BioWorld International Correspondent

Jerini AG regained full control over its lead drug candidate Icatibant, following a decision by Abbott to terminate its interest in the program.

Abbott is paying Jerini an undisclosed termination fee, and Jerini will pay Abbott, of Abbott Park, Ill., undisclosed sales royalties for 24 months following the launch of the product in North America.

Berlin-based Jerini has decided to market the product itself in the U.S., and is contracting a third-party service provider to assist in its pre-launch activities.

"It's a great opportunity for us to launch a product in the U.S.," Jerini CEO Joern Aldag told a conference call audience Tuesday. "We believe this outcome represents an enormous increase in the company's valuation," he said.

Icatibant is a synthetic peptidomimetic molecule that blocks the action of the hormone bradykinin by binding the bradykinin B2 receptor. It has completed Phase III clinical trials in hereditary angioedema, a rare and sometimes life-threatening genetic condition characterized by recurrent swelling of subcutaneous tissue, the gastrointestinal tract and the larynx.

The company plans to complete a new drug application filing with the FDA during the third quarter.

If it obtains priority review - the compound has fast-track status - it could receive approval by the second quarter of 2008, according to the "best case scenario," Aldag said. The compound also could gain European approval by then.

The London-based European Medicines Agency recently accepted for review Jerini's marketing authorization application.

Abbott had inherited the development and commercialization agreement following its $3.7 billion cash acquisition of Cranbury, N.J.-based Kos Pharmaceuticals Inc. However, the main focus in that deal was Kos's portfolio of marketed and pipeline products in the lipid management arena.

Kos itself had entered an agreement covering the U.S. and Canada with Jerini in November 2005. Jerini gained an up-front payment of €12 million (US$15 million) at the time, plus an equity investment of €10 million, and it stood to gain additional milestones and royalties.

Although Aldag would not rule out a future partnering deal, he said the company had enough resources to launch Icatibant on both sides of the Atlantic.

The company is open to discussions with partners for rights in other territories and for extending Icatibant into other indications, such as drug-induced edema, he said.

The company has decided to postpone until next year a clinical trial in the latter indication, Aldag noted.

Shares in Jerini (Frankfurt:JI4) were trading at €3.45 during late afternoon trading, down more than 1 percent from the previous day's close of €3.49.