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Keystone Orthopaedic Specialists, LLC, and Orthopaedic Associates of Reading, Ltd., In the Matter of

Keystone Orthopaedic Specialists, LLC, an orthopedic practice formed through a combination of six independent orthopedic practices, agreed to settle charges that the merger substantially reduced competition for orthopedic services in Berks County, Pennsylvania. The complaint also names Orthopaedic Associates, one of the six practices that merged into Keystone in 2011, which was split off from Keystone in 2014. Under the terms of the settlement, Keystone and Orthopaedic Associates are required to obtain prior approval from the Commission before acquiring any interests in each other, before acquiring another orthopedic practice in Berks County, and before hiring or offering membership to an orthopedist who has provided services in Berks County in the past year. The settlement is designed to maintain competition in the relevant market by preserving Orthopaedic Associates’ separation, and allowing health plans to avail themselves of current market conditions by renegotiating existing Keystone contracts.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
141 0025

Endo International plc, In the Matter of

Pharmaceutical companies Endo International plc and Par Pharmaceuticals, Inc. agreed to divest all of Endo’s rights and assets to generic glycopyrrolate tablets and generic methimazole tablets in order to settle FTC charges that Endo’s proposed $8 billion acquisition of Par would likely be anticompetitive. New Jersey-based generic drug marketer Rising Pharmaceuticals will acquire the divested assets. Under the settlement, Endo must supply Rising with the divested products for two years, while it transfers the manufacturing technology to Rising’s chosen third-party manufacturer. Endo also must provide technical assistance, training, and other transitional services to help Rising establish manufacturing capabilities. Without the divestitures required by the proposed order, the FTC alleges that the acquisition would combine the two most significant suppliers in the market for generic glycopyrrolate tablets, which are used with other drugs to treat certain types of ulcers, and two of only four active suppliers in the market for generic methimazole tablets, which are used to treat the body’s production of excess thyroid hormone.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
151 0137
Docket Number
C-4539

Wright Medical Group, Inc./Tornier N.V., In the Matter of

Wright Medical Group, Inc. and Tornier N.V. agreed to sell Tornier’s U.S. rights and assets related to its total ankle replacements and total silastic toe joint replacements to resolve FTC charges that the proposed $3.3 billion merger would illegally reduce competition for these devices. According to the complaint, the merger would likely substantially lessening competition in the U.S. markets for total ankle replacements and total silastic toe joint replacements. Under the settlement, Wright and Tornier will divest the rights and assets to these devices to Integra Lifesciences Corporation and provide Integra with intellectual property, manufacturing technology, and existing inventory, as well as other assets and assistance to ensure that Integra can effectively compete in the markets. The order also requires Wright and Tornier to supply Integra with total ankle replacements for up to three years and total silastic toe joint replacements for up to a year, while Integra transitions to become an independent competitor in these markets.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
151 0018

Concordia Healthcare / Par Pharmaceutical, In the Matter of

Pharmaceutical companies Concordia Pharmaceuticals Inc. and Par Pharmaceutical, Inc. settled FTC charges that they entered into an unlawful agreement not to compete in the sale of generic versions of Kapvay, a prescription drug used to treat Attention Deficit Hyperactivity Disorder. As part of the settlement, the companies agreed not to enforce the anticompetitive provisions of their agreement. Until May 15, 2015, Concordia and Par were the only two firms permitted by the FDA to market generic Kapvay. Rather than competing against one another, Concordia agreed not to sell an authorized generic version of Kapvay in exchange for a share of Par’s revenues. Under the terms of the settlements, Concordia is prohibited from enforcing the anticompetitive provisions of its agreement with Par, including the profit-sharing provisions, and Par is prohibited from enforcing provisions that bar Concordia from agreeing not to sell an authorized generic version of Kapvay. Concordia began selling generic Kapvay after learning of the FTC’s investigation.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
151 0030

FTC Staff Comment Submitted to the Food and Drug Administration, In Response to FDA's Request For Comments on Its Guidance for Industry on the “Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability”

Date
Matter Number
P131208
Docket Number
FDA-2013-D-1543 [80 Fed. Reg. 52296 (Aug. 28, 2015)]
FTC staff submitted a comment to the FDA, in response to the FDA’s request for comment on its draft guidance addressing nonproprietary names for biological products. The comment expressed concern that...

Pfizer Inc./Hospira, Inc., In the Matter of

Pfizer Inc. agreed to sell the rights and assets related to four pharmaceutical products in order to settle FTC charges that its proposed $16 billion acquisition of Hospira, Inc. would likely be anticompetitive. Pfizer is one of the world’s largest drug companies and principally competes with Hospira in markets for certain sterile injectable pharmaceutical products. The order requires Pfizer to supply Alvogen with the clindamycin phosphate injection product for three years while Pfizer transfers the manufacturing technology to Alvogen or its designee. Pfizer also is required to provide transitional services to Alvogen to assist with establishing manufacturing capabilities and securing FDA approvals to market all of the divested products.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
151 0074
Docket Number
C-4537

Steris/Synergy Health, In the Matter of

The FTC issued an administrative complaint charging that Steris Corporation’s proposed $1.9 billion acquisition of Synergy Health plc would violate the antitrust laws by significantly reducing future competition in regional markets for sterilization of products using radiation, particularly gamma or x-ray radiation. The Commission also authorized agency staff to seek a temporary restraining order and preliminary injunction in federal court to maintain the status quo pending an administrative trial on the merits. According to the FTC, it is unlikely that new competitors in the market for contract radiation sterilization services would replicate the competition that would be eliminated by the merger. The Commission alleged that the challenged acquisition would eliminate likely future competition between Steris’s gamma sterilization facilities and Synergy’s planned x-ray sterilization facilities in the United States, thus depriving customers of an alternative sterilization service and additional competition. On September 25, 2015 the district court denied the FTC motion for a PI. On October 30, the Commission dismissed the administrative complaint.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
151 0032
Docket Number
9365