Teva, which has lost court battle after court battle to stave off generics of its top-selling MS drug Copaxone, has caught a lucky break that has nothing to do with its frantic legal efforts. The impending approval of a copy of Teva’s long-acting Copaxone version from Momenta is now expected to be delayed because the Pfizer plant where it is being finished was slapped with an FDA warning letter.
Momenta and partner Sandoz, which already have a 20 mg version on the market, had expected approval of the more valuable 40 mg dose any day, putting it in position to reap some of the $3.6 billion in sales the Teva drug earned last year. But late Friday the Cambridge, Massachusetts-based biotech announced that because of the warning letter, “Momenta expects that an approval in the first quarter of 2017 is unlikely.”
The drugmaker said it is working with Sandoz to deal with the matter but that an approval of the 40 mg version of Glatopa depends on Pfizer resolving the FDA’s compliance concerns at the fill-finish plant. The Pfizer plant also does the fill-finish work on the 20 mg version but has told Momenta and Sandoz the warning letter does not affect supply of that version.
In an emailed statement, Pfizer said the plant that received a warning letter was a site in McPherson, Kansas. That is a facility the company picked up in its 2015 buyout of Hospira and one where the FDA has found repeated issues: the plant has received Form 483 during inspections every year beginning in 2012, including during an inspection last year, according to HealthCo Research.
Pfizer said it has responded to the questions the FDA raised during its May 2016 inspection and that it has determined the FDA concerns do not impact any products currently on the market.
"Since the inspection, the McPherson site has been diligently implementing commitments made to the FDA. We will continue to identify assessments and potential corrective actions to ensure the FDA’s observations are addressed."
It a big break for Teva, which has repeatedly lost its court battles over the Copaxone patents. Just last month, the Israeli drugmaker had four patents on the long-acting Copaxone overturned by a federal court in Delaware paving the way for generics to soon hit.
“For Teva, this is a much needed relief, reducing odds of generic entry in the near future and materially reducing risk for breaching covenants/having to eliminate dividend,” Bernstein analyst Ronny Gal told investors after the news.
Gal said this just delays the inevitable. He expects the Momenta and Sandoz version to eventually get approval, as well as copy from other generic makers. In fact, the Momenta problem could be a break as well for Mylan, which also is seeking approval of a Copaxone generic and may now be the first to market.
Just how long the anticipated approval of the Momenta drug will be delayed is hard to say. EvercoreISI analyst Umer Raffat and his cohorts analysed 20 years of FDA warning letters related to cGMP manufacturing and found that, on average, it has taken 17 months to get them resolved. The median was 13 months and the shortest was resolved in five.
The Momenta situation is just the latest in what has become a significant string of drug approvals delays tied to manufacturing problems. In October, Sanofi and partner Regeneron received a complete response letter for their experimental IL-6 inhibitor sarilumab, an expected blockbuster that will compete with AbbVie’s Humira. The CRL was issued because Sanofi had still not resolved to the FDA’s satisfaction compliance issues at a fill-finish plant in France.
Sanofi CEO Olivier Brandicort said earlier this month that the FDA has indicated its response about fixing the issues are acceptable and that he expects the FDA to return soon for a reinspection that could lead to approval of the drug.
In December, Roche said the FDA had delayed the PDUFA date for its new MS drug candidate Ocrevus by three months because of questions it had over production of the drug.