After a long and arduous seven-year review Momenta has finally won FDA approval for its generic version of Teva’s blockbuster multiple scelrosis drug, Copaxone. Ongoing legal wrangling over a pivotal September patent seems to have ruled out an immediate launch, but with a court decision due any time, the company and its partner Sandoz should not have much longer to wait.
An at-risk launch before then is still a possibility, of course, but few seem to consider it likely. Still, Momenta has made it clear that the warehouses are sufficiently stocked for whenever Sandoz decides to pull the trigger, and with other copycats awaiting an FDA verdict the risk is there for the taking.
A 4% dip in Teva’s share price yesterday suggests that some believe cut-price competition will reach the market sooner than September, although the drop also likely reflects the removal of an outside chance that the FDA would never have become comfortable enough to approve a Copaxone generic. The complexity of the glatiramer acetate molecule and the fact that it is hydrolysed almost as soon as it is injected, making bioequivalence testing difficult, made the US regulator exceptionally cautious in its assessments.
And Momenta and Sandoz might not need to go at risk with Glatopa, as the product is to be branded. If the appeal court with which the case currently rests invalidates the September 1 patent launch can go ahead immediately. The timing of such judgements is almost impossible to predict.
Teva itself has based financial guidance for the year on the appearance in September of two generic competitors for the 20mg or once-daily drug; a Mylan product licensed from Natco is considered the second contender. Consensus sales forecasts from EvaluatePharma show that analysts expect Mylan also to launch this year.
Estimates are not available for Sandoz; the product is probably not judged sufficiently sizeable to move the needle for the Novartis unit. And figures for Momenta in the table below are alliance revenues, not in-market sales.
|The Copaxone landscape|
|Annual sales ($m)|
|Glatopa (M356)||Branded generic||Sandoz (Novartis)||not available||Approved|
|Glatopa (M356)||Branded generic||Momenta*||-||49||188||203||Approved|
|Glatiramer acetate||Branded generic||Mylan||-||104||209||231||Filed|
|Glatiramer acetate 3TW||Branded generic||Dr. Reddy's Laboratories||-||-||40||50||Filed|
|*Figures reflect alliance revenues, not in-market sales. Source: EvaluatePharma.|
But Momenta stands to benefit from some chunky economics, with a 50% profit share worldwide, meaning that these numbers point to an assumption that Glatopa will be the more commercially successful copycat.
There is not much in it, however. Sandoz, which will ultimately make the decision, also has to consider that the longer it waits the more time Teva has to switch patients to the three-times weekly product, which has at least two years of patent protection left. This has been achieved very successfully to date, with around two thirds of Copaxone patients now thought to be on this schedule.
However, while these factors swing the decision towards an at-risk launch, the associated legal costs and any damages that might be awarded provide an equally persuasive case for waiting for the court decision.
Any notable step up in Teva’s efforts to drive switching to three-times weekly Copaxone could swing the decision back towards launching at risk, analysts at Leerink suggest.
But with less than five months before the patent expires a decision to wait a little bit longer would be understandable. And at the same time hope that Mylan and Natco are having just as hard a time in front of the FDA.