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prensaestatal.com Diciembre 17, 2017


Teva faces early rival to longer-acting Copaxone in US

06 Octubre 2017, 01:17 | Martinez Canez

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Natco Pharma shares jump 20% as partner Mylan's injections get USFDA approval

Mylan said that shipping was imminent for its Glatiramer Acetate 40 mg/mL for 3-times-a-week injection and 20 mg/mL for once-daily injection.

This is the first time Copaxone will face generic competition at its 40 milligram dose.

Mylan Chief Executive Heather Bresch, in a statement, said the company looks forward to "leading the marketing and selling of this important product in our European markets". Mylan also noted that it could (along with any other generic versions that get approved) have a 180-day exclusivity period.

Teva said it will be appealing against the earlier orders by Patent Trial Appeal Board and US District Court for the District of DE that came against at least four patent claims.

Mylan confirmed the launch of both the 40 mg and 20 mg formulations in the United States on Wednesday. He believes that the market had taken into account that there could be a generic version of Copaxone at any moment although there was a consensus that it would likely happen in 2018 near the start of the second quarter. Investors sent Natco Pharma's shares up 20 percent, the stock's biggest jump in more than four years, when news of the FDA's approval broke.

The prices on these complex medicines, which hinder patient access to essential drugs, are a "public health concern the FDA should address", Dr. Gottlieb added.

MYL stock was up 19% and TEVA stock was down 14% as of Wednesday afternoon.

"We have planned for the eventual introduction of a generic competitor to glatiramer acetate", said Dr. Yitzhak Peterburg, Teva's Interim President and CEO.

As such, the drug is generic drugmaker Teva's biggest moneymaker, bringing in $4.2 billion in revenue previous year. The U.S. generics industry is facing significant competitive and pricing pressure.

It said the effect of the launches on revenues will decrease earnings by around $0.25 cents per share. "We're undertaking a number of efforts to ensure that the pathways for approval for generic versions of complex drug products are as".



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