Two companies which should have pre-announced fourth quarter revenue during their J.P. Morgan presentations but didn't, which is not a good sign: Vivus (VVUS) and Spectrum Pharmaceuticals (SPPI).
Vivus announced a near doubling of Qsymia prescriptions in December compared to November. Of course, if Vivus know the total number of Qsymia prescriptions for the fourth quarter, the company also knows how much revenue was generated from those Qsymia prescriptiosn. My guess is Vivus chose to publicize prescriptions totals while keeping sales hidden because the latter number is small and disappointing.
Likewise, Spectrum could have easily given us fourth-quarter revenue, including all-important Fusilev sales, like the company has done in the past when it had something to brag about. Monthly Fusilev third-party sales estimates have been in decline for the fourth quarter, however, which likely explains Spectrum's silence.
Two companies with interesting and potential lucrative drug pipelines that deserve another look, even from this skeptic: Isis Pharmaceuticals (ISIS) and Sangamo BioSciences (SGMO).
is a drug pipeline story in 2013. Who knew? Among several potential big products in the works is ALKS 5461 for major depressive disorder in a fully enrolled phase II study with results expected in the second quarter.
Orexigen Therapeutics (OREX)
has a stronger marketing partner for Contrave in Takeda
than Arena Pharmaceuticals (ARNA)
has for Belviq in Eisai
, which is expected to launch the weight-loss pill late in the third quarter or early in the second quarter. An approval decision from European regulators is expected in the first half of the year, although Arena's most ardent retail investor supporters (the Areniacs) expect European approval on Friday following the close of the January CHMP meeting.
Fifty-eight percent of patients in the Belviq registration trials failed to lose 5% or more of their baseline weight after 12 weeks of treatment, which is the stopping rule included in the drug's FDA label. During Arena's breakout session, Arena CEO Lief expressed his belief that real-world patients will be more compliant to Belviq treatment and lose more weight than what was observed in the clinical trials. Lief's assertion was met with a fair amount of skepticism because the norm is almost always the reverse -- study results are almost always better than what's observed once a drug is used in "real" patients.
Sarepta Therapeutics (SRPT)
CEO Chris Garabedian did a nice really nice job laying out the rationale for accelerated approval of eteplirsen in Duchenne muscular dystrophy. An FDA meeting to discuss the phase II data and request permission to file early is on the calendar for the first quarter, as expected.
We're still waiting on phase III study results from Celsion (CLSN)
, Ziopharm (ZIOP)
and Keryx Pharmaceuticals (KERX)
-- all expected in the first quarter, or in Keryx's case, already overdue.
-- Reported by Adam Feuerstein in Boston.