Momenta says Pfizer will fix plant but reiterates that Glatopa 40mg ANDA delay likely

By Gareth Macdonald contact

- Last updated on GMT

Momenta predicts problems at Pfizer plant will be resolved in 2017

Related tags: Teva pharmaceutical industries, Generic drug, Food and drug administration, Pfizer

Momenta Pharmaceuticals has reiterated its belief that problems at a US Pfizer plant mean the FDA is unlikely to reach a decision on its 40mg version of Teva’s Copaxone before April.

Last week​ Momenta said problems at the McPherson, Kansas facility would delay the agency’s decision on an abbreviated new drug application (ANDA) for Glatopa 40mg which was submitted by partner Sandoz.

CEO Craig Wheeler reiterated this view at Momenta’s fourth quarter earnings call last night (transcript on Seekingalpha​) commenting that “we do not yet have an estimate of the timing of resolution​.”

He declined to provide details of the deficiencies, saying that “there are multiple finish lines in the plant and those observations accrued in the plant but they did not accrue specifically to Glatopa​.”

Wheeler did stress, however, that the inspection took place in June last year adding that, according to Pfizer, many of the problems identified by the FDA in the as yet unpublished warning letter have been resolved.

He also hinted the firm is making contingency plans, telling analysts "I think at this point in time, we remain pretty confident that we will be able to resolve whatever issues there are existing in the McPherson plant, but obviously we’ll be looking at all of other options​.”

Revenues

Wheeler also made clear that the 20mg version of the drug – which is also fill/finished at the facility – will not be impacted by the problems.

Momenta reported that the 20mg strength version of Glatopa generated revenue of $75m (Eur71m) last year, up from $43m in 2015. 

The firm claims the product has a 20% share of the multiple sclerosis market with Teva Pharmaceutical Industries' originator holding the rest.

Competition

Momenta is not the only firm to have sought Pfizer’s support to launch a Copaxone (glatiramer acetate injection) generic in the US.

In 2015, Synthon granted Pfizer exclusive US commercialization rights to 20mg and 40mg versions of the multiple-sclerosis drug. According to the deal Synthon will manufacture the products with Pfizer’s sole responsibility being commercialization.

Synthon did not respond when we asked for confirmation.

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