Healthcare Industry News:  hereditary angioedema 

Biopharmaceuticals Regulatory

 News Release - April 24, 2008

Jerini Receives Positive CHMP Opinion Recommending European Approval for Icatibant in the Treatment of HAE; FDA Issues Not Approvable Letter

BERLIN, April 24, 2008 (Healthcare Sales & Marketing Network) -- Jerini AG (FSE:JI4) announced today that the company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Icatibant in the treatment of acute attacks of hereditary angioedema (HAE). The committee will now recommend that the European Commission grant marketing authorization for Icatibant, which is normally issued within 67 days from adoption of the CHMP opinion.

In addition, Jerini has received a not approvable letter from the FDA for its New Drug Application (NDA) for Icatibant in the treatment of HAE. The company is reviewing the contents of the letter and plans to meet with the FDA at the earliest opportunity to address the agency's concerns.

``The CHMP's positive opinion is outstanding news for Jerini and HAE patients in Europe. Icatibant will be the first product to be approved in all European countries for the acute treatment of HAE, and our sales and marketing teams are in place and ready to launch following the European Commission's marketing authorization,'' said Jens Schneider-Mergener, CEO of Jerini. ``It is extremely unfortunate that patients in the US will not have access to Icatibant in order to treat this debilitating and potentially life-threatening disease as quickly as in Europe. We intend to work closely with the FDA to obtain Icatibant's approval as soon as possible.''

Audio Webcast and Conference Call

Jerini will host an audio webcast including an open question and answer session on April 25, 2008 to discuss the above information.

Date: Friday, April 25, 2008

Time: 13:00 p.m. CET / 07:00 a.m. EDT

Telephone Access:
+49 (0)69 5007 1314 Deutschland
+44 (0)20 7806 1955 UK
+1 718 354 1388 USA
+41 (0)22 592 7453 Schweiz

Confirmation Code: 8763264

Please dial-in 10 minutes prior to start of the conference call.

About Icatibant

Icatibant, a synthetic peptidomimetic, is a first-in-class compound, and 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. Icatibant has been granted orphan drug status for the treatment of angioedema by the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA), potentially securing, upon approval, market exclusivity for ten and seven years, respectively.

Among Icatibant's key benefits to patients are its safety and efficacy profile demonstrated in clinical studies to date, subcutaneous administration, and room temperature stability. Icatibant will be packaged in a pre-filled syringe.

About 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 United States 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. The prevalence of HAE is estimated between one in 50,000 and one in 10,000 individuals, and it is estimated that between 15,000 and 75,000 people are affected with HAE in the European Union and the United States.

About Jerini AG

Jerini is a pharmaceutical company based in Berlin, Germany, focusing on the discovery, development, and commercialization of novel peptide-based drugs. 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 has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology oncology, and inflammatory disease.

Source: Jerini

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