FDAnews Drug Daily Bulletin

For Mylan Laboratories to go forward with its proposed $6.6 billion acquisition of Merck KGaA’s generics business, both companies will have to divest all assets related to several generic drugs to Amneal Pharmaceuticals, the FTC announced last week.

The transaction allegedly would result in significantly reduced competition for the sale and manufacture of the five generic drugs in the U.S., which are currently produced by both companies, according to the FTC’s Sept. 27 announcement. Under a consent order resolving the FTC’s complaint, the companies will divest all assets related to the drugs within 10 days of completing the deal.

In conducting its investigation of the proposed acquisition, the FTC identified competitive overlaps in the U.S. markets for several generic drugs. They are generic Sectral (acebutolol HCl) capsules, generic Tambocor (flecainide acetate) tablets, generic Tenex (guanfacine HCl) tablets, generic Cardene (nicardipine HCl) capsules and generic Betapace AF (sotalol HCl) tablets. All are cardiovascular drugs.

The FTC’s complaint alleged the transaction as proposed would be anti-competitive and would violate Section 5 of the FTC Act and Section 7 of the Clayton Act. Generic drug pricing is heavily influenced by the number of competitors, according to the FTC. In its investigation, the FTC found evidence that the acquisition could lead to higher prices for these drugs.

The consent order will be subject to public comment until Oct. 27, after which the commission will decide whether to make it final. More information on the consent order is available at www.ftc.gov/os/caselist/0710164/0710164.shtm.