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Clinical Trials of Companies Pending Approval Milestones, December 17, 2007
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| Fund | Milestone Date | Company | Product | Partners | Milestone | Details |
| HHM, HHN, HHU, HRD, HHG, HHQ | 12/21/2007 | Solvay SA (SOLB BB) | Luvox | Jazz Pharmaceuticals | PDUFA Date | |
| HHG, HHN, HHQ, HRD, HRW | 4Q07 | Mylan Labs (MYL) | Nebivolol | Forest Labs | FDA Review/FDA Action | Forest licensed nebivolol from Mylan Laboratories in January 2006 and has responsibility for all sales and marketing as well as the current and future development programs. Mylan has retained an option to co-promote the product in the future. |
| HHN | 4Q07 | Neurochem Inc (NRMX) | Kiacta / Fibrillex | Centocor Inc / Johnson & Johnson | EMEA Approval | |
| HHU, HHM | 4Q07 | Indevus Pharma (IDEV) | Valstar | | FDA Action/Market Launch | The submission of the VALSTAR sNDA is an important milestone for Indevus. VALSTAR is the only approved drug for the treatment of BCG- refractory bladder cancer in patients who are not candidates for surgical bladder removal. They are hopeful that they will be able to reintroduce VALSTAR to the marketplace by the end of 2007 and provide physicians and patients with a much needed treatment option. In addition, they believe VALSTAR has the potential to be effective in other clinical indications and they plan to begin exploring additional development opportunities that may result in expanding the overall VALSTAR market potential. |
| HHG, HHQ, HHR, HHU | 2H07 | Theravance (THRX) | Telavancin/TD-6424 | Astellas Pharma | Market Launch | Their goals with telavancin are to complete enrollment for the HAP program in the first half of 2007 and, if they receive FDA approval, commercially launch telavancin for the treatment of cSSSI with their partner Astellas in the second half of 2007. |
| HRD, HRW | 2007 | Angiotech Pharma (ANPI) | Taxus Liberte Paclitaxel - eluting coronary stent | | Market Launch | The Company received the CE Mark for the TAXUS Liberte stent in Europe and other international markets in September 2005, and it is currently the market-leading drug-eluting stent outside the United States (the TAXUS Liberte stent is not available for sale in Japan). The TAXUS Liberte stent is not indicated for direct stenting in the European Union. The TAXUS Liberte stent is currently pending approval by the U.S. Food and Drug Administration and is not available for sale in the United States. The Company plans to launch the TAXUS Liberte stent in the United States in 2007. |
| HHA, HHK | 1/17/2008 | ZymoGenetics (ZGEN) | rhThrombin | | PDUFA Date | |
| HHM, HHN, HHU, HRD, HHG, HHQ | 1/19/2008 | Solvay SA (SOLB BB) | Tedangin/Pulzi | | PDUFA Date | |
| HRD | 1/19/2008 | Cardiome Pharma (CRME) | Verakalant | Astellas Pharma | PDUFA Date | In preparation for the panel, and at the request of the FDA, Astellas has agreed to file additional information including final safety and efficacy data from the ACT 2 clinical trial, which was ongoing at the time of original NDA submission. As a result of this amendment to the NDA, the FDA has indicated that the action date under the Prescription Drug User Fee Act (PDUFA) will be extended by three months to January 19, 2008. It is expected that discussions related to the application review and labelling will continue with FDA throughout the intervening period. |
| HHU, HHN | 1/23/2008 | Adolor Corp (ADLR) | Entereg | GlaxoSmithKline / Shire Pharma | FDA Review | |
| HHQ, HHJ | 1/30/2008 | Progenics Pharma (PGNX) | Methylnaltrexone | Wyeth | PDUFA Date | June 28, 2007�� Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced positive results from a three-month open-label extension study of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients with advanced illness. |
| HHU, HHN | 2/10/2008 | Adolor Corp (ADLR) | Entereg | GlaxoSmithKline / Shire Pharma | FDA Action | �Adolor Corporation and GlaxoSmithKline announced that the U. S. Food and Drug Administration has accepted as complete, Adolor's response to the November 2006 New Drug Application (NDA) approvable letter for Entereg (alvimopan) for the management of postoperative ileus (POI). The FDA informed Adolor that the response is considered a complete class 2 response with a Prescription Drug User Fee Act (PDUFA) goal date of February 10, 2008. |
| HHK, HHZ | 2/29/2008 | Regeneron Pharma (REGN) | Rilonacept | | PDUFA Date | Regeneron Pharmaceuticals, Inc announced that it received notification from the United States Food and Drug Administration that the action date for FDA's priority review of the Biologics License Application (BLA) for rilonacept (IL-1 Trap) for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) has been extended to February 29, 2008. The original action date under the Prescription Drug User Fee Act (PDUFA) for the BLA was November 29, 2007. |
