Jerini and Bachem Announce Collaboration for Icatibant Production.Business Editors/Health/Medical Writers BIOWIRE2K BERLIN & BUBENDORF, Switzerland--(BUSINESS WIRE)--March 18, 2004 Jerini AG and Bachem AG today announced a collaboration agreement for production and supply of Jerini's lead compound Icatibant. At present, Icatibant is tested in several clinical trials to treat refractory ascites Ascites Definition Ascites is an abnormal accumulation of fluid in the abdomen. Description Rapidly developing (acute) ascites can occur as a complication of trauma, perforated ulcer, appendicitis, or inflammation of the colon or other in liver cirrhosis as well as hereditary angioedema. By 2006 Jerini plan to bring Icatibant to market. "With Bachem we have gained a reliable and experienced partner to secure fast high-quality production of Icatibant. Furthermore, Bachem is well experienced in regulatory affaires and procedures", said Jochen Knolle, PhD, Jerini's head of R&D. "We are very pleased to contribute to further developing Icatibant by producing the substance and supporting all phases from clinical studies to market introduction. Icatibant for us seems to be a very promising drug compound", said Walter Isler, Head of Marketing and Sales, Bachem AG. Icatibant, a synthetic decapeptide (peptidomimetic) with a similar structure to bradykinin bradykinin /brady·ki·nin/ (-ki´nin) a nonapeptide kinin formed from HMW kininogen by the action of kallikrein; it is a very powerful vasodilator and increases capillary permeability; in addition, it constricts smooth muscle and (BK), is the most potent of the BK receptor antagonists known so far. At present, Icatibant is tested in a Phase II trial in patients with refractory ascites in liver cirrhosis and hereditary angioedema. Available clinical results are very promising. Jerini has been granted orphan drug designation for Icatibant for the treatment of angioedema by the Office of Orphan Products Development of the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) as well as by the European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ). Orphan drug designation gives the designated drug several years of market exclusivity. Under the terms of the agreement, Bachem will supply Jerini with cGMP-produced Icatibant for clinical trials. Bachem will assume the entire process validation including necessary documentation for the registration process. First approval for Icatibant in the indication angioedema is targeted for 2006. Jerini AG Jerini AG (www.jerini.com) is a drug discovery and development company based in Berlin, Germany. The company has built a pipeline of several preclinical and two clinical projects (phase II) with its proprietary Peptides-To-Drugs (P2D P2D Point to Discover P2D Power-Dependent S-Parameter P2D PointLineCad 2D Drawing - 2D Document (File Extension) P2D Packed-To-Decimal (function for number format conversion) ) discovery platform. P2D addresses extra- and intra-cellular targets and was developed to overcome the limitations of conventional HTS or protein-based discovery approaches. P2D includes massive parallel syntheses and screening of peptide leads, pharmacophore pharmacophore the group of atoms in the molecule of a drug responsible for the drug's action. identification and transformation into peptidomimetic and/or small molecule drugs. The peptide lead to a small molecule conversion step is a direct process that does not include any intermediate modifications of the peptide lead. It is supported by medicinal chemistry and cheminformatics and guided by matching the pharmacophore derived from massive peptide SAR (Segmentation And Reassembly) The protocol that converts data to cells for transmission over an ATM network. It is the lower part of the ATM Adaption Layer (AAL), which is responsible for the entire operation. See AAL. SAR - segmentation and reassembly data information against a virtual small molecule library. Jerini's platform allows the rapid identification and/or optimization of agonists and antagonists for (difficult) target proteins. The technology has been successfully demonstrated in in-house and partnered programs for highly valuable but difficult targets where conventional methods have failed. Jerini's approach creates value by reducing time and costs and by decreasing attrition rates. Key Facts: +++ Founded 1994 +++ 86 Employees +++ Executive Board: +++ Prof. Jens Schneider Mergener (CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. ) +++ Dr. Jochen Knolle (Head R&D) +++ Dr. Adi Hoess (CBO CBO See: Collateralized Bond Obligation. ) +++ Berndt Modig(CFO See Chief Financial Officer. ) +++ Bachem AG Bachem is an independent, technology-based company, specialized in the production of innovative biochemicals for research purposes and pharmaceutical compounds for the pharma and biotech industries, as well as in the development of optimal manufacturing processes. With headquarters in Bubendorf, Switzerland, and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in its field. Key Facts: +++ Founded 1971 +++ over 500 Employees +++ Executive Board: +++ Dr. Rolf Nyfeler (CEO) +++ Reto Conrad (CFO) +++ Dr. Daniel Erne (CTO) +++ |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion