UPCOMING MILESTONES
Below is a list of publicly disclosed milestones of drug candidates being developed for the treatment of type 2 diabetes and/or obesity. If you would like to add your company's upcoming milestones to this list, please send us an email at contactus@diabesitydigest.com.
| Target date | Company | Compound | Milestone | Source | Update |
1H 2008 | 7TM Pharma | TM30339 | initiate a clinical Phase II trial for obesity | 7TM press release February 27, 2008 | initiated Phase I/IIa clinical trial September 2, 2008 |
Q3 2008 | OSI Pharmaceuticals, Inc. | PSN821 (GPR119 agonist) | initiate a clinical Phase I trial for type 2 diabetes | OSI 10K filed February 28, 2008 | initiated September 4, 2008 |
| Surface Logix, Inc. | SLx-4090 | initiate a PhaseIIb trial for dyslipidemia | Surface Logix press release January 29, 2008 | In March 2009, Surface Logix announced the start of the Phase IIb trial | |
Q4 2008 | Action Pharma A/S | AP1030 | key results from Phase I trial for type 2 diabetes | Action press release June 16, 2008 | |
| Novo Nordisk AS | Victoza (Liraglutide / NN2211) | initiate Phase III trial for obesity | Novo Nordisk press release September 26, 2008 | ||
| Vivus, Inc. | Qnexa | Results from Phase III obesity trial (OB-301 or EQUATE study) and results from the Phase II type 2 diabetes (DM-230) trial | Vivus Q3 2008 conference call | On December 11 and 12, 2008, Vivus annouced positive results from the EQUATE study and the DM-230 study, respectively. | |
2H 2008 | Athersys, Inc. | ATHX-105 | initiate a clinical Phase II trial for obesity | Athersys 10Q filed August 6, 2008 | On September 23, 2008, Athersys announced that the FDA requested additional information relating to it's Investigational New Drug (IND) application for a 12-week Phase II clinical trial of ATHX-105, and has placed the study on partial hold. |
| CombinatoRx | CRx-401 | results from Phase II trial for type 2 diabetes | CombinatoRx investor presentation July 23, 2008 | On November 20, 2008, CombinatoRx announced that interim analysis of the Phase II trial is unlikely to detect a treatment advantage of CRx-401. | |
| Phenomix Corporation | Dutogliptin (PHX1149) | initiate Phase III trial for type 2 diabetes | Phenomix | On October 23, 2008, Phenomix announced that they initiated Phase III clinical development for dutogliptin in the third quarter 2008. | |
2009 | Amylin Pharmaceuticals, Eli Lilly and Company, Inc. | Byetta (exenatide, AC2993) | FDA review of Byetta as a stand alone therapy | Amylin press release December 8, 2008 | |
| Elixir Pharmaceuticals | Metgluna (mitiglinide and metformin) | file NDA submission to the FDA for type 2 diabetes | Elixir press release November 19, 2008 | ||
| Elixir Pharmaceuticals | Mitiglinide (Glufast, Glinsuna) | file NDA submission to the FDA for type 2 diabetes | Elixir press release November 19, 2008 | ||
| Glenmark Pharmaceuticals Limited | Melogliptin (GRC 8200) | initiate Phase III trial for type 2 diabetes | Glenmark investor presentation April 2008 | ||
| Incyte Corporation | INCB13739 | Phase IIb results for type 2 diabetes | Incyte investor presentation September 2008 | ||
| Metabasis Therapeutics, Inc. | MB07803 | initiate Phase IIb trial for type 2 diabetes | Metabasis press release July 29, 2008 | initiated a second Phase lla trial at higher doses September 4, 2008 | |
| Orexigen Therapeutics, Inc. | Contrave (naltrexone SR/bupropion SR) | file NDA with the FDA for obesity | Orexigen press release July 9, 2008 | ||
| Sanofi-Aventis | Rimonabant (Acomplia) | file NDA with the FDA for type 2 diabetes | Sanofi-Aventis general meeting presentation May 14, 2008 | On November 5, 2008, Sanofi-Aventis announced that it was discontinuing the ongoing rimonabant clinical development program in all indications | |
Q1 2009 | Arena Pharmaceuticals | Lorcaserin (APD356) | results from the BLOOM trial (two-year Phase III pivotal trial ) | Arena press release October 30, 2008 | On March 30, 2009, Arena announced positive top-line results from BLOOM |
