Jerini AG and Bachem AG have 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 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, 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 (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 (FDA) as well as by the European Agency for the Evaluation of Medicinal Products (EMEA). 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.