Go for the Gold!
| Aug 1, 2012
The Olympics are in full swing, and like many I’m glued to the TV watching and rooting for our athletes as they compete to be the best of the best. I just watched 17-year old Missy Franklin win her first gold medal in the 100m backstroke for the US and Lithuania’s Ruta Meilutyte win gold in the 100m breaststroke. Michael Phelps took a disappointing second in the 200m butterfly on July 31, coming in a tough 0.05 seconds behind South Africa’s Chad Le Clos. In gymnastics, the US men’s team choked, the injury-plagued Chinese men’s team turned things around to win gold, and Britain’s men’s team gave outstanding performances that earned them their first Olympic medal in this sport in a century.
So what analogies can be drawn between the Olympics and oncology?
Mediocre performance won’t earn you a gold (and maybe not even silver or bronze) medal. Thinking about what’s coming down the pipeline, my first thoughts go to Zaltrap™ (aflibercept; Sanofi/Regeneron) and tivozanib (AVEO/Astellas). Zaltrap is expected to gain approval this week for the treatment of second-line metastatic colorectal cancer after it was shown to improve overall survival when combined with chemotherapy, compared to chemotherapy alone. While any improvement in survival is always a positive outcome, the 1.4-month benefit observed was underwhelming, especially when the majority of physicians already utilize Avastin® (bevacizumab; Roche) in this setting (off-label, to a degree) and the similar level of benefit that Avastin recently demonstrated in the same setting. Tivozanib significantly improved progression-free survival (PFS) compared to Nexavar® (sorafenib; Onyx/Bayer) in first-line metastatic renal cell carcinoma. And while the mPFS was the highest observed in clinical trials to date, there’s a general feeling that the drug underperformed, and the lack of comparison with a more active agent (namely Sutent® (sunitinib; Pfizer), the market leader). Based on recent market research we conducted, Zaltrap and tivozanib are both anticipated to capture only a minority share of their respective markets. Sometimes, not every contender will live up to the pre-game hype.
A personal best is great for your ego (and your growth and development), but you still have to beat all other competitors to win the gold. Tivozanib and Zaltrap fit nicely into this analogy as well, but GlaxoSmithKline’s dabrafenib and trametinib also come to mind. Both drugs significantly improved PFS compared to chemotherapy in BRAF mutant metastatic melanoma, and global regulatory filings are under way. However, chemotherapy is no longer the standard of care in these patients, and stiff competition exists in the incumbent, Roche/Daiichi Sankyo’s Zelboraf® (vemurafenib). On paper, dabrafenib looks to have comparable efficacy to Zelboraf, but “comparable” won’t be enough to unseat Zelboraf; our market research suggests dabrafenib will make only a small dent in Zelboraf’s market share. However, even if you can’t win individual events, there’s always a chance for success in a team event. Much like France’s 4x100m men’s freestyle relay (Lavaux-Gilot-Lefert-Agnel) pulled off a surprise win against the US team (Adrian-Phelps-Cullen-Lochte), so might GlaxoSmithKline win when they pit the combination of dabrafenib and trametinib against Zelboraf.
Country of origin doesn’t matter – the beauty of the Olympics is that gold can be won by anyone, even the underdogs. China has always been a strong contender in the Olympics, and they have demonstrated their worth (literally) in the pharmaceutical market in recent years. With the numerous patent cliffs facing pharma and the stagnant growth in the G7, the “emerging markets” are where most of the industry is currently focusing their growth efforts. At first the focus was on BRIC (Brazil, Russia, India, China), but the breadth of “emerging market” focus has grown rapidly to include Mexico, Turkey, Latin America, MENA, Eastern Europe and an expanded scope in Asia. All athletes have a limited competition lifespan, and so may the G7 as the breadwinner for pharma. Indeed, a glance through strategic development plans for just about every global pharmaceutical company includes discussion on their growing focus on these markets. Just as Ruta Meilutyte can win gold for Lithuania in swimming and Australia’s William Henzell can upset the high-ranked competition in table tennis, so may several previously forgotten countries leapfrog over the traditional favorites to help pharma realize the growth potential that it so desperately needs.
Fortunately, we don’t have to wait four, or even two, years until the next big oncology gold medals. Several new entrants have blockbuster potential, which is arguably the equivalent of a gold medal for pharma.