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.

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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-na´ve 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