Swedish Orphan Biovitrum AB (publ) : Sobi and Savient Pharmaceuticals Announce
Co-Promotion Agreement for Kineret® (anakinra) in the U.S.
Swedish Orphan Biovitrum (Sobi) AB
Chief Operating Officer
+46 8697 20 90
Savient Pharmaceuticals, Inc.
John P. Hamill
Senior Vice President and Chief Financial Officer
Stockholm, Sweden / Bridgewater, New Jersey, February 19, 2013 - Sobi (STO:
Sobi) and Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that
they have entered into an agreement for the co-promotion of Kineret®
(anakinra) in the U.S.
Kineret, a recombinant IL-1 receptor antagonist, is a treatment for rheumatoid
arthritis (RA) and indicated for the reduction in signs and symptoms and
slowing the progression of structural damage in moderately to severely active
RA in patients 18 years of age or older who have failed one or more disease
modifying antirheumatic drugs (DMARDs). Kineret is also indicated in the U.S.
for the treatment of children and adults with the severe form of
Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset
Multisystem Inflammatory Disease (NOMID).
"Savient's organization will enhance our support for Kineret in the United
States," saidAlan Raffensperger, Chief Operating Officer of Sobi. "The
collaboration will expand our reach to U.S. physicians who treat patients
suffering from rheumatoid arthritis and augment our own ability to directly
support the pediatric community.Kineret is an important treatment for these
Savientis a specialty biopharmaceutical company that has developed and
commercialized KRYSTEXXA^®(pegloticase) for the treatment of refractory
chronic gout in the U.S. Savient's specialized sales force has strong,
established relationships with rheumatologists in the U.S., making Savient an
excellent partner for Sobi.
"We are pleased to announce the collaboration with Sobi," said Lou Ferrari,
President and Chief Executive Officer of Savient. "Kineret complements the
strategic direction and focus of Savient, as we continue to build upon our
existing relationships with rheumatologists and patients while marketing our
own product, KRYSTEXXA. We look forward to working with Sobi to make Kineret
more widely available to patients with rheumatoid arthritis."
Under the terms of the agreement, Sobi has granted to Savient the exclusive
right to co-promote the sale of Kineret with Sobi in the U.S. Savient will
market and promote Kineret beginning April 1, 2013. Sobi will remain
responsible for all Kineret commercial drug manufacturing, supply, safety, and
About Swedish Orphan Biovitrum AB (Sobi)
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on inflammation and genetic diseases, with three late stage biological
development projects within hemophilia and neonatology. We also market more
than 40 specialty and rare disease products for partner companies. Sobi is a
pioneer in biotechnology with world-class capabilities in protein biochemistry
and biologics manufacturing. In 2011, Sobi had total revenues of SEK 1.9
billion (€ 214 M) and about 500 employees. The share (STO: SOBI) is listed on
NASDAQ OMX Stockholm. More information is available at www.sobi.com.
About Rheumatoid Arthritis
Rheumatoid arthritis is a common systemic disease that affects connective
tissue. Arthritis is the dominant clinical manifestation, involving many
joints, especially those of the hands and feet. The course is variable, but
often chronic and progressive, leading to deformity and disability.Patients
with rheumatoid arthritis produce excess amounts of inflammatory cytokines,
among them Interleukin-1. This leads to harmful effects such as swelling and
About CAPS and NOMID
Cryopyrin associated periodic syndromes (CAPS) are a group of rare inherited
autoinflammatory diseases caused by autosomal dominant mutations in a gene
called NLRP3. CAPS is characterized by uncontrolled overproduction of
IL-1beta. IL-1 induces a number of inflammatory responses such as fever, pain
sensitization, bone and cartilage destruction and acute plasma protein
responses. In the most severe form NOMID, also called chronic infantile
neurologic cutaneous and arthritis syndrome (CINCA) in Europe, it is
associated with increased mortality and fever, rash, chronic aseptic
meningitis, sensorineural hearing loss, craniofacial abnormalities, and bone
lesions. When of intermediate severity, the disease is typically associated
with episodic, intense and enduring flares and morbidity, including
progressive hearing loss and kidney failure secondary to amyloidosis (a
condition where amyloid proteins are deposited in organs and/or tissues). The
mildest form presents with cold-induced episodes of fever, rash and malaise.
The incidence of CAPS is estimated to be 1:1,000,000 worldwide.
About Kineret (anakinra)
Kineret^® is a recombinant protein drug approved for the treatment of children
and adults with NOMID, and the reduction in signs and symptoms and slowing the
progression of structural damage in moderately to severely active rheumatoid
arthritis (RA), in patients 18 years of age or older who have failed one or
more disease modifying antirheumatic drugs (DMARDs). Kineret blocks the
biological activity of IL-1 by binding to the interleukin-1 type 1 receptor,
expressed in a wide variety of tissues and organs. IL-1 is a key mediator of
inflammation and driver of autoinflammatory diseases in both adults and
children. For more information on Kineret see the Prescribing Information.
Kineret - Important Safety Information
Do not take Kineret if you have an allergy to:
oproteins made from bacterial cells (E. coli). Ask your healthcare provider
if you are not sure.
oany of the ingredients in Kineret. See the end of the patient leaflet for
a complete list of ingredients in Kineret.
Before taking Kineret, tell your healthcare provider if you:
ohave an infection, a history of infections that keep coming back or other
problems that can increase your risk of infections.
ohave an allergy to rubber or latex. The needle cover on the prefilled
syringe contains latex. Do not handle the needle cover if you are allergic
ohave kidney problems.
oare scheduled to receive any vaccines. People using Kineret should not
receive live vaccines.
oare pregnant or plan to become pregnant. It is not known if Kineret will
harm your unborn baby.
oare breastfeeding or plan to breastfeed. It is not known if Kineret passes
into your breast milk. You and your healthcare provider should decide if
you will take Kineret or breastfeed.
