Sobi acquires full rights for Kineret(R) and additional clinical data for
Kepivance(R) from Amgen
STOCKHOLM, Sweden, Sept. 9, 2013 (GLOBE NEWSWIRE) --
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that they have
acquired the full rights to develop and commercialize Kineret (anakinra) from
American biotechnology company Amgen for all therapeutic indications. The
revised agreement builds on the previous agreement that gave Sobi rights for
Kineret within the field of Rheumatoid arthritis (RA) and four orphan drug
indications, including Cryopyrin Associated Periodic Syndrome (CAPS).
Sobi also acquired the right to additional data for Kepivance allowing the
company to explore a potential new therapeutic indication based on two completed
phase III trials performed by Amgen. The two randomized double blind placebo
controlled trials, involving over 400 patients, demonstrate the potential for
Kepivance to reduce the incidence of severe oral mucositis in patients
undergoing treatment for advanced head and neck cancer.
"This amendment to our existing agreement builds on a strong partnership with
Amgen," said Geoffrey McDonough, CEO and President for Sobi. "Kineret is already
an important product for Sobi and this amended agreement offers the potential
for Sobi to explore its application to new indications, and the clinical trial
data for Kepivance may allow us to make this therapy available to a
substantially larger group of patients in the future."
Under the terms of the amended agreement, Sobi and Amgen have restructured the
financial terms of their original deal to accommodate the acquisition of
additional rights and data.
About Kineret (anakinra)
Kineret is a recombinant protein drug approved for, and the reduction in signs
and symptoms and slowing the progression of structural damage in moderately to
severely active rheumatoid arthritis (RA) in combination with methotrexate, in
patients 18 years of age or older who have had an inadequate response to
methotrexate alone. 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. For more information on Kineret see the Prescribing Information.
In early 2013, Sobi announced that the US Food and Drug Administration (FDA) had
approved Kineret for the treatment of children and adults with neonatal-onset
multisystem inflammatory disease (NOMID), the most severe form of CAPS. Kineret
thereby became the first and only FDA-approved therapy for NOMID (CAPS).
Kepivance is indicated to decrease the incidence, duration and severity of
severe mucositis in adult patients with haematological malignancies receiving
myeloablative radiochemotherapy associated with a high incidence of severe
mucositis and requiring autologous haematopoietic stem cell support. Information
about Kepivance can be found on: www.kepivance.com
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 haemophilia and neonatology. We also market a
portfolio of 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 2012, Sobi had total revenues of SEK 1.9 billion
(€ 215 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com.
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Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor
T: +46 70410 71 80 T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
Sobi acquires full rights for Kineret® and additional clinical data: http://hugin.info/134557/R/1727885/576941.pdf
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