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 identify 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 had the best chances for upward stock price movement. The result was the groundbreaking Life Sciences Report Watchlist 2013. Now a quarter into 2013, the Watchlist has been updated with the most current information and catalysts.
| Company | Drug | Disease | Catalyst | |
|---|---|---|---|---|
| Ariad Pharmaceuticals Inc. (ARIA:NASDAQ) |
Iclusig (ponatinib) FDA approved Dec. 14, 2012 AP26113 |
Chronic myelogenous leukemia (CML) Non-small cell lung cancer |
Favorable phase 3 EPIC trial data could result in approval for first-line use in CML in Q4/13.
Approval of Iclusig in the EU in Q3/13; company expects to be "launch-ready" by July 1, 2013. Regulatory submissions for Iclusig in Canada, Switzerland and Australia in H2/13 Regulatory submission in Japan in mid-2014 Data from interim analysis of phase 3 EPIC trial comparing Iclusig to imatinib (Gleevec) in newly diagnosed CML expected in mid-2014 Clinical updates at the American Society of Clinical Oncology (ASCO) meeting in June Clinical updates at European Society of Medical Oncology in September |
|
| Amarin Corporation plc (AMRN:NASDAQ) |
Vascepa (icosapent ethyl)
FDA approved July 26, 2012 |
Hypertriglyceridemia Mixed dyslipidemia |
Quarterly sales figure catalysts Acceptance of supplemental new drug application (sNDA) for mixed lipidemia by mid-May |
|
| Medivation Inc. (MDVN:NASDAQ) |
Xtandi (enzalutamide)
FDA approved Aug. 31, 2012 |
Prostate cancer
Chemo-naive metastatic castration-resistant prostate cancer |
Quarterly sales figures Mid-2013: Positive phase 3 PREVAIL study data |
|
| Trius Therapeutics Inc. (TSRX:NASDAQ) | TR-701 (tedizolid phosphate) | Complex skin and skin structure infections, including methicillin-resistant Staphylococcus aureus |
New drug application (NDA) in H2/13
FDA acceptance of the NDA filing FDA approval in mid-2014 |
|
| Sangamo BioSciences Inc. (SGMO:NASDAQ) | SB-728-T | HIV/AIDS |
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 |
Phase 3 RESONATE trial of 350 patients in ibrutinib monotherapy versus ofatumumab in relapsed or refractory CLL/small lymphocytic lymphoma with primary endpoint of progression-free survival improvement. First readout from interim analysis is anticipated in Q1/14. | |
| Navidea Biopharmaceuticals Inc. (NAVB:NYSE) |
Lymphoseek (technetium Tc 99m tilmanocept)
FDA approved March 13, 2013 |
Intraoperative detection of diseased lymph vessels and nodes | Next catalysts will be based on uptake of Lymphoseek by surgeons and revenue associated with that uptake | |
| Celsion Corp. (CLSN:NASDAQ) | ThermoDox (liposome-encapsulated doxorubicin) | Hepatocellular carcinoma (primary liver cancer) | Phase 3 failure reported on Jan. 31, 2013; future uncertain | |
| Onyx Pharmaceuticals Inc. (ONXX:NASDAQ) |
Kyprolis (carfilzomib) FDA approved July 20, 2012 Stivarga (regorafenib; multikinase inhibitor) FDA approved Sept. 27, 2012 |
Multiple myeloma Metastatic colorectal cancer (mCRC) Locally advanced, unresectable or metastatic gastrointestinal stromal tumors |
Quarterly sales data Revenue upside related to March 25, 2013 approval in Japan Revenue upside related to February 2013 approval in the U.S. |
|
| Sarepta Therapeutics Inc. (SRPT:NASDAQ) | Eteplirsen | Duchenne muscular dystrophy (DMD) |
Protocol development of phase 3 trial in H2/13 FDA to decide if eteplirsen would be considered for accelerated approval End-of-phase 2 meeting with FDA is now anticipated for Q3/13 |
|
| Hyperion Therapeutics Inc. (HPTX:NASDAQ) |
Ravicti (formerly HPN-100 (glycerol phenylbutyrate) FDA approved Feb. 1, 2013 |
Urea cycle disorders | Product is shipping; success of commercial rollout | |
| Prana Biotechnology Ltd. (PRAN:NASDAQ) | PBT2 (a hydroxyquinoline derivative) |
Alzheimer's disease Huntington's disease |
Phase 2b data in Q4/13 Phase 2a data in Q3/13 |
|
| Peregrine Pharmaceuticals Inc. PPHM:NASDAQ | Bavituximab (first-in-class; targeting phsophatidylserine) |
First-line non-small cell lung cancer (NSCLC) in combination with
carboplatin and paclitaxel Second line NSCLC; in combination with docetaxel Investigator-sponsored phase 1 trials in HER2(-) breast cancer with paclitaxel and in liver cancer with sorafenib |
Median overall survival results on phase 2b trial in Q2/13 Final results of salvaged data from phase 2b trail in Q2/13 (most likely at ASCO) Phase 3 trail could begin by year-end; data possible in Q2/13 Data possibly in Q2/13 |
|
| Celldex Therapeutics (CLDX:NASDAQ) |
rindopepimut (formerly CDX-110) CDX-011 (fully human antibody conjugated to chemo agent monomethyl auristatin E) CDX-1401 CDX-1127 CDX-301 |
gliobastoma (GBM) (EGFRvIII-expressing) Triple-negative breast cancer (GPNMB expressing) Solid tumors Solid tumors Hematopoietic stem cell transplant |
Phase 2 (proof-of-concept) data in patients with aggressive GBM with
rindopepimut + Roche AG's Avastin (bevacizumab) Initiation of phase 3 trial in H2/13 Completion of phase 2 Completion of phase 1 in H2/13 Complation of phase 1 accrual in H2/13 |
|
| Galena Biopharma Inc. (GALE:NASDAQ) |
NeuVax (nelipepimut or E75) FBP(folate binding protein-E39) |
Breast cancer prophylaxis to prevent recurrence in disease-free patients expressing low levels of
HER2 Prophylaxis for tumors expressing folate receptor alpha |
Phase 3 update of PRESENT trial enrollment in H1/13 Now in phase 2b, data from the phase 1 trial will be announced at American Society of Clinical Oncology (ASCO) meeting in June |
|
| Celgene Corp. (CELG:NASDAQ) |
CC-10004 (apremilast) Pomalyst (pomalidomide) FDA approved Feb. 8, 2013 Revlimid (lenalidomide) Abraxane |
Rheumatoid and psoriatic arthritis Multiple myeloma (MM) Myelofibrosis Multiple myeloma Pancreatic cancer Melanoma |
FDA submission for psoriasis and psoriatic arthritis in H1/13. Submission for approval in the EU in
H2/13 Approval in the EU in H2/13 Phase 3 data in H1/13 MM-020 study (H2/13) could result in European approval in first-line MM File sNDA Mature overall survival data |
|
| NewLink Genetics Corp. (NLNK:NASDAQ.GM) |
HyperAcute Pancreas (algenpantucel-L) Indoximod |
Pancreatic cancer Metastatic breast cancer |
Results of interim analysis of IMPRESS trial in H1/13 Phase 2 enrollment update |
|
| 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 | ||||
