Healthcare Industry News:  hereditary angioedema 

Biopharmaceuticals Regulatory

 News Release - July 15, 2008

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

BASINGSTOKE, England and CAMBRIDGE, Massachusetts, July 15 (HSMN NewsFeed) -- Shire Limited (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, notes that Jerini AG (FSE:JI4) has announced today that the European Commission has granted the company marketing authorization for its lead compound FIRAZYR® (Icatibant) in the treatment of acute attacks of hereditary angioedema (HAE). HAE is a debilitating and potentially life-threatening genetic disease characterized by spontaneous and recurring attacks of edema.

As announced by Shire on 3 July, 2008, Maia Elfte Vermogensverwaltungs-GmbH, to be renamed "Shire Deutschland Investments GmbH", a German indirect subsidiary of Shire Limited, has launched a voluntary public takeover offer for all shares in Jerini AG. Jerini's Supervisory and Management Boards unanimously support the transaction and are recommending acceptance of the offer to its shareholders. Subject to completion of certain sale and purchase agreements and registration of the newly issued shares, Shire will have rights to approximately 75% of Jerini's share capital before the receipt of any takeover offer acceptances. It is anticipated that the offer will be open for acceptance by the remaining shareholders until the end of Q3 2008 and is contingent upon the fulfilment of certain customary terms and conditions, including approval by relevant merger control authorities.

The European Commission's approval allows Jerini to market FIRAZYR in the European Union's 27 member states, making it the first product to be approved in 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 Jerini today. This is an important step in bringing this first in class orphan treatment to patients who suffer from HAE attacks. We look forward to the completion of our transaction with Jerini which will enable us to work together 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, which works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks. FIRAZYR has been granted orphan drug status for the symptomatic treatment of acute attacks of angioedema by the European Medicines Agency (EMEA) and the US FDA, potentially securing, upon approval, market exclusivity for ten and seven years, respectively. Among the key benefits of FIRAZYR for patients, are its safety and efficacy profile demonstrated in clinical studies to date, subcutaneous administration, and room temperature stability. FIRAZYR will be packaged in a pre-filled syringe.

About hereditary angioedema (HAE)

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

The prevalence of HAE is estimated as one in 50,000 people with approximately 10,000 HAE patients in the European Union region, 7,000 in the US/Canada and 8,000 patients in Latin America and ROW. As awareness of the condition is low, it is estimated that only 50% of HAE patients in the world are correctly diagnosed and managed today.


Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website:

About Jerini AG (FSE: JI4)

Jerini is a pharmaceutical company based in Berlin, Germany, focusing on the discovery, development, and commercialization of novel peptide-based drugs. As of 31st March 2008 Jerini had gross assets of EUR36.1 million and in the year ended 31 December 2007 made a net loss of EUR29m. The company pursues disease indications that have limited or no treatment options and has built a drug pipeline composed of its own programs, as well as others in collaboration with established partners. Jerini's lead compound, FIRAZYR, is a first-in-class compound developed for the treatment of HAE and European product launch is planned in the second half of 2008. Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease. For more information, please see


Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development including, but not limited to the successful development of JUVISTA® (Human TGFb3) and veleglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.

Source: Shire plc

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