Shire on the Wire - Pharmaceutical Executive


Shire on the Wire

Pharmaceutical Executive

Attention Must Be Paid

In 1995, alert to Ritalin's then-burgeoning market in childhood ADHD, Shire got its hands on a potential competitor stimulant called Obetrol (originally an anti-obesity drug) through the acquisition of Rexar Pharmaceuticals. A year later, Shire renamed the molecule Adderall, won FDA approval—and the rest, as they say, is blockbuster history. By 2007, the extended release form of Adderall owned about one-quarter of the $3.7 billion ADHD market.

A full five years before the doomsday patent loss of Adderall XR, Shire began pressing into service its plans for an allclass ADHD franchise. Led by Cola—who had helped AstraMerck steer both Prilosec and Nexium through patent death—the strategy focused on priming the portfolio with four new products.

The new flagship is less than novel: Vyvanse, a prodrug of dextroamphetamine. With its longtime ADHD sales and marketing network, Shire boasts that Vyvanse can reap Adderall-sized profits. With sales estimated as high as $1.3 billion by 2015, some analysts agree. But Decision Resources analyst Jonathan Searles projects Vyvanse to hit blockbuster status only late in its patent life, suggesting that Shire faces the near future without an Adderall 2.0.

Launched in 2007, the prodrug's sales were $318 million in 2008. "Vyvanse is doing about as well as can be expected in a very crowded market," Searles says. "Its advantages are distinct but subtle, and that can be a hard message to promote." To help boost uptake in the US, Shire signed a three-year co-promotion deal with GlaxoSmithKline in 2009, doubling its sales force capacity.

Shire also won approval in 2007 for Daytrana, a transdermal patch containing methylphenidate (the active ingredient in Concerta and Ritalin) for kids who can't take capsules. But Daytrana's launch has been a comedy of errors, mainly due to problems caused by poor manufacturing. In December, Shire was forced to recall batches for the eighth—yes, eighth—time in the drug's short life. Sales are a dismal $78 million, and scripts are falling.

In 2009, the strategy hit its stride. Last February, Shire bought the non-US rights to market UCB's methylphenidate, Equasym. The deal serves Shire's goal to go global, starting with the underdeveloped market in Europe, where ADHD had been viewed until recently with Old-World skepticism. "Europe is an emerging market as far as ADHD is concerned, but there's tremendous potential," says Cola.

Last November, Shire launched its only truly novel ADHD offering, Intuniv, a nonstimulant for children in whom first-line stimulants fail or who are diagnosed with so-called oppositional defiant disorder. An XR version of an generic anti-hypertensive. Intuniv is poised to seize the niche that Strattera, another ADHD nonstimulant, has lost due to safety concerns.

Yet certain Shire tactics struck critics as less than entirely savory. Prior to the Vyvanse launch, the company raised the price of Adderall XR by 20 percent, a not-so-subtle attempt to prompt a wholesale switch to the newer and cheaper product. "This was not especially successful," says Searles. "Physicians were critical. And it turns out that 60 percent of all Vyvanse scrips are coming from non-Adderall patients." The tactic's failure may be a blessing in disguise: promoting the two drugs as essentially interchangeable threatened to undermine Vyvanse's value proposition.

In September, Shire was issued a subpoena by federal investigators looking into improper promotion of its three ADHD drugs, including free coupons for Vyvanse available on the web and in retail pharmacies. Russell's reply? "We are a very regulated industry and it is becoming normal practice that from time to time companies of our size or bigger have inquiries from the government." (Numerous pharma bloggers commented with dismay at what they viewed as the CEO's shrugging "everybody does it" response.)

Shire's future plans for its ADHD franchise appear to focus on global growth. There are no novel compounds in its pipeline. Innovations in the field will most likely come from nonstimulants with stimulant-level efficacy, says Decision Resources' Searles, and cognitive enhancement treatments also may be in the offing. Mike Cola hinted that Shire is investigating the potential of Vyvanse as a cognitive enhancer for ADHD and Alzheimer's.


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