Pending Approval Milestones as of August 16, 2007
Phase III Milestones as of August 16, 2007
| Fund | Milestone Date | Company | Product | Partners | Milestone | Details |
|---|---|---|---|---|---|---|
| HHM | 8/30/2007 | Tercica Inc (TRCA) | Somatuline Autogel | Ipsen | FDA Action | Tercica, Inc. reported that its partner IPSEN received notice that the U.S. Food and Drug Administration has accepted the filing of its New Drug Application (NDA) for Somatuline Autogel (60, 90, 120 mg) in the United States as a 28-day sustained-release formulation to treat patients with acromegaly. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Tercica expects the FDA will complete its review or otherwise respond to the Somatuline Autogel NDA by August 30, 2007. |
| HHN, HHQ, HRD | 3Q07 | Biovail Corp (BVF) | Bupropion EA Salt | PDUFA Date | a New Drug Application was submitted to the FDA in September 2006 for BVF-033, the Company's novel bupropion salt formulation. The FDA action date for this application is late July 2007. | |
| HHU | 3Q07 | Indevus Pharma (IDEV) | Sanctura XR | Shire PLC / Madaus GmbH | FDA Action | They are actively working with their partner Esprit Pharma on the launch plan for Sanctura XR and assuming an August 2007 approval, they would anticipate a September 2007 launch. |
| HRD | 3Q07 | Momenta Pharma (MNTA) | M-Enoxaparin | Novartis AG | FDA Action | Momenta Pharmaceuticals Inc also is developing a generic version of enoxaparin with Sandoz. The partners' ANDA for M-Enoxaparin low molecular weight heparin is under FDA review with a decision expected by 3Q07. In August 2006, sanofi-aventis Group filed a suit related to the ANDA against Sandoz, which is the generics division of Novartis AG. |
| HHA | 10/18/2007 | ZymoGenetics (ZGEN) | rhThrombin | PDUFA Date | The Biologics License Application for rhThrombin was submitted to the FDA on December 15, 2006 and the Prescription Drug User Fee Act (PDUFA) date is October 18, 2007. The Phase III pivotal study, which was completed in the fall of 2006, showed that rhThrombin had comparable efficacy and a superior immunogenicity profile compared to the marketed bovine thrombin product. | |
| HHM, HHN, HHU, HRD, HHG, HHQ | 12/21/2007 | Solvay SA (SOLB BB) | Luvox | Jazz Pharmaceuticals | PDUFA Date | |
| HHQ, HHU, HRW | 4Q07 | Mentor Corp. (MNT) | Puragen Plus | FDA Action | During the quarter, the company made substantial progress in its HA development programs and, subsequent to the end of the first quarter, submitted PMAs to the FDA for Prevelle Plus and Puragen Plus. Mentor anticipates approval for these products in the U.S. in late fiscal 2008 or early fiscal 2009. | |
| HHQ, HHU, HRW | 4Q07 | Mentor Corp. (MNT) | Prevelle Plus | FDA Action | During the quarter, the company made substantial progress in its HA development programs and, subsequent to the end of the first quarter, submitted PMAs to the FDA for Prevelle Plus and Puragen Plus. Mentor anticipates approval for these products in the U.S. in late fiscal 2008 or early fiscal 2009. | |
| HHA | 4Q07 | ZymoGenetics (ZGEN) | rhThrombin | FDA Action / Market Launch | Plan to be ready to launch the product in late 2007. | |
| HHA, HHM, HHU, HRW | 4Q07 | Ligand Pharma (LGND) | Viviant | Wyeth | FDA Action / MAA Filing | Wyeth expects a year-end 2007 FDA action date. The company also plans to submit an MAA for Viviant later 2007. |
| HHG, HHN, HHQ, HRD, HRW | 4Q07 | Mylan Labs (MYL) | Nebivolol | Forest Labs | FDA Review | 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. |
| HHG, HHQ, HHR, HHU | 4Q07 | Theravance (THRX) | Telavancin/TD-6424 | Astellas Pharma | PDUFA Date | Theravance Inc's lead product is telavancin, a lipoglycopeptide antibiotic that is partnered with Astellas Pharma Inc and is under review in the U.S. and Europe to treat complicated skin and skin structure infections (cSSSIs). The PDUFA date in the U.S. is in mid-to late October 2007. |
| HHK, HRJ | 4Q07 | GPC Biotech (GPCB) | Satraplatin | Spectrum Pharma / Pharmion Corp | Market Launch | Contingent on positive FDA Action |
| HHN | 4Q07 | Neurochem Inc (NRMX) | Kiacta / Fibrillex | Centocor Inc / Johnson & Johnson | EMEA Approval | |
| HHU | 4Q07 | Indevus Pharma (IDEV) | Valstar | 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. | |
| HHZ | 4Q07 | Akorn Inc (AKRX) | Diclofenac Sodium Ophthalmic Solution | FDA Action / Market Launch | Akorn, Inc announced that the U.S. Food and Drug Administration has granted tentative approval for Akorn's Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution 0.1% in 2.5 ml and 5 ml dropper bottles. Final approval is expected upon expiry of patent protection for Voltaren Ophthalmic Solution 0.1% in October 2007. |
