Top Pharma Innovations In 2006

Here’s my year-end list of the top pharma innovations of 2006.  In order to qualify for the list, the innovation must have been approved for human use by the U.S. FDA this year. 

To all my readers, I wish you a very happy, healthy and prosperous new year.  Talk to you in early 2007, when I’ll review the year past and ahead.

1. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil, (GSK)).  2006 might very well be remembered as the year of the cervical cancer vaccine–deservedly so.  The idea that a virus was the cause of cervical cancer seemed heretical 40 years ago, but Harald zur Hausen and others persisted in their belief, fueled by tantalizing experimental evidence.  This persistence paid off when a postdoc in zur Hausen’s lab cloned HPV-16, one of the HPV serotypes responsible for cervical cancer, in 1983.  These and other findings led directly to Gardasil and provided the rationale for future prophylactic vaccines against other virus-induced cancers.
2. Ranibizumab (Lucentis, Genentech (DNA)).  Prompted by evidence that retinal ischemia-induced iris neovascularization (the hallmark of “wet” age-related macular degeneration) requires vascular endothelial growth factor [VEGF], scientists at Genentech engineered ranibizumab, a humanized monoclonal antibody against VEGF, and quickly advanced it into the clinic.  Some eight years after its synthesis, Lucentis is widely anticipated to become the standard of care for wet AMD.
3. Sitagliptin (Januvia, Merck (MRK)).  The discovery by DPP-IV in the mid-1960’s set the stage for the development of DPP-IV inhibitors, of which sitagliptin is the first to be marketed for human use in type 2 diabetes.  Sitagliptin was synthesized by Merck (MRK) scientists.  It inhibits DPP-IV selectively, effectively increasing the body’s production of insulinotropic peptides (i.e. incretins, particularly GLP-1) in response to ingestion of food.  The decreased metabolism of incretins enhances food-induced insulin secretion and gastric emptying and diminishes glucagon secretion, leading to reduced postprandial and fasting blood glucose without weight gain in patients with type 2 diabetes.
4. Zoster vaccine, live (Zostavax, Merck (MRK)).  Building on their experience with Varivax in children (the only previously licensed varicella virus vaccine in the U.S.), Merck (MRK) developed Zostavax to prevent herpes zoster in older adults.  This population has been unserved by an effective means to prevent this very painful and debilitating condition.  Zostavax, with an immunogenic potency 14-fold greater than Varivax, filled the bill, reducing the burden of herpes zoster illness in an elderly population by about 60%.
5. Sunitinib (Sutent, Pfizer (PFE)) and dasatinib (Sprycel, (BMY)).  These multi-receptor tyrosine kinase inhibitors were both approved this year, for different types of cancer. Pfizer and BMY built on the foundations created by Novartis (NVS)’ Gleevec, but these drugs represent a divergence from the traditional one-kinase/one-inhibitor thinking that gave birth to Gleevec.  Neither Sutent nor Sprycel will win any awards for their brand names or their immediate impacts to prolong cancer survival, but they represent an exciting new wave of TK inhibitors for cancer treatment.
6. Vorinostat (Zolinza, Merck (MRK)).  Originally known as SAHA (suberoylanilide hydroxamic acid), vorinostat was acquired by Merck (MRK) when it purchased Aton Pharma in 2004.  Aton was co-founded by SAHA’s discoverer (PA Marks).  It is the first histone deacteylase (HDAC) inhibitor approved for treatment of a malignancy.  HDAC inhibitors “open up” chromatin, but the specifc mechanisms of their anti-neoplastic effects are incompletely understood.  Zolinza is indicated in the relatively rare cutaneous T-cell lymphomas and is being studied clinically in a wide variety of solid organ and blood malignancies.