Jerini Receives European Commission Approval for FIRAZYR(R) (Icatibant) in the Treatment of HAE

Wednesday, July 16, 2008 General News
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BASINGSTOKE, England and CAMBRIDGE, Massachusetts, July 15 Shire Limited (LSE: SHP, NASDAQ: SHPGY), the globalspecialty biopharmaceutical company, notes that Jerini AG (FSE:JI4) hasannounced today that the European Commission has granted the companymarketing authorization for its lead compound FIRAZYR(R) (Icatibant) in thetreatment of acute attacks of hereditary angioedema (HAE). HAE is adebilitating and potentially life-threatening genetic disease characterizedby spontaneous and recurring attacks of edema.

As announced by Shire on 3 July, 2008, Maia ElfteVermogensverwaltungs-GmbH, to be renamed "Shire Deutschland InvestmentsGmbH", a German indirect subsidiary of Shire Limited, has launched avoluntary public takeover offer for all shares in Jerini AG. Jerini'sSupervisory and Management Boards unanimously support the transaction and arerecommending acceptance of the offer to its shareholders. Subject tocompletion of certain sale and purchase agreements and registration of thenewly issued shares, Shire will have rights to approximately 75% of Jerini'sshare capital before the receipt of any takeover offer acceptances. It isanticipated that the offer will be open for acceptance by the remainingshareholders until the end of Q3 2008 and is contingent upon the fulfilmentof certain customary terms and conditions, including approval by relevantmerger control authorities.

The European Commission's approval allows Jerini to market FIRAZYR in theEuropean Union's 27 member states, making it the first product to be approvedin all EU countries for the treatment of HAE.

Sylvie Gregoire, President of Shire Human Genetic Therapies (HGT)business commented:

"We are very pleased that European approval has been granted to Jerinitoday. This is an important step in bringing this first in class orphantreatment to patients who suffer from HAE attacks. We look forward to thecompletion of our transaction with Jerini which will enable us to worktogether and ultimately build FIRAZYR into a global gold standard treatment."

Jerini's press release is available on as well as

Notes to editors


In development since 2001, FIRAZYR is a first-in-class compound, whichworks by blocking the B2 receptor as an antagonist to the peptide-hormonebradykinin. Bradykinin has been shown to be elevated in HAE patients andresponsible for edema formation during HAE attacks. FIRAZYR has been grantedorphan drug status for the symptomatic treatment of acute attacks ofangioedema by the European Medicines Agency (EMEA) and the US FDA,potentially securing, upon approval, market exclusivity for ten and sevenyears, respectively. Among the key benefits of FIRAZYR for patients, are itssafety and efficacy profile demonstrated in clinical studies to date,subcutaneous administration, and room temperature stability. FIRAZYR will bepackaged in a pre-filled syringe.

About Hereditary Angioedema (HAE)

HAE is a debilitating and potentially life-threatening genetic diseasecharacterized by unpredictable recurring swelling attacks in the hands, feet,face, larynx, and abdomen. It is estimated that approximately 10,000 patientsin the US and Europe have been diagnosed with HAE. HAE attacks affecting theface, hands, and feet can be disfiguring, while attacks in thegastrointestinal tract result in severe pain caused by swelling in theintestinal wall. Attacks that affect the larynx are life-threatening becauseswelling of the larynx constricts the upper airways and can lead to death bysuffocation. Patients frequently experience such episodes (up to 20 in ayear).

The prevalence of HAE is estimated as one in 50,000 people withapproximately 10,000 HAE patients in the European Union region, 7,000 in theUS/Canada and 8,000 patients in Latin America and ROW. As awareness of thecondition is low, it is es

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