| Fund | Milestone Date | Company | Product | Partners | Milestone | Details |
|---|---|---|---|---|---|---|
| HHQ, HHU, HRW | Mid-07 | Mentor Corp (MNT) | Puragen Plus | Genzyme Corp | Complete NDA Filing | On February 6, 2006, they announced that, with respect to their Puragen Plus program in the U.S., they had identified potential issues that required further evaluation of their clinical study data and would result in a delay to their PMA submission timeline. They performed this evaluation, and they concurrently reviewed some of their critical production processes. Based on the results of this evaluation they have developed a plan to move forward with their Puragen Plus PMA process, and are targeting to submit the first module to FDA in late summer or early fall this year 2006, and to complete the submission in the spring of 2007. |
| HHA, HHG, HHM, HHN, HHQ, HHU, HHZ, HRD, HRW | Mid-07 | Watson Pharma (WPI) | Oxybutynin Gel | Phase III Trial End | Phase III studies on Watson's gel formulation of oxybutynin for overactive bladder remain ongoing and the Company remains on target to complete the studies in mid 2007. | |
| HHR | Mid-07 | Pharmaxis Ltd (PXSL) | Bronchitol | New Zealand/Australian/UK Phase III Trial Results | The double blinded placebo controlled Phase III trial, which commenced dosing subjects in May 2006, is being conducted at 22 hospitals across Australia, New Zealand and the United Kingdom. It is expected to complete and report in the middle of 2007 for Bronchitol. | |
| HHK, HHN, HHQ | 3Q07 | Cephalon (CEPH) | Treanda | NDA Filing | A Phase III trial of Treanda in indolent NHL refractory to rituximab is ongoing at sites in the United States and Canada. If results from this study are positive, they would expect to file an NDA for Treanda in the first half of 2007. | |
| HHA | 3Q07 | GW Pharma (GWP) | Sativex | Almirall Prodesfarma / Otsuka Pharma | Canada second Phase III trial result | GW has recently commenced a second pivotal Phase III study in this indication. This study supplements a completed positive pivotal Phase III study as well as a number of supportive studies. This second pivotal study, which is expected to report results in approximately in September 2007, is intended to complete a data package to support a regulatory submission in Europe in this indication. In addition, the study will be submitted to the Canadian regulators in order to achieve a full Notice of Compliance. |
| HHD, HHK | 3Q07 | Myriad Genetics (MYGN) | Flurizan | Interim Phase III Trial Results | The Company completed enrollment of about 1,600 patients in a doubleblind, placebo-controlled, U.S. Phase III trial. Last August, the company amended the trial's protocol to increase enrollment to 1,600 from 750 patients, restrict enrollment to include only patients with mild disease and use only an 800 mg dose instead of 800 and 400 mg doses. The Company amended the protocol after a failed Phase II trial showed that patients with mild AD given 800 mg Flurizan twice-daily had the greatest benefit. Flurizan also is in an international Phase III trial in 800 patients with mild AD. | |
| HHK, HHN, HHQ | 3Q07 | MGI Pharma (MOGN) | Aquavan | NDA Filing | Provide sedation in patients undergoing minor surgical procedures. Submit NDA (3Q07) | |
| HHM | 3Q07 | 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 | |
| HRD | 3Q07 | Medicines Company | Angiomax | Nycomed / Biogen Idec | sNDA Filing | Medicines anticipates submitting an sNDA for Angiomax for use in the treatment of patients with emergency ACS in the third quarter of 2007. |
| HHM | 4Q07 | Depomed Inc (DEPO) | Gabapentin ER | NDA Filing | ||
| HHB, HHD, HHK, HHQ | 4Q07 | Fresenius AG | Removab | MAA 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. | |
| HHN | 4Q07 | Neurochem Inc (NRMX) | Alzhemed | Praecis Pharma | N. America Phase III trial Result | The Company notes that in a clinical trial of the size, duration and complexity of the tramiprosate Phase III study, such a process is not uncommon (adjusting the statistical model). The Company has been informed that it could take several weeks, perhaps longer, before the results are known. Neurochem continues to expect to announce these results during the second quarter of 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. |
