Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Manufacturing Delay Of Generic Drug From Pfizer Inc. (PFE) A Relief For Teva Pharmaceutical Industries Ltd (ADR) (TEVA)

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.

Pfizer PFE pharmaceutical stock

pio3 /

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 Pharmaceuticals, Inc. (NASDAQ:MNTA)/Sandoz’s supply chain for 40-milligram Glatopa. Apparently, Teva Pharmaceutical Industries Ltd (ADR) (NYSE: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.

Follow Teva Pharmaceutical Industries Ltd (NYSE:TEVA)
Trade (NYSE:TEVA) Now!

What Next For Pfizer And Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA)

Pfizer Inc. (NYSE:PFE) 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.

Follow Momenta Pharmaceuticals Inc (NASDAQ:MNTA)
Trade (NASDAQ:MNTA) Now!

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 Inc. (NYSE:PFE). Meanwhile, Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA)’s stock closed at $36.65 witnessing an increase of $1.45 or 4.12%.

Follow Pfizer Inc (NYSE:PFE)
Trade (NYSE:PFE) Now!

Note: This article is written by Andy Parker and originally published at Market Exclusive.