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2017-02-01

Swedish Orphan Biovitrum AB: Sobi and Bioverativ to reveal new long-term safety and efficacy data of Elocta® and Alprolix® at EAHAD

Swedish Orphan Biovitrum AB (publ) (http://www.sobi.com/) (Sobi™) and
Bioverativ Inc. (http://www.bioverativ.com) (NASDAQ: BIVVV) will
present new haemophilia data at the 10th Annual Congress of the
European Association for Haemophilia and Allied Disorders (EAHAD),
taking place in Paris, France, 1-3 February 2017. Nine abstracts from
Sobi- and Bioverativ[1] (http://connect.ne.cision.com#_ftn1)-led
studies have been accepted for presentation during EAHAD, reflecting
the companies' commitment to the haemophilia community.

The nine posters include data on the long-term safety and efficacy of
the companies' extended half-life therapies, Elocta® (efmoroctocog
alfa), marketed as ELOCTATE® [Antihemophilic Factor (Recombinant), Fc
Fusion Protein] in the United States, Japan and Canada, and Alprolix®
(eftrenonacog alfa), in people of all ages with haemophilia A and B,
respectively, providing an updated analysis of long-term data from
the registration studies ASPIRE and B-YOND.

"Sobi and Bioverativ are committed to supporting the haemophilia
community to better understand the potential of extended half-life
factor treatments," says Krassimir Mitchev, MD, PhD, vice president
and medical therapeutic area head of Haemophilia at Sobi. "These data
present how to individualise dosing and consumption in order to gain
a comprehensive protection beyond prevention of bleeds."

"These data provide additional insights for physicians and people
living with haemophilia, and reinforce the well-characterised safety
and efficacy profile for Elocta/ELOCTATE and Alprolix. These are the
only haemophilia therapies utilizing Fc fusion technology, which uses
the body's natural pathway to prolong the time the therapy remains in
the body," said Maha Radhakrishnan, MD, senior vice president of
medical at Bioverativ.

Elocta/ELOCTATE - Long-term safety and efficacy data across all age
groups

· Poster P023: Dosing Regimens Before and During Long-Term Treatment
With Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Children
With Severe Haemophilia A: An Updated Analysis of the ASPIRE Study

· Poster P100: Dosing Regimens Before and During Long-Term Treatment
With Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Adults
and Adolescents With Severe Haemophilia A: An Updated Analysis of the
ASPIRE Study

Alprolix - Long-term safety and efficacy data across all age groups

· Poster P108: Individualised Prophylaxis in Children With
Haemophilia B Treated Long Term With Recombinant Factor IX Fc Fusion
Protein (rFIXFc): Updated Interim Results of the B-YOND Extension
Study

· Poster P094: Individualised Prophylaxis With Recombinant Factor IX
Fc Fusion Protein (rFIXFc) in Adults/Adolescents With Haemophilia B:
Updated Interim Results of the B-YOND Extension Study

· Poster P069: Long-Term Safety and Efficacy of Recombinant Factor
IX Fc (rFIXFc) For Treatment of Severe Haemophilia B: European
Subgroup Interim Analysis of the B-Yond Study

· Poster P088: Impact of Adherence On Outcomes of Prophylactic
Treatment in Severe Haemophilia Patients

Further the understanding of the potential with the haemophilia
treatments

· Poster P195: The Cost-Utility Analysis of ELOCTA® (Efmoroctocog
Alfa) in the Swedish Setting

· Poster P098: Utilisations and Costs of Bypass Therapies For the
Management of Haemophilia A Patients With Inhibitors

· Poster P086: Burden of Illness in Haemophilia Across the Life
Course

Abstracts are available through the EAHAD 2017 web site,
http://eahad2017.com/ .

---

About haemophilia A and B
Haemophilia is a rare, genetic disorder in which the ability of a
person's blood to clot is impaired. Haemophilia A occurs in about one
in 5,000 male births annually, and more rarely in females.
Haemophilia B occurs in about one in 25,000 male births annually, and
more rarely in females. The World Federation of Hemophilia estimates
that approximately 180,000 people are currently diagnosed with
haemophilia A and B world-wide[vii]
(http://connect.ne.cision.com/#_edn1).

