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Fresenius Medical Care AG & Co. KGaA, et al., In the Matter of

The Commission challenged Fresenius Medical Care’s proposed purchase of an exclusive sublicense for the manufacture and supply of the drug Venofer to US dialysis clinics from Daiichi Sankyo Company. Venofer is an intravenously administered iron sucrose preparation used primarily to treat iron-deficiency anemia in dialysis patients with chronic kidney disease. The agreement would have given Fresenius, the largest operator of dialysis clinics in the country, the ability to artificially inflate its internal costs for Venofer, and effectively increase Medicare reimbursement payments for all buyers of the drug. In order to settle these concerns about anticompetitive self-dealing, the Commission issued a consent order restricting Fresenius from reporting internally inflated Venofer prices by mandating that the current market price for the drug be used in reporting the average selling price to Medicare.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
081 0146

Sun Pharmaceutical Industries Ltd., In the Matter of (Taro Pharmaceuticals)

The Commission charged that Sun Pharmaceutical Industries Ltd’s proposed acquisition of Taro Pharmaceuticals Industries, Ltd would substantially reduce competition, likely resulting in higher prices for three distinct generic formulations of the anticonvulsant drug carbamazepine, used widely as an antiepileptic and to prevent and control seizures. The proposed deal would have reduced the number of drug suppliers to a level where the number of competitors has a direct and substantial impact on prices. In order to remedy these concerns, Sun agreed to divest all of its rights and assets needed to develop three generic forms of carbamazepine: 1) immediate-release tablets; 2) chewable tablets; and 3) extended-release tablets.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
071 0193

Equitable Resources, Inc., Dominion Resources, Inc., Consolidated Natural Gas Company, and The Peoples Natural Gas Company

The Commission charged that Schering-Plough’s proposed $14.4 billion acquisition of Organon Biosciences N.V. threatened to substantially reduce competition in the U.S. market for three popular vaccines used to treat poultry, a staple in American food markets. The November 2007 order settling the charges required the sale of assets required to develop, manufacture, and market these vaccines to Wyeth. In addition, Schering-Plough was required to sign a supply and transition services agreement with Wyeth, under which Schering will provide the vaccines for a period of two years, allowing time for the necessary FDA approvals.

Type of Action
Federal
Last Updated
FTC Matter/File Number
710132

Schering-Plough Corporation, In the Matter of

The Commission charged that Schering-Plough’s proposed $14.4 billion acquisition of Organon Biosciences N.V. threatened to substantially reduce competition in the U.S. market for three popular vaccines used to treat poultry, a staple in American food markets. The November 2007 order settling the charges required the sale of assets required to develop, manufacture, and market these vaccines to Wyeth. In addition, Schering-Plough was required to sign a supply and transition services agreement with Wyeth, under which Schering will provide the vaccines for a period of two years, allowing time for the necessary FDA approvals.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
071 0132

Warner Chilcott Holdings Company III, Ltd.; Warner Chilcott Corporation; Warner Chilcott (US) Inc.; Galen (Chemicals) Ltd.; and Barr Pharmaceuticals, Inc.

The Commission settled with Barr Laboratories concluding its federal court action challenging an agreement between Warner Chilcott and Barr in which, the Commission alleged, Barr agreed not to sell a lower-priced generic substitute of Warner Chilcott’s branded Ovcon 35, an oral contraceptive drug, for several years for $20 million. On November 5, 2005 a complaint was filed in District Court for the District Columbia seeking to put an end to an agreement between drug manufacturers Galen Chemicals Ltd. (now known as Warner Chilcott) and Barr Laboratories that denies consumers the choice of a lower priced generic version of Warner Chilcott’s Ovcon® oral contraceptive. According to the FTC’s complaint, Barr planned to launch a generic version of Ovcon as soon it received regulatory approval from the Food and Drug Administration. Warner Chilcott expected to lose half its Ovcon sales within the first year if Ovcon faced competition from a generic equivalent. Faced with this prospect, instead of competing with Barr, Warner Chilcott entered into an agreement 24 with Barr, preventing entry of Barr’s generic Ovcon into the United States for five years. In exchange for Barr’s promise not to compete, Warner Chilcott paid Barr $20 million. In September 2006, under the threat of a preliminary injunction sought by the Commission, Warner Chilcott waived the exclusionary provision in its agreement, and the next day Barr announced its intention to start selling generic Ovcon in the United States. Under the terms of the October 2006 order settling the Commission’s charges, Warner Chilcott agreed to certain terms to protect generic entry into the market.
Type of Action
Federal
Last Updated
FTC Matter/File Number
0410034

Mylan Laboratories Inc. and E. Merck oHG., In the Matter of

The Commission ordered divestitures to resolve competitive concerns in the U.S. market for five generic drugs stemming from Mylan Laboratories’ proposed acquisition of the generic arm of Merck Pharmaceuticals, a transaction valued at approximately $6.6 billion. Under a September 2007 consent order with the Commission, Mylan and Merck must divest all assets relating to flecainide acetate tablets, acebutolol hydrochloride capsules, guanfacine hydrochloride tablets, nicardipine hydrochloride capsules, and sotalol hydrochloride. The generic drugs at issue are used for the treatment of many conditions, including hypertension and heart arrhythmia. The order requires the divestiture of all assets related to the relevant products to Amneal Pharmaceuticals, a generic drug manufacturer.
Type of Action
Administrative
Last Updated
FTC Matter/File Number
0710164

Actavis Group hf. and Abrika Pharmaceuticals, Inc., In the Matter of

The Commission prevented a merger-to-monopoly in the sale of generic isradipine capsules by challenging the proposed $235 million purchase of Abrika Pharmaceuticals, Inc., by the Actavis Group, an international generic pharmaceuticals company. To maintain competition in the market for this important generic drug, used to lower blood pressure and to treat hypertension, ischemia, and depression, the consent order requires the divestiture of all rights and assets necessary to produce, market, and sell generic isradipine to Cobalt Laboratories, Inc.
Type of Action
Administrative
Last Updated
FTC Matter/File Number
0710063