| HHA, HHG, HHK, HHM, HHQ, HHV, HRD | 4Q07 | Human Genome Sciences (HGSI) | Albuferon | Novartis AG | Achieve II/III patient enrollment end | Human Genome Sciences, Inc announced that it has initiated dosing in ACHIEVE 2/3, a Phase III clinical trial of Albuferon (albinterferon alfa-2b) in combination with ribavirin in treatment-na�ve patients with chronic hepatitis C genotypes 2 and 3. ACHIEVE 2/3 is the second of two pivotal Phase III trials of Albuferon that HGS is conducting, with the goal of filing global marketing applications in 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006. Enrollment of both Phase III trials of Albuferon to be completed in late 2007 |
| 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. | |
| HHK, HHN, HHQ | 4Q07 | Cephalon (CEPH) | CEP-701 | Phase II/III Trial End | As of December 31, 2006, 112 patients have been randomly assigned to one of two treatment arms in the Phase II/III clinical trial: standard chemotherapy alone, or chemotherapy followed two days later by a daily 80-mg orally administered dose of CEP-701, continued for up to 113 days. They are targeting late 2007 for the completion of this study, with an NDA submission planned for early 2008. They also are planning to initiate studies of CEP-701 in patients with myeloproliferative disorder in 2007. | |
| HHM | 4Q07 | Arena Pharma (ARNA) | Lorcaserin Hydrochloride | Second & Third Phase III Trial initiations | ||
| HHM | 4Q07 | Depomed Inc (DEPO) | Gabapentin ER | NDA Filing | ||
| HHM | 4Q07 | NPS Pharma (NPSP) | Sensipar | Amgen / Kirin Brewery | Add'l Phase III Trial Result | Data from a Phase III trial in about 400 patients in the setting of chronic renal insufficiency showed that "all efficacy endpoints were positive. However,Amgen Inc will not seek approval because of hypocalcemia seen in cinacalcet patients. Additional data will be available in 4Q07. |
| HHJ, HHM, HHQ | 4Q07 | GTX Inc (GTXI) | Acapodene | Ipsen / Orion Corp | Phase III Trial Results / Mexico Phase III Trial End | Patients treated with Acapodene had statistically significantly lower levels of total cholesterol, LDL, and triglycerides, as well as a reduction in the ratio of total cholesterol to HDL, when compared to patients on placebo. GTX INC/TN expects to receive final data from the trial in the fourth quarter of 2007. Co. announced on July 12, 2007 that an interim safety review by an independent DSMB recommended that GTx continue clinical development as planned with its two clinical trials of Acapodene. |
| HHG, HHN, HHQ, HRW | 4Q07 | Valeant Pharma (VRX) | Virimidine | Schering-Plough | Phase IIb 12-week trial result | Valeant will perform analyses of the study data after all patients have reached the week 12 time point which is the primary endpoint of the study. The results at week 12 are typically predictive of a full 48-week treatment course. Based on the 12-week data, the company will decide whether to begin another Phase III study at a more appropriate dose than used in the VISER studies. Additionally, if the week 12 data are encouraging, the company intends to continue the current study for a full 48-week treatment course with a post-treatment follow-up at week 72. The 12-week results are expected to be available and be released by the end of the year 2007 for Viramidine. |
| HHN, HHQ, HHU, HRJ | 4Q07 | Schwarz Pharma AG (SWTZY) | Rotigotine CDS | Otsuka Pharma / Aderis Pharma | NDA Filing / MAA Filing | |
| HHQ, HHR, HHU, HHG | 4Q07 | Theravance (THRX) | Telavancin | Astellas Pharma | Phase III Trial Result | |
| HRD | 4Q07 | AtheroGenics Inc (AGIX) | AGI-1067 | PreMD Inc / Canadian Institutes of Health Research | MAA Filing | |
| HHA, HHK, HHQ, HHR, HHU, HHG | 4Q07 | Medarex (MEDX) | HuMax-CD4/ MDX CD-4 | Genmab A/S | Phase III Trial Result | Genmab A/S said Merck Serono S.A.unit ended a 2005 deal to develop Genmab A/S zanolimumab (HuMax-CD4). The human MAb against CD4 is in Phase III testing to treat cutaneous T cell lymphoma (CTCL) and has completed Phase II trials to treat non-cutaneous T cell lymphoma (NCTCL). Data from the NCTCL trial are expected by late 2007, and data from the CTCL trial are expected in 2008. |
| HHA, HHG, HHK, HHQ, HHR, HHU | 2H07 | Medarex (MEDX) | HuMax- CD20 | Genmab / GlaxoSmithKline | Phase III Trial Result | Genmab A/S is responsible for development costs until 2008, after which the partners will split the costs. GlaxoSmithKline plc is responsible for manufacturing and commercialization. The human antibody against CD20 is in Phase III trials to treat B cell chronic lymphocytic leukemia (B CLL) that is refractory to Rituxan rituximab and to treat non-Hodgkin's lymphoma (NHL); Genmab A/S expects data from both Phase III trials in 2H07. |
