Alkermes Boasts Strong Portfolio and Impressive Pipeline
We issued an updated research report on Alkermes plc. ALKS on Oct 16.
Alkermes’ revenues are being driven by its proprietary products, Vivitrol and Aristada, and five partnered products — Risperdal Consta, Invega Sustenna/Xeplion, Invega Trinza/Trevicta, Ampyra/Fampyra and Bydureon. We expect these products to continue contributing to the company’s top-line growth in the coming quarters.
Aristada is growing impressively in a long-acting injectable (LAI) market. The United States LAI market could cross $4 billion in 2020. The company expects Aristada net sales to double to $140-$160 million in 2018.
On Jul 2, the FDA approved Aristada Initio extended-release product for the treatment of schizophrenia in adults. The approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day one, which plays a significant role to treat a complex disease like schizophrenia.
The company’s progress with pipeline candidates targeting major CNS disorders, such as schizophrenia, addiction, depression and multiple sclerosis, has been impressive. An important pipeline candidate is ALKS 5461, being developed for the treatment of major depressive disorder (MDD). On Apr 16, the FDA accepted for review the new drug application (NDA) for ALKS 5461. The FDA had initially issued a Refusal to File letter on Mar 30 for the candidate, stating that the NDA did not have enough evidence for the oral medication to work. The FDA suggested that additional studies might be required to demonstrate the drug’s overall effectiveness for the proposed indication. The FDA has set an action date of Jan 31, 2019.
Another interesting candidate is ALKS 3831, which is in phase III for the treatment of schizophrenia. Top-line data is expected in the fourth quarter of 2018 and if the study is positive, the company expects to submit the NDA in the first half of 2019. The candidate is also in a phase I metabolic study to assess its effects on insulin sensitivity, lipid metabolism and other important metabolic parameters compared with Eli Lilly and Company’s LLY Zyprxa.
In September 2018, Alkermes announced that it has expanded its ongoing phase I study for ALKS 4230, an immuno-oncology drug candidate, to evaluate its safety and anti-tumor activity when administered in combination with Merck & CO.’s MRK PD-1 inhibitor Keytruda (pembrolizumab) in patients with advanced solid tumors.
BIIB098 (initially known as ALKS 8700) is being developed in collaboration with Biogen Inc. BIIB to treat relapsing forms of multiple sclerosis (MS). Alkermes expects to submit a new drug application (NDA) for BIIB098 to the FDA later in 2018. Alkermes may also receive a $150-million milestone payment from Biogen upon the FDA approval of the NDA for BIIB098, on or before Dec 31, 2021.
Successful development and subsequent commercialization of these candidates would be a huge boost for the company.
However, Alkermes is highly dependent on manufacturing and/or royalty revenues.
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