-- Submission of European Marketing Authorization Application
completed
-- Accelerated Assessment granted by EMEA for expedited review
-- Completion of U.S. filing with FDA expected in third quarter 2007
BERLIN, Aug. 14, 2007 (PRIME NEWSWIRE) -- Jerini AG (Frankfurt:JI4) reported financial results for the first six months ended June 30, 2007 and also confirmed the completed filing of its Marketing Authorization Application (MAA) for Icatibant in the treatment of hereditary angioedema (HAE) to the European Medicines Evaluation Agency (EMEA). In addition, the EMEA has granted Jerini accelerated assessment, which shortens the regulatory review period from 210 to 150 days and is granted to drug candidates addressing major public health interest and therapeutic innovation.
"Completion of the EMEA submission marks a key milestone for Jerini, and we are especially pleased to have received accelerated assessment from the agency. We expect to receive notification regarding filing acceptance from the agency very soon," said Jens Schneider Mergener, CEO of Jerini. "Our EU sales and marketing teams continue to build the commercial framework necessary for Icatibant's European launch, currently planned for 2008. With our European filing completed, we are now finalizing our U.S. submission, which we plan to complete in the third quarter."
Under International Financial Reporting Standards (IFRS), total revenues for this period increased by 10.0 percent to EUR 6.9 million (compared to EUR 6.3 million in the prior year period). Revenues from collaboration agreements (EUR 4.8 million) remained unchanged compared to the prior year period. Cash and cash-equivalents as of June 30, 2007 amounted to EUR 53.7 million.
Research and development expenses remained nearly unchanged in this six-month period at EUR 11.6 million (compared to EUR 11.5 million in the prior year period), the result of expenses for the start of a Phase I trial for JSM 6427 in the treatment of AMD, the filing of U.S. and EU marketing authorization applications for Icatibant in the treatment of HAE, as well as the advancement of other projects. Marketing and sales costs increased to EUR 3.0 million (prior year period: EUR 2.5 million) due to the hiring of key account managers and other expenses associated with Icatibant's planned market launch. General and administrative expenses increased to EUR 4.7 million (EUR 3.6 million in the prior year period), primarily related to the hiring of new employees and other expenses. Loss from operations before tax and finance cost (EBIT) amounted to EUR 13.2 million (compared to EUR 12.1 million in the prior year period). Net loss for this period amounted to EUR 12.1 million (compared to EUR 11.0 million in the prior year period) and loss per share amounted to EUR 0.23 (prior year period: EUR 0.21).
Net cash burn for the first six months of 2007 amounted to EUR 12.6 million. Net cash burn is calculated by the addition of cash used in operating activities (EUR 12.1 million) and cash used in investing activities (EUR 0.5 million), as disclosed in the unaudited consolidated cash-flow statements for the six-month period ended June 30, 2007.
Outlook
Further developments planned for the remainder of 2007 include the third quarter completion of the FDA marketing authorization filing and the start of Phase I clinical testing of JSM 6427 in the treatment of AMD.
Following its acquisition of Kos Pharmaceuticals in December 2006, Abbott acquired the licensing agreement for the North American marketing rights to Icatibant in the treatment of angioedema. Jerini is currently in late stage discussions with Abbott in connection with the licensing agreement and expects to conclude these discussions shortly.
In preparation for Icatibant's planned European launch, Jerini is establishing commercial infrastructures and implementing pre-marketing programs. Through market research, medical and patient conference participation, and media publications, Jerini is working to raise awareness of HAE, Icatibant, and Jerini as a company.
Management forecasts a net cash burn of approximately EUR 40 million for 2007 and a further increase in operating loss compared to 2006. Clinical development expenses, market launch preparations, and further development of other preclinical programs are the main factors behind higher cash burn and spending in 2007 as compared to 2006.
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 completed Phase III clinical trials of Icatibant in the subcutaneous treatment of hereditary angioedema and plans to file marketing authorization applications with the US Food and Drug Administration and European Medicines Agency 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.
ISIN: DE0006787476
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