Tag: Prescription Drugs

Pharmaceutical companies Impax Laboratories Inc. and CorePharma, LLC agreed to divest all of CorePharma’s rights and assets to generic pilocarpine tablets and generic ursodiol tablets, in order to settle FTC charges that Impax’s proposed $700 million acquisition of CorePharma would likely be anticompetitive. Without the divestitures required by the proposed order, the FTC alleges that the acquisition would reduce the number of future suppliers in the markets for generic pilocarpine tablets, which are used to treat dry mouth, and generic ursodiol tablets, which are used to treat biliary cirrhosis, a chronic disease of the liver, as well as gall bladder diseases. CorePharma’s entry as an independent competitor would likely have resulted in significantly lower prices for each of these drugs. According to the FTC’s complaint, there are currently only two suppliers in the market for generic pilocarpine tablets, and Impax and CorePharma are the only likely new entrants into this market in the near future. In the market for generic ursodiol tablets, there are currently four suppliers, including Impax. This market
has recently experienced supply shortages, which can diminish competition among suppliers. CorePharma is one of a limited number of firms likely to enter the generic ursodiol market in the near future.

Global pharmaceutical company Novartis AG agreed to divest Habitrol, its nicotine replacement therapy patch, to settle FTC charges that its consumer health care products joint venture with GlaxoSmithKline (GSK) would likely be anticompetitive. Under the terms of the proposed joint venture agreement, GSK will control the joint venture and contribute, among other products, its nicotine patch business. Novartis will have a 36.5 percent interest in the joint venture, and without the divestitures required by the proposed order, would continue to own the Habitrol business. According to the complaint, without the divestiture contained in the proposed settlement, Novartis’s ownership of both Habitrol and a substantial interest in the joint venture that sells GSK’s nicotine patches would substantially reduce competition and lead to higher prices for Habitrol and Novartis’s private-label patches.  (C-4498)

Separately, Novartis AG also agreed to divest all assets related to its BRAF and MEK inhibitor drugs, products in development, to Boulder, Colorado-based Array BioPharma to settle FTC charges that Novartis’s $16 billion acquisition of GlaxoSmithKline’s portfolio of cancer-treatment drugs would likely be anticompetitive. According to the complaint, the Switzerland-based Novartis and the London-based GSK are two of a small number of companies with either a BRAF or MEK inhibitor currently on the market or in development, and two of only three companies marketing or developing a BRAF/MEK combination product to treat melanoma. If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. Under the terms of the consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. (C-4510)

Pharmaceutical companies Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. agreed to divest Ranbaxy’s interests in generic minocycline tablets in order to settle FTC charges that Sun’s $4 billion proposed acquisition of Ranbaxy would likely be anticompetitive. Torrent Pharmaceuticals Ltd., a global drug company based in India that markets generic drugs in the United States, will acquire the divested assets. Under the settlement, Sun and Ranbaxy must also sell Ranbaxy’s generic minocycline capsule assets to Torrent, to enable Torrent to achieve regulatory approval for a change in ingredient suppliers for its minocycline tablets as quickly as Ranbaxy would have been able to do in the absence of the deal. In addition, Sun and Ranbaxy must supply generic minocycline tablets and capsules to Torrent until the company establishes its own manufacturing infrastructure.

Eli Lilly and Company agreed to divest its Sentinel product line of medications for treating heartworm disease in dogs in order to settle FTC charges that its proposed $5.4 billion acquisition of Novartis Animal Health would likely be anticompetitive. Under the settlement, Eli Lilly will divest its Sentinel product line and associated assets to the French pharmaceutical company, Virbac S.A. The FTC’s complaint challenging the transaction alleges that the proposed acquisition would be anticompetitive and lead to higher prices. According to the complaint, Eli Lilly’s Trifexis and Novartis Animal Health’s Sentinel products are particularly close substitutes because they are the only two products that are given orally once a month, contain the same active ingredient, and also treat fleas and other internal parasites in dogs.

The Commission challenged Schering-Plough’s proposed $41.4 billion acquisition of Merck & Co., and required divestitures to preserve competition in markets for human and animal pharmaceuticals. The proposed consent order requires that Merck sell its interest in Merial Limited, an animal health joint venture with Sanofi-Aventis S.A., and that Schering-Plough sell its assets related to significant drugs for nausea and vomiting in humans.

Akorn, Inc. has agreed to sell its rights to develop, manufacture, and market the generic injectable tuberculosis drug, rifampin, in order to settle FTC charges that Akorn’s proposed acquisition of VersaPharm Inc. and its parent company, VPI Holdings Corp., would likely be anticompetitive. According to the FTC’s complaint, only VersaPharm and two other firms currently have FDA approval to sell generic injectable rifampin and there are no viable substitutes for rifampin as a course of treatment for tuberculosis. The FTC’s proposed settlement with Akorn requires the company to divest its Abbreviated New Drug Application for generic injectable rifampin – which is currently pending before the Food and Drug Administration – to Watson Laboratories, Inc.

Pharmaceutical companies Actavis plc and Forest Laboratories, Inc. agreed to sell or relinquish their rights to four generic pharmaceuticals that treat hypertension, angina, cirrhosis, and prevent seizures to settle FTC charges that Actavis’s acquisition of Forest likely would be anticompetitive. According to the FTC’s complaint, Actavis’s acquisition of Forest, as originally proposed, would violate federal antitrust laws by reducing competition in the markets for three current generic products. In addition, the FTC’s complaint also alleges that the proposed transaction would delay the introduction of another generic drug. Under the proposed FTC settlement order, the companies have agreed to relinquish their rights to market generic diltiazem hydrochloride (AB4) to Valeant Pharmaceuticals International, Inc.; sell generic ursodiol and generic lamotrigine ODT to Impax Laboratories, Inc.; and sell generic propranolol hydrochloride to Catalent Pharma Solutions, Inc. Under the terms of the proposed settlement, Actavis and Forest must ensure the viability, marketability, and competitiveness of the drugs that are
being divested until they are sold.

Valeant Pharmaceuticals International, Inc. and Precision Dermatology, Inc. agreed to sell or relinquish rights to Precision’s branded single-agent topical tretinoins and generic Retin-A, common acne treatments, to settle FTC charges that Valeant’s proposed $475 million acquisition of Precision would likely be anticompetitive. According to the FTC complaint, Valeant’s proposed acquisition of Precision would likely reduce competition in the market for branded and generic single-agent topical tretinoins, and in a separate market for generic Retin-A. The proposed consent order requires Valeant to sell Precision’s assets related to Tretin-X, its branded single-agent topical tretinoin, to Actavis, Inc., and Precision’s assets related to generic Retin-A to Matawan Pharmaceuticals LLC, a subsidiary of Rouses Point Pharmaceuticals.

Akorn Enterprises, Inc. and Hi-Tech Pharmacal, Inc. agreed to sell the rights and assets to three generic prescription eye medications and two generic topical anesthetics to Watson Laboratories, Inc., to settle FTC charges that Akorn’s proposed $640 million acquisition of Hi-Tech would be anticompetitive and lead to higher prices for consumers. The proposed order requires the parties to sell either Akorn’s or Hi-Tech’s rights and assets to each of the five drug products to Watson, and requires Akorn to assign Watson its contract for making branded and generic EMLA cream within 10 days after the deal is consummated. In addition, the companies must maintain the drugs to be sold as viable, marketable, and competitive pending their divestiture, and must allow the FTC to appoint a monitor to ensure that the companies comply with the order’s requirements.