Pfizer Inc. (NYSE:PFE) has been slapped with a warning letter by the Food and Drug Administration in regards to one of its fill/finish factories. This will also have an impact on the Cambridge, Massachusetts-based Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), which is seeking collaboration with Novartis AG (ADR) (NYSE:NVS) subsidiary Sandoz on the generic drug. Of course, the news will cause a manufacturing delay of the generic version of MS drug Copaxone but it will also be a relief for Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) rival drug.
The warning letter was about compliance issues associated with multiple sclerosis drug Glatopa and was particularly about a site in McPherson, Kansas. According to a HealthCo Research, the facility has been having repeated issues and over the years, it has received Form 483 during inspections.
The impacts of the warning letter and the manufacturing delay
The warning letter was obviously unexpected; hence it is likely to result in some major consequences. It is not likely that the 40-mg drug in Q1will gets an endorsement from the FDA. Momenta says, “Under FDA policy, an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product.”
It is worth mentioning that the factory is a primary resource of Momenta/Sandoz’s supply chain for 40-milligram Glatopa. Apparently, Teva has in the previous past lost a couple of court battles over the Copaxone patents; thus the more reason it will be celebrating the new twist of events. Bernstein analyst Ronny Gal told investors that the delays will reduce a possible generic entry in the near future.
What next for Pfizer and Momenta
Pfizer claims that it has responded to questions raised by the FDA during the May 2016 inspection. The company also sounds confident that the latest concerns will not have any impact on the rest of its products.
Apparently, there has been a notable significant string of drug approvals delays most of them linked to manufacturing problems. Nonetheless, they all get resolved with time. It remains to be seen how soon the FDA will recall its warning letter to Pfizer. Meanwhile, Teva’s stock closed at $36.65 witnessing an increase of $1.45 or 4.12%.