Executive Summary

CAL BIO REACQUIRING AURICULIN RIGHTS FROM WYETH-AYERST under an agreement-in-principle announced April 7. Cal Bio explained that "due to a change in the direction of Wyeth-Ayerst's cardiovascular R&D program and due to the relatively small size of the intravenous infusion market for acute congestive heart failure, Wyeth-Ayerst has elected not to make the investment necessary to resolve the remaining development issues concerning Auriculin (atrial natriuretic factor)." The deal, the second installment of a two-part buyback, marks the end of Wyeth-Ayerst parent American Home Products' first product development agreement with a biotechnology R&D start-up. Forged almost three years ago, the association began to unravel in September 1988, when Cal Bio reacquired the rights to Auriculin-related compounds ("The Pink Sheet" Sept. 12, 1988, T&G-7). However, American Home retains a nearly 14% equity position in the biotech firm. Cal Bio noted in its release that "discussions with potential marketing partners are currently underway" for development of the Auriculin-related compounds, which may lead to oral or nasal treatments for hypertension and heart failure. The agreement-in-principle "will give Cal Bio the right to proceed with commercial development and marketing on its own behalf, in exchange for certain payments," the release says. Cal Bio said that it is currently evaluating the data from Wyeth-Ayerst's Phase II trials on injectable Auriculin for congestive heart failure to determine what the next steps should be in the development of the product. In January, Wyeth-Ayerst ended a separate 1986 agreement with Cal Bio covering development and marketing rights to a nasal insulin product, Nazlin, which is based on Cal Bio's Nazdel nasal delivery system. At the time, Wyeth-Ayerst said it was unable to obtain a cost-effective supply of insulin with which to begin clinical trials ("The Pink Sheet" Jan. 23, T&G-9). Cal Bio has an active development program for Nazlin with Lilly. Under a September 1986 agreement, Lilly is conducting clinical trials with the product. Lilly has non-exclusive U.S. marketing rights and exclusive marketing rights for the rest of the world. Cal Bio has the option to find another licensee for the nasal insulin.