People with haemophilia A or B experience bleeding episodes that can
cause pain, irreversible joint damage and life-threatening
haemorrhages. Prophylactic injections of factor VIII or IX can
temporarily replace the clotting factors that are needed to control
bleeding and prevent new bleeding episodes[viii]
(http://connect.ne.cision.com/#_edn2). The World Federation of
Hemophilia recommends prophylaxis as the optimal therapy as it can
prevent bleedings and joint destruction[ix]
(http://connect.ne.cision.com/#_edn3).

About Elocta®/ELOCTATE®
Elocta® (efmoroctocog alfa), is a recombinant clotting factor therapy
developed for haemophilia A with prolonged circulation in the body
using Fc fusion technology. 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 Elocta 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, Sobi
and Bioverativ have optimised the technology and are the first
companies to utilise it in the treatment of haemophilia. Elocta is
manufactured using a human cell line in an environment free of animal
and human additives.

Elocta is approved for the treatment of haemophilia A in the European
Union, Iceland, Liechtenstein, Norway, Switzerland, and Kuwait, and
marketed by Sobi. In the United States, Japan, Canada, Australia, New
Zealand, Brazil, and other countries, it is approved as ELOCTATE®
[Antihemophilic Factor (Recombinant), Fc Fusion Protein], and
Bioverativ has marketing rights in these regions.

As with any factor replacement therapy, allergic-type hypersensitivity
reactions and development of inhibitors may occur in the treatment of
haemophilia A. Inhibitor development has been observed with
Elocta/ELOCTATE, including in previously untreated patients. For more
information, please see the full U.S. prescribing information
(http://www.eloctate.com/pdfs/full-prescribing-information.pdf) for
ELOCTATE. Note that the indication for previously untreated patients
in not included in the EU Product Information
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici...)
for Elocta.

About Alprolix®
Alprolix® (eftrenonacog alfa) [Coagulation Factor IX (Recombinant), Fc
Fusion Protein], is a recombinant clotting factor therapy developed
for haemophilia 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 optimised the technology and are the first companies to
utilise it in the treatment of haemophilia. Alprolix is manufactured
using a human cell line in an environment free of animal and human
additives.

Alprolix is approved for the treatment of haemophilia B the European
Union, Iceland, Liechtenstein, Norway and Switzerland, and marketed
by Sobi. It is also approved in the United States, Canada, Japan,
Australia, New Zealand, Brazil and other countries, and Bioverativ
has marketing rights in these regions.

Allergic-type hypersensitivity reactions and development of inhibitors
have been observed with Alprolix in the treatment of haemophilia B,
including in previously untreated patients. For more information,
please see the full U.S. prescribing information
(http://www.alprolix.com/pdfs/PrescribingInformation.pdf) for
Alprolix. Note that the indication for previously untreated patients
is not included in the EU Product Information
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici...).

About Bioverativ
Bioverativ (NASDAQ: BIVV) is a global biotechnology company dedicated
to transforming the lives of people with haemophilia and other rare
blood disorders through world-class research, development and
commercialisation 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 haemophilia
therapies, when launched, represented the first major advancements in
haemophilia treatment in more than two decades. For more information,
visit www.bioverativ.com or follow @bioverativ on Twitter. Beginning
tomorrow, February 2, 2017, the company will trade on the NASDAQ
Global Select Market under the ticker symbol "BIVV."

Bioverativ was created as a spin-off from Biogen's hemophilia business
and separated from Biogen effective February 1, 2017. Bioverativ is
an independent, publicly-traded company, headquartered in Waltham,
Massachusetts. During a temporary transition period, which includes
time to allow Bioverativ to establish certain licenses and consents
related to ELOCTATE and ALPROLIX, each of Bioverativ and Biogen will
have a relationship to the products.

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 2015, Sobi had total revenues of SEK 3.2 billion
(USD 385 M) and about 700 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
commercialisation of Alprolix and ELOCTATE/Elocta. Bioverativ has
final development and commercialisation 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).

For more information please contact

Media relations Investor relations Sobi
Sobi
Linda Holmström, Senior Jörgen Winroth, Vice
C...

Författare WKR

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