Tell your healthcare provider about all the medicines you take, including
prescription and non-prescription medicines, vitamins and herbal supplements.
Tell your healthcare provider if you take other medicines that affect your
Especially tell your healthcare provider if you use: ENBREL^® (etanercept),
HUMIRA^® (adalimumab), or REMICADE^® (infliximab).
Kineret may cause serious side effects, including:
oserious infections. Kineret may lower your ability to fight infections.
During treatment with Kineret, call your healthcare provider right away if
you get an infection, have any sign of an infection including a fever,
chills, or have any open sores on your body.
olow white blood cell count (neutropenia). Kineret may cause you to have a
lower number of certain white cells (neutrophils). Neutrophils are
important in fighting infections. You should have blood tests before
starting treatment with Kineret, then monthly for 3 months. After the
first 3 months you should have your blood tested every 3 months for up to
oallergic reactions. Stop using Kineret and call your healthcare provider
or get emergency help right away if you have any of these symptoms of an
allergic reaction: swelling of your face, lips, mouth or tongue; trouble
breathing; wheezing; severe itching; skin rash, redness, or swelling
outside of the injection site area; dizziness or fainting; fast heartbeat
or pounding in your chest (tachycardia); or sweating.
The most common side effects of Kineret include:
oinjection site skin reactions, including redness, swelling, bruising,
itching, and stinging. Most injection site reactions are mild, occur early
during treatment, and last about 2-4 weeks. Injection site reactions have
been observed less frequently in people with NOMID.
onausea and vomiting
ofeeling like you have the flu
osore throat or runny nose
opain in your stomach area
These are not all of the possible side effects of Kineret. Tell your
healthcare provider if you have any side effect that bothers you or does not
go away. For more information ask your healthcare provider or pharmacist.
Enbrel^® is a registered trademark of Immunex Corporation, Thousand Oaks, Ca.
Remicade^® is a registered trademark of Centocor, Inc., Malvern, Pa. Humira^®
is a registered trademark of Abbott Laboratories, Abbot Park, IL.
The information above includes forward-looking statements. Actual results may
differ from those stated. Internal factors such as the successful management
of research programs and intellectual property rights may affect future
results. There are also external conditions such as the economic climate,
political changes and competing research programs that may affect Swedish
Orphan Biovitrum's results. The information above has been published pursuant
to the Swedish Securities Market Act and/or the Financial Instruments Trading
Act. The information was released for public distribution on 19 February, 2013
at 2:30 p.m. CET.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused
on developing and commercializing KRYSTEXXA^® (pegloticase) for the treatment
of chronic gout in adult patients who do not respond to conventional therapy.
Savient has exclusively licensed worldwide rights to the technology related to
KRYSTEXXA and its uses from Duke University ("Duke") and Mountain View
Pharmaceuticals, Inc. ("MVP"). Duke developed the recombinant uricase enzyme
and MVP developed the PEGylation technology used in the manufacture of
KRYSTEXXA. MVP and Duke have been granted US and foreign patents disclosing
and claiming the licensed technology and, in addition, Savient owns or co-owns
US and foreign patents and patent applications, which collectively form a
broad portfolio of patents covering the composition, manufacture and methods
of use and administration of KRYSTEXXA. Savient also supplies Oxandrin^®
(oxandrolone tablets, USP) CIII in the US For more information, please visit
the Company's website at www.savient.com.
Allstatements other than statements of historical facts included in this
press release are forward-looking statements that are subject to certain
risks, trends and uncertainties that could cause actual results and
achievements to differ materially from those expressed in such statements.
These risks, trends and uncertainties are in some instances beyond our
control. Words such as "anticipate," "believe," "estimate," "expect,"
"intend," "plan," "will" and other similar expressions identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. In particular, any statements regarding the
co-promotion arrangement for Kineret, our commercialization of KRYSTEXXA and
our relationship with rheumatologistsare forward-looking statements. These
forward-looking statements involve substantial risks and uncertainties and are
based on our assessment and interpretation of the currently available data and
information, current expectations, assumptions, estimates and projections
about our business and the biopharmaceutical and specialty pharmaceutical
industries in which we operate. Important factors that may affect our ability
to achieve the matters addressed in these forward-looking statements include,
but are not limited to, our ability to co-promote Kineret and continue our
commercialization of KRYSTEXXA; our ability to retain the personnel;
competition from existing therapies and therapies that are currently under
development; whether we are able to obtain financing, if needed; economic,
political and other risks associated with foreign operations; risks of
maintaining protection for our intellectual property; risks of an adverse
determination in intellectual property litigation; and risks associated with
stringent government regulation of the biopharmaceutical industry and other
important factors and other important factors set forth more fully in our
reports filed with the Securities and Exchange Commission, to which investors
are referred for further information. We may not actually achieve the plans,
intentions or expectations disclosed in our forward-looking statements, and
you should not place undue reliance on our forward-looking statements, which
speak only as of the date of publication of this press release. Actual results
or events could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements that we make. Our forward-looking
statements do not reflect the potential impact of any future acquisitions,
mergers, dispositions, joint ventures or investments that we may make. We do
not have a policy of updating or revising forward-looking statements and,
except as required by law, assume no obligation to update any forward-looking
# # #
Sobi Press Release on February 19, 2013, in PDF format
This announcement is distributed by Thomson Reuters on behalf of Thomson
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE
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