Tag: Prescription Drugs

The FTC authorized a lawsuit to block CSL Limited’s proposed $3.1 billion acquisition of Talecris Biotherapeutics Holdings Corporation, charging that the deal would would substantially reduce competition in the U.S. markets for four plasma-derivative protein therapies – Immune globulin (Ig), Albumin, Rho-D, and Alpha-1. These therapies are used to treat patients suffering from illnesses such as primary immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, alpha-1 antitrypsin disease, and hemolytic disease of the newborn. In approving the administrative complaint seeking to block the deal, the Commission also authorized the staff to seek a preliminary injunction in federal district court in Washington, D.C., to stop the transaction pending completion of the administrative trial.  Following the FTC's lawsuit to block the transaction, CSL Limited announced that it would not proceed with its proposed acquisition.

In December 2008, the Commission settled antitrust concerns raised by the proposed $8.9 billion acquisition of Barr Pharmaceuticals by Teva Pharmaceutical Industries. The proposed acquisition would have lessened competition in the markets for 17 commonly used generic medications including drugs used in the treatment of cancer, bacterial infections, diabetes, acid reflux, and depression as well as several varieties of oral contraceptives. According to the Commission’s complaint, the acquisition would have likely led to higher prices for consumers through the removal of one of only four competitors in each of these markets. The Commission’s consent agreement requires both Teva and Barr to sell assets in 29 U.S. markets to either Watson Pharmaceuticals or Qualitest Pharmaceuticals.

In late 2008, the Commission issued a consent order to restore competition in the market for oral long-acting opioids (LAOs). The FTC intervened in King Pharmaceutical’s proposed $1.6 billion acquisition of rival drug-maker Alpharma Inc. because the transaction would have joined the two leading producers of morphine sulfate oral LAO’s in the United States, a market which was already highly concentrated and which had annual sales of $4 billion in 2007. In order to maintain competition in the market, the Commission’s consent order requires King to divest its Kadian business to Actavis, a company which already manufactured the drug for King, and which could then produce a generic equivalent of the drug sooner than would have been permitted under King’s patent, which would not have expired until 2010.

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.

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.