Next quarter is make or break for some biotechs
Clinical trials, drug launches and FDA approval decisions fill the calendar for these companies at the start of the new year.
The first quarter of 2013 is shaping up to be action-packed for biotech investors.
Volatility junkies rejoice because I count six clinical trials that should read out in the first three months of next year. Four of these trials carry life-or-death stakes for the companies involved.
Celsion (CLSN) is up first. Last week, the company announced the passing of the 380th progression event in its pivotal study of the liver cancer therapy Thermodox. Celsion is now locking up the study and analyzing data, with results expected in January.
Celsion's market cap of $186 million is low for a company with looming phase III cancer drug data, making this stock an easy double on positive results. Celsion will crater if Thermodox fails.
Oncothyreon (ONTY) will also live or die based on first-quarter clinical trial results. Final data from the phase III study of the lung cancer drug Stimuvax will be ready in the first quarter, Merck KGaA CEO Karl-Luwdwig Kley told Reuters last Thursday.
The German Merck is Oncothyreon's development partner for Stimuvax, a cancer immunotherapy. Oncothyreon shares were cut in half last March because an interim analysis of the Stimuvax lung cancer study wasn't robust enough to demonstrate a survival advantage. Expectations for Stimuvax are low right now, so Oncothyreon is another easy double if the cancer "vaccine" can buck the odds and win when the final results from the lung cancer study are announced.
The other four late-stage studies expected to read out in the first quarter:
- Ziopharm's (ZIOP) palifosfamide in first-line soft-tissue sarcoma.
- Exact Sciences' (EXAS) Cologuard for colon cancer screening.
- Two phase III studies involving Gilead Sciences' (GILD) hepatitis C pill GS-7977.
- Celgene (CELG) has already announced positive results from the Abraxane phase III study in pancreatic cancer but the actual survival benefit won't be disclosed until data are presented at a cancer conference starting Jan. 24.
Biotech investors have obsessed over Amarin (AMRN) and Arena Pharmaceuticals (ARNA) for most of 2012 -- a trend that will only escalate as both companies are expected to roll out commercial launches of their respective drugs in the first quarter.
Will Amarin launch Vascepa, its triglyceride-lowering fish-oil pill, on its own, without a Big Pharma partner? And will Arena and its partner Eisai be more successful with the initial marketing of their obesity pill Belviq than Vivus (VVUS) has been with Qsymia?
Lastly, FDA drug approval decisions on the calendar for the first three months of 2013:
- NuPathe (PATH): Zelrix migraine patch on Jan. 17.
- Impax Pharmaceuticals (IPXL): Rytary for idiopathic Parkinson's disease on Jan. 21.
- Hyperion Therapeutics (HPTX): Ravicty for urea cycle disorders on Jan. 23.
- Sucampo Pharmaceuticals (SCMP): Amitiza for opioid-induced constipation in patients with chronic, non-cancer pain on Jan. 25.
- Isis Pharmaceuticals (ISIS) and Sanofi (SNY): Kynamro for homozygous familial hypercholesterolemia on Jan. 29.
- Raptor Pharmaceuticals (RPTP): RP103 for nephropathic cystinosis on Jan. 30.
- Hemispherx Biopharma (HEB): Ampligen for chronic fatigue syndrome on Feb. 2
- Celgene: Pomalidomide for multiple myeloma on Feb. 8.
- Dynavax (DVAX): Heplisav for immunization against hepatitis B on Feb. 22.
- Roche (RHHBY) and ImmunoGen (IMGN): T-DM1 for metastatic breast cancer on Feb. 26.
- Zogenix (ZGNX): Zohydro for moderate to severe chronic pain on March 1.
- AP Pharma (APPA): APF530 for prevention of nausea and vomiting due to chemotherapy on March 27.
- Biogen Idec (BIIB): BG-12 for multiple sclerosis on March 28.
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