Drugmakers Baxter International and Claris Injectables agreed to divest two pharmaceutical products to settle Federal Trade Commission antitrust concerns over Baxter's proposed $625 million acquisition of Claris' injectable drugs business, the agency announced Thursday.
Under the proposed settlement, the companies will divest all of Claris' rights to fluconazole in saline intravenous bags and milrinone in dextrose intravenous bags to New Jersey-based pharmaceutical company Renaissance Lakewood. If the FTC determines that Renaissance is not acceptable or that the divestiture is not adequately executed, they will divest the products to an agency-approved company.
According to the FTC's complaint, the acquisition proposed in December would likely reduce competition in the U.S. for the antifungal agent fluconazole, which is used to treat fungal and yeast infections. In the U.S. market, Illinois-based Baxter and India-based Claris are two of only four significant competitors and have a combined market share of nearly 60%.
It would also reduce future competition for intravenous milrinone, which dilates the blood vessels, lowers blood pressure and allows blood to flow more easily through the cardiovascular system, the FTC said. It is currently sold by three companies—Baxter, Hikma and Pfizer—for short-term treatment during heart failure. Claris is expected to enter this market shortly, if the U.S. Food and Drug Administration approves its application. These developments would likely increase prices, the FTC said.
Increasing generic competition has been a priority of the FDA. Drug prices start to come down when four generic suppliers compete, regulators argue. The FDA is looking to fast-track its review of applications for generics, known as abbreviated new drug applications, or ANDAs, for drugs with less than four competitors—a policy move that the FDA called the first of its kind.
Consolidation among pharmaceutical companies can lead to price spikes and drug shortages that delay treatments and put providers in a financial bind, health policy experts said at the U.S. Food and Drug Administration's meeting on drug competition Tuesday. Problems arise when there aren't enough manufacturers making alternatives, research shows.
The commission will decide on the proposed consent order on Aug. 21.
