Sobi offers new thinner, latex-free needle for Kineret® (anakinra)

WALTHAM, MA - Sobi announced that Kineret® (anakinra) will begin shipping with a new, thinner, latex-free needle. Kineret is indicated to reduce the signs and symptoms, as well as slow progress of structural damage, in moderately to severely active rheumatoid arthritis (RA) and to treat Neonatal-Onset Multisystem Inflammatory Disease (NOMID), one of the Cryopyrin-Associated Periodic Syndromes (CAPS).

Sobi developed this new needle as part of the continual quest to enhance their value offering. The thinner 29-gauge needle replaces the 27-gauge needle that is currently used with Kineret. This is a fresh option for patients using Kineret. Rami Levin, President of Sobi North America, notes, "Sobi is committed to addressing the needs of patients and caregivers. As part of this commitment, we are delighted to launch a new, thinner, latex-free 29-gauge needle for the administration of Kineret."

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About Kineret

Kineret is a recombinant protein drug indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 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. For more information on Kineret, see the Prescribing Information (www.kineretrx.com). 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 Cryopyrin-Associated Periodic Syndromes (CAPS). Kineret thereby became the first and only FDA-approved therapy for NOMID (CAPS).

INDICATIONS

Kineretis an interleukin-1 receptor antagonist indicated for:

Rheumatoid Arthritis (RA)

* Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease-modifying antirheumatic drugs (DMARDs).

Cryopyrin-Associated Periodic Syndromes (CAPS)

* Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

IMPORTANT SAFETY INFORMATION

* Kineretis contraindicated in patients with known hypersensitivity to E. coli-derived proteins, Kineret, or to any components of the product

* In RA, discontinue use if serious infection develops. In Kineret-treated NOMID patients, the risk of a NOMID flare when discontinuing Kineret treatment should be weighed against the potential risk of continued treatment. Do not initiate Kineret in patients with active infections

* Use in combination with Tumor Necrosis Factor (TNF) blocking agents is not recommended

* Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported

* The impact of treatment with Kineret® (anakinra) on active and/or chronic infections and the development of malignancies is not known

* Live vaccines should not be given concurrently with Kineret

* Neutrophil counts should be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly for 3 months, and thereafter quarterly for a period up to 1 year

* RA: Most common adverse reactions (incidence > 5%) are injection site reaction, worsening of rheumatoid arthritis, upper respiratory tract infection, headache, nausea, diarrhea, sinusitis, arthralgia, flu-like symptoms, and abdominal pain

* NOMID: The most common AEs during the first 6 months of treatment (incidence > 10%) are injection site reaction, headache, vomiting, arthralgia, pyrexia, and nasopharyngitis

* A higher rate of serious infections has been observed in RA patients treated with concurrent Kineret and etanercept therapy than in patients treated with etanercept alone. Use of Kineret in combination with TNF blocking agents is not recommended

* Because there is a higher rate of infections in the elderly population in general, caution should be used in treating the elderly

* Kineret is substantially excreted by the kidney, and the risk of toxic reactions to Kineret may be greater in patients with impaired renal function

Please visit www.kineretrx.com to view the full Prescribing Information.

About 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 haemophilia, inflammation, and genetic diseases. We also market a portfolio of specialty and rare disease products for partner companies across Europe, the Middle East, North Africa, and Russia. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion (USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com .

For more information, please contact

Rami Levin 
President, Sobi North America 
781.786.7373 
Rami.levin@sobi.com