It's show me time

The pregnant question of the moment is: What's next? CEO Wiinberg calls the erosion of the big anti-depressant franchise around Cipralex/Lexapro a natural development in the product cycle, one that management has been anticipating for some time. Vortioxetene, a potentially winning replacement for Cipralex/Lexapro, is poised and ready for regulatory approval in key markets. Last month, the company filed an application with the European Medicines Agency, noting that vortioxetene is the first filing of a novel anti-depressant in Europe since 2007. Overall, the company claims a fairly full pipeline, enough for Wiinberg to make the pledge to analysts that by 2015 one half of worldwide revenues will come from new products—in other words, filling the gap left by the fading market leader.

In presentations to analysts, management touts three drugs that, in addition to vortioxetene, it sees as real breakthroughs: Selincro, designed to treat alcohol dependence and destined to be marketed in Europe; Treanda, in-licensed from Cephalon/Teva for treatment of chronic lymphocytic leukemia, to be marketed only in Latin America and Canada; and aripiprazole depot, a once-monthly injectible version of the Otsuka drug Abilify, to treat schizophrenia. Together, and assuming appropriate regulatory approvals over the next 18 months, the drugs carry a potential revenue stream of nearly $2 billion, or more than enough to replenish the base lost to generic competition. There is also a diamond in the rough: AE58054, a drug candidate specifically aimed at cognition repair among Alzheimers patients, has completed Phase II trials and could advance the state of care by slowing basic skills deterioration. Lundbeck is considering partners to move this compound forward.

What analysts refer to as a "promising" pipeline is in some ways the surround sound for a much bigger agenda. As the Japanese industry well knows, good science and promising drugs do not by themselves spin profits. Resources, expertise and geographical reach are necessary to avoid having to share the bounty with others that already possess the scale to compete. The implicit desire of any middle-size company is to grow enough to partner on the basis of choice, not necessity. To shed the burden of dependence and— literally—have it all.

In deciding to move up, Lundbeck is moving in—on the big prize, the tough US market. As the industry becomes more global, it is apparent that no enterprise with aspirations to be global can succeed without carving out a strong presence here in the United States. The intense competition in the home base of the industry's biggest companies acts as a training ground for operational excellence; you learn from a process of Darwinian selection that separates the strong from the weak. CEO Wiinberg notes that the real value of being in the US market is the breadth and richness of the contacts. "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 there."

Peter Anastasiou, Lundbeck USA's vice president and general manager for psychiatry, states it simply to Pharm Exec. "The destination for future growth in most other pharma companies is China, India—the emerging country markets. Our emerging market is the United States." And there are two therapeutic platforms where Lundbeck USA is vying for market leadership: specialty neurology products, with an adapted portfolio of difficult-to-treat epilepsy products as well as for rare hereditary conditions like Huntington's disease; and psychiatry practice medicines, including novel next generation anti-depressants and anti-psychotics for schizophrenia.