Actelion, Merck renin alliance achieves third milestone

By E. Janene Geiss

Philadelphia, July 6 - Actelion Ltd. said Thursday that the renin alliance with Merck & Co., Inc. has achieved its third milestone.

The alliance, which produced a new renin inhibitor, started full clinical development with its first testing in humans, triggering a $7 million milestone payment by Merck to Actelion, according to an Actelion news release.

Actelion and Merck said they formed an exclusive worldwide alliance in December 2003 to discover, develop and market new classes of orally available renin inhibitors for patients suffering from cardio-renal diseases.

Through a joint committee, the parties are collaborating on the development of products.

Research and development funding initially has been the responsibility of Actelion, officials said.

The two companies said they will jointly fund phase 2 development with Merck responsible for funding all phase 3 and outcome studies.

Merck said it will lead and fund commercialization. Actelion retains a worldwide option to co-promote any product resulting from this alliance as a paid-for sales force, officials said.

Upon signing the alliance, Actelion received $10 million. Actelion said it also is eligible to receive significant research, development and approval milestone payments of up to $262 million for the successful commercialization of the first collaboration product.

A first milestone of $15 million was achieved in March 2004 with the completion of the technology transfer, which provided Merck with unrestricted access to Actelion's multiple renin inhibitor classes.

A second milestone was achieved in March 2005 when the first compound was selected for full preclinical development.

Actelion said it also will be eligible to receive certain milestone payments for the successful commercialization of additional products, and Merck will pay Actelion substantial royalties on the sale of all products resulting from this renin inhibitor alliance.

Renin plays a key role in the regulation of blood volume, arterial pressure and cardiac and vascular function by serving as an early component of the renin-angiotensin system. Therapeutic manipulation of the renin-angiotensin pathway has become very important in treating hypertension and heart failure.

Merck is a Whitehouse Station, N.J., pharmaceutical company.

Actelion is an Allschwil, Switzerland, biopharmaceutical company.

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