Kos Life Sciences and Jerini US form development and marketing agreement for Icatibant

By Angela McDaniels

Seattle, Nov. 8 - Kos Life Sciences Inc., a subsidiary of Kos Pharmaceuticals Inc., and Jerini US Inc., a subsidiary of Jerini AG, said they have signed an exclusive agreement for the development, marketing and distribution of Jerini's compound Icatibant in the United States and Canada.

The strategic partnership includes an upfront licensing payment of €12 million and a €10 million equity investment priced at the higher of the weighted average of the closing price of Jerini's shares during the last four trading days, or the initial public offering price of €3.20 per share.

Undisclosed milestone payments and sales royalties are also specified in the agreement.

Kos and Jerini swill collaborate on the global branding and positioning of Icatibant, the companies said.

Jerini will retain the commercial rights to Icatibant outside the United States and Canada and will responsible for Icatibant's phase-3 clinical trials, regulatory approval and supplies of the compound. Hereditary angioedema is the first of several diseases for which Icatibant offers a potential treatment, the companies said. The agreement outlines collaboration in the hereditary angioedema area as well as other forms of angioedema, asthma and refractory ascites in liver cirrhosis indications. Proof-of-concept trials have already been completed in these indications, the companies said.

"Currently there are no approved treatment options for HAE [hereditary angioedema] in the United States or most other countries. We are hopeful that Icatibant may be able to fulfill a serious unmet medical need in this patient population," said Adrian Adams, Kos president and chief executive officer, in a company press release.

"The product has received orphan drug and fast track review status by the FDA, and could potentially be launched in the first half of 2007."

Icatibant has shown a 100% response rate in 1,000 hereditary angioedema patients in phase-2 clinical trials, the according to the press release.

Phase-3 clinical trials are being conducted in the United States, Canada and Europe. Results from these trials are expected to be reported in mid-2006, with filing for market approval in the United States and Europe also planned in 2006, the companies said.

Kos Pharmaceutical is a pharmaceutical company based in Cranbury, N.J., that develops prescription products for the treatment of chronic diseases with a particular focus on the cardiovascular, metabolic and respiratory disease areas.

Jerini is a pharmaceutical company based in Berlin that develops peptide-derived peptidomimetic and small molecule therapeutics.

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