Stan Bernard
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What would happen if you could not differentiate your brand based solely on its clinical profile? As the pharmaceutical industry
transitions from the commercial to the competitive stage of its lifecycle, it has become increasingly more difficult to compete
primarily on the molecular differences among products (see Pharm Exec, January 2009 "Pharma vs. Pharma"). Many therapeutic areas, such as hypertension, rheumatoid arthritis, and diabetes, have
numerous brands, presenting hurdles to establishing a place in the market. Many payers refuse to acknowledge brand differences,
typically lumping brands as equivalents within the same class, and often limiting or rejecting reimbursement for "me-toos."
More important, brands are increasingly competing earlier and more often against generics, which renders clinical differentiation
virtually irrelevant.
As a result, pharmaceutical professionals must learn to win beyond the molecule. Their new challenge is to find new competitive
approaches beyond the clinical attributes of their products. Some companies have already gained a competitive advantage by
applying these new tools of differentiation. The following are five examples:
1) Clinic Networks
When launching its rheumatoid arthritis drug Remicade in Canada, Schering-Plough (now Merck) found that when delivered via
infusion as opposed to injection (as is its competitors), the drug would not readily receive reimbursement in a hospital setting.
To address this, Schering formed the "Remicade Infusion Network," a country-wide network of outpatient clinics, often conveniently
located in or near physician offices. This approach enhanced patient reimbursement, compliance, and outcomes; financially
incentivized specialty pharmacists; and excluded future infusion-administered biologic competitors. Remicade became the preferred
biologic in Canada. Schering subsequently launched these clinics in several other countries.
2) Combination Products
In 2004, Gilead Sciences combined two of its HIV drugs, Viread and Emtriva, to form the best-selling drug Truvada. In 2006,
the company added a third component, Sustiva, from Bristol-Myers Squibb, to create the first, once-daily, triple-therapy Atripla,
which became the world's best-selling HIV compound in 2008. Gilead is collaborating with Johnson & Johnson to develop a single
pill nicknamed "Btripla," combining Truvada with TMC-278 (rilpivirine hydrochloride) to improve patient tolerability and adherence.
To further extend Gilead's AIDS cocktail franchise, Gilead is also developing a once-daily "Quad" pill containing four different
Gilead-owned HIV agents. Analysts project Quad sales to exceed $1.5 billion by 2015; Gilead's HIV franchise is expected to
earn over $5 billion per year during the next decade.
In 2010, Jeff Taylor of the AIDS Treatment Activist Coalition (ATAC) declared that, "Gilead revolutionized HIV care with its
fixed-dose combinations." Once-daily combination products have enabled Gilead to become so dominant in the HIV category that
it compelled Pfizer and GSK to form a joint HIV venture ViiV Healthcare to try to compete with them.
3) Novel Delivery Device
GlaxoSmithKline markets Advair (also known as Seretide), the world's third-best-selling prescription with over $8 billion
in annual sales. One reason for Advair's success is its unique inhalation device, the "Diskus." The Advair Diskus is favored
by physicians and patients for its convenience and ease of use. A Decision Resources survey revealed that, despite increased
competition from several emerging agents, the Advair Diskus will remain pulmonologists' and primary care physicians' favored
fixed-dose long-acting beta2 agonist/inhaled corticosteroid combination inhaler through 2013 for asthma and chronic obstructive
pulmonary disease.
The Diskus confers competitive advantages against both branded and generic competitors. Recognizing the significant influence
of regulators on generic entries, GSK's Regulatory Affairs group worked closely with the FDA to ensure the agency understood
the various complexities associated with the development and manufacture of the Advair Diskus. As a result, the FDA raised
the standards for generic entry so high that companies wishing to launch a generic version of Advair have to complete full
clinical programs—including long-term safety studies—to gain access to the US market. Consequently, Novartis/Sandoz backed
out of its deal with Vectura for a generic version of Advair in the US. Teva, the world's largest generic manufacturer, will
now be required to conduct a full clinical program for its "branded generic" before it can enter the US market in approximately
2016. As a result, GSK will gain at least six more years of exclusivity for its blockbuster Advair in the world's largest
pharmaceutical market.
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