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24 October 2018Americas

Teva asks FTC to reopen Actavis and Watson merger decision

The US Federal Trade Commission (FTC) yesterday said that Teva Pharmaceuticals has asked the commission to reopen and modify its decision and order regarding the 2012 merger of Actavis and Watson Pharmaceuticals.

The FTC said that it is now accepting public comments on an application made by Teva requesting the commission extends a supply agreement involving Pfizer.

According to the FTC, the merger risked lessening future competition in the US for a number of generic drugs, including generic versions of the opioid painkiller sold under the name Embeda (morphine sulfate and naltrexone HCl).

A 2012 FTC decision and order required Watson and Actavis to supply Embeda to Pfizer for no more than four years, starting from Pfizer’s 2015 re-launch of Embeda.

Pfizer did not have the capability to independently manufacture Embeda in 2012.

In addition, Watson and Actavis were required to assist in the technology transfer for manufacturing Embeda to Pfizer or a third party.

In June 2015, Actavis changed its name to Allergan, although the company’s US and Canadian generics business continued to operate under the name Actavis.

Then, in 2016, Teva acquired Allergan’s generics division, and assumed the obligations under the Embeda supply agreement and continued plans to develop a generic version of Embeda.

“Teva seeks to extend, at Pfizer’s request, the Embeda supply agreement for an additional period,” said the FTC.

“Teva claims that Pfizer has not yet completed the technology transfer for Embeda manufacturing to a third party and that without Teva’s supply of Embeda, Pfizer will be unable to supply patients with Embeda after December 2018.”

According to Teva’s application, “the public interest heavily favours removing or extending” the agreement past December. In doing so, Teva claimed that it will “preserve Pfizer’s ability to supply patients with Embeda”.

In addition, Teva claimed that extending the agreement will not impact its own plans to introduce a generic version of the drug.

The FTC will decide whether it will approve the application following a 30-day public comment period which will end on November 23.

Comments can be filed electronically or sent to: FTC Office of the Secretary, 600 Pennsylvania Ave., N.W., Washington. (FTC File No. 1210132; the staff contact is Elizabeth Piotrowski, Bureau of Competition, 202-326-2623.)

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Big Pharma
19 December 2018   The Federal Trade Commission (FTC) has approved an application by pharmaceutical company Teva to re-open and modify its decision and order regarding the 2012 merger of Actavis and Watson Pharmaceuticals.

More on this story

Big Pharma
19 December 2018   The Federal Trade Commission (FTC) has approved an application by pharmaceutical company Teva to re-open and modify its decision and order regarding the 2012 merger of Actavis and Watson Pharmaceuticals.

More on this story

Big Pharma
19 December 2018   The Federal Trade Commission (FTC) has approved an application by pharmaceutical company Teva to re-open and modify its decision and order regarding the 2012 merger of Actavis and Watson Pharmaceuticals.