MOLECULAR INSIGHT PHARMACEUTICALS, INC.
160 Second Street
Cambridge, Massachusetts 02142
October 29, 2009
VIA EDGAR AND FEDERAL EXPRESS
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington D.C. 20549
Mail Stop 4720
| | |
Re: | | Molecular Insight Pharmaceuticals, Inc. |
| | Form 10-K for the Fiscal Year Ended December 31, 2008 |
| | Schedule 14A |
| | File Number: 001-33284 |
Dear Mr. Riedler:
We are in receipt of your letter dated September 21, 2009, containing the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on Form 10-K of Molecular Insight Pharmaceuticals, Inc. (the “Company”) for the Fiscal Year Ended December 31, 2008 and Schedule 14A.
On September 30, 2009, we sent you a letter via EDGAR requesting that our response time be extended to October 30, 2009.
Set forth below are our responses to the comments of the Staff. For your convenience, the full text of each of the Staff’s comments is set forth below, and the Company’s response to each comment directly follows the applicable text.
Form 10-K
Business
Patents and Proprietary Rights, page 10
| 1. | Please provide proposed disclosure to be included in your next Form 10-K which expands your discussion to identify which patents are related to which product families, the range of expiration dates of those patents, and the same details about your in-licensed patents. |
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 2
Response
In response to the Staff’s comments, we are providing to the Staff the following draft narrative disclosure, which expands our discussion of our patents, owned and in-licensed, to include identification of which patents are related to which product families and the range of expiration dates of those patents. The draft disclosure will be included in the section of “Patents and Proprietary Rights” under “Item 1. Business” of the Company’s annual report on Form 10-K for the Fiscal Year ended December 31, 2009 (the “2009 Annual Report”). The draft disclosure is subject to update and modification to reflect any changes to the status of patents or patent applications as of December 31, 2009. We confirm, however, that the actual disclosure in the 2009 Annual Report will include disclosure substantially similar to the draft narrative.
As of December 31, 2009, we had 12 issued U.S. Patents, 17 U.S. Pending Patent Applications, 28 Granted Foreign Patents, and 43 Pending Foreign Patent Applications, that have been nationalized in various countries. Additionally, we have obtained licenses from third parties for the patent rights to U.S. and foreign patents and patent applications to make, use, sell and import certain proprietary technologies and compounds. Patent rights for in-licensed technologies are not included in the above totals. While our patents and patent applications may be important for certain aspects of our business, such as those related to specific product candidates such as BMIPP derivatives whose patents and applications expire between 2016 and 2023, we believe that our success also depends upon innovation, technical expertise, and responsiveness to the medical needs of an aging patient population. While our patented technology may delay or deter a competitor in offering a competing product, we believe our technical capability could allow us to obtain limited market exclusivity in the United States under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, and abroad through similar legislation. Patents owned or in-licensed by us that we consider important to our business include the following:
Molecular Imaging Pharmaceutical Product Candidates
Zemiva - We own patents directed to specific stereoisomers of Zemiva and the use of these stereoisomers as imaging agents (Table 1). All patents in this family are set to expire in November 2016. We are also pursuing three additional patent families (in the United States and internationally) to provide up to 18 years of new patent-based exclusivity for certain aspects of BMIPP and BMIPP-derivative compositions and their uses, with the patent and patent applications expiring generally in 2023.