| HHK | 1Q08 | Onyx Pharma (ONXX) | Nexavar | | EMEA Approval | Onyx gained dollar 3.42 (10%) to dollar 37.04 last Monday after it and partner Bayer said Nexavar sorafenib significantly improved overall survival vs. placebo, the primary endpoint, in a Phase III trial to treat advanced hepatocellular carcinoma. The drug is under review in the U.S. for the liver indication, with a decision expected by late 2007. A decision in Europe is expected in 1Q08. Nexavar is marketed to treat advanced renal cell carcinoma (RCC). Onyx� finished up dollar 6 (18%) to dollar 39.62 last week. |
| HHG, HHK, HHN, HHQ | 1Q08 | Abraxis BioScience Inc (ABBI) | Irinotecan hydrochloride | | Market Launch | As one of the only companies to receive a tentative approval, APP is in the process of securing contracts and expects to commence marketing of this product upon patent expiry in February 2008. |
| HHR | 1Q08 | Discovery Labs (DSCO) | Surfaxin | Quintiles Transnational / Laboratorios De Dr. Esteve / Dompe Laboratorios | FDA Review | Discovery anticipates filing its formal response to the Approvable Letter in September or October 2007, followed by a six-month review( March 2008) cycle by the FDA for potential approval of its New Drug Application (NDA) for Surfaxin |
| HHN | 4/2/2008 | Neurochem Inc (NRMX) | Kiacta / Fibrillex | Centocor Inc / Johnson & Johnson | PDUFA Date | |
| HRW | 2Q08 | Photocure ASA (PHO) | Metvix w/ Aktilte | | FDA Action | The submission is a supplement to the previously approved NDA for Metvixia (Metvixia is the US trade name). The current supplement comprises data from two new pivotal and three supportive Phase III studies to document the efficacy of Metvixia in combination with the new lamp developed by Photocure, the Aktilite CL 128. In the pivotal studies, 211 patients with multiple AKs in face or scalp were treated with Metvixia Cream or placebo prior to illumination with Aktilite. Both studies showed significantly better response with Metvixia compared to placebo at 3 months after treatment. The results confirm the excellent results seen in earlier phase III studies with Metvix PDT. Photocure expect the first response from FDA to the application after 10 months, in May 2008. |
| HRD | 2Q08 | Medicines Company (MDCO) | Angiomax | | Market Launch | |
| Phase III Milestones, December 17, 2007
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| Fund | Milestone Date | Company | Product | Partners | Milestone | Details |
| HHM | 4Q07 | Depomed Inc (DEPO) | Gabapentin ER | | NDA Filing | |
| HRD, HRW | 4Q07 | Angiotech Pharma (ANPI) | Central Venous Catheter | | Preliminary pivotal trail result | |
| HRJ, HHQ, HHG, HRW | 4Q07 | Basilea Pharma AG (BPMUF) | BAL4079 (alitretinoin) | | NDA Filing | Basilea Pharmaceutica Ltd announced that its placebo-controlled pivotal Phase III BACH trial (Benefit of Alitretinoin in Chronic Hand dermatitis) successfully met its primary objective. Alitretinoin was effective in patients suffering from severe and refractory chronic hand dermatitis, as determined by the stringent endpoint of clear and almost clear hands. Currently, no approved treatment exists for this debilitating disease which prevents patients from using their hands normally. These positive data will form the basis of regulatory submissions later 2007. |
| HHA | 4Q07 | Aspreva Pharma (ASPV) | CellCept | Roche Holdings | Phase III Trial End | There have been several small published studies that report that multiple sclerosis patients treated with CellCept have experienced an improvement in lesions, as measured by magnetic resonance imaging, a decreased rate of relapse and a reduced expanded disability status scale rating. They have committed to fund an IIT to investigate the use of CellCept in mono and combination therapy with Avonex in patients with relapse-remitting multiple sclerosis. The trial has been initiated and patient recruitment has begun. The study is expected to complete by the end of 2007. |
| HHA, HHM, HHU, HRW | 4Q07 | Ligand Pharma (LGND) | Aprela | Wyeth | NDA Filing | Wyeth said Aprela was effective in a Phase III trial to treat vasomotor symptoms and that the compound had a favorable safety and tolerability profile. The pharma company would not disclose any additional data. Aprela is partnered with Ligand Pharmaceuticals Inc. |
| HHK, HHN, HHQ | 4Q07 | Cephalon (CEPH) | Fentora / Accelanyl | | sNDA Filing | Pending positive data from an ongoing 12-week study in patients with non-cancer breakthrough pain, their goal is to submit an sNDA in the second half of 2007 to expand the label indication for Fentora. |
| HHU | 4Q07 | Salix Pharma (SLXP) | Granulated Mesalamine | | NDA Filing | |
