Novartis Gains FDA Approval for Delayed MS Generic

Manufacturing problems caused million-dollar delay

Novartis’s Sandoz division has won FDA approval for a larger dosage of glatiramer acetate injection (Glatopa) for multiple sclerosis (MS) patients, ending a costly delay that allowed rival generics makers to beat it to market, according to a Reuters report.

The FDA approved a 40-mg/mL injection of the Novartis copy of Copaxone, Teva’s blockbuster medicine, Sandoz said in a statement.

Israel-based Teva Pharmaceutical Industries began facing competition for its 40-mg version of Copaxone from Mylan in October and has been bracing for more copycat versions of its bestselling drug.

Sandoz began selling a 20-mg/mL Glatopa dosage to U.S. patients with relapsing MS in 2015 but missed out on millions of dollars in sales when the double-dosage version was pushed back last year after contamination problems at the Pfizer fill-and-finish plant being used by Sandoz, Reuters reported.

The FDA approval, which Novartis had expected in the second half of this year, could help to compensate for the recent FDA delay of a Sandoz version of GlaxoSmithKline’s asthma and chronic obstructive pulmonary disease drug Advair (fluticasone propionate and salmeterol inhalation powder), analysts said. That drug’s launch is now unlikely before 2019.

“The earlier than expected authorization [of Glatopa] and commercial launch might add an estimated $200 million to Sandoz’ 2018 top line, translating in a low-single-digit divisional growth,” said Baader Helvea analyst Bruno Bulic. “We see ... Glatopa 40 mg offsetting the Advair setback and reiterate our buy rating.”

Novartis developed Glatopa with Massachusetts-based Momenta Pharmaceuticals.

Teva last week forecast sales of Copaxone would fall to $1.8 billion in 2018 from $3.8 billion last year.

“We have anticipated and planned for a second generic Copaxone to enter the market in 2018,” Teva said in an emailed statement to Reuters. “We remain committed to providing Teva’s Copaxone 40 mg to patients and continuing to support our patients.”

Source: Reuters; February 13, 2018.