Home » Business News » 2012 » November » November 19, 2012

Sobi files to expand Kineret(R) label to include CAPS

November 19, 2012 - Stockholm, Sweden

Sobi (STO: SOBI) has filed an applicationfor an EU Marketing Authorization withthe European Medicines Agency (EMA) for Kineret® (anakinra) for theindicationof cryopyrin associated periodic syndromes (CAPS).

The filing is based on positive safety and efficacy outcome data from along-term treatment study in children and adults withneonatal-onset multisysteminflammatory disease (NOMID), the most severe form of CAPS. The EMA filingfollows the filing for Kineret for NOMID with the US Food and DrugAdministration (FDA) in July 2012, which has been granted priority reviewwithan expected approval date of 25 December 2012.

"The filing of Kineret for CAPS and NOMID in the EU and the US respectivelyareimportant milestones on Sobi's journey to increase our support for thepediatricrheumatology field as well as for the rare disease community as a whole,"saidDr. Geoffrey McDonough, CEO of Sobi. "In reaching these goals, we aim toprovidean important treatment option to benefit patients affected byIL-1-related conditions."

Commenting on Sobi's decision to file, Dr. Marco Gattorno of GasliniChildren'sHospital in Genova, Italy and Principal Investigator of the EurofeverRegistryfor Autoinflammatory Diseases, stated: "CAPS is a life-long, severelydebilitating disease where patients suffer substantial pain and progressivereduction in their quality of life. We need to find these patients earlyand toprovide demonstrated safe and effective treatment options to avoid diseaseprogression leading to organ damage. Each patient is different, and theadditionof new treatment alternatives would lead to increased flexibility andbetteropportunities for optimal treatment for all patients."

About CAPS

Cryopyrin associated periodic syndromes (CAPS) consist of three rare,autosomaldominant autoinflammatory conditions of varying severity and oftentimesoverlapping symptoms. At the milder end of the scale (FCAS), it ischaracterized by life-long, cold-induced inflammatory episodes of fever,rashand malaise. When of intermediate severity (Muckle Wells syndrome), it istypically associated with more intense and enduring flares and morbidity,including progressive hearing loss and kidney failure secondary toamyloidosis(a condition where amyloid proteins are abnormally deposited in organsand/ortissues). In the most severe form (NOMID/CINCA), it is associated withincreasedmortality and nearly continuous rash, fevers, chronic aseptic meningitis,sensorineural involvement, craniofacial abnormalities and bone lesions. Theincidence of CAPS is estimated to be 1:1,000,000 worldwide.

CAPS is characterized by uncontrolled overproduction of IL-1 beta.IL-1 inducesa number of inflammatory responses such as fever, pain sensitization, boneandcartilage destruction and acute plasma protein response.

About Kineret (anakinra)Kineret is a recombinant protein drug approved for the treatment ofrheumatoidarthritis (RA). Kineret blocks the biological activity of IL-1 by bindingto theinterleukin-1 type 1 receptor, expressed in a wide variety of tissues andorgans. IL-1 is a key mediator of inflammation and driver ofautoinflammatorydiseases in both adults and children. For more information on Kineret seetheSummary of Product Characteristics.

About Swedish Orphan Biovitrum (Sobi)

Sobi is an international specialty healthcare company dedicated to rarediseases. Our mission is to develop and deliver innovative therapies andservices to improve the lives of patients. The product portfolio isprimarilyfocused on inflammation and genetic diseases, with three late stagebiologicaldevelopment projects within hemophilia and neonatology. We also market morethan40 products for companies in the specialty and rare disease space. Sobi isapioneer in biotechnology with world-class capabilities in proteinbiochemistryand biologics manufacturing. In 2011, Sobi had total revenues of SEK 1.9billion(EUR 214 M) and about 500 employees. The share (STO: SOBI) is listed onNASDAQ OMXStockholm. More information is available at

Sobi Press Release on November 19, 2012 in pdf format:

This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. 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 the information contained therein.

Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE


For further information, please contact:
Birgitte Volck
Senior Vice President Development, Chief Medical Officer
Tel: +46 8 697 20 94


Comment on this story