| | | | | | | | |
TABLE 1 |
|
Stereoisomers of Fatty Acid Analogs for Diagnostic Imaging |
| | | | |
Country | | Status | | Appl. Date | | Appl. No. | | Patent No. |
EPO | | Granted | | 11/25/1996 | | 96941503.3 | | 0869821 |
United Kingdom | | Granted | | 11/25/1996 | | 96941503.3 | | 0869821 |
Spain | | Granted | | 11/25/1996 | | 96941503.3 | | 0869821 |
Netherlands | | Granted | | 11/25/1996 | | 96941503.3 | | 0869821 |
Italy | | Granted | | 11/25/1996 | | 96941503.3 | | 0869821 |
Germany | | Granted | | 11/25/1996 | | 96941503.3 | | P69636881.1 |
France | | Granted | | 11/25/1996 | | 96941503.3 | | 0869821 |
EPO | | Pending | | 11/25/1996 | | 06025944.7 | | |
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 3
| | | | | | | | |
TABLE 1 |
|
Stereoisomers of Fatty Acid Analogs for Diagnostic Imaging |
| | | | |
Country | | Status | | Appl. Date | | Appl. No. | | Patent No. |
Hong Kong | | Pending | | 11/25/1996 | | 07110322.1 | | |
Hong Kong | | Granted | | 11/25/1996 | | 99101613.7 | | HK1016494 |
Canada | | Granted | | 11/25/1996 | | 2238860 | | 2238860 |
Japan | | Granted | | 11/25/1996 | | 09-520669 | | 4272259 |
Japan | | Pending | | 11/25/1996 | | 2008-006447 | | |
U.S.A. | | Granted | | 05/5/2003 | | 10/429416 | | 7005119 |
U.S.A. | | Granted | | 11/16/2005 | | 11/274505 | | 7314609 |
U.S.A. | | Pending | | 4/2/2008 | | 12/061528 | | |
Trofex - We own patent applications related to the composition and methods of use for MIP-1072 and MIP-1095 (Table 2). No application has been granted. Should any rights be granted in these applications, they would expire in November 2027.
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TABLE 2 |
|
Heterodimers of Glutamic Acid |
| | | |
Country | | Status | | Appl. Date | | Appl. No. |
U.S.A. | | Pending | | 11/7/2007 | | 11/936,659 |
Taiwan | | Pending | | 11/7/2007 | | 96142019 |
Australia | | Pending | | 11/7/2007 | | 2007316391 |
Brazil | | Pending | | 11/7/2007 | | PI0718700-9 |
Canada | | Pending | | 11/7/2007 | | 2669127 |
China | | Pending | | 11/7/2007 | | 200780049490.2 |
EPO | | Pending | | 11/7/2007 | | 07844938.6 |
India | | Pending | | 11/7/2007 | | 1787/KOLNP/2009 |
Japan | | Pending | | 11/7/2007 | | 2009-536459 |
Molecular Radiotherapeutic Oncology Product Candidates
Azedra - We have in-licensed patents and a pending application from The University of Western Ontario that relate to the precursor material, UltratraceTM benzyl guanidine, a process of preparing the precursor material, and Ultratrace™ technology used to produce Azedra (Table 3). These patents are set to expire in October 2018. The pending US application in the family has recently received a Notice of Allowance.
| | | | |
TABLE 3 |
|
Preparation of Radiolabelled Haloaromatics Via Polymer-Bound Intermediates |
| | |
Country | | Appl. Date | | Patent No./ Application Serial No. |
Canada | | 10/2/1998 | | 2345710 |
U.S.A. | | 8/20/2002 | | 7273601 |
U.S.A. | | 7/18/2000 | | 6461585 |
U.S.A. | | 9/5/2007 | | 11/850,306 |
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 4
Onalta- We have in-licensed certain patents and patent applications from Novartis Pharma AG and Mallinckrodt relating to certain aspects of Onalta. Tables 4-6 summarize the patents and patent application in-licensed from Novartis Pharma AG. Table 7 summarizes the patents and patent application in-licensed from Mallinckrodt. The patents summarized in Tables 4-7 will expire between November 2009 and September 2017.
