Momenta announced its quarterly financial results yesterday, providing an update on the patent litigation front as well. Based on historical timelines, it expects Sanofi's appeal of the court ruling to take six to nine months. This has no effect on when the FDA will rule on its generic drug application for Lovenox.
If Momenta or other generic competitors like Teva Pharmaceuticals
Speaking of which, Momenta expects to hear back sometime between now and August on whether it can market a generic Lovenox, based on its previous estimates of an 18-to-24-month review period for its Abbreviated New Drug Application. On the conference call, though, Momenta said that this was its own estimate of the review period length, not any sort of official FDA guidance, so there may be some degree of optimistic spin on this timeline.
In regards to its finances, Momenta expects cash burn in the range of $50 million to $60 million for 2007, which will leave it at year's end with $131 million to $141 million in cash. That gives it more than enough money to move anticoagulant drug M118 into phase 2 trials later in the year. Investors don't seem to be giving this early-stage compound much thought at the moment, but if the phase 1 study results are positive, this drug could be worth more than Momenta's generic Lovenox -- if it can make it to market.
With so much going on, the rest of 2007 is sure to be a wild ride for Momenta investors.