- Manufacturing infractions at a Pfizer facility will likely push back the Food and Drug Administration's approval decision for a new dose of Momenta Pharmaceuticals' generic multiple sclerosis drug.
- Momenta develops the drug, Glatopa (glatiramer acetate injection), a copycat to Teva's Copaxone, through a longstanding partnership with Novartis' Sandoz, which in turn contracted Pfizer to provide fill/finish services for a 40 mg dose of the treatment awaiting FDA approval. A 20 mg generic dose is already on the market.
- The letter stemmed from an inspection of the facility between May and June 2016, Momenta's CEO Craig Wheeler said during a Feb. 21 earnings call. Even though Pfizer told Wheeler's company it had already taken care of many of the FDA-cited problems, Momenta now expects an approval decision won't come during the first quarter.
Momenta could not provide further details on type or severity of the infractions or how long it would take for Pfizer to resolve them during that call. While the company said it is keeping its manufacturing options open, including potentially moving production to a second facility, it signaled optimism that the Pfizer plant would work out its issues.
Still, these new facility problems have taken much of the wind out of Momenta's sails. The company had just notched a huge victory last month, when the U.S. District Court for the District of Delaware invalidated four patents that Teva said Sandoz infringed upon with its production of the 40 mg Glatopa dose.
Momenta did clarify the warning letter did not reference the Glatopa 40 mg product, nor does it affect production or safety of the 20 mg dose, which gained U.S. approval in April 2015 and is produced along the same manufacturing line.
Conversely, the news could give Teva, which has fretted about generic competition to Copaxone for some time, a small respite. During its own fourth quarter earnings call, the Israeli drugmaker said such competition could siphon about $1.3 billion worth of revenue in 2017.
Glatopa 20 mg sales made up about 75% of Momenta's total revenues in 2016, and contributed to a 31% jump in Sandoz's annual biopharmaceutical sales.
"On our Glatopa application, we have no outstanding questions. We’ve answered everything. So, we don’t anticipate that there is anything significant beyond this warning letter," said Momenta's Wheeler. "But of course, it’s an FDA application. So, you can never be sure because they have a right to ask a question until the moment they actually give you the approval."