Drug/indication: Apremilast for psoriasis and psoriatic arthritis (phase III) and rheumatoid arthritis (phase II)
Top-line results expected in the second half of the year.
Achieving European approval for first-line use of Revlimid in multiple myeloma remains the most important catalyst for the stock in the remainder of 2012. After that, however, Celgene becomes a clinical trial story for the first time in awhile. As a pill, apremilast has the potential to take a bit out of the market share in psoriasis and rheumatoid arthritis now dominated by biologic injectable therapies.
Drug/indication: Thermodox in liver cancer (phase III trial)
Top-line results expected in the fourth quarter
The "HEAT" study compares Thermodox plus radiofrequency thermal ablation (RFA) versus RFA alone in patients with primary liver cancer. The primary endpoint of the study is improvement in progression-free survival.
An interim analysis of the "HEAT" study was conducted in November 2011 but did not result in a patient benefit large enough to stop the study early.
Drug/indication: CCX140 for diabetic nephropathy (phase II trials)
Top-line results expected in late fourth quarter 2012 but possibly early 2013
ChemoCentryx is conducting two phase II studies of CCX140 versus placebo in patients with diabetic nephropathy.
Clovis Oncology (CLVS)
Drug/indication: CO-101 for pancreatic cancer (phase III trial)
Top-line results expected in fourth quarter
The "LEAP" study compares CO-101 versus gemcitabine in metastatic, chemo-naive pancreatic cancer patients whose tumors express low levels of hENT1, a protein which gemcitabine requires to enter cells. Survival is the study's primary endpoint.
Eli Lilly (LLY)
Johnson & Johnson (JNJ), Pfizer (PFE), Elan (ELN)
Drugs/indication: Solanezumab and bapineuzumab for Alzheimer's disease. (phase III trials)
Expected top-line results: Second half 2012
Two different drugs in separate and large phase III clinical trial programs, but solanezumab and bapineuzumab are linked because both are antibodies designed to break up sticky clumps of protein known as amyloid beta that lodge in the brain and are believed to cause the memory problems which are the signal manifestation of Alzheimer's disease.
Lilly is conducting two, large phase III studies (EXPEDITION AND EXPEDITION II) of solanezumab in patients with mild to moderate Alzheimer's. The studies' primary endpoint is change or improvement in memory (cognition) and activities of daily loiving. Results from a previous phase II study showed no benefit for patients while a different but similar Lilly Alzheimer's drug, semegacestat, failed a phase III study in 2010. [Semegacestat-treated patients actually did worse than placebo.]
Johnson & Johnson is conducting four phase III studies of bapineuzumab, separated into North American and rest -of-world patients as well as patients who carry or don't carry the APOE4 gene, a marker for more aggressive and earlier-onset Alzheimer's. Primary endpoints are the same as those used in the solanezumab studies. A phase II study of bapineuzumab failed to demonstrate a benefit for Alzheimer's patients.