Editor's note: This article originally appeared in Senior Columnist Adam Feuerstein's Biotech Select newsletter on Dec. 17.It's true, we're not quite finished with 2008 just yet, but I've certainly started to plan for next year. For me, that begins with compiling a calendar of meaningful clinical trials and data-related events expected to take place in the new year. So I've put together a list, in alphabetical order, of biotech and drug companies with important (stock-moving) clinical trials expected to have data available in the first six months of 2009. I use a list like this for planning and research purposes, so I'm prepared in advance for when these data are released. Thanks to BioMedTracker, a service of Sagient Research, for assisting with the research for this list. A prepared biotech investor is a richer biotech investor. Perhaps I should have that printed on T-shirts Anyway, here is my clinical trials list. I hope you find it useful. Alnylam Pharmaceuticals ( ALNY) is conducting a phase II study of its lead RNA interference (RNAi) drug ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus with results to be released in mid-2009. Amgen ( AMGN) is expanding its experimental long-acting osteoporosis denosumab drug into cancer indications with phase III studies seeking to reduce skeletal related events in prostate, breast and other solid tumor cancers. The data are set to be available in mid-2009. Amicus Therapeutics ( FOLD) is running a phase II study of its drug Plicera in Gaucher disease with results due in mid-2009. Arena Pharmaceuticals ( ARNA): The first phase III data from its obesity drug lorcaserin are expected at the end of March. Biogen Idec ( BIIB) is conducting two phase II studies of its experimental drug BIIB-014 in early and late-stage Parkinson's disease with data due in the first half of 2009.
Chelsea Therapeutics ( CHTP) has a phase III study of droxidopa in patients with neurogenic orthostatic hypotension (dizziness caused by sudden drop in blood pressure when standing) due in the second quarter 2009. Genentech's ( DNA) phase III study of Avastin in adjuvant colon cancer is expected in mid-2009. Gilead Sciences ( GILD) is running a phase III study of darusentan in patients with resistant hypertension with results expected in mid-2009. Human Genome Sciences ( HGSI) has two ongoing trials with near-term data: a phase III study of long-acting interferon, Albuferon, in patients with hepatitis C, genotype 1 expected in March; and a phase III study of Lymphostat-B in patients with systemic lupus erythematosus due mid-2009. InterMune ( ITMN) is conducting a 14-day phase I study of hepatitis C drug candidate ITMN-191 in combination with standard of care to be reported in January and a phase III study of pirfenidone in idiopathic pulmonary fibrosis, which is due in February. Isis Pharmaceuticals ( ISIS) has a phase III study of the drug mipomersen in homozygous familial hypercholesterolemia (a rare genetic disorder that causes exceptionally high levels of LDL cholesterol) with results expected in mid-2009. Medicines Co. ( MDCO): Two phase III studies of Cangrelor in acute coronary syndrome and percutaneous coronary interventions are expected in mid-2009. Data could be ready at the end of March in time for the American College of Cardiology annual meeting. Neurocrine BioSciences ( NBIX): Phase II studies of its drug elagolix in endometriosis due in early-to-mid-2009. Onyx Pharmaceuticals ( ONXX): A phase III study of Nexavar in melanoma patients is expected in mid-2009.
Orexigen Therapeutics ( OREX): Results from a phase III study of its obesity drug candidate Contrave are scheduled to be presented at the JPMorgan Healthcare conference, Jan. 12 through 15. Osiris Therapeutics ( OSIR) is conducting a phase III study of its mesenchymal stem cell product Prochymal in patients with steroid-refractory graft-vs.-host disease with results due in the second quarter 2009. Poniard Pharmaceuticals' ( PARD) cancer drug picoplatin is being tested in a phase III study of patients with small-cell lung cancer with data expected in mid-2009. Rigel Pharmaceuticals ( RIGL): Two phase IIb studies of R788 in rheumatoid arthritis are expected mid-2009. Synta Pharmaceuticals' ( SNTA) phase III trial of elesclomol in melanoma expected to be completed in the first quarter 2009. United Therapeutics ( UTHR): The "Champion-M" study of the oral drug Remodulin given as monotherapy in patients with pulmonary arterial hypertension will be ready for release in March. Vivus ( VVUS): Two phase III trials of its obesity drug Qnexa are due mid-2009.