Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
6,716.09
(
0.25%
)
US TECH 100
24,132.40
(
0.00%
)
Dow Jones
46,993.26
(
0.10%
)
Brent Oil
99.32
(
-1.33%
)
Bitcoin
73,895.28
(
-0.06%
)
News Focus
News Focus

Replies to post #115006 on Biotech Values

Replies to #115006 on Biotech Values
icon url

dewophile

02/18/11 1:48 PM

#115110 RE: DewDiligence #115006

re GAD patents

Timing uncertain: District Court ruling on the ancillary lawsuit involving Teva’s “Gad” patents relating to measurement of molecular weight



it sounds like MNTA is going to work around these patents with alternate methods of measuring molecular weight. from the Q4 cc:


Duane Nash – Wedbush Securities

Good morning and thanks for taking the questions. Craig during the claim construction hearing for Copaxone, I believe your attorneys commented that your version of Copaxone mainly to be reformulated. Is that correct, if so could you clarify how long that may take?

Craig Wheeler

So first, I will assure you that our partner [ph] is not mean to be reformulated so and as of our attorney said that then I would want to what they were talking about but there were series of patents that have asserted here that we have – have to defend in the court but we have no reformulation required at all.

Rick Shea

Duane, let me just add, the Teva has a patents called a Gad patents where – which are used, it’s nothing is used to measure molecule weight. And so what was indicated in the course was that we needed or that we intended to use a different method for measuring molecule a weight, and so that would simply, had nothing to do with change in formulation.



it sounds as if MNTA needs to submit an amendment. the fact management does not think this will be rate limiting in approval tells me copaxone approval is at the earliest a late 2011 event

Duane Nash – Wedbush Securities

And, using a different method, would there be any FDA implications where you have to modify the filing in any way or -

Craig Wheeler

All of our methods have to be into our application.

Duane Nash – Wedbush Securities

So, changing this method would it incur any significant delay.

Craig Wheeler

We don't believe so.

icon url

DewDiligence

02/22/11 5:35 PM

#115292 RE: DewDiligence #115006

MNTA 2011 News Flow

[MNTA’s motion for expedited discovery in Lovenox case has been denied;
in place of the hearing on this motion that would have occurred on 3/11/11,
a hearing will occur on 3/15/11 regarding pretrial scheduling.]


Lovenox

• 15-Mar-2011: Court hearing on pretrial scheduling in NVS/MNTA’s patent-infringement suit against Teva.


Copaxone

• Soon: District Court ruling on Markman hearing. This may provide early feedback on the likely outcome of the Copaxone patent trial with respect to Teva’s Orange-Book and process patents.

• Timing uncertain: District Court ruling on the ancillary lawsuit involving Teva’s “Gad” patents relating to measurement of molecular weight.

• 2H11/1H12: Start of trial on validity/enforceability of Teva’s Orange-Book and process patents.

• Timing uncertain: FDA feedback on Copaxone ANDA. MNTA would presumably disclose these details only if they were deemed to have a material affect on the probability or timing of FDA approval.


Other programs

• Mid 2011: IND filing for M402, MNTA’s proprietary heparin-based cancer drug, followed by the start of a phase-1 trial.

• Timing uncertain: Announcements regarding MNTA’s FoB programs.

• Timing and occurrence uncertain: M118 partnership. (Phase-2b/3 trials in ACS are sufficiently large and expensive that MNTA will not conduct such trials without a partner.)