The Pfizer fill-finish plant whose manufacturing problems have gut-punched the expected approval of a generic of Teva’s long-acting Copaxone is a former Hospira plant with a history of issues.
Execs at Momenta, which is developing the generic drug with Sandoz, said this week that they think an approval is still possible this year, but at least one researcher that has taken a deep dive into the Form 483 issued to the plant says he will be surprised if the issues can be resolved before late next year.
The FDA issued a warning letter last week to the McPherson, Kansas, plant which is handling the fill and finish of Glatopa for Momenta and Sandoz. The facility already produces their 20-mg version, which was approved in 2015, and which Pfizer says is unaffected by the warning letter. The more valuable long-lasting 40-mg dose was expected to be approved this quarter.
“...(W)e did learn a little bit about the warning letter and how long it takes to resolve and so, what we signaled in our release is that we believe it is still possible to see an approval this year,” Craig Wheeler, CEO of Cambridge, Massachusetts-based Momenta, told analysts Tuesday, according to a Seeking Alpha transcript of its earnings call.
Pfizer said in an email that since an inspection last May which resulted in a Form 483, “the McPherson site has been diligently implementing commitments made to the FDA” and the company will continue to identify potential corrective actions to make sure the observations are addressed.
But in a note to clients this week, Manoj Garg of HealthCo Research, pointed out the long history of issues at the former Hospira plant which Pfizer got with its 2015 buyout of the generic drugmaker. He said the plant received Form 483s in quarter one 2012, quarter two 2012, quarter three 2013, quarter four 2014, quarter two 2015, and most recently in quarter two 2016 after the inspection in May and June.
“The situation at McPherson is even more concerning in that a $120 million modernization initiative was announced in June 2014 for that facility,” his note says.
Healthco, which obtained copies of the documents, said the Form 483 last June had 14 observations. Garg said that the company’s assessment is the “current Warning Letter situation is likely to persist into at least late-2018/early-2019.”
Other analysts have also suggested the delay could run to next year. EvercoreISI analyst Umer Raffat and his staff analyzed 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 problem faced by Momenta is similar to approval delays for an increasing number of drugs in the last year. The FDA actually issued five complete response letters to drugmakers last year that were tied primarily to concerns the FDA had over manufacturing, more than 40% of the 12 CRLs the FDA issued in 2016. In 2014 and 2015, the FDA issued only one CRL each year tied to manufacturing concerns.
In one of the five situations last year, the drugmaker and its contractor were able to respond quickly and get the drug approved in a matter of months, but the other four have yet to be approved although the FDA has accepted resubmissions for two of them.