Jerini

  Jerini AG is a pharmaceutical company based in Berlin, Germany, focusing on the discovery and development of novel peptide-based drugs. Using its proprietary technology platform, Peptides-to-Drugs (P2D), Jerini pursues disease indications for which limited, inadequate, or no treatment options exist. As a result, Jerini has established a drug pipeline composed of its own programs as well as others in collaboration with partners. Jerini's commercialization strategy is to market new drugs in niche indications independently and in larger indications with partners.

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Icatibant

Jerini's Lead Compound is Icatibant, offers a novel subcutaneous treatment for HAE, a disease causing acute swelling attacks in patients due to elevated levels of the hormone bradykinin. By binding to the bradykinin receptor, Icatibant reduces the effects associated with increased levels of bradykinin. The compound was in-licensed from Aventis in 2001 and Jerini recently completed Phase III clinical trials of Icatibant for the subcutaneous treatment of HAE. The positive results of these studies, which were conducted in the US, Europe, and other countries, were reported on September 21, 2006, and the company plans to begin submissions for regulatory approval with the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) at first half of 2007. Both agencies have granted orphan drug status to Icatibant for the treatment of HAE, 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, thereby facilitating closer communication with the agency.

Jerini plans to broaden the therapeutic potential of Icatibant by addressing additional disease indications in which the pathophysiological role of elevated bradykinin levels has been established. Based on data obtained in Phase IIa clinical studies, Jerini and its US partner Kos Pharmaceuticals (now part of Abbott) are evaluating Icatibant’s thera-peutic potential in asthma and liver cirrhosis. Jerini has obtained positive preclinical data demonstrating Icatibant’s effect in severe burn models. The FDA has also granted Jerini orphan designation in this indication.

Proprietary Peptides-to-Drugs (P2D) platform

Based on its P2D platform, Jerini has established several in-house development programs, which address indications within the ophthalmology, oncology, and inflammatory therapeutic areas. The most advanced of these programs targets age-related macular degeneration (AMD), the leading cause of vision loss and blindness in people over the age of 55 in developed countries. Jerini's compound (JSM 6427) has shown significant efficacy in combating disease progression in preclinical models and is currently scheduled to enter clinical trials in H1 2007.

Jerini's proprietary Peptides-to-Drugs (P2D) technology is used to identify peptide drug lead structures and systematically transform them into peptidomimetic (injectable) and small-molecule (oral) drugs, depending on the indication. As a result, Jerini is able to develop novel drug candidates against disease targets that are difficult to address using traditional discovery methods. The ability to create both peptidomimetic and small-molecule drug candidates facilitates parallel development of acute and chronic treatment possibilities for the same disease target, providing multiple business and partnering opportunities.

Business collaborations

Although its primary focus is to discover and develop its own drug products, Jerini collaborates with other pharmaceutical companies. These partnerships further validate Jerini's P2D technology, and also enable the company to take advantage of the potential commercial benefits from products generated through these collaborations. In November 2005, Jerini and Kos Pharmaceuticals, Inc. signed an exclusive agreement for the development, marketing, and distribution of Jerini's compound, icatibant, in the United States and Canada. In addition, Jerini has discovery and development collaborations with Baxter AG and Alcon Research Ltd.

Collaboration agreements:

• Alcon Research Ltd.
• Baxter AG
• Abbott
• Sanofi Aventis

Corporate history

Jerini started operations in 1994. As of December 2006 it has 139 employees. Subsidiaries are JPT Peptide Technologies GmbH and Jerini US, Inc.

Jerini is listed on the Prime Standard of the Frankfurt Stock Exchange (JI4), and has raised a total of over 130 million Euro in public and private financing to date.

The present management consists of:

• Jens Schneider-Mergener, Chief Executive Officer
• Adi Hoess, Chief Commercial Officer
• Jochen Knolle, Chief Scientific Officer, Head of R & D
• Berndt Modig, Chief Financial Officer