There has been a lot of news in the past several months about the possibility of legislation that would clear up the vague regulatory environment regarding how best to introduce generic equivalents of hard-to-characterize and biologic drugs. One drug developer unwilling to endure a potential years-long wait for this regulatory process to be finalized is Momenta Pharmaceuticals (Nasdaq: MNTA ) , which is attempting to introduce M-Enoxaprin, a generic equivalent of Sanofi-Aventis' (NYSE: SNY ) blockbuster blood thinner, Lovenox.
Last Friday, Momenta announced results from a fairly eventful third quarter. The first bit of positive news was that Momenta finally entered its own proprietary anti-coagulant, named M118, into clinical trials after several years of promising to do so. Results from the phase 1 trial for M118 will arrive in the first half of 2007.
During its conference call, Momenta finally formally announced that it was working on developing a generic version of the $1.4-billion-a-year drug Copaxone, used for the treatment of multiple sclerosis. This drug is designated M365 and is partnered with Sandoz, a subsidiary of Novartis (NYSE: NVS ) . Sales of Teva's (NYSE: TEVA ) Copaxone are up more than 20% this year, so becoming the only generic entrant against the drug would be huge, since the retail price of a generic drug averages 94% of the branded price when there's only one generic competitor.
In the short and intermediate term, much of the value of Momenta resides in its M-Enoxaparin program. The next big event for this drug candidate will be the upcoming patent trial over Lovenox; the inequitable-conduct portion of the case is slated to start Dec. 4. Results from this part of the trial are expected in the first quarter of next year. If successful, the case would most likely be appealed and ruled on again around next year's third quarter.
With two more undisclosed generic drugs in the works with partner Sandoz, Momenta isn't putting all its eggs in the anticoagulant drug basket. If (and that's a huge if) it can prove its technological prowess in developing generic versions of many of these difficult-to-reproduce drugs, shares of Momenta will be valued many times higher than today's price.