- Post-hoc longitudinal analysis from
B-LONG and B-YOND studies shows patients who progressed to
individualized prophylactic dosing intervals of 14 days or longer
maintained low annualized bleeding rates
Bioverativ Inc. (NASDAQ:BIVV) and Swedish Orphan Biovitrum AB
(publ) (Sobi™) (STO:SOBI) today announced the results of a new,
post-hoc longitudinal analysis demonstrating that individualized
dosing with extended half-life therapy, ALPROLIX® [Coagulation
Factor IX (Recombinant), Fc Fusion Protein], every 14 or more days
may be a potential option for people with severe hemophilia B who
seek the benefits of protection from a prophylactic therapy with
reduced treatment burden. The analysis is being presented in a
poster session at the 59th Annual Meeting of the American Society
of Hematology (ASH).
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ALPROLIX is a recombinant clotting factor IX therapy developed
using Fc fusion technology to prolong circulation in the body.
ALPROLIX has the longest real-world experience of any hemophilia B
extended half-life therapy and has been studied in more than 150
adult, adolescent, and pediatric patients over three years as part
of a robust clinical development program and an extension
study.
Using data from the pivotal Phase 3 B-LONG study of 123 patients
with severe hemophilia B, and B-YOND, the long-term extension study
of ALPROLIX that included 93 patients from B-LONG, researchers
evaluated long-term outcomes of 22 study participants (adults and
adolescents ≥12 years) in the individualized treatment group who
progressed to long-term prophylactic dosing regimens of 14 days or
longer. Data from this longitudinal analysis showed these study
participants achieved consistent bleed protection with extended
prophylactic dosing intervals for up to three years.
“These data show that individualized prophylactic treatment with
ALPROLIX, starting at weekly or ten-day dosing intervals with the
possibility to extend to 14 days or longer, has the potential to
deliver optimal protection against bleeds for people with
hemophilia B,” said Maha Radhakrishnan, M.D., Senior Vice President
of Medical at Bioverativ. “Individualized dosing intervals allow
patients and their physicians to personalize treatment plans that
balance the need to maximize bleed protection while minimizing
treatment burden. We remain committed to improving the long-term
outcomes for people with hemophilia B.”
Data for 22 study participants on varying pre-study treatment
regimens, including those who switched to extended dosing at any
time during the study, were included in this longitudinal review.
Prior to treatment with ALPROLIX, 10 of the 22 study participants
had received prophylactic treatment and 12 participants were on
episodic treatment. Results from this analysis showed that:
- Patients who received pre-study
prophylactic treatment were well protected with extended dosing
intervals of 14 days or longer with an annualized bleed rate (ABR)
of 1.8 as compared to 2.0 pre-study
- Median ABR decreased from 25 (22 - 36)
to 1.4 (0.6–5.8) for the participants who received pre-study
episodic treatment
- The median (IQR) duration of treatment
on the ≥14-day regimen in the 22 patients was 3.4 years
(1.8-4.0)
- Study participants treated with ≥14
dosing intervals were well controlled with a median spontaneous ABR
of 0.7 over three years
“These findings reinforce a history of successfully delivering
long-acting protection against spontaneous and joint bleeds in
hemophilia B by dosing with ALPROLIX at one to two-week intervals,”
said Armin Reininger, M.D., Ph.D., Head of Medical and Scientific
Affairs, Sobi. “In collaboration with Bioverativ, we will continue
to explore the potential of ALPROLIX to reduce the burden of
disease and create meaningful improvement in the lives of people
living with hemophilia.”
Earlier at ASH, Bioverativ presented data from the preclinical
imaging study, Extravascular Distribution of Conventional and EHL
FIX Products Using In Vivo SPECT Imaging Analysis in Hemophilia B
Mice, which showed that ALPROLIX demonstrates higher tissue
distribution and retention in joint areas compared to other factor
IX molecules. These results were part of an ongoing imaging
collaboration with Invicro, LLC, to investigate the impact of
extravascular distribution of factor IX therapies, including
ALPROLIX, on protection from bleeds and improvement in joint
health.
About the B-YOND Extension Study
B-YOND enrolled 116 previously-treated males, including 93
participants (81%) who completed B-LONG, and 23 (100%) of those who
completed Kids B-LONG. The primary outcome measure is development
of inhibitors. Secondary endpoints include the annualized number of
bleeding episodes per subject (including spontaneous joint bleeding
rates), ALPROLIX exposure days per participant, ALPROLIX
consumption (total IU/kg per subject per year), and the
participant’s assessment of response to treatment of a bleeding
episode.
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, 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 B
Hemophilia 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 Bioverativ
Bioverativ (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.
About Sobi
Sobi is an international specialty healthcare company dedicated
to rare diseases. Sobi’s mission is to develop and deliver
innovative therapies and services to improve the lives of patients.
The product portfolio is primarily focused on Haemophilia,
Inflammation and Genetic diseases. Sobi also markets a portfolio of
specialty and rare disease products across Europe, the Middle East,
North Africa and Russia for partner companies. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry
and biologics manufacturing. In 2016, Sobi had total revenues of
SEK 5.2 billion (USD 608 M) and about 760 employees. The share
(STO: SOBI) is listed on Nasdaq Stockholm. More information is
available at www.sobi.com.
About the Bioverativ and Sobi Collaboration
Bioverativ 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).
Bioverativ Safe Harbor
This press release contains forward-looking statements,
including statements about the potential benefits of individualized
prophylactic treatment with ALPROLIX in patients with hemophilia B.
These forward-looking statements may be accompanied by such words
as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “intend,” “may,” “plan,” “potential,” “project,”
“target,” “will” and other words and terms of similar meaning. You
should not place undue reliance on these statements. These
statements involve risks and uncertainties that could cause
Bioverativ’s actual results to differ materially from those
reflected in such statements, including, without limitation,
unexpected concerns that may arise from data, findings, analysis or
results obtained from research or 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, and other risks and uncertainties
associated with Bioverativ’s drug development and commercialization
activities described in the Risk Factors section of Bioverativ’s
filings with the Securities and Exchange Commission. These
statements are based on Bioverativ’s current beliefs and
expectations and speak only as of the date of this press release.
Bioverativ does not undertake any obligation to publicly update any
forward-looking statements.
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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BIOVERATIVMedia Contact:Marianne McMorrow,+1 781 663
4376media@bioverativ.comorInvestor Relations Contact:Susan
Altschuller, +1 781 663 4360IR@bioverativ.comorSOBIMedia
Contact:Linda Holmstr�m, + 46 708 73 40
95linda.holmstrom@sobi.comorInvestor Relations Contact:J�rgen
Winroth, +1 347-224-0819jorgen.winroth@sobi.com
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