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Generic Copaxone launches in US

Sandoz and Momenta Pharmaceuticals started shipping Glatopa in reaction

Teva Copaxone 

Teva's efforts to protect the US patents on its multiple sclerosis blockbuster Copaxone ended in failure yesterday when an appeals court cleared the way for generic versions of the drug.

Immediately, Novartis' Sandoz generics division and partner Momenta Pharmaceuticals started to ship their Glatopa brand of 20mg glatiramer acetate, which was approved by the FDA in April for relapsing-remitting forms of MS.

Teva had been trying to stave off generic competition in the US until September, with every additional month of exclusivity worth millions of dollars in revenue. Last year, Copaxone brought in $4.24bn for the Israeli company, around a fifth of its total revenues, with the US accounting for three quarters of all the drug's sales.

Reports suggest that Glatopa will be priced at $173 per syringe, which is a 15% discount to Teva's once-daily version of Copaxone, although the price may be expected to dip further once additional generics reach the market. 

Teva has however been working hard to switch patients to its new formulation of the drug that reduces injection frequency to three times a week, which was given a green light in January 2014.

According to the Israeli drugmaker's first-quarter results statement it had already converted two thirds of Copaxone patients to the new formulation, which could limit the impact of competition from Glatopa. 

The new formulation is also under threat however from a three-times-a-week generic that has been filed for approval in the US by Natco and Mylan, currently being pursued by Teva as a takeover target.

In a statement, Novartis said that Sandoz will offer "financial assistance to qualified patients, personalised injection training and 24-hour access to nurses for non-clinical questions" as part of the Glatopa package.

Momenta will receive a $10m milestone payment on the first commercial sale of Glatopa, and is also in line for up to $120m in additional milestone if the drug reaches certain commercial and sales-based targets in the US.

Article by
Phil Taylor

19th June 2015

From: Sales

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