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Friday, October 30, 2020

Pfizer/Mylan agree to FTC conditions for go-ahead on combined drug firm

  • The U.S. Federal Trade Commission (FTC) announces that Pfizer (PFE -0.7%) and Mylan N.V. (MYL +1.1%) have agreed to agency conditions for approving the proposed combination of Pfizer's Upjohn unit and Mylan which will do business as Viatris.
  • Citing harm to competition in 10 generic drug markets, seven in the U.S. by reducing the number of suppliers and three where the merger would delay or eliminate a likely entrant thereby reducing the likelihood of price decreases, the agency is requiring product divestment.
  • The seven U.S. product markets are: (1) amlodipine besylate/atorvastatin calcium tablets, which combine a calcium channel blocker to treat hypertension with a lipid-lowering agent to treat high cholesterol; (2) eplerenone tablets, a diuretic prescribed in combination with other medications when treating hypertension or congestive heart failure after a heart attack; (3) phenytoin chewable tablets, which are used to prevent epileptic seizures; (4) prazosin HCl capsules, an alpha-adrenergic blocker that treats hypertension by relaxing the veins and arteries so that blood can more easily pass; (5) spironolactone HCTZ tablets, a diuretic used to treat hypertension; (6) gatifloxacin ophthalmic solution, an eye drop that treats bacterial conjunctivitis; and (7) medroxyprogesterone acetate injectable solution, an injectable solution used to treat certain types of dysfunctional uterine bleeding.
  • The three others are: (1) levothyroxine sodium tablets, which treat hypothyroidism or are used in combination with other drugs to treat thyroid cancer; (2) sucralfate tablets, which are used to treat and prevent ulcers in the small intestines; and (3) varenicline tartrate tablets, which are a smoking cessation aid offered under Pfizer’s Chantix brand.
  • The FTC is stipulating that Pfizer divest Upjohn's  amlodipine besylate/atorvastatin calcium tablets, phenytoin chewable tablets, prazosin HCl capsules, spironolactone HCTZ tablets, gatifloxacin ophthalmic solution, and medroxyprogesterone acetate injectable solution to privately held Prasco, LLC and Mylan to divest its eplerenone tablets to Prasco.
  • The divested drugs will continue to be manufactured by Pfizer and Mylan's current suppliers. Pfizer will be Prasco's contract manufacturer.
  • The agency will also require Upjohn, Mylan or Viatris to obtain its prior approval before acquiring a future interest or control over any third party's rights to levothyroxine sodium tablets, sucralfate tablets and varenicline tartrate tablets.
  • The companies announced the deal in July 2019. The transaction should close this quarter.
  • https://seekingalpha.com/news/3629173-pfizer-mylan-agree-to-ftc-conditions-for-go-ahead-on-combined-drug-firm

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