Pharma’s Cutting Edge

I indicated in my year-end 2008 post that I was looking forward to a productive 2009 for the pharmaceutical/biopharmaceutical industry.  Indeed, there’s a good chance that the number of approved new molecular entities in 2009 in Europe and the US will be noticeably more than in the last several years.

I’ve selected some particularly interesting NMEs that have a reasonable chance of being approved and launched in either the US or EU some time during 2009 (my own estimatation).  The list below is not intended to be a complete list of all possible NME launches, nor does it include any non-NMEs that might launch in 2009 (e.g. reformulations, combinations, new indications, etc).  I focus on drugs, but I’m including some drug-like therapies here as well.   If you would like to add your own candidate to the list, just post a comment with your therapy candidate and your reason for including it. 

The list format is nonproprietary name (proposed brand name), sponsor(s), brief MOA, and probable lead indication, sorted alphabetically by nonproprietary name.

• Adult mesenchymal stem cells (Prochymal), Osiris, immunomodulator, steroid-resistant graft-versus-host disease (GvHD)
• Canakinumab, Novartis, IL1 beta-specific MAb, Cryopyrin-Associated Periodic Syndromes (CAPS)
• Denosumab, Amgen, human RANKL MAb, postmenopausal osteoporosis and osteoporosis in men
• Ecallantide, Dyax, plasma kallikrein inhibitor, acute attacks in herdeitary angioedema
• Iclaprim, Arpida, dihydrofalate reductase inhibitor, complicated skin and skin strcuture infections
• MalPEG-Hb in Lactated Ringer’s solution (Hemospan), Sangart, Cell-free, colloidal oxygen carrier and volume expander (pegylated hemoglobin), prevention/treatment of hemodynamic instability during orthopedic surgery
• Ofatumumab (Arzerra),  Genmab/GSK, human MAb against CD20, fludarabine-refractory Chronic Lymphocytic Leukaemia (CLL) and follicular NHL
• Oxidized glutathione aka disodium glutathione disulfide aka NOV-002, Novelos, glutathione mimetic chemoprotectant/immunomodulator, first-line therapy of non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel
• Prasugrel (Effient/Efient), Lilly/Daiichi-Sankyo, P2Y12 (ADP) receptor inhibitor, antiplatelet anticoagulant, adjuvant to percutaneous coronary interventions (PCI) in acute coronary syndromes (ACS)
• Retigabine, Valeant , potassium channel opener, refractory partial-onset seizures in adults
• Rivaroxaban (Xarelto), Bayer, Factor Xa inhibitor, VTE prevention, approved in Europe Q4 2008
• Rolofylline, Merck, A1 receptor antagonist, acute heart failure decompenasation with renal function protection
• Sipuleucel-T (Provenge), Dendreon, active immunotherapy targeting prostatic acid phosphatase, advanced androgen-independent prostate cancer (see also here and here)
• Sitimagene ceradenovec (Cerepro), Ark Therapeutics, AD5-mediated thymidine kinase gene therapy plus ganciclovir, surgical adjuvant for operable malignant glioma
• Telcagepant, Merck, Calcitonin-Gene Related Peptide antagonist, migraine
• Tocilizumab (Actemra), Roche/Chugai, IL-6 receptor MAb. Rheumatoid Arthritis
• Tolvaptan, Otsuka, V2 antagonist, hyopnatremia and autosomal-dominant polycystic kidney disease
• Ustekinumab (Stelara), J&J, human MAb for interleukin 12 (IL-12) and interleukin 23 (IL-23),  moderate to severe plaque psoriasis
• Vandetanib (Zactima), AstraZeneca, oral VEGF/EGF inhibitor for NSCLC

January 2nd, 2009 | Category: Technology | Subscribe to comments | Leave a comment | Trackback URL