Pfizer reported earnings today, including good news for Novartis and partner Momenta. Pfizer says the FDA has upgraded the compliance status on a fill-finish plant in Kansas, lifting the hold that has kept Novartis and Momenta from getting FDA approval for their long-acting Copaxone generic.
Pfizer said the FDA this month upgraded the status of its McPherson, Kansas, manufacturing facility to Voluntary Action Indicated based on an October 2017 inspection. It said that in addition to lifting the compliance hold “on approval of pending applications,” it was a step toward resolving the issues cited nearly a year ago in an FDA Warning Letter for the facility.
Cambridge, Massachusetts-based Momenta today passed the word to shareholders. It prefaced (PDF) the news by saying that while its copy, Glatopa 40 mg, remains under regulatory review, the company believes the application review could be completed at any time now that the plant status has changed.
“We are extremely pleased with this outcome. This past year of uncertainty regarding the resolution of the McPherson facility warning letter has been difficult for Momenta and its shareholders, but with this announced change in status we believe we are well-positioned to gain marketing approval and launch our Glatopa 40 mg in the first half of 2018,” stated Craig Wheeler, Momenta CEO. “We remain committed to our goal of providing patients with relapsing forms of multiple sclerosis a more affordable, high-quality treatment option.”
Momenta and Novartis' Sandoz unit already has a 20 mg Glatopa dose on the market, but the long-acting 40 mg dose is the real prize. The partners had expected to be first to market, but the FDA’s February 2017 warning letter to Pfizer threw those plans off track and already the market has changed.
Mylan won a surprise FDA approval of its 20 mg and 40 mg Copaxone copies in October. Since then, Mylan’s knockoff has already claimed a 10% share of the total-prescriptions pie, Credit Suisse analyst Vamil Divan, M.D., wrote to clients recently. And that was based on IMS Health data as of the week ended Dec. 22. He said that Teva’s long-acting Copaxone continued to have a 72% share, while Teva’s original formulation of the multiple sclerosis blockbuster, Copaxone 20 mg, still had 12%.
It is not only Pfizer’s CMO clients that will benefit from the change of status at the McPherson plant. The New York-based drugmaker had it own proposed epoetin alfa ( Epogen) biosimilar sidelined by a complete response letter in June that was tied to issues raised in the FDA warning letter for the fill-finish facility.
The Kansas plant is one of the facilities the company got in its $15 billion buyout of Hospira in 2015. The scathing warning letter in February scolded Pfizer for its failure not to recognize long ago there were issues that needed addressing since the agency had cited five other Hospira plants for similar problems in four warning letters issued in 2010, 2013, 2014 and 2015. At the time that Pfizer bought Hospira, it had assured investors that its superior quality assurance programs would quickly resolve problems at the Hospira plants.
The drugmaker says it will be making investments in its U.S. manufacturing operations. In its earnings today, Pfizer said U.S. manufacturing would get at least some of the $5 billion it will invest in capital projects in the U.S. in the next five years.