Copy of Copy of King of CNS, Always Imitated
Although several big pharmaceutical companies have their own blockbuster products, when it comes to the most prominent players in the CNS (Central Nervous System) field, the clear leader is undoubtedly Lundbeck, the Danish pharmaceutical company. Its products are also widely imitated by many companies both domestically and internationally.
In 2023, Lundbeck achieved sales of 19.9 billion Danish krone (roughly equivalent to RMB), a year-on-year growth of 8% based on fixed exchange rates. For 2024, the company expects sales to grow by 7%-10%, though the actual performance could exceed this. As of the first three quarters of 2024, Lundbeck's revenue reached nearly 16.5 billion Danish krone, showing a 13% year-on-year increase.
Seventy-four percent of this revenue comes from four key strategic brands:
These four brands contributed a 21% year-on-year revenue increase for the first three quarters of 2024, with particularly strong performance in the U.S. market. Additionally, older products like Cipralex/Lexapro (escitalopram), primarily used in China, accounted for 10% of the revenue. However, due to the impact of generic competition globally, their growth has stagnated. Other mature products are in a state of decline and are no longer highlighted separately.
1. Rexulti (Brexpiprazole)
Brexpiprazole, the company's leading product, contributed DKK 3.806 billion in the first three quarters of 2024, accounting for 23% of Lundbeck's total revenue, with a 16% year-on-year increase. The U.S. is the largest market, with demand continuing to grow. Other major markets include Brazil and Canada.
Brexpiprazole was originally developed by Otsuka Pharmaceutical and later jointly developed with Lundbeck. It is a third-generation antipsychotic drug, acting as a partial agonist at serotonin 5-HT1A receptors and dopamine D2 and D3 receptors, while being a partial antagonist at serotonin 5-HT2A and 5-HT2B receptors, as well as adrenergic α-1 and α-2 receptors.
In 2015, the U.S. FDA approved brexpiprazole for the adjunctive treatment of major depressive disorder (MDD) and schizophrenia. In May 2023, the FDA further approved it for agitation associated with Alzheimer's disease (AADAD). Although Alzheimer's drugs can only slow disease progression, alleviating related symptoms and improving quality of life is crucial.
Agitation is a common symptom in Alzheimer's patients, affecting about half of those with the condition. Since receiving FDA approval for this indication in April 2023, prescriptions for this use have increased by 361%, while prescriptions for other indications grew by only 15%.
In April 2024, the FDA also accepted an application for brexpiprazole in combination with sertraline for the treatment of post-traumatic stress disorder (PTSD), another significant indication.
Given its potential, brexpiprazole has become a target for generic drug companies, including those in China. In June 2024, brexpiprazole tablets were approved in China for schizophrenia. Remarkably, in less than six months, 20 companies had submitted applications for generic versions, including new formulations like orally disintegrating tablets and films.
There are three key reasons for this:
2. Brintellix/Trintellix (Vortioxetine)
Brintellix/Trintellix is an antidepressant developed by Lundbeck in collaboration with Takeda. It enhances the action of serotonin in the CNS, a neurotransmitter involved in anxiety regulation, which helps alleviate symptoms of anxiety.
In the first three quarters of 2024, vortioxetine generated DKK 3.576 billion in sales, a 14% year-on-year increase, slightly behind brexpiprazole. The main contributors to sales were the U.S., Spain, Italy, and Japan.
Approved for import into China in 2017, vortioxetine’s compound patent expired in October 2022, though multiple generic versions were approved starting in 2021. However, the patent on its crystalline form is still valid until 2027. Domestic companies have challenged the crystalline form patent, with some successfully bypassing it. As a result, the time for the original product to maintain exclusivity in China is limited.
3. Abilify LAI (Aripiprazole Long-Acting Injection)
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Abilify, a classic example of lifecycle management, has been developed into various formulations, including oral tablets, long-acting injectables, and the more recent large-dose long-acting injections, aimed at improving patient compliance.
In 2024, sales from the long-acting injectable series reached DKK 2.618 billion in the first three quarters, showing a 10% increase. The series was expanded with new formulations like the 960mg dose, approved by the FDA and EMA in 2023 and 2024, respectively, for the maintenance treatment of schizophrenia and bipolar I disorder.
Like brexpiprazole and vortioxetine, aripiprazole is facing generic competition, but the expanded product range has helped prolong its market presence.
4. Vyepti (Eptinezumab)
Vyepti, a CGRP monoclonal antibody for migraine prevention, is Lundbeck’s first monoclonal antibody. It was approved by the U.S. FDA in February 2020.
Sales for Vyepti reached DKK 2.116 billion in the first three quarters of 2024, a 76% year-on-year growth, quickly closing in on Abilify LAI in terms of revenue. The patent for Vyepti still has 13 years of protection.
Lundbeck is speeding up Vyepti's entry into China. In 2023, it was approved for use in a medical trial at a hospital in Hainan, and by 2024, it began expanding in the Greater Bay Area. Clinical trials targeting Asian populations, such as the SUNRISE study, are also underway, with plans to submit for approval in China, Japan, and Korea by the end of 2025.
In addition to Vyepti, Lundbeck is also investigating new migraine treatments, including drugs targeting different signaling pathways and mechanisms, such as the PACAP (pituitary adenylate cyclase-activating polypeptide) receptor, with the goal of improving treatment outcomes for the 40-70% of patients who do not benefit sufficiently from current CGRP-targeting therapies.
Lundbeck has expanded its research beyond traditional CNS indications (depression, schizophrenia, Alzheimer's, and Parkinson’s) to focus on new biological mechanisms such as:
This strategic shift aligns with the growing scientific breakthroughs in neurology, driven by advancements in technology, medicine, and drug regulations. New drug modalities, biomarkers, and regulatory innovations are creating new opportunities for treating neurological disorders, placing Lundbeck at the forefront in Europe and the U.S.
Acquisitions and New Developments
In October 2024, Lundbeck acquired Longboard for $2.6 billion to obtain a selective 5HT2c agonist, bexicaserin, which has shown potential in treating developmental and epileptic encephalopathies (DEE). Clinical trials for bexicaserin are progressing, with plans to file for approval in 2028 and peak sales estimated at $1.5-2 billion.
Lundbeck is also working on innovative treatments for Parkinson’s disease and other neurodegenerative diseases like Multiple System Atrophy (MSA). In collaboration with Genmab, the company is developing Amlenetug (Lu AF82422), a monoclonal antibody targeting α-synuclein C-terminus, which has shown promise in delaying clinical progression by 27%.
Lundbeck's investment in external acquisitions and strategic collaborations has contributed to the development of its current pipeline, which includes multiple assets with the potential to address unmet medical needs in CNS and neurological diseases.
In summary, Lundbeck's success in the CNS field can be attributed to a combination of groundbreaking research, effective lifecycle management, strategic acquisitions, and a proactive approach to maintaining its market leadership amidst the growing competition from generic drugs.