The Federal Trade Commission is requiring Hikma Pharmaceuticals PLC to divest two generic injectables - the anticonvulsant phenytoin and promethazine, used for treatment of allergies, nausea and anxiety - as a condition for its proposed acquisition of Baxter Healthcare Corp.'s entire generic injectable pharmaceutical business.

FTC announced the consent agreement with London-based Hikma on April 27. Hikma is to sell the two products to X-Gen Pharmaceuticals Inc., a privately-owned generics company based in Horseheads, NY, within 10 days of acquiring Baxter's business.

The commission said that without the divestiture Hikma's acquisition would be anticompetitive and likely result in higher prices for the two drugs. Hospira Inc. is the only other company besides Hikma and Baxter that sells phenytoin and promethazine in the United States.

In 2009, U.S. sales of generic injectable phenytoin totaled $1.5 million while U.S. sales of generic injectable promethazine totaled $17 million. FTC said Hikma is the market leader for phenytoin, holding a 44% market share. Baxter has 38% of the market and Hospira 18%. Hikma and Baxter are the market leaders for promethazine, selling lower priced ampules and vials. FTC said Hospira's product, a premium-priced pre-filled syringe "has limited competitive significance."

The FTC said a fourth company has approval to sell generic injectable promethazine in the U.S. and has historically offered the product, but is not currently manufacturing it and a re-entry date is unknown.

Teva is approved from multiple strengths of the injectable version of the product under ANDA 040454, but production may have been interrupted due to the problems at its injectables plant in Irvine, Calif. (Also see "GMP Warning Letter: Teva Preempts FDA In Disclosing Problems At Jerusalem Plant" - Pink Sheet, 14 February, 2011.).

Hikma announced in November that its U.S. subsidiary West-Ward Pharmaceutical Corp. was acquiring Baxter's generic injectable business for $112 million in cash (Also see "Deals Of The Week: Sanofi, Teva, Ablexis; Kadmon Emerges From Stealth Mode" - Pink Sheet, 1 November, 2010.). Baxter's business sells about 40 different drugs in various dosage strengths and was on track to achieve $180 million in revenue in 2010. The deal puts Hikma in second place behind Hospira in the U.S. generic injectables market.

-Brenda Sandburg (b.sandburg@elsevier.com)

Hikma To Divest Phenytoin, Promethazine Injectables To Acquire Baxter Business

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