| HHA, HHG, HHK, HHQ, HHR, HHU | 2H07 | Medarex (MEDX) | HuMax-EGFr | Genmab / GlaxoSmithKline | Phase III Trial Result | |
| HHG, HHN, HHQ, HRW | 2H07 | Valeant Pharma (VRX) | Retigabine | Meda AB / Viatris GmbH & Co / Xcel Pharma | Phase III Trial Result | Results from two Phase III studies are anticipated to be available in the second half of 2007. Expecting Market Launch in 4Q08. |
| HHG, HHN, HHQ, HHR, HHU | 2H07 | King Pharma (KG) | Altace HCT | | NDA Filing | They expect to file an NDA with the FDA for their Altace/diuretic combination product in the second half of 2007. |
| HHZ | 2H07 | Ista Pharma (ISTA) | Xibrom QD | | sNDA Filing | Based upon the preliminary results of the Xibrom QD Phase III studies and pending final analyses, they plan to file a supplemental New Drug Application, or sNDA, with the FDA in the second half of 2007 for Xibrom QD for the treatment of ocular pain and inflammation associated with cataract surgery. |
| HHZ | 2H07 | Ista Pharma (ISTA) | Bepotastine | Senju Pharma | NDA Filing | |
| HHA, HHK, HHN, HHQ, HHV, HRD | 2007 | Millennium Pharma (MLNM) | Velcade | Johnson & Johnson Ortho Biotech | NDA Filing | The IFM group continues to enroll patients to achieve the target of 480 patients. Response data for the interim analysis are being determined by an independent data review committee. An early filing opportunity may be possible in 2007 for Velcade. |
| HHJ | 2007 | Telik Inc | Telcyta/TLK286 | | Assist-5 Patient Enrollment end | |
| HHN | 1Q08 | Forest Laboratories (FRX) | Namenda once-daily | | Phase III Trial Result | during the 2007 fiscal year they initiated a Phase III Alzheimer's disease study of Namenda in a modified-release, once-daily formulation and expect results to be available in early calendar 2008. |
| HHM | 1Q08 | Arena Pharma (ARNA) | Lorcaserin Hydrochloride | | Phase III Trial Analysis | Completing the enrollment of more than 3,100 patients in the BLOOM trial in a little over four months reflects the significant need for additional options in the treatment of obesity. They are looking forward to the DSMB's review of the month-six echocardiographic data in the third quarter and the initiation of two additional one-year pivotal Phase III studies later 2007 for Lorcaserin |
| HHD, HHK | 1Q08 | Myriad Genetics (MYGN) | Flurizan | | Phase III Trial Result | Flurizan (tarenflurbil), their lead therapeutic candidate for the treatment of Alzheimer's disease, is being tested in two Phase III clinical trials in patients with mild Alzheimer's disease. They believe that their U.S. Phase III trial is proceeding on schedule and its 18-month term of study will conclude as planned at the end of March 2008. They anticipate that they will report the top-line results of this study by the end of June 2008. |
| HHA, HHG, HHK, HHQ, HHR, HHU | 1Q08 | Medarex (MEDX) | MDX-010 | IDM Pharma / Bristol Myers Squibb | BLA Filing | Potential NDA submission in early 2008 |
| HRD, HRW | 1Q08 | Angiotech Pharma (ANPI) | Central Venous Catheter | | Final Pivotal Trail Result | |
| HHN, HHQ, HHU, HRD, HHG | 1Q08 | Barr Pharmaceuticals (BRL) | DR-5001 / Adenovirus Vaccine | | Market Launch | |
| HHJ, HHQ | 1Q08 | GTX Inc (GTXI) | Acapodene | Ipsen | NDA Filing | The DSMB reviewed safety data of the approximately 3,000 patients enrolled in the two pivotal Phase III Acapodene clinical trials and recommended that GTx continue with the trials as planned under the existing protocols. This was the final planned DSMB review prior to the last patient's completion of the ADT clinical trial in late November of 2007and the anticipated release of top line results from this trial in the first quarter of 2008. The extensive safety database aggregated in the two large Acapodene clinical trials, along with the more than 350,000 patient years of experience with toremifene citrate 60 mg, which has already been approved for the treatment of advanced breast cancer, will be a critical component of the applications for marketing approval of Acapodene which, if efficacy and safety criteria are met, they are planning to submit beginning in 2008. |
| HHA, HHG, HHK, HHQ, HHR, HHU | 1Q08 | Medarex (MEDX) | MDX-010 | IDM Pharma / Bristol Myers Squibb | NDA Filing | Potential NDA submission in early 2008 |
| HHK, HHN, HHQ | 1Q08 | Cephalon (CEPH) | CEP-701 | | NDA Filing | |
| HHN, HHU | 1Q08 | Adolor Corp (ADLR) | Entereg | GlaxoSmithKline / Roberts Pharma | sNDA Filing | |
| HHR | 1Q08 | Pharmaxis (PXSL) | Aridol | | Korean Review | The Korean regulatory approval process is expected to complete in Q1 2008, afterwhich Pharmax is would seek reimbursement approval through the national health� scheme. Pharmaxis plans to begin pre-marketing immediately approval is granted and is currently in discussion with potential Korean distribution partners to launch Aridol. |
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