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TABLE 4 |
|
Somatostatin Peptides for In Vivo Imaging of Somatostatin Receptor Positive Tumors and Metastasis |
| | |
Country | | Appl. Date | | Patent No. |
Australia | | 12/4/1989 | | 633859 |
Austria | | 11/30/1989 | | 403476 |
Belgium | | 12/5/1989 | | 1002296 |
Canada | | 12/4/1989 | | 2004532 |
Cyprus | | 8/30/1996 | | 1893 |
Denmark | | 12/5/1989 | | 175338 |
Finland | | 12/04/1989 | | 101967 |
Finland | | 12/4/1989 | | 102540 |
France | | 12/4/1989 | | 8915993 |
Germany | | 11/30/1989 | | 3991505 |
Great Britain | | 12/1/1989 | | 2225579 |
Greece | | 12/4/1989 | | 1002475 |
Hong Kong | | 12/21/1995 | | 1899/95 |
Hungary | | 6/15/1995 | | 211468 |
Ireland | | 12/4/1989 | | 62091 |
Israel | | 12/4/1989 | | 92534 |
Italy | | 12/6/1989 | | 1239285 |
Japan | | 8/4/1997 | | 3686503 |
Japan | | 12/4/1989 | | 2726320 |
Korea-South | | 12/4/1989 | | 156541 |
Luxemburg | | 12/5/1989 | | 87633 |
Malaysia | | 3/13/1990 | | 106120 |
Netherlands | | 12/4/1989 | | 194828 |
New Zealand | | 12/4/1989 | | 231623 |
Nigeria | | 12/5/1989 | | 10732 |
Pakistan | | 12/5/1989 | | 132014 |
Philippines | | 5/7/1993 | | 29649 |
Poland | | 12/4/1989 | | 163432 |
Portugal | | 12/4/1989 | | 92487 |
Singapore | | 12/1/1989 | | 38709 |
South Africa | | 12/5/1989 | | 89/9285 |
Spain | | 12/5/1989 | | 2023533 |
Sweden | | 12/4/1989 | | 8904087-7 |
Switzerland | | 11/30/1989 | | 678329-6 |
Tanganyika | | 12/1/1989 | | 2533 |
Trinidada + Tobago | | 12/1/1989 | | 78/95 |
USA | | 6/6/1995 | | 5753627 |
USA | | 6/6/1995 | | 5776894 |
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 5
| | | | |
TABLE 5 |
|
Therapeutic Use of Somatostatin Peptides |
| | |
Country | | Appl. Date | | Patent No. |
Belgium | | 2/19/1991 | | 1004645 |
France | | 2/18/1991 | | 9101993 |
Germany* | | | | |
Great Britain | | 2/18/1991 | | 2241167 |
Hong Kong | | 4/10/1997 | | 43497 |
Italy | | 2/19/1991 | | 1244496 |
Japan | | 2/21/1991 | | 3288055 |
Switzerland | | 2/19/1991 | | 683318-4 |
USA | | 6/13/1994 | | 6123916 |
* Germany: patent application still pending. Filing number: P4104308.1 | | | | |
| | | | | | | | |
TABLE 6 |
|
Chelated Peptides, Complexes Thereof Pharmaceutical Compositions Containing Them and Their Use as Radiopharmaceuticals |
| | | | |
Country | | Status | | Appl. Date | | Appl. No. | | Patent No. |
Argentina | | Granted | | 9/5/1995 | | 333413 | | AR256010M |
Australia | | Granted | | 9/4/1995 | | 30414/95 | | 703057 |
Austria | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Belgium | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Brazil | | Granted | | 9/5/1995 | | PI9503936-8 | | PI9503936-8 |
Canada | | Pending | | 9/5/1995 | | 2157530 | | |
Chile | | Granted | | 9/5/1995 | | 1351/95 | | 40732 |
China | | Granted | | 9/5/1995 | | 115610/95 | | ZL95115610.1 |
Colombia | | Granted | | 9/5/1995 | | 95040393 | | 27134 |
Czech Republic | | Granted | | 9/4/1995 | | PV1995-2263 | | 287012 |
Denmark | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Ecuador | | Granted | | 9/5/1995 | | SP 95-1528 | | PI 97-1158 |
Europe | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Finland | | Granted | | 9/4/1995 | | 4147/95 | | 117424 |
France | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Germany | | Granted | | 9/4/1995 | | 69520256.1 | | 714911 |
Great Britain | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Greece | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Hungary | | Granted | | 9/4/1995 | | 2577/95 | | 218284 |
India | | Pending | | 8/24/1995 | | 1092/MAS/95 | | |
Ireland | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Israel | | Granted | | 9/4/1995 | | 115154 | | 115154 |
Italy | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Japan | | Granted | | 9/5/1995 | | 227906/95 | | 3054346 |
Korea-South | | Granted | | 9/5/1995 | | 28905/95 | | 364111 |
Luxemburg | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Malaysia | | Pending | | 9/5/1995 | | PI95002626 | | |
Mexico | | Granted | | 9/4/1995 | | 9503785 | | 195731 |
Netherlands | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 6
| | | | | | | | |
TABLE 6 |
|
