Moneycontrol
Jun 16, 2017 07:02 PM IST | Source: Moneycontrol.com

Natco may have to wait longer to launch copy of multiple sclerosis drug Copaxone in US

The launch is likely to get further delayed as US drug regulatory agency FDA sought more information from its partner Mylan on its filing.

Natco may have to wait longer to launch copy of multiple sclerosis drug Copaxone in US

Viswanath Pilla

Moneycontrol News

Drugmaker Natco Pharma’s hope of a possible early launch of generic version of top-selling multiple sclerosis drug Copaxone in US market may need tempering.

The launch is likely to get further delayed as US drug regulatory agency FDA sought more information from its partner Mylan on its filing.

Mylan has earlier indicated that it was expecting a decision by US FDA in June on both the versions of Copaxone 20 mg and 40 mg, as the ‘target action date’ or the internal timeline set by the regulator to take action on an application fell in June.

However, Mylan said it has received an "information request" from US FDA on its 20 mg generic version - indicating the agency may need more data to make its decision.

The agency’s request could delay the launch of the product further.

Evercore analyst Umer Raffat says he doesn't expect a generic version of Copaxone to hit the market in 2017.

Mylan was silent on the status of the generic Copaxone 40 mg version filing.

Mylan was silent on the status of the generic Copaxone 40 mg version filing.Natco teamed up with Mylan to challenge Teva’s Copaxone 20 mg and 40 mg patents. Under their agreement, Natco will supply the drug and Mylan will market it in the US and both the companies will share the profits.

Generic Copaxone is the much anticipated launch for Natco – that has the potential generate a massive windfall to the company.

Copaxone alone contributed a fifth of Israeli drug maker Teva's USD 21 billion sales in 2016.

Generically known as glatiramer acetate injection, Copaxone is an injectable drug to treat relapsing forms of multiple sclerosis which damages the central nervous system and affects some 400,000 Americans.

Though Copaxone is not a biological drug, but it’s considered to be highly complex drug and difficult to replicate than most traditional generic drugs.

Momenta Pharmaceuticals and Sandoz, the generic unit of Swiss pharma major Novartis have secured FDA approval for their generic version of Copaxone 20 mg.

However, Momenta-Sandoz combine failed to make much impact as Teva succeeded in switching many patients to the thrice-a-weekly treatment with 40 mg version from the original version consisting of 20 milligrams taken every day.

Along with Natco-Mylan combine Momenta-Sandoz, DrReddy’s Laboratories and Synthon BV Pfizer are in the race to launch a generic version of the 40 mg version.

In February – Momenta-Sandoz were dealt with a blow when the facility contracted to manufacture 40 mg version of Copaxone received a warning letter.

Natco-Mylan claim that they are the first companies to have filed a substantially complete abbreviated new drug application containing a Paragraph IV certification for three times per week Glatiramer Acetate Injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the US upon successful litigation and final USFDA approval.
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