Healthcare Industry News: hereditary angioedema
News Release - September 4, 2007
Jerini Regains Commercialization Rights to Icatibant for the Treatment of Hereditary Angioedema in North AmericaBERLIN, Sept. 4, 2007 (Healthcare Sales & Marketing Network) -- Jerini AG (FSE:JI4) announced today the termination of the license agreement between its affiliate, Jerini US, Inc., and Kos Life Sciences, Inc. for the development, marketing, and distribution of Icatibant in the United States and Canada. The license agreement between Jerini US, Inc. and Kos Life Sciences, Inc. was acquired by Abbott as part of the company's December 2006 Kos Pharmaceuticals acquisition. After an in-depth review following the Kos acquisition, Abbott determined that Icatibant did not strategically fit the company's core areas of therapeutic expertise.
Under the terms of the termination agreement concluded on September 4, 2007, Jerini regains all rights licensed to Kos Life Sciences, Inc., including Icatibant's North American commercialization rights in all forms of angioedema as well as its North American development and commercialization rights in other licensed indications. As part of the termination agreement, Abbott has agreed to pay Jerini an undisclosed amount, and Jerini will pay Abbott undisclosed royalties on North American sales for the first 24 months following product launch.
``Abbott's acquisition of Kos presented Jerini with a unique opportunity, which we actively pursued, and we are especially pleased to have regained Icatibant's North American commercialization rights,'' said Jens Schneider-Mergener, CEO of Jerini. ``Jerini will now take full responsibility for the global commercialization of Icatibant in HAE, and fully execute previously planned pre-launch activities in North America. Having already established a solid commercial framework in Europe, we are confident we can build the necessary sales and marketing infrastructure to successfully launch Icatibant in North America in 2008.''
Audio Webcast and Conference Call
Jerini will host an audio webcast including an open question-and-answer session to discuss the above information on:
Date: Tuesday, September 4, 2007 Time: 4:30 PM CET/10:30 AM EDT
+49 (0) 69 5007 1308 Germany
+44 (0) 20 7806 1958 UK
+1 718 354 1388 USA
+41 (0) 43 456 9299 Switzerland
Please dial in 10 minutes prior to start of the conference call.
The conference can be accessed live via audio webcast on http://www.jerini.com. A replay of the audio webcast will be available on Jerini's website an hour after conclusion of the conference call.
Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin. Bradykinin has been shown to be elevated in hereditary angioedema (HAE) patients and responsible for edema formation during HAE attacks. Icatibant has been granted orphan drug status for the treatment of angioedema by the Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), potentially securing, upon approval, market exclusivity for seven and ten years, respectively. In addition, the FDA has granted fast-track designation to Icatibant in the indication HAE. Icatibant's subcutaneous administration, excellent safety profile demonstrated in clinical studies to date, and its one-year stability at room temperature, all offer key benefits to HAE patients.
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 hands, face, and feet can be disfiguring, while attacks in the gastrointestinal tract result in severe pain caused by swelling of 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.
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 completed Phase III clinical trials of Icatibant in the subcutaneous treatment of HAE. The company's marketing authorization application has been accepted for review by the EMEA and granted accelerated assessment by the agency, shortening the regulatory review period from 210 to 150 calendar days. Jerini plans to complete its US submission to the FDA in the third quarter of 2007. Based on its technology platform, Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease.
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