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Abbott Diagnostics Manufacturing Issues Could Decrease Alza Merger Value

Executive Summary

Abbott's pending merger with Alza could give FDA leverage in discussions over quality control problems in Abbott's diagnostics business.

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Abbott/Alza

New merger vote will likely not occur until next year. Alza shareholders had originally approved the merger Sept. 21. On Sept. 28, Abbott announced it was in discussions with FDA on a consent decree for its diagnostics manufacturing business, which it has since signed with the agency (1"The Pink Sheet" Oct. 4, p. 14). Alza and Abbott have agreed to a second shareholder vote in light of the decline in the merger's value since the consent decree process began

Abbott/Alza

New merger vote will likely not occur until next year. Alza shareholders had originally approved the merger Sept. 21. On Sept. 28, Abbott announced it was in discussions with FDA on a consent decree for its diagnostics manufacturing business, which it has since signed with the agency (1"The Pink Sheet" Oct. 4, p. 14). Alza and Abbott have agreed to a second shareholder vote in light of the decline in the merger's value since the consent decree process began

Abbott/Alza

Federal Trade Commission is discussing divestiture of Alza's Viadur, a Duros leuprolide product for advanced prostate cancer. TAP, Abbott's joint venture with Takeda, markets leuprolide in a depot formulation as Lupron. The companies say there is "significant interest" in Viadur from other pharmaceutical companies and they still expect to close the merger by the end of the year. Alza submitted an NDA for Viadur around the end of April. FTC is investigating TAP's marketing practices for Lupron

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