Thursday, December 22, 2011

N-of-8 case study: how to look at the same brand hallmarks in new ways

Here’s a case study that exemplifies seeing the same hallmarks in new ways – in other words, looking at the same product attributes, and applying them a new ways.

 N-of-8 Brand Story Development played an early role in the market preparation for Advicor, a combination of time-release niacin and lovastatin in once-a-night dosage.  It provides stronger cholesterol modulation by increasing HDL cholesterol and lowering LDL, triglycerides (TG), and lipoprotein-a.

The innovator was Kos Pharmaceuticals, which filed its New Drug Application for the product in September 2000. In preparation for product launch, Kos signed a marketing agreement with DuPont Pharmaceuticals. DuPont agreed to invest up to $80 million in Kos, beginning with an initial equity investment of $30 million plus $20 million for product development. Kos and DuPont agreed to share equally in Advicor promotional costs as well as profits, less initial royalties paid to Kos.

They engaged the N-of-8 process to create a core brand story and launch branding program for Advicor.  In reviewing the data, we found that clinical trials showed that Advicor increased HDL cholesterol up to 30 percent while it lowered LDL as much as 42 percent, TG down 44 percent, and lipoprotein-a down 22 percent.

During our N-of-8 story groups, physicians recognized the feature of combination therapy in a single tablet.  They helped us coin Advicor as “dual-component therapy for cholesterol modulation.”

Further, the N-of-8 brand development groups created a story of “multidimensional lipid management” and a visual identity of a 4-D gyroscope.  The ad testing documented the Advicor launch insert as achieving the highest recall and relevance of any cardiovascular product ad to date.

Kos received final marketing clearance for Advicor on December 18, 2001 and entered the fast-growing $10 billion cholesterol market with its innovative new medicine backed by a well-established clinical profile, a well-developed story, and a well-tested brand.

This reinforced Kos’ confidence to launch Advicor with a force of 300 sales representatives – more than five times the resources for marketing than for its first product, Niaspan.  The company expanded its market base to primary care physicians and incorporated a medical education program. A two-year marketing agreement with Quintiles Transnational added 150 more sales representatives specially trained in cardiovascular health to Kos' sales efforts. Sales of Advicor reached $27 million in 2002 and seemed to benefit sales of Niaspan, which rose 73 percent to $146 million.

Initial international expansion focused on Europe and Canada. Kos applied to the European Union to market Advicor in July 2002 and, a few months later, signed an agreement with Merck KGaA to market Niaspan and Advicor outside of North America and Japan. Kos received an initial payment of $15 million to be supplemented with licensing and milestone fees, expected to add up to $46 million in revenues, as well as royalties of 25 percent of net sales. In August 2003 Kos signed an agreement with Oryx Pharmaceuticals to market Niaspan and Advicor in Canada, granting Oryx exclusive rights. Kos expected the drugs to be approved by late 2005.

Kos continued to advance its sales efforts within the United States. Kos signed a comarketing agreement with Takeda Pharmaceuticals-North America to market Niaspan and Advicor to 48,000 physicians. More than 1,000 Takeda sales representatives sold the products as a complement to Takeda's ACTOS, used by patients with type 2 diabetes associated with cardiovascular disease. Kos expected 10 percent revenue growth from the association with Takeda during 2004.

In order to better compete with large pharmaceutical companies, Kos continued to approach health insurance providers to advocate for coverage of Niaspan and Advicor. Kos emphasized its role as a specialty manufacturer providing a lower-priced option. Price comparisons illustrated the difference. For instance one published report showed that a bottle of 60 tablets of 500 mg Niaspan sold at Walgreen’s for $79.99, while 30 tablets of 40 mg of Pfizer's Lipitor sold for $95.99; 500 mg Advicor was priced at $55.99. Comparatively, the daily dose was $1.70 for Niaspan, $1.97 for Advicor, and $2.42 for Lipitor.

Kos continuously sought to expand medical applications for Advicor, maintaining the foundation of “multidimensional lipid management” we had created in N-of-8 brand development.  An independent study proved it to be an effective treatment for cholesterol modulation in patients with metabolic syndrome. Metabolic syndrome involves more than one contributing factor in coronary heart disease, including obesity, high blood pressure, and high blood sugar, in combination with a high level of bad cholesterol and a low level of good cholesterol.

I’m often asked, “What’s a good story worth?”  Well, here is one measure of value.

In 2006, Abbott Laboratories acquired Kos Pharma for $3.7 billion in order to add Advicor and Niaspan to its arsenal. Abbott also gained the rights to another cholesterol-lowering medication Simcor, a new combination pill. Later, the FDA cleared Abbott's cholesterol drug TriLipix, the first fibrate to be combined with a statin for treating unhealthy cholesterol levels.

Abbott and AstraZeneca were working together to develop a fixed-dose combination of TriLipix and Crestor, AZ's blockbuster cholesterol drug. The companies announced plans to submit an NDA for the combo drug to the FDA in the second half of 2009. The companies also had an agreement to co-promote Crestor in the U.S.

All these innovations are based on the concept of “dual-component therapy for cholesterol modulation” shaped in the N-of-8 brand story development process.

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