Jerini Submits New Drug Application for Icatibant in the Treatment of
HAE to the FDA and Requests Priority Review
Berlin, October 29, 2007 - Jerini AG (FSE:JI4) announced today the
submission of its electronic New Drug Application (NDA) for Icatibant
in the treatment of hereditary angioedema (HAE) to the US Food and
Drug Administration (FDA) as well as the company's request for
priority review. Jerini has received technical clearance of its eCTD
(Electronic Common Technical Document) from the agency, which ensures
that the documentation meets the agency's technical standards. The
FDA has up to 60 days to determine whether the application is
complete and meets the regulatory requirements for filing. Priority
review designation, which shortens the regulatory review period from
ten to six months, will also be decided by the agency in this
timeframe.
"The NDA submission is a major milestone for Jerini. This important
regulatory step in the US along with Icatibant's already accepted
European filing demonstrates our commitment to bring this novel
treatment to HAE patients in both the US and Europe," said Jens
Schneider-Mergener, CEO of Jerini."
About Icatibant
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 HAE patients and
responsible for edema formation during HAE attacks. Icatibant has
been granted orphan drug status for the treatment of angioedema by
the US 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.
About HAE
HAE is a debilitating and potentially life-threatening genetic
disease characterized by unpredictable recurring swelling attacks of
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.
About Jerini
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
(HAE). The company's marketing authorization application has been
accepted for review by the European Medicines Evaluation Agency
(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 Food and Drug
Administration (FDA) in the fourth 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
For questions, please contact:
Stacy Wiedenmann
Director Investor Relations &
Corporate Communications
Jerini AG
Invalidenstr. 130
10115 Berlin
T + 49 - 30 - 97893 - 285
X + 49 - 30 - 97893 - 599
wiedenmann@jerini.com
