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Replies to #62941 on Biotech Values
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DewDiligence

05/27/08 3:43 PM

#62942 RE: ghmm #62941

>MNTA – On page three of the annual report (not the 10-k portion) there is the following text at the end of the M356 update We made significant progress in this program in 2007 and look forward to substantial advancement in 2008<

My interpretation of substantial advancement is that MNTA expects to submit the M356 (generic Copaxone) ANDA during 2008.
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ThomasS

05/29/08 12:57 AM

#62992 RE: ghmm #62941

MNTA: from my #msg-28933653 of 30 Apr:
MS webcast: My impressions based on statements:

Copaxone (M356)
MNTA states that they are in a "quiet period" of sorts. My take: FDA filing in 2008.

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ThomasS

05/29/08 2:42 AM

#62994 RE: ghmm #62941

MNTA: For the benefit of others, from the Annual Proxy {Looks as if generic M356 Copaxone made "substantial progress"}:

Under our annual incentive cash bonus program, corporate goals are proposed by management and approved by the
compensation committee and the entire board of directors. Each corporate goal is assigned a percentage value (e.g., 10%,
15%, 20%, etc.) and within each corporate goal there are achievement milestones that are expressed in the following target percentages: 70%, 100% and 130%. Each computed actual level of achievement is rounded up to the nearest whole number.
The corporate goals for 2007 were: advancement of the M-Enoxaparin program (15% for approval of the M-Enoxaparin
ANDA and 10% for supply chain development); the initiation of Phase 2a clinical trials for M-118 (15%); development of a
corporate strategy plan for future development and funding (10%); achievement of financial discipline goals (10%);
participation in the debate before Congress regarding potential follow-on biologics legislation (10%); and advancement of our M356 and glycoprotein programs (15% for each program). In early 2008, the CEO, with input from the executive officers, assessed our performance against corporate goals for 2007 and provided recommendations for the 2007 annual incentive cash bonus pool to the compensation committee. The compensation committee then reviewed and discussed these recommendations, taking into account mitigating and/or extraordinary circumstances. After discussion, the compensation committee determined that we had achieved 88% of the 2007 corporate goals, as follows:
Goal Percentage Value(%)/Actual Level of Achievement(%)

Approval of M-Enoxaparin ANDA
15/0
Timing of M-Enoxaparin Supply Chain Development:
Drug Substance Related

5/130
Timing of M-Enoxaparin Supply Chain Development:
Drug Product Related

5/70
Initiation of M118 Phase 2a Clinical Trials
15/100
Develop Corporate Strategy for Future Development and Funding
10/70
Financial Discipline Goals
10/100
Participation in the Debate before Congress regarding Potential Follow-on Biologics Legislation
10/100
Advancement of our M356 Program
15/130
Advancement of our Glycoprotein Programs
15/100

Total: 100/88