleeding episodes in
joints and muscles that cause pain, decreased mobility and
irreversible joint damage. In the worst cases, these bleeding
episodes can cause organ bleeds and life-threatening hemorrhages.
Infusions of factor IX temporarily replace clotting factors
necessary to resolve bleeding and, when used prophylactically, to
prevent new bleeding episodes.1
About BioverativBioverativ (NASDAQ: BIVV) 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 the
potential benefits of ALPROLIX based on observations in preclinical
studies, and potential plans, advancements, developments and
benefits that may be achieved or derived from the collaboration
with Invicro. 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. You should not place undue reliance on these
statements. These statements involve risks and uncertainties that
could cause actual results to differ materially from those
reflected in such statements, including, without limitation, risk
and uncertainties regarding early stage research and trials, which
may not be indicative of full results or results from later stages
of clinical trials; unexpected concerns may arise from data,
analysis or results obtained during clinical trials or post hoc
analysis of studies; regulatory authorities may require additional
information or further studies, regulatory authorities may fail to
expand product labeling; uncertainty regarding the ability to
achieve the expected benefits from the collaboration; reliance on
third parties over which Bioverativ may not always have full
control; and other risks and uncertainties that are described in
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, whether as a result of new
information, future events or otherwise.
References
1 World Federation of Hemophilia. About Bleeding Disorders –
Frequently Asked Questions: Available at:
https://www.wfh.org/en/sslpage.aspx?pid=637#Difference_A_B.
Accessed on: November 11, 2017.2 World Federation of Hemophilia.
Report on the Annual Global Survey 2016. Available at:
http://www1.wfh.org/publications/files/pdf-1690.pdf. Accessed on:
November 11, 2017.
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version on businesswire.com: http://www.businesswire.com/news/home/20171209005041/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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