Chelated Peptides, Complexes Thereof Pharmaceutical Compositions Containing Them and Their Use as Radiopharmaceuticals |
| | | | |
Country | | Status | | Appl. Date | | Appl. No. | | Patent No. |
New Zealand | | Granted | | 9/4/1995 | | 272919 | | 272919 |
Norway | | Granted | | 9/4/1995 | | 19953457 | | 316569 |
Pakistan | | Granted | | 9/3/1995 | | 467/95 | | 134791 |
Peru | | Granted | | 9/4/1995 | | 277844 | | 001736 |
Philippines | | Granted | | 9/4/1995 | | 51237 | | 1-1995-51237 |
Poland | | Granted | | 9/4/1995 | | P310274 | | 182434 |
Portugal | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Russia | | Granted | | 9/4/1995 | | 95114740 | | 2156774 |
Singapore | | Granted | | 9/4/1995 | | 9501282-9 | | 50356 |
Slovak Republic | | Granted | | 9/4/1995 | | 1088/95 | | 283774 |
Slovenia | | Granted | | 9/4/1995 | | P9530491 | | 714911 |
South Africa | | Granted | | 9/6/1995 | | 95/7475 | | 7475/95 |
Spain | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Sweden | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Switzerland | | Granted | | 9/4/1995 | | 95810545.4 | | 714911 |
Taiwan | | Granted | | 9/8/1995 | | 84-109395 | | 114095 |
Thailand | | Granted | | 9/4/1995 | | 27824/95 | | 11623 |
Turkey | | Granted | | 9/6/1995 | | 1094/95 | | TR199501094B |
USA | | Granted | | 6/5/2000 | | 09/609844 | | 6277356 |
USA | | Granted | | 4/23/1997 | | 08/842125 | | 6183721 |
Venezuela | | Granted | | 9/6/1995 | | 1572-95 | | |
| | | | |
TABLE 7 |
|
Stabilizers to Prevent Autoradiolysis of Radiolabeled Peptides and Proteins |
| | |
Country | | App. Date | | Patent No. |
US | | 10/13/1993 | | 5,384,113 |
EPO | | 7/31/1992 | | EP 600 992B1 |
Austria | | 7/31/1992 | | AT 196428T |
Germany | | 7/31/1992 | | DE 69231469T |
Denmark | | 7/31/1992 | | DK 600 992 |
Spain | | 7/31/1992 | | ES 2150916T |
Greece | | 7/31/1992 | | GR 3035067T |
Canada | | 7/31/1992 | | CA 2113995C |
Japan | | 7/31/1992 | | JP 6510539T |
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 7
Solazed - The patent and patent applications relating to Solazed are provided in Table 8. Patent term for this family expires between March 2024 and March 2025.
| | | | | | | | |
TABLE 8 |
|
Radiohalogenated Benzamide Derivatives and Their Use in Tumor Diagnosis and Tumor Therapy |
| | | | |
Country | | Status | | Appl. Date | | Appl. No. | | Patent No. |
Argentina (AR) | | Pending | | 3/10/2005 | | P050100925 | | |
Bolivia (BO) | | Pending | | 3/10/2005 | | SP-250047 | | |
Chile (CL) | | Pending | | 3/10/2005 | | 0507-2005 | | |
Germany (DE) | | Pending | | 3/10/2004 | | 102004011720.9 | | |
Guatemala (GT) | | Pending | | 3/10/2005 | | PI-2005-0046 | | |
Malta (MT) | | Pending | | 3/3/2005 | | 2654 | | |
Malaysia (MY) | | Pending | | 3/8/2005 | | PI20050946 | | |
Panama (PA) | | Pending | | 3/10/2005 | | 86260-01 | | |
Peru (PE) | | Pending | | 3/10/2005 | | 000276-2005 | | |
El Salvador (SV) | | Pending | | 3/10/2005 | | E-3385-2005 | | |
Thailand (TH) | | Pending | | 3/8/2005 | | 098358 | | |
Taiwan (TW) | | Pending | | 3/10/2005 | | 094107360 | | |
United States (US) | | Granted | | 3/10/2005 | | 11/076023 | | 7427390 |
United States (US) | | Pending | | 9/10/2008 | | 12/207774 | | |
Uruguay (UY) | | Pending | | 3/10/2005 | | 28801 | | |
Venezuala (VE) | | Pending | | 3/10/2005 | | 2005-000421 | | |
Schedule 14A
Compensation Discussion and Analysis
Factors Considered to Determine Total Direct Compensation, page 20
| 2. | Your Compensation Discussion and Analysis does not disclose or quantify each of the individual or corporate objectives set for use in determining your executive officers’ bonus payments. Regardless of whether incentive bonuses were paid, you should disclose the goals that were set, and the extent of achievement of each of those goals. Please provide us with draft disclosure for your next proxy statement which provides the following: |
| • | | The performance objectives set by the compensation committee for 2009; |
| • | | Confirmation that you will discuss the achievement of the objectives; and |
| • | | A discussion of how the level of achievement will affect the actual bonuses to be paid. |
To the extent that the objectives are quantified, the discussion in your proxy statement should also be quantified.
