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Novartis gains U.S. approval for delayed MS drug

ZURICH (Reuters) – Novartis’s Sandoz division has gained U.S. approval for a bigger dosage of its Glatopa drug for a number of sclerosis (MS) sufferers, ending a expensive delay that allowed rival generics makers to beat it to market.

The U.S. Food and Drug Administration (FDA) accepted a 40 milligrams per milliliter injection of the Novartis copy of Copaxone, Teva’s blockbuster medication, Sandoz mentioned in an announcement on Tuesday.

Israel-based Teva Pharmaceutical Industries started dealing with competitors for its 40 mg model of Copaxone from Mylan in October and has been bracing for extra copycat variations of its bestselling drug.

Its New York-listed shares have been down 2 p.c in premarket commerce having been down four p.c earlier.

Sandoz started promoting a 20 mg/ml Glatopa dosage to U.S. sufferers with relapsing MS in 2015 however missed out on hundreds of thousands of in gross sales after the double-dosage model was pushed again final yr after contamination issues on the Pfizer fill-and-finish plant being utilized by Sandoz.

The FDA approval, which Novartis had anticipated within the second half of this yr, might assist to compensate for the latest FDA delay of a Sandoz model of GlaxoSmithKline’s bronchial asthma and COPD drug Advair, analysts mentioned. The drug’s launch is now unlikely earlier than 2019.

“The earlier than expected authorisation (of Glatopa) and commercial launch might add an estimated $200 million to Sandoz’ 2018 top line, translating in a low-single-digit divisional growth,” mentioned Baader Helvea analyst Bruno Bulic.

“We see … Glatopa 40mg offsetting the Advair setback and reiterate our buy rating.”

Novartis developed Glatopa with Massachusetts-based Momenta Pharmaceuticals.

Teva final week forecast gross sales of Copaxone would fall to $1.eight billion in 2018 from $three.eight billion final yr.

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

FIRST TO MARKET

The Pfizer plant issues scuttled plans to have the bigger Glatopa dosage on sale first in 2017, permitting Mylan to muscle in on profitable market share with its quicker-to-market Copaxone copy.

Pfizer mentioned final month that the FDA had upgraded the compliance standing of its Kansas facility, clearing the way in which for the Novartis-Momenta medication.

Overall, Sandoz has been a drag on Novartis ends in latest months, with its tablets portfolio significantly delicate to U.S. value stress. The division’s gross sales fell 1 p.c final yr to $10.1 billion and Novartis expects gross sales to be dented by stagnating or declining income at Sandoz in 2018.

Novartis is reviewing Sandoz’s U.S. tablets enterprise for a possible disposal and goals to give attention to extra complicated injectible medication in its generics portfolio, corresponding to Glatopa, in addition to biosimilars.

“The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products,” Sandoz head Richard Francis mentioned in an announcement.

Additional reporting by John Revill and by Tova Cohen in Tel Aviv; Editing by David Goodman and Jane Merriman

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