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Pfizer links with Synthon on generic Copaxone

US giant looking to grab a share of the copycat market for the MS drug

Copoxane packshot 

Teva is facing heavyweight competition for its blockbuster multiple sclerosis treatment Copaxone after Pfizer licensed rights to a generic version of the drug.

Copaxone (glatiramer acetate) already has one rival in the US market in the form of Sandoz and Momenta's Glatopa, and Pfizer will also try to grab a slice of the generic market after licensing a generic developed by Synthon that is currently under review at the FDA.

Sales of Teva's drug were $1.99bn in the first six month of the year, accounting for around 20% of its total revenues, and Glatopa's launch came too late in the second quarter to have much impact on the product.

Teva has been trying to shift patients from its once-daily 20mg formulation of Copaxone - the same dose as Glatopa - to a 40mg three-times-a-week product that it says offers greater convenience and value to patients.

Pfizer has licensed Synthon's once-daily 20mg generic, which was filed in 2011, as well as a 40mg formulation that was filed last year and - according to the company - could have six months' marketing exclusivity in the US under the generic first-to-file rule. Another 40mg generic has been filed in the US by Natco and Mylan.

On Teva's second-quarter results call, the head of Teva's specialty medicines division Robert Koremans said that despite two weeks availability of Glatopa, prescriptions for both the 20mg and 40mg formulations of Copaxone had increased and there was "strong acceptance" of the higher dose among patients, doctors and health plans.

Teva said it is still rolling out its 40mg formulation in Europe - it is currently available in seven countries including Germany and France - with a 15% conversion rate from the once-daily version which Koremans said was ahead of expectations.

Under the terms of the agreement, Pfizer has rights to sell the Copaxone generic while Synthon is responsible for the clinical development, manufacture and supply of the drug.

Article by
Phil Taylor

4th August 2015

From: Sales

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