Raising the Stakes in CNS - Pharmaceutical Executive


Raising the Stakes in CNS

Pharmaceutical Executive

Laddering up to commercialization

As a mid-sized specialty firm with a rare diseases business and a recently added regenerative medicine unit—the latter of which Jonas also serves as SVP, R&D—Shire can't succeed through brute force, says Jonas. "We're not going to give sales reps data and just hope they can make a market. They have to have real data, comparator data, that's how a specialty model thrives." Generating so-called "real" data can be a problem in CNS, particularly at the earliest stages, which is one of the reasons that Jonas is happy to stay out of the discovery game with Shire. "People use these animal models that really aren't relevant to beings with frontal lobes and cortexes...the models are anthropomorphized," says Jonas. "I don't know when a rat is really sad. Is not running on a wheel sad? I don't know." Jonas believes that CNS is a pragmatist's game, and it's an incrementalist market for treatment of depression. The way forward in depression will be to focus on treatments for patients that don't respond to currently available products; Vyvanse is being studied as an adjunctive therapy. "You'll see new antidepressants get launched. Will they be fully differentiated? No. Will they do fine? Yeah. But we're not interested in the brute force model," says Jonas, adding that data requirements for making promotional claims will force the sales model to evolve. In the first quarter of 2012, Intuniv (guanfacine), Shire's third best-selling ADHD drug (behind Vyvanse and Adderall XR, respectively) increased its sales by 54 percent compared with first quarter of 2012, a development Angus Russell, on an earnings call, attributed to "new consumer marketing campaigns" and an expanded approval last year for use as an adjunctive therapy in combination with a stimulant.

In addition to Shire's patient marketing efforts in ADHD (which currently involve a retired Philadelphia Phillies outfielder, and a pop/rock singer), there's "a group of non-promotional sales reps who are not compensated by sales but are actually more geared toward disease state," says Jonas. Shire is also "growing our medical science liaison (MSL) organization in Europe, to prepare to work with European thought leaders around launching" Vyvanse. The company has an in-house program in the works called "virtual MSL" that "will allow MSLs to be available for questions any time, 24/7," says Jonas. Offering up the obligatory comment with respect to selling medicines in Europe, Jonas says companies "have to pay attention to reimbursement strategies because it's almost like you have two parallel paths you must follow to get the drug on the market, the regulatory and the pricing."

Steinberg says that Europe "seems finally ready for the ADHD market to take hold, and who's better in ADHD than Shire?" Global expansion is an important strategic initiative at Shire, and last November the company announced a partnership with Shionogi to "co-develop and co-commercialize certain of Shire's ADHD medicines in Japan," but the specifics of the deal were not disclosed. Shire's last co-promote deal on Vyvanse ended badly. The three-year agreement struck in 2009 with GlaxoSmithKline was an attempt to expand Vyvanse's reach to US primary care docs, but it fizzled in September of 2010, after sales goals were not achieved, and no payment was made (or was due, per the agreement), to GSK.

Interestingly, Shire's decision to go for a binge eating indication would most likely require additional sales reps, per Steinberg and probably the muscle of a large pharmaceutical company. Shire says binge eating patients are the province of psychiatrists, and they have that covered if the indication is approved. There are no currently approved treatments for binge eating, and primary care docs would presumably be making most of the diagnoses. Jonas is very bullish on a binge eating indication, but says he'll live or die by the data results. "I think it's a major opportunity. The patients are well-defined, and the pharmacoeconomics will be good, so I'm very excited about it, if the study is positive....I think it's an opportunity that might dwarf almost everything else we're doing, in terms of value and in terms of time to market." For a diagnosis of binge eating disorder to be made, a patient must experience binges for two days per week for a minimum of six months.

Jonas says Shire has built up its health economics group and its assessments group in recent years, and new talent has been brought in, and talent has departed. On the latter point, Michael Cola, president of specialty pharmaceuticals, announced his resignation at the end of March. But the biggest cultural shift since Jonas came on board has been "the acknowledgement of how you take risk and how you stop projects as well as keep them going when they're successful."


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