Editor’s Note: The Warning Letter issued to Pfizer, dated February 14, 2017, has now been posted on the US Food and Drug Administration website, fda.gov.

Momenta Pharmaceuticals, a Cambridge, Massachusetts-based biotechnology company, which is partnered with Sandoz, the generic drug arm of Novartis, for Glatopa (glatiramer acetate injection), a generic version of Teva Pharmaceutical Industries’ blockbuster multiple sclerosis drug, Copaxone (glatiramer acetate injection), reported a delay in the regulatory review of a 40-mg formulation of the drug due to a manufacturing issue with the contract manufacturer of the fill-finish of the product. Momenta was informed by Pfizer, Sandoz’s contracted fill/-finish manufacturing partner for Glatopa, that it had received a Warning Letter from the US Food and Drug Administration (FDA) relating to a May to June 2016 FDA inspection of Pfizer’s fill-finish facility in McPherson, Kansas.

Momenta and Sandoz have a collaboration agreement for Glatopa under which Sandoz is responsible for manufacturing. In 2015, Sandoz launched a 20-mg formulation of the drug, and the companies had filed an abbreviated new drug application (ANDA) with the FDA for the 40-mg formulation of the drug. Teva successfully applied a generic defense strategy for Copaxone when it launched the 40-mg/mL formulation of the product with a three-times a week dosing regime following the patent expiration of a first-generation 20-mg/mL formulation with more frequent dosing. Patents covering Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. The 40-mg/mL Copaxone was launched in the US in January 2014 and was approved in Europe in December 2015.

The Pfizer facility is a key part of the supply chain for Momenta’s Glatopa products, generic versions of Teva’s Copaxone (glatiramer acetate injection). Copaxone is a top-selling drug for Teva with 2016 sales of $4.2 billion.

The Warning Letter, which relates to a May to June 2016 FDA inspection of Pfizer’s fill/finish facility in McPherson, Kansas, is expected to impact the timing for approval of Momenta’s/Sandoz’s Glatopa 40-mg formulation of product, according to Momenta in a February 21, 2017 investor call. Pfizer has indicated that the Warning Letter does not restrict the production or shipment of the Glatopa 20-mg product that is currently marketed by Sandoz in the US.

In a company statement, Pfizer confirmed that it received a Warning Letter from the FDA with respect to its McPherson manufacturing facility. Pfizer gained the facility through its $17-billion acquisition of Hospira in 2015. “We responded to the questions raised during the inspection of our manufacturing site in May 2016 and submitted a corrective and preventive action plan to the FDA at that time,” said Pfizer in a statement. “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. We also have conducted an assessment and concluded that the issues cited in the Warning Letter do not have any impact on products that are currently on the market that were manufactured at the McPherson site.”

Sandoz’s ANDA for Glatopa 40 mg remains under regulatory review with the FDA. Under FDA policy, approval is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product. Momenta expects that an approval in the first quarter of 2017 is unlikely. Momenta does not yet have an estimate for the timing of the resolution but  said it is working with Sandoz, Pfizer, and the FDA to resolve the issue, Momenta said in its conference call.

Source: Momenta Pharmaceuticals and Pfizer