| HHJ | 2H07 | Adventrix Pharmaceuticals (ANX) | CoFactor (Fotrexorin Calcium) | Synteract | European Phase Iib Trial Result | This trial is significant for them in that it will compare the safety and efficacy of CoFactor/5-FU with leucovorin/5-FU in an infusional setting, a common method of administration of 5-FU for treatment of metastatic colorectal cancer in Europe. |
| 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. | |
| HHK, HHQ, HHR, HRD | 2H07 | United Therapeutics (UTHR) | OvaRex Mab | Phase III Trial Result | OvaRex, a murine MAb targeting CA 125, is in two Phase III trials, with data expected in 2H07. Virexx Medical Corp plans to submit an application to begin a Phase I study of Occlusin 500 in 2007. | |
| HHN, HHQ, HHU, HRJ | 2H07 | Schwarz Pharma AG (SWTZY) | Lacosamide | Harris FRC Corp | NDA Filing / MAA Filing | Filings for Diabetic Neuropathic Pain |
| HHZ | 2H07 | Ista Pharma (ISTA) | Bepotastine | Senju Pharma | NDA Filing | |
| HHA, HHK, HHQ | 2007 | PDL Biopharma (PDLI) | Nuvion / Smart anti-CD3 antibody | Phase II/III Trial End | ||
| HHA, HHG, HHK, HHQ, HHR, HHU | 2007 | Medarex (MEDX) | CNTO 1275 | Centocor / Johnson & Johnson | BLA Filing | An Investigational New Drug (IND) application was submitted in June 2005 to commence a Phase I dose escalation clinical trial evaluating the safety, tolerability and pharmacokinetics of Valortim in healthy adult volunteers. Filing of an FDA Biological License Application (BLA) could occur as early as 2007. |
| HHA, HHM, HHU, HRW | 2007 | Ligand Pharma (LGND) | Promacta | GlaxoSmithKline PLC | Phase III Trial Result / NDA Filing | Positive phase III data for Promacta (eltrombopag) were recently received for the short-term treatment of patients with idiopathic thrombocytopenic purpura (ITP). These data will be presented at scientific congresses in 2007 and the company is working closely with regulatory agencies to determine whether these data will be sufficient to file for approval in 2007 |
| 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 | Bioenvision Inc (BIVN) | Clolar/Evoltra | Genzyme / Hospira | EMEA Approval | Bioenvision, Inc announced that it has completed the substantive work and analysis involved with finalizing the Marketing Authorization Application (MAA) to expand the Evoltra (clofarabine) label and is involved with the administrative aspects of formally submitting the filing to the European Medicines Agency (EMeA) for the use of Evoltra in adult AML patients over 65 years and who are considered unsuitable for intensive therapy. The formal submission of the MAA is expected in the early part of Q1 2007. Bioenvision continues to expect a decision on this regulatory filing in calendar 2007. |
| HHJ | 2007 | Cell Genesys (CEGE) | GVAX Prostate Cancer Vaccine | Phase III Trial End | ||
| HHG, HHQ, HRJ | 2007 | Crucell NV (CRXL) | Flavimun | NDA Filing/ Market Launch | Flavimun a vaccine against yellow fever, is currently in Phase III studies and is expected to be licensed and launched in 2007. | |
| HHA, HHK, HHQ | 2007 | PDL Biopharma (PDLI) | Nuvion / Smart anti-CD3 antibody | Phase II/III Trial End | ||
| HHJ | 2007 | Telik Inc | Telcyta/TLK286 | Assist-5 Patient Enrollment end | ||
| HHA, HHM, HHU, HRW | 2007 | Ligand Pharma (LGND) | Promacta | GlaxoSmithKline PLC | Phase III Trial Result / NDA Filing | Positive phase III data for Promacta (eltrombopag) were recently received for the short-term treatment of patients with idiopathic thrombocytopenic purpura (ITP). These data will be presented at scientific congresses in 2007 and the company is working closely with regulatory agencies to determine whether these data will be sufficient to file for approval in 2007 |
| HHM | 2007 | Tercica Inc. (TRCA) | Increlex | Genentech / Cambrex / Ipsen | EU Launch | They are pleased with the orphan product designation granted to Increlex by the European Commission. They look forward to bringing this new treatment option to children in the EU and continue to target a 2007 launch of Increlex in the EU, subject to timely regulatory approval. |
| HHN, HHQ, HHU, HRJ | 2007 | Schwarz Pharma AG (SWTZY) | Lacosamide | Harris FRC Corp | NDA Filing / MAA Filing | Filings For Epilepsy |
| HHN, HHQ, HRJ | 2007 | H. Lundbeck AS (HLUKF) | Lexapro | Abbott Labs / Forest Labs / Mochida Pharma / Johnson & Johnson | Market Launch | |
| HHU | 2007 | Salix Pharma (SLXP) | Granulated Mesalamine | NDA Filing |