Just as Momenta Pharmaceuticals was about to reach its zenith, disaster struck. FDA approval of its generic form of the 40mg dose of Teva’s multiple sclerosis drug Copaxone had been expected any day; the delay of this approval owing to manufacturing issues is a severe blow for the company, more or less built around this one product. Momenta opened down 21% today.
It is a welcome reprieve for Teva, which ought to get another few months to wring what value it can from the branded drug; its shares were up 8% in early trading today. But Momenta’s manufacturing problems could represent an opening for other players, including Mylan. According to Momenta, first-to-file status, is shared between several generic forms of Copaxone. Exclusivity now seems to hinge on being the first to secure approval. The race is on.
The door to generic versions of Copaxone was opened last month when all but one of Teva’s remaining patents were struck down (Teva’s $1bn Copaxone blow, January 31, 2017). One patent remains, but is widely expected to be insufficient to put generics makers off.
Having secured FDA approval for a generic 20mg dose, Glatopa 20mg, Momenta and its partner Novartis were widely expected to be first to secure FDA approval of their 40mg generic – worth much more, since this less frequently administered dose represents around 80% of the commercial value of the Copaxone franchise.
Momenta no longer expects approval this quarter after the Pfizer facility, in which syringes are filled with the drug, received a warning letter; the site is a former Hospira facility. Technically the wording used in the FDA letter is that the FDA “may” delay approval for drugs manufactured at the site, but Momenta is not confident that the approval will go ahead soon, and neither is anyone else.
Analysts from Bernstein write that it could be at least six months before Momenta can get Glatopa 40mg on the market, either through reapproval of the facility or Pfizer shifting manufacturing elsewhere. Other analysts from Evercore ISI and Leerink put the likely delay at 18 months and up to two years respectively.
Teva had previously guided to a generic 40mg entrant in mid-February.
On a conference call today, Momenta's chief executive, Craig Wheeler, said the FDA had not confirmed whether the review of Momenta’s ANDA for Glatopa 40mg was complete, but said there were no outstanding questions – so the warning letter was the only thing standing in the way of the generic’s approval.
The trouble is, this might be sufficient for someone else to steal Momenta’s thunder. The company says the ANDA is “prioritised as a first generic filing”, but on the call Mr Wheeler said Momenta was sharing first-to-file status with other generics companies.
“Our view of it is that it’s a shared first-to-file, because there was no patent filed in the Orange Book when we and others first filed our application,” Mr Wheeler said.
The status of first-to-file, and with it the valuable 180 days' exclusivity, is awarded to the first generic for which a substantially complete generic drug application is submitted to the FDA. This does not appear to apply here; according to Mr Wheeler, under the regulations of Paragraph IV a generic cannot be certified first-to-file unless there is a patent for the reference drug in the Orange Book.
This appears to mean in this case the market exclusivity will go to whichever generic gains approval first. Other companies readying Copaxone generics include Mylan, Pfizer and Synthon, Dr Reddy’s and Amneal. Mylan and Pfizer/Syntheon explicitly state that their candidates may be eligible for Hatch-Waxman exclusivity, so this is at least a three-way race.
And Momenta is some way behind the other competitors. If there is a lesson here, it is to choose a contract manufacturer with great care.