The Life Sciences Report
WATCHLIST 2013
Which biotech companies will take off in 2013? To zero in on possible winners, The Life Sciences Report teamed up with Sagient Research to crunch the numbers for companies with potential catalysts on the calendar. The results were sent to experts who, based on their experience in the space, could determine which companies have the best chances for upward stock price movement. The result is this groundbreaking Life Sciences Report Watchlist 2013.
| Company | Drug | Disease | Catalyst | |
|---|---|---|---|---|
| Ariad Pharmaceuticals Inc. (ARIA:NASDAQ) | Iclusig (ponatinib) | Chronic myelogenous leukemia (CML) |
Quarterly sales figure catalysts Favorable phase 3 EPIC trial data could result in approval for first-line use in CML in Q4/13. |
|
| Sangamo BioSciences Inc. (SGMO:NASDAQ) | SB-728-T | HIV |
Preliminary phase 2 data due in H1/13 Full data set from phase 2 trials by end of 2013 |
|
| Pharmacyclics Inc. (PCYC:NASDAQ) | ibrutinib (PCI-32765) |
Chronic lymphocytic leukemia (CLL) B-cell lymphomas |
Start of phase 3 Positive phase 3 data in CLL and in new indications could expand market and company valuation |
|
| Amarin Corporation plc (AMRN:NASDAQ) | Vascepa (icosapent ethyl) |
Hypertriglyceridemia Mixed dyslipidemia |
Quarterly sales figure catalysts On 2/28/13, the company is scheduled to file a supplemental new drug application (sNDA) for Vascepa in mixed dyslipidemia; market penetration in this area could be a significant value driver |
|
| Medivation Inc. (MDVN:NASDAQ) | Xtandi (enzalutamide) | Prostate cancer |
Quarterly sales figures Mid-2013: Positive phase 3 PREVAIL study data in chemotherapy-naïve cancer should pave the way for establishment of Xtandi as a best-in-class drug (versus Johnson & Johnson's Zytiga (abiraterone acetate) |
|
| Trius Therapeutics Inc. (TSRX:NASDAQ) | TR-701 (tedizolid phosphate) | Complex skin and skin structure infections | In Q1/13, phase 3 data from the second pivotal trial of TR-701; the probability for good results is high | |
| Navidea Biopharmaceuticals Inc. (NAVB:NYSE) | Lymphoseek (technetium Tc 99m tilmanocept) | Intraoperative detection of diseased lymph vessels and nodes |
PDUFA date: 4/30/13 Approval probability is high, but FDA has previously postponed the PDUFA date and the original application received a Complete Response Letter |
|
| Celsion Corp. (CLSN:NASDAQ) | ThermoDox (liposome-encapsulated doxorubicin) | Hepatocellular carcinoma (primary liver cancer) | Pivotal phase 3 trial results are imminent | |
| Onyx Pharmaceuticals Inc. (ONXX:NASDAQ) |
Kyprolis (carfilzomib) Kyprolis Stivarga (regorafenib) |
Multiple myeloma Multiple myeloma Metastatic colorectal cancer (mCRC) |
Quarterly sales data Begin front-line trial versus bortezomib (Q1/13) Anticipated approval by European Medicines Agency (EMEA) for mCRC H1/13 |
|
| Sarepta Therapeutics Inc. (SRPT:NASDAQ) | Eteplirsen | Duchenne muscular dystrophy (DMD) |
Meeting with FDA to present phase 2b trial data and discuss pivotal trial design in Q1/13 76-week data of DMD Study 202 in Q1/13 Protocol development of phase 3 trial for eteplirsen in DMD in H2/13 |
|
| Hyperion Therapeutics Inc. (HPTX:NASDAQ) | HPN-100 (glycerol phenylbutyrate) | Urea cycle disorders | Phase 3 trial data in 2013 | |
| Prana Biotechnology Ltd. (PRAN:NASDAQ) | PBT2 (a hydroxyquinoline derivative) | Huntington's disease, Alzheimer's disease |
Data in H2/13 These are tough indications, and even an inkling of efficacy in the data could excite investors |
|
| Celldex Therapeutics (CLDX:NASDAQ) |
rindopepimut (formerly CDX-110) CDX-011 (fully human antibody conjugated to chemo agent monomethyl auristatin E) |
gliobastoma (GBM) (EGFRvIII-expressing) Breast cancer (GPNMB expressing) |
Phase 2 (proof-of-concept) data in patients with aggressive GBM with rindopepimut + Roche AG's Avastin (bevacizumab) FDA meeting in Q1/13; this is an important conference |
|
| Galena Biopharma Inc. (GALE:NASDAQ) | NeuVax (nelipepimut or E75) | Breast cancer prophylaxis to prevent recurrence in disease-free patients expressing low levels of HER2 | Phase 3 update of PRESENT trial enrollment in H1/13 | |
| Celgene Corp. (CELG:NASDAQ) |
CC-10004 (apremilast) CC-4047 (pomalidomide) Revlimid (lenalidomide) |
Rheumatoid and psoriatic arthritis Multiple myeloma (MM) Multiple myeloma |
Phase 3 data in H2/13 PDUFA date: 2/10/13; high likelihood of approval due to positive data in pivotal trial data in Revlimid-refractory patients MM-020 study (Q1/13) could result in European approval of Revlimid in first-line MM |
|
| NewLink Genetics Corp. (NLNK:NASDAQ.GM) | HyperAcute Pancreas (algenpantucel-L) | Pancreatic cancer | Interim analysis of IMPRESS trial in H1/13 | |
| Information for this chart was provided by Mara Goldstein/Cantor Fitzgerald, Raghuram Selvaraju/Aegis Capital Corp. and company websites. George S. Mack, The Life Sciences Report | ||||
