Watch CBS News

Biotech Events to Watch in 2010: FDA Approvals, Expected Deals and Surprises!

There's a lot to keep track of in the biotech industry, as January has evidenced.

We've already seen FDA approvals of Novo Nordisk's diabetes drug Victoza (liraglutide) and Acorda Therapeutics' multiple sclerosis walking drug Ampyra (dalfampridine), as well as deals between Galapagos and Roche, Inspiration and Ipsen, and others. Not to mention financings, data, earnings...

What's coming next? Here's a peek at some of the most anticipated biotech events of the year:

FDA Decisions

  • Feb. 12: Cadence (CADX) pain drug acetavance
  • Feb. 13: Gilead (GILD) cystic fibrosis drug Cayston (aztreonam)
  • Feb. 28: Shire (SHPGY) Gaucher's drug velaglucerase
  • March 5: Amylin (AMLN) diabetes drug Exenatide LAR
  • March 29: Cephalon (CEPH) jet lag indication for Nuvigil (armodafinil)
  • April 23: Cell Therapeutics (CTIC) lymphoma drug pixantrone (advisory meeting Feb. 10)
  • May 1: Dendreon (DNDN) prostate cancer vaccine Provenge (sipuleucel-T)
  • And coming later in the year: NicOx (COX.PA) arthritis drug naproxcinod, Intermune (ITMN) idiopathic pulmonary fibrosis drug pirfenidone, Shire Fabry drug Replagal (agalsidase alfa), Pfizer (PFE) and Protalix (PLX) Gaucher's drug Uplyso (taliglucerase), Human Genome Sciences (HGSI) lupus drug Benlysta, MannKind (MNKD) diabetes drug Afrezza and Amgen (AMGN) osteoporosis drug Prolia (denosumab)
Partnerships. No one can say if/when these will happen, but here are a few predictions:
  • Lots of folks are wondering if the big three obesity drugs (Vivus' (VVUS) Qnexa, Orexigen's (OREX) Contrave and Arena's (ARNA) lorcaserin) will find partners this year
  • Deutsche Bank analyst Mark Schoenebaum notes that other unpartnered late-stage assets include Dendreon's Provenge, MannKind's Afrezza and Optimer's (OPTR) antibiotic fidaxomicin
  • Piper Jaffray analyst Edward Tenthoff likes the odds for Anadys (ANDS) to partner Phase II hepatitis C drug ANA-598 and Ardea (RDEA) to partner Phase II gout drug RDEA-594
Surprises. Courtesy of the Cowen biotech analysts:
  • Big pharma doesn't bite on biotech's biggest M&A candidates (DNDN, HGSI, SVNT, VRTX). Probability = 20%
  • ViroPharma (VPHM) keeps the Vancocin generics at bay. Probability = 15%
  • Big biotech trades stock buybacks for dividends. Probability = 5%
Want More?
View CBS News In
CBS News App Open
Chrome Safari Continue
Be the first to know
Get browser notifications for breaking news, live events, and exclusive reporting.