Two notable events today in the world of Momenta.
First, TEVA held its quarterly conference call. All ears were tuned for the status of TEVA's generic Lovenox ANDA application. When MNTA received approval in July 2010, TEVA claimed their approval was just a month behind.
....Then approval was to be autumn
...Then they would be disappointed if no approval by year-end 2010
...Finally in January, TEVA announced that it had received a Minor Deficiency Letter from the FDA, which means they had to respond to concerns and approval was at least 6 months away most likely.
...Now today, they don't even want to talk about this drug candidate. Here is the quote from Bill Marth himself:
"We hope to lanuch enoxaparin in 2011, but we really are not going to talk much about that at this point in time"
...Part of the sudden reticence to talk about this program may be that MNTA has sued TEVA, claiming that their patents cover the methods TEVA is using to make its generic Lovenox.
All this contributes to the very real possibility that MNTA/NVS will remain on the market as the only generic Lovenox, capturing roughly half of a multi-BILLION market. TEVA has been spouting off for so long that MNTA's stock is valued for approval of the TEVA drug, or worse. In the meantime, the cash keeps rolling in and MNTA is a great bargain.
Secondly, after the market close, MNTA announced the issuance of a US patent related to their generic Copaxone program- which of course is the largest contributor to TEVA's profits.
For more information on these complicated saga, the following message board link is a great compilation of relevant information
First, TEVA held its quarterly conference call. All ears were tuned for the status of TEVA's generic Lovenox ANDA application. When MNTA received approval in July 2010, TEVA claimed their approval was just a month behind.
....Then approval was to be autumn
...Then they would be disappointed if no approval by year-end 2010
...Finally in January, TEVA announced that it had received a Minor Deficiency Letter from the FDA, which means they had to respond to concerns and approval was at least 6 months away most likely.
...Now today, they don't even want to talk about this drug candidate. Here is the quote from Bill Marth himself:
"We hope to lanuch enoxaparin in 2011, but we really are not going to talk much about that at this point in time"
...Part of the sudden reticence to talk about this program may be that MNTA has sued TEVA, claiming that their patents cover the methods TEVA is using to make its generic Lovenox.
All this contributes to the very real possibility that MNTA/NVS will remain on the market as the only generic Lovenox, capturing roughly half of a multi-BILLION market. TEVA has been spouting off for so long that MNTA's stock is valued for approval of the TEVA drug, or worse. In the meantime, the cash keeps rolling in and MNTA is a great bargain.
Secondly, after the market close, MNTA announced the issuance of a US patent related to their generic Copaxone program- which of course is the largest contributor to TEVA's profits.
For more information on these complicated saga, the following message board link is a great compilation of relevant information
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