Q2 2009 | Novo Nordisk AS | Victoza (Liraglutide / NN2211) | receive FDA marketing approval - Novo Nordisk has announced that the FDA will hold an FDA Advisory Committe meeting on April 2, 2009 to discuss the NDA for liraglutide | Novo Nordisk press release September 5, 2008 | In April 2009, the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA finalised its discussions of questions related to liraglutide. |
| Xoma Ltd. | Xoma 052 | Initiate Phase II trials for type 2 diabetes | Xoma press release December 10, 2008 | ||
1H 2009 | 7TM Pharma | TM38837 | initiate Phase I trial | 7TM Pharma press release September 2, 2008 | |
| Alantos Pharmaceuticals - ACQUIRED by Amgen, Amgen, Inc., Servier (Les Laboratoires) | AMG 222 (ALS2-0426) | Disclosure of Phase IIa results | Amgen 10K filed February 27, 2009 | ||
| Amylin Pharmaceuticals, Eli Lilly and Company, Inc., Alkermes, Inc. | Exenatide Once Weekly (LAR) | file NDA submission to the FDA | Lilly press release December 11, 2008 | ||
Q4 2009 | AstraZeneca, Bristol-Myers Squibb Co. | Onglyza and metformin | file MAA to the EMEA for type 2 diabetes | AstraZeneca pipeline update January 29, 2009 | |
2H 2009 | Amylin Pharmaceuticals | davalintide (AC2307) | Phase II results for obesity trial | Amylin 10K filed February 27, 2009 | |
| Boehringer Ingelheim GmbH, Vitae Pharmaceuticals, Inc. | PSN602 (S1RUP) | initiate Phase IIa | Q4 2008 Earnings Call, February 20, 2009 | ||
| Boehringer Ingelheim GmbH, Vitae Pharmaceuticals, Inc. | 11 beta-HSD1 inhitors | European regulatory filing (EMEA) | Lilly press release December 11, 2008 | ||
| Intekrin Therapeutics | INT131 (AMG 131 / T-131) | Phase IIb trial results (2H 2009) for type 2 diabetes | Intekrin press release March 11, 2009 | ||
2010 | Boehringer Ingelheim GmbH, Vitae Pharmaceuticals, Inc. | 11 beta-HSD1 inhitors | file NDA submission to to the FDA | Merck annual bus. brief. December 9, 2008 | |
| Ipsen, Roche | Taspoglutide (R1583, BIM-51077) | projected filing date for type 2 diabetes | Roche pipeline July 21, 2008 | ||
| Merck & Co.,Inc. | MK-0431D: stiagliptin and simvastatin | file NDA submission to the FDA | Merck annual bus. brief. December 9, 2008 | ||
| Sanofi-Aventis | AVE0010 (ZP10) | file NDA submission to the FDA and MAA to the EMEA for type 2 diabetes | SanofiAventis corporate R&D presentation September 17, 2007 | ||
1H 2010 | Intekrin Therapeutics | INT131 (AMG 131 / T-131) | initiate Phase III trial (1H 2010) for type 2 diabetes | Intekrin press release March 11, 2009 | |
2H 2010 | AstraZeneca, Bristol-Myers Squibb Co. | Onglyza and metformin | file NDA submission to the FDA for type 2 diabetes | AstraZeneca pipeline update January 29, 2009 | |
| AstraZeneca, Bristol-Myers Squibb Co. | Dapagliflozin (BMS-512148) | file NDA submission to the FDA and MAA to the EMEA for type 2 diabetes | AstraZeneca pipeline update January 29,2009 | ||
2011 | AstraZeneca, Bristol-Myers Squibb Co. | Dapagliflozin and metformin | file NDA submission to the FDA and MAA to the EMEA for type 2 diabetes | AstraZeneca pipeline update January 29, 2009 | |
| Daiichi-Sankyo | Rivoglitazone (CS-011) | file NDA submisstion to the FDA for type 2 diabetes indication | Daiichi-Sankyo 2008 R&D meeting (February 21, 2008) | ||
| Merck & Co.,Inc. | Janumet extended release formulation | file NDA submission to the FDA | Merck annual bus. brief. December 9, 2008 | ||
| Merck & Co.,Inc. | MK-0431C: sitagliptin and pioglitazone | file NDA submission to the FDA | Merck annual bus. brief. December 9, 2008 | ||
| Novo Nordisk AS | Victoza (Liraglutide / NN2211) | one-year data from Phase III trial for obesity | Novo Nordisk press release September 26, 2008 | ||
| Sanofi-Aventis | Rimonabant (Acomplia) | file NDA submission to the FDA for cardiovascular indication | Sanofi general meeting presentation May 14, 2008 | On November 5, 2008, Sanofi-Aventis announced that it was discontinuing the ongoing rimonabant clinical development program in all indications | |