Filling the specialty gap
It’s hard to compete for a global asset if you have no presence to tap the innovations that come from all the scientists,
thought leaders, entrepreneurs, and dealmakers who make their home in the United States. — Ulf Wiinberg
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Lundbeck is choosing its US growth targets carefully, with an emphasis on specialty niches in neurology and psychiatry while
relying on its marketing partners—including Takeda and Otsuka—to cover high-cost forays into the primary care space, where
big sales forces are a prerequisite for doing business. Since the Ovation takeover, Lundbeck has doubled the size of its neurology
sales force and is recruiting highly experienced detailers who know the disease profiles enough to build long-lasting relationships
with key prescriber physicians. "We want community builders—experienced sales professionals with the technical knowledge to
liaise with specialist physicians, but who are also able to bring awareness of CNS diseases forward to the patient organizations
and care givers," said Dan Brennan.
At the same time, Lundbeck is creating a psychiatry sales force from scratch to prepare for a number of important product
launches in the next 18 months. The centerpiece is vortioxetene, the highly-touted successor to Lexapro, with a new mode of
action that will give clinicians additional options in treating patients who have cycled through existing treatment options
such as SSRIs. The compound is part of the alliance with Takeda, which, if the drug is approved, will assume the major role
in marketing and promoting it among GPs. Lundbeck will focus on specialist prescribing. And the point man for this effort
is VP for US psychiatry Peter Anastasiou. "We're creating that sales force as we speak. All of our recruits must have demonstrated
prior success in CNS. More important, we are pursuing a much more interactive, relationship-driven, needs-oriented and highly
specialized sales model where we provide solutions to help our customers. It's not going to be a role that involves just showing
up to deliver three message points and some literature."
Vortioxetene has completed Phase III testing and the companies hope to file an NDA with the FDA before the end of this year.
Other targets being pursued for the US market include the aripiprazone depot formulation, which is being developed jointly
with Otsuka and is now awaiting final FDA action pending resolution of some manufacturing challenges with a third party supplier
of sterile water identified by the agency. Two additional prospects are desmoteplase, a compound designed to significantly
extend the time window for remedial treatment of stroke; and LUAE58054, the Alzheimers cognition treatment that the company
is considering for possible partnership support.
Prising out pitfalls
Creating a viable, permanent business in the world's most competitive market is no simple task—and, as the experience of other
foreign newcomers has shown, success in the United States is never earned overnight. In fact, Lundbeck faces a number of early
wake up calls, including filling the short-term revenue gap from the LOE on Lexapro and digging roots for the future by securing
timely registration of the new products that will cement its reputation among activist patients and a notoriously insular
circle of prescribers. Both tasks depend heavily on forging new relationships and elbowing into turf that Big Pharma rivals
have been cultivating for decades.
The US promotional environment is also changing at warp speed. Tactics used to woo customers in the past—such as the sponsorship
of professional medical conferences, which are particularly important in the complex CNS space—are now either discouraged
or illegal. "Creating a product message that resonates is more challenging than ever because there is so much new regulation
coupled with endless 'white noise' competition," observes Pharm Exec advisory board member Al Topin, who leads his own marketing agency. "Resources are important. New, mid-sized contenders like
Lundbeck must work that much harder to differentiate themselves from all the alternatives available to payers and patients."
Further on that score, the company had to overcome a potentially damaging reputational hit linked to a Federal Trade Commission
claim of anti-competitive pricing on products acquired through the purchase of Ovation – a case Lundbeck won in district court
and on appeal.
Yet in a bigger world that astounds with complexity, there is much virtue in simplicity. According to CEO Wiinberg, Lundbeck
will prevail because its mission is simple, with all assets pointed in one direction. "We began as a European company; have
become an international company; and now aim to be global, with a permanent presence in the United States and diseases of
the brain as our focus." Watch and wait—the Danes are here.
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