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 8
Response
In response to the Staff’s comments, we are providing to the Staff on a supplemental basis draft narrative disclosure relating to the Company’s annual cash bonus plan to be included in the Company’s proxy statement on Schedule 14A for its 2010 annual meeting of stockholders (the “2010 Proxy Statement”). Because the actual annual cash bonus plan disclosure in the 2010 Proxy Statement will depend on (i) the financial performance of the Company and the individual performance of each of the named executive officers; (ii) the determinations made by the Compensation Committee relating to whether the financial and individual performance goals relating to the annual cash bonus were achieved and to what extent; (iii) the recommendations of the Chief Executive Officer with respect to the performance of each of the named executive officers other than himself; and (iv) the subjective judgment of the Compensation Committee as to the achievement of the financial and individual performance goals, the draft disclosure is subject to change and modification based on actual facts and circumstances. We confirm, however, that the 2010 Proxy Statement will include disclosure substantially similar to the narrative included in the draft disclosure relating to (i) the identification of the performance goals under the annual cash bonus plan; (ii) the achievement of the financial and individual performance goals by the Company and the named executive officers, as applicable; (iii) the impact of the level of achievement of the financial and individual performance goals on the amount of cash bonus to be paid to each individual named executive officer; and (iv) the quantification of the various financial and individual performance goals.
The draft narrative provides sample disclosure on an individual basis for each of the current President & Chief Executive Officer and Executive Vice President & Chief Scientific Officer. The actual narrative in the 2010 Proxy Statement will include comparable disclosure for each of the named executive officers identified as such in the 2010 Proxy Statement. We have not attempted to identify other named executive officers in the draft narrative at this time as, other than with respect to the Chief Financial Officer, the identity of those named executive officers will not be known until the Compensation Committee makes and/or finalizes, as applicable, all of the executive compensation decisions for 2009. We believe that the narrative disclosure of the President & Chief Executive Officer’s and Executive Vice President & Chief Scientific Officer’s individual goals provides the Staff with the best model of the detailed form that the draft narrative will take.
We are sending under separate cover the draft narrative requested by the Staff in this comment. We are providing these materials to the Staff on a confidential basis pursuant to Commission Rule 83 (17 C.F.R. §200.83). By separate letter, we have requested confidential treatment of such materials pursuant to the provisions of 17 C.F.R. §200.83.
Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
October 29, 2009
Page 9
Summary Compensation Table, page 26
| 3. | Please include disclosure for the past three years in this table. |
Response
In response to the Staff’s comments, the Company will include disclosure for the past three years in the Summary Compensation Table in its 2010 Proxy Statement.
* * *
Pursuant to the Staff’s request in its Comment Letter dated September 21, 2009, and in connection with the foregoing, we hereby acknowledge that:
| • | | the Company is responsible for the adequacy and accuracy of the disclosure in the filing; |
| • | | Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and |
| • | | the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. |
If the Staff has any questions with respect to the foregoing, please contact the undersigned at (617) 492-5554 or Gabor Garai, Esq. at (617) 342-4000.
| | |
Very truly yours, |
|
MOLECULAR INSIGHT PHARMACEUTICALS, INC. |
| |
By: | | /s/ Daniel L. Peters |
| | Daniel L. Peters |
| | President and Chief Executive Officer |
| | |
CC: | | Gabor Garai, Esq. |
| | Foley & Lardner LLP |
| | 111 Huntington Avenue |
| | Boston, MA 02199 |
| | Fax: 617-342-4001 |