3 Win The Pre-Launch Phase
Once HECs find their products, they are experts at launching them. These top competitors conduct election-style — not military-style
—launch campaigns and seek to win the "Pre-Launch Years" versus the traditional but belated "Launch Year." Novo's launch of
GLP-1 diabetes agent Victoza demonstrated such extensive pre-market preparation. At an analysts meeting in 2010, Novo SVP
Jakob Riis said, "We've also been very conscious about early on opting our resources and our preparedness to engage in ...
200,000 interactions last year of more than an hour's length with physicians globally explaining the science behind GLP-1"
to maximize pre-launch awareness. Novo successfully counter-launched against Lilly's GLP-1 rivals Byetta and Bydureon, including
stealing their thunder prior to the 2008 American Diabetes Association Meeting. The Journal of Managed Care Pharmacy highlighted
Victoza's launch as a textbook case, saying the product "came to the market with unusually robust data demonstrating clinical
comparative efficacy and safety," including head-to-head studies versus Byetta and other competitors. Despite being delayed
by regulatory authorities, Victoza became a U.S. blockbuster within one year.
Biogen trumpeted its new MS therapy Tecfidera so much prior to its 2013 U.S. launch that analysts claimed there was "a bolus
of patients in the queue ready to transition to therapy" with an estimated $100 million in pent up demand, which the Wall
Street Journal reported "overwhelmed some pharmacies." Called the holy mother of all launches" by ISI analyst Mark Shoenebaum,
Tecfidera doubled analysts' first quarter projections and is expected to reach blockbuster status in 2014 and exceed $5 billion
annual global sales by 2018. FirstWord rates the launches of Tecfidera, Celgene's multiple myeloma agent Pomalyst, and Roche's
breast cancer therapy Kadcyla as the top three 2013 product launches outperforming analysts' consensus projections.
4 Play Their Game
HECs shape their specialty markets to force rivals to play their game. For example, Gilead shaped the HIV market to be a drug
combination game based predominantly on its compounds. A relatively late player in the HIV space, the company in 2004 launched
the two-drug fixed-dose drug ("FDC") Truvada and two years later the three-drug FDC Atriplia, consisting of Truvada and Bristol-Myers
Squibb's Sustiva (efavirenz). Preferring to use all Gilead ingredients, the company in 2012 launched a four-drug, once-daily
single-tablet regimen nicknamed the "Quad" and branded as Stribild, which is projected to have 2015 sales exceeding $3 billion.
Gilead is determined to dominate the HCV space using the same game plan: leverage its new agent Sovaldi as the backbone for
first-line HCV therapy and fixed-dosed combinations. As a testament to the company's competitiveness, Gilead has refused to
collaborate with Bristol-Myers Squibb on co-development of a highly promising regimen featuring Sovaldi and BMS's drug daclatasvir;
instead, Gilead has chosen to develop a similarly-effective HCV regimen featuring only Gilead products. Gilead's market-leading
approach to drug combinations has transformed the HIV treatment paradigm and is